Empowering Patients to Participate in Health Care Decisions

Rehabilitation Clinical Trial

Official title:

Empowering Patients With Long-term Impaired Work Ability to Participate in Health Related Decisions

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04254367
• Other study ID #: Learn-to-Cope
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 14, 2020
• Est. completion date: June 30, 2023

Study information

• Verified date: September 2022
• Source: Vastra Gotaland Region
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study aims to evaluate whether an intervention with patient education in study circles, aiming to empower patients to participate in health care an rehabilitation by increasing health literacy and sense of coherence, may have a causal effect on perceived health, ability and function as well as independence and quality of life for patients with long-term health-related disabilities and passive coping strategies.

Description:

Chronic poor health and impaired work ability entails both personal suffering and considerable social costs. Poverty, homelessness, difficulties to handle complex issues, and maltreatment may affect health outcomes in the long run. Both sense of coherence (SOC) and the ability to understand health-related information (health literacy) influences personal coping strategies and thus the motivation to participate in health care and rehabilitation, which is known to have a positive impact on health outcome. The purpose of this study is to evaluate whether an intervention with patient education in study circles, aiming to empower patients to participate in health care and rehabilitation by increasing health literacy and sense of coherence, may have a causal effect on perceived health, ability and function as well as independence and quality of life for patients with long-term health-related disabilities and passive coping strategies. The study design is a cluster randomized controlled study comparing the intervention in addition to treatment as usual (TAU) with TAU. Follow-up is performed with validated questionnaires after 3, 6 and 12 months. Primary outcome is net inactivity days (net days without employment or rehabilitation) and secondary outcome variables are the number of net and gross days with sick leave during the follow-up period, sense of coherence, health literacy, health-related quality of life, confidence in own problem solving ability, work ability and work satisfaction, social function and health habits, symptoms of depression, anxiety, and exhaustion as well as pain and catastrophization. Randomization will be performed at Primary Care Center (PCC) level. Around 30 Primary Care Centers and 400 patients will be included in the study. The intervention consists of patient education with study circles meeting half a day per week for eight following weeks. The study is expected to show whether patient education in study circles aiming to increase health literacy and sense of coherence has a causal effect on perceived health, ability and function, independence and quality of life for patients with long-term health-related disabilities and passive coping strategies compared to TAU.

The research subjects will answer all questionnaires in a web based tool approved for storing research data, esMaker (Entergate AB) on their mobile phone, iPad or computer. Individual web links to the questionnaires will be distributed via e-mail. Research subject identity is replaced with individual codes in esMaker. The research assistant will be in charge of the CodeKey and responsible for distributing the web links and for reminding the research subjects to fill in the questionnaires.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 400
• Est. completion date: June 30, 2023
• Est. primary completion date: March 14, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

Inclusion Criteria:

Patients attending primary care centers included in the study.

• Aged 18-64 years

• Health-related impaired work ability > 60 net days last 6 months

Exclusion Criteria:• Acute crisis

• Serious mental disorder needing psychiatric specialist care

• Serious somatic disease a definite barrier to rehabilitation for a foreseeable future

• Cognitive impairment or not speaking /understanding Swedish

Related Conditions & MeSH terms

• Rehabilitation

Intervention

Behavioral:
• Learn-to-Cope
Patient education in study circles, aiming to empower patients to participate in health care and rehabilitation by increasing health literacy and sense of coherence. The study circles will meet half a day each week for eight following weeks.

Locations

Country	Name	City	State
Sweden	Dominique Hange	Gothenburg	Region Vastra Gotaland

Sponsors (2)

Lead Sponsor	Collaborator
Vastra Gotaland Region	Göteborg University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Net days with sceduled activity	What is the effect of interactive patient education in supervised study groups on net days with scheduled activity in patients of working age with long-term health-related work impairment (measured as change in net days with work / scheduled work preparatory rehabilitation (unemployed) / scheduled work preparatory rehabilitation during sick leave (on sick leave) from baseline to 6 months after baseline).	Change from base-line net days with scedulded activity at 6 months
Secondary	Net days with sceduled activity	What is the effect of interactive patient education in supervised study groups on net days with scheduled activity in patients of working age with long-term health-related work impairment (measured as change in net days with work / scheduled work preparatory rehabilitation (unemployed) / scheduled work preparatory rehabilitation during sick leave (on sick leave) from baseline to 3 months after baseline).	Change from base-line net days with scedulded activity at 3 months
Secondary	Net days with sceduled activity	What is the effect of interactive patient education in supervised study groups on net days with scheduled activity in patients of working age with long-term health-related work impairment (measured as change in net days with work / scheduled work preparatory rehabilitation (unemployed) / scheduled work preparatory rehabilitation during sick leave (on sick leave) from baseline to 12 months after baseline).	Change from base-line net days with scedulded activity at 12 months
Secondary	Health-related quality of life	What is the effect of interactive patient education in supervised study groups on participants' health-related quality of life (measured by change in scores in EQ-5D from baseline to 3 months after baseline). The EQ-5D-3L descriptive system comprises the following five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results into a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.	Change from base-line scores EQ-5D at 3 months
Secondary	Health-related quality of life	What is the effect of interactive patient education in supervised study groups on participants' health-related quality of life (measured by change in scores in EQ-5D from baseline to 6 months after baseline). The EQ-5D-3L descriptive system comprises the following five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results into a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.	Change from base-line scores EQ-5D at 6 months
Secondary	Health-related quality of life	What is the effect of interactive patient education in supervised study groups on participants' health-related quality of life (measured by change in scores in EQ-5D from baseline to 12 months after baseline). The EQ-5D-3L descriptive system comprises the following five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results into a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.	Change from base-line scores EQ-5D at 12 months
Secondary	Sense of coherence (SOC)	What is the effect of interactive patient education in supervised study groups on the participants' sense of coherence (measured by changes in scores in SOC-13 scale in Swedish9 from baseline to 3 months after baseline). Antonovsky developed the 29 item Orientation to Life Questionnaire to measure the sense of coherence, having 11 items measuring comprehensibility, 10 items measuring manageability, and 8 items measuring meaningfulness. The response alternatives are a semantic scale of 1 point to 7 points. The questionnaire yields a summed score with a range from 29 to 203. A shorter version of 13 questions of the original form was developed by Antonovsky, where the score ranges between 13 and 91 points,	Change from base-line scores SOC-13 scale at 3 months
Secondary	Sense of coherence (SOC)	What is the effect of interactive patient education in supervised study groups on the participants' sense of coherence (measured by changes in scores in SOC-13 scale in Swedish9 from baseline to 6 months after baseline). Antonovsky developed the 29 item Orientation to Life Questionnaire to measure the sense of coherence, having 11 items measuring comprehensibility, 10 items measuring manageability, and 8 items measuring meaningfulness. The response alternatives are a semantic scale of 1 point to 7 points. The questionnaire yields a summed score with a range from 29 to 203. A shorter version of 13 questions of the original form was developed by Antonovsky, where the score ranges between 13 and 91 points,	Change from base-line scores SOC-13 scale at 6 months
Secondary	Sense of coherence (SOC)	What is the effect of interactive patient education in supervised study groups on the participants' sense of coherence (measured by changes in scores in SOC-13 scale in Swedish9 from baseline to 12 months after baseline). Antonovsky developed the 29 item Orientation to Life Questionnaire to measure the sense of coherence, having 11 items measuring comprehensibility, 10 items measuring manageability, and 8 items measuring meaningfulness. The response alternatives are a semantic scale of 1 point to 7 points. The questionnaire yields a summed score with a range from 29 to 203. A shorter version of 13 questions of the original form was developed by Antonovsky, where the score ranges between 13 and 91 points,	Change from base-line scores SOC-13 scale at 12 months
Secondary	Health literacy	What is the effect of interactive patient education in supervised study groups on participants' health literacy (measured by change in scores in HLS-EU-Q16-SE from baseline to 3 months after baseline). The instrument consists of 16 items focusing on four HL dimensions reflecting perceived ease or difficulty in an individual's ability to access/obtain health information, understand health information (not only in written form), process/appraise health information, and apply/use health information. More specifically, the 16 items include perceived skills for understanding health information, where to seek consultation and health information on prevention, early detection, and health care, health warnings, advice given by family and friends, how to seek a second opinion, and how to apply advice given by care providers. Response options include "very easy," "easy," "difficult," and "very difficult."	Change from base-line scores HLS-EU-Q16-SE scale at 3 months
Secondary	Health literacy	What is the effect of interactive patient education in supervised study groups on participants' health literacy (measured by change in scores in HLS-EU-Q16-SE from baseline to 6 months after baseline). The instrument consists of 16 items focusing on four HL dimensions reflecting perceived ease or difficulty in an individual's ability to access/obtain health information, understand health information (not only in written form), process/appraise health information, and apply/use health information. More specifically, the 16 items include perceived skills for understanding health information, where to seek consultation and health information on prevention, early detection, and health care, health warnings, advice given by family and friends, how to seek a second opinion, and how to apply advice given by care providers. Response options include "very easy," "easy," "difficult," and "very difficult."	Change from base-line scores HLS-EU-Q16-SE scale at 6 months
Secondary	Health literacy	What is the effect of interactive patient education in supervised study groups on participants' health literacy (measured by change in scores in HLS-EU-Q16-SE from baseline to 12 months after baseline). The instrument consists of 16 items focusing on four HL dimensions reflecting perceived ease or difficulty in an individual's ability to access/obtain health information, understand health information (not only in written form), process/appraise health information, and apply/use health information. More specifically, the 16 items include perceived skills for understanding health information, where to seek consultation and health information on prevention, early detection, and health care, health warnings, advice given by family and friends, how to seek a second opinion, and how to apply advice given by care providers. Response options include "very easy," "easy," "difficult," and "very difficult."	Change from base-line scores HLS-EU-Q16-SE scale at 12 months
Secondary	General self-efficacy	What is the effect of interactive patient education in supervised study groups on participants' general self-efficacy (measured as change in scores in S-GSE from baseline to 3 months after baseline). About: This scale is a self-report measure of self-efficacy.; Items: 10 Reliability: Internal reliability for GSE = Cronbach's alphas between .76 and .90; Validity: The General Self-Efficacy Scale is correlated to emotion, optimism, work satisfaction. Negative coefficients were found for depression, stress, health complaints, burnout, and anxiety.; Scoring: All questions 1 2 3 4 The total score is calculated by finding the sum of the all items. For the GSE, the total score ranges between 10 and 40, with a higher score indicating more self-efficacy.	Change from base-line scores S-GSE scale at 3 months
Secondary	General self-efficacy	What is the effect of interactive patient education in supervised study groups on participants' general self-efficacy (measured as change in scores in S-GSE from baseline to 6 months after baseline). About: This scale is a self-report measure of self-efficacy.; Items: 10 Reliability: Internal reliability for GSE = Cronbach's alphas between .76 and .90; Validity: The General Self-Efficacy Scale is correlated to emotion, optimism, work satisfaction. Negative coefficients were found for depression, stress, health complaints, burnout, and anxiety.; Scoring: All questions 1 2 3 4 The total score is calculated by finding the sum of the all items. For the GSE, the total score ranges between 10 and 40, with a higher score indicating more self-efficacy.	Change from base-line scores S-GSE scale at 6 months
Secondary	General self-efficacy	What is the effect of interactive patient education in supervised study groups on participants' general self-efficacy (measured as change in scores in S-GSE from baseline to 12 months after baseline). About: This scale is a self-report measure of self-efficacy.; Items: 10 Reliability: Internal reliability for GSE = Cronbach's alphas between .76 and .90; Validity: The General Self-Efficacy Scale is correlated to emotion, optimism, work satisfaction. Negative coefficients were found for depression, stress, health complaints, burnout, and anxiety.; Scoring: All questions 1 2 3 4 The total score is calculated by finding the sum of the all items. For the GSE, the total score ranges between 10 and 40, with a higher score indicating more self-efficacy.	Change from base-line scores S-GSE scale at 12 months
Secondary	Social function	What is the effect of interactive patient education in supervised study groups on participants' social function (measured as change in scores in the two questions used in the sub scale "Social function" of RAND-36 from baseline to 3 months after baseline). The RAND 36-Item Health Survey laps eight concepts: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. It also includes a single item that provides an indication of perceived change in health. Scoring the RAND 36-Item Health Survey is a two-step process. First, precoded numeric values are recoded per the scoring key. Note that all items are scored so that a high score defines a more favourable health state.	Change from base-line scores sub scale "Social function" of RAND-36 at 3 months
Secondary	Social function	What is the effect of interactive patient education in supervised study groups on participants' social function (measured as change in scores in the two questions used in the sub scale "Social function" of RAND-36 from baseline to 6 months after baseline). The RAND 36-Item Health Survey (Version 1.0) laps eight concepts: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. It also includes a single item that provides an indication of perceived change in health. Scoring the RAND 36-Item Health Survey is a two-step process. First, precoded numeric values are recoded per the scoring key given. Note that all items are scored so that a high score defines a more favourable health state. I	Change from base-line scores sub scale "Social function" of RAND-36 at 6 months
Secondary	Social function	What is the effect of interactive patient education in supervised study groups on participants' social function (measured as change in scores in the two questions used in the sub scale "Social function" of RAND-36 from baseline to 12 months after baseline). The RAND 36-Item Health Survey (Version 1.0) laps eight concepts: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. It also includes a single item that provides an indication of perceived change in health. Scoring the RAND 36-Item Health Survey is a two-step process. First, precoded numeric values are recoded per the scoring key given. Note that all items are scored so that a high score defines a more favourable health state.	Change from base-line scores sub scale "Social function" of RAND-36 at 12 months
Secondary	Work ability	What is the effect of interactive patient education in supervised study groups on participants' work ability (measured as change in scores in WAI from baseline to 3 months after baseline). Work ability was measured by means of the Work Ability Index (WAI) which consists in a 7-part self-assessment: current ability, work ability in relation to physical and mental demands of the job, reported diagnosed diseases, estimated impairment due to health status, sick leave over the last 12 months, self-prognosis of work ability in the 2 years to come and mental resources of the individual. The WAI measured in this way ranges from 7 to 49 points and 4 categories have been suggested to describe WAI levels: poor (7-27), moderate (28-36), good (37-43) and excellent (44-49).	Change from base-line scores WAI scale at 3 months
Secondary	Work ability	What is the effect of interactive patient education in supervised study groups on participants' work ability (measured as change in scores in WAI from baseline to 6 months after baseline). Work ability was measured by means of the Work Ability Index (WAI) which consists in a 7-part self-assessment: current ability, work ability in relation to physical and mental demands of the job, reported diagnosed diseases, estimated impairment due to health status, sick leave over the last 12 months, self-prognosis of work ability in the 2 years to come and mental resources of the individual. The WAI measured in this way ranges from 7 to 49 points and 4 categories have been suggested to describe WAI levels: poor (7-27), moderate (28-36), good (37-43) and excellent (44-49).	Change from base-line scores WAI scale at 6 months
Secondary	Work ability	What is the effect of interactive patient education in supervised study groups on participants' work ability (measured as change in scores in WAI from baseline to 12 months after baseline). Work ability was measured by means of the Work Ability Index (WAI) which consists in a 7-part self-assessment: current ability, work ability in relation to physical and mental demands of the job, reported diagnosed diseases, estimated impairment due to health status, sick leave over the last 12 months, self-prognosis of work ability in the 2 years to come and mental resources of the individual. The WAI measured in this way ranges from 7 to 49 points and 4 categories have been suggested to describe WAI levels: poor (7-27), moderate (28-36), good (37-43) and excellent (44-49).	Change from base-line scores WAI scale at 12 months
Secondary	Job content	What is the effect of interactive patient education in supervised study groups on participants' job content (measured as change in score in Karasek Job Content Questionnaire from baseline to 3 months after baseline). Designed to measure scales assessing psychological demands, decision latitude, social support, physical demands, and job insecurity.	Change from base-line scores Karasek Job Content Questionnaire scale at 3 months
Secondary	Job content	What is the effect of interactive patient education in supervised study groups on participants' job content (measured as change in score in Karasek Job Content Questionnaire from baseline to 6 months after baseline). Designed to measure scales assessing psychological demands, decision latitude, social support, physical demands, and job insecurity.	Change from base-line scores Karasek Job Content Questionnaire scale at 6 months
Secondary	Job content	What is the effect of interactive patient education in supervised study groups on participants' job content (measured as change in score in Karasek Job Content Questionnaire from baseline to 12 months after baseline). Designed to measure scales assessing psychological demands, decision latitude, social support, physical demands, and job insecurity.	Change from base-line scores Karasek Job Content Questionnaire scale at 12 months
Secondary	Total number of net and gross sick leave days	What is the effect of interactive patient education in supervised study groups on the total number of net and gross sick leave days during the follow-up period (measured as change in measures defined by the Swedish Social Insurance Agency from baseline to 3 months after baseline).	Change from base-line total number of net and gross sick leave days at 3 months
Secondary	Total number of net and gross sick leave days	What is the effect of interactive patient education in supervised study groups on the total number of net and gross sick leave days during the follow-up period (measured as change in measures defined by the Swedish Social Insurance Agency from baseline to 6 months after baseline).	Change from base-line total number of net and gross sick leave days at 6 months
Secondary	Total number of net and gross sick leave days	What is the effect of interactive patient education in supervised study groups on the total number of net and gross sick leave days during the follow-up period (measured as change in measures defined by the Swedish Social Insurance Agency from baseline to 12 months after baseline).	Change from base-line total number of net and gross sick leave days at 12 months
Secondary	Physical activity	What is the effect of interactive patient education in supervised study groups on participants' level of physical activity (measured as change in time spent on physical activities during leisure time according to LTPAI from baseline to 3 months after baseline).	Change from base-line scores LTPA (level of physical activity) scale at 3 months
Secondary	Physical activity	What is the effect of interactive patient education in supervised study groups on participants' level of physical activity (measured as change in time spent on physical activities during leisure time according to LTPAI from baseline to 6 months after baseline).	Change from base-line scores LTPAI (level of physical activity) scale at 6 months
Secondary	Physical activity	What is the effect of interactive patient education in supervised study groups on participants' level of physical activity (measured as change in time spent on physical activities during leisure time according to LTPAI from baseline to 12 months after baseline).	Change from base-line scores LTPAI (level of physical activity) scale at 12 months
Secondary	BMI	What is the effect of interactive patient education in supervised study groups on participants' Body Mass Index, BMI (measured as change in BMI from baseline to 3 months after baseline).	Change from base-line scores BMI at 3 months
Secondary	BMI	What is the effect of interactive patient education in supervised study groups on participants' Body Mass Index, BMI (measured as change in BMI from baseline to 6 months after baseline).	Change from base-line scores BMI at 6 months
Secondary	BMI	What is the effect of interactive patient education in supervised study groups on participants' Body Mass Index, BMI (measured as change in BMI from baseline to 12 months after baseline).	Change from base-line scores BMI at 12 months
Secondary	Symptoms of depression	What is the effect of interactive patient education in supervised study groups on participants' symptoms of depression (measured as change in score in MADRS-S from baseline to 3 months after baseline).; Scale: 0 to 6 - normal/symptom absent 7 to 19 - mild depression 20 to 34 - moderate depression >34 - severe depression	Change from base-line scores MADRS-S scale at 3 months
Secondary	Symptoms of depression	What is the effect of interactive patient education in supervised study groups on participants' symptoms of depression (measured as change in score in MADRS-S from baseline to 6 months after baseline).; Scale: 0 to 6 - normal/symptom absent 7 to 19 - mild depression 20 to 34 - moderate depression >34 - severe depression	Change from base-line scores MADRS-S scale at 6 months
Secondary	Symptoms of depression	What is the effect of interactive patient education in supervised study groups on participants' symptoms of depression (measured as change in score in MADRS-S from baseline to 12 months after baseline).; Scale: 0 to 6 - normal/symptom absent 7 to 19 - mild depression 20 to 34 - moderate depression >34 - severe depression	Change from base-line scores MADRS-S scale at 12 months
Secondary	Symptoms of anxiety	What is the effect of interactive patient education in supervised study groups on participants' symptoms of anxiety (measured change in score in GAD-7 from baseline to 3 months after baseline).; Management Scores =10: Further assessment (including diagnostic interview and mental status examination) and/or referral to a mental health professional recommended.; Score Symptom Severity Comments 5-9 Mild Monitor 10*-14 Moderate Possible clinically significant condition >15 Severe Active treatment probably warranted	Change from base-line scores GAD-7 scale at 3 months
Secondary	Symptoms of anxiety	What is the effect of interactive patient education in supervised study groups on participants' symptoms of anxiety (measured change in score in GAD-7 from baseline to 6 months after baseline).; Score Symptom Severity Comments 5-9 Mild Monitor 10*-14 Moderate Possible clinically significant condition >15 Severe Active treatment probably warranted	Change from base-line scores GAD-7 scale at 6 months
Secondary	Symptoms of anxiety	What is the effect of interactive patient education in supervised study groups on participants' symptoms of anxiety (measured change in score in GAD-7 from baseline to 12 months after baseline).; Score Symptom Severity Comments 5-9 Mild Monitor 10*-14 Moderate Possible clinically significant condition >15 Severe Active treatment probably warranted	Change from base-line scores GAD-7 scale at 12 months
Secondary	Symptoms of exhaustion	What is the effect of interactive patient education in supervised study groups on participants' symptoms of exhaustion (measured as change in score in KEDS from baseline to 3 months after baseline). items; 9 items/symptoms Scoring 0-6/item Total 0-54; =/>19 p exhaustion	Change from base-line scores KEDS scale at 3 months
Secondary	Symptoms of exhaustion	What is the effect of interactive patient education in supervised study groups on participants' symptoms of exhaustion (measured as change in score in KEDS from baseline to 6 months after baseline).; 9 items/symptoms Scoring 0-6/item Total 0-54; =/>19 p exhaustion	Change from base-line scores KEDS scale at 6 months
Secondary	Symptoms of exhaustion	What is the effect of interactive patient education in supervised study groups on participants' symptoms of exhaustion (measured as change in score in KEDS from baseline to 12 months after baseline).; 9 items/symptoms Scoring 0-6/item Total 0-54; =/>19 p exhaustion	Change from base-line scores KEDS scale at 12 months
Secondary	Pain catastrophizing	What is the effect of interactive patient education in supervised study groups on participant pain catastrophizing (measured as change in score in PCS from baseline to 3 months after baseline).; 13 items Degree 0 - not at all; - to a slight degree; - to a moderate degree; - to a great degree; - all the time	Change from base-line scores pain catastrophizing scale at 3 months
Secondary	Pain catastrophizing	What is the effect of interactive patient education in supervised study groups on participant pain catastrophizing (measured as change in score in PCS from baseline to 6 months after baseline).; 13 items Degree 0 - not at all; - to a slight degree; - to a moderate degree; - to a great degree; - all the time	Change from base-line scores pain catastrophizing scale at 6 months
Secondary	Pain catastrophizing	What is the effect of interactive patient education in supervised study groups on participant pain catastrophizing (measured as change in score in PCS from baseline to 12 months after baseline).; 13 items Degree 0 - not at all; - to a slight degree; - to a moderate degree; - to a great degree; - all the time	Change from base-line scores pain catastrophizing scale at 12 months
Secondary	Participant pain	What is the effect of interactive patient education in supervised study groups on participant pain (measured as change in score in OMPSQ from baseline to 3 months after baseline). A higher score indicates a higher disability. Maximum score is 210 points; a score of < 105 points indicates a low disability, that between 105 and 130 points indicates a moderate disability and that > 130 points indicates a high disability	Change from base-line scores OMPSQ scale at 3 months
Secondary	Participant pain	What is the effect of interactive patient education in supervised study groups on participant pain (measured as change in score in OMPSQ from baseline to 6 months after baseline).; Maximum score is 210 points; a score of < 105 points indicates a low disability, that between 105 and 130 points indicates a moderate disability and that > 130 points indicates a high disability	Change from base-line scores OMPSQ scale at 6 months
Secondary	Participant pain	What is the effect of interactive patient education in supervised study groups on participant pain (measured as change in score in OMPSQ from baseline to 12 months after baseline).; Maximum score is 210 points; a score of < 105 points indicates a low disability, that between 105 and 130 points indicates a moderate disability and that > 130 points indicates a high disability	Change from base-line scores OMPSQ scale at 12 months
Secondary	Pain spreading	What is the effect of interactive patient education in supervised study groups on participant pain spreading (measured as change in number of painful body regions from baseline to 3 months after baseline). The diagram documents pain in 19 anatomic areas. Based on the distribution of the anatomic areas, we established six different body regions. Generalized linear regression was used to evaluate the association between the number of painful nonindex body regions (categorized as 0; 1-2; or 3-6) with our measures of interest. Participants reporting no body pain, low (1-2 regions) and high (= 3 regions).	Change from base-line scores in number of painful body regions at 3 months
Secondary	Pain spreading	What is the effect of interactive patient education in supervised study groups on participant pain spreading (measured as change in number of painful body regions from baseline to 6 months after baseline). The diagram documents pain in 19 anatomic areas. Based on the distribution of the anatomic areas, we established six different body regions. Generalized linear regression was used to evaluate the association between the number of painful nonindex body regions (categorized as 0; 1-2; or 3-6) with our measures of interest. Participants reporting no body pain, low (1-2 regions) and high (= 3 regions).	Change from base-line scores in number of painful body regions at 6 months
Secondary	Pain spreading	What is the effect of interactive patient education in supervised study groups on participant pain spreading (measured as change in number of painful body regions from baseline to 12 months after baseline). The diagram documents pain in 19 anatomic areas. Based on the distribution of the anatomic areas, we established six different body regions. Generalized linear regression was used to evaluate the association between the number of painful nonindex body regions (categorized as 0; 1-2; or 3-6) with our measures of interest. Participants reporting no body pain, low (1-2 regions) and high (= 3 regions).	Change from base-line scores in number of painful body regions at 12 months
Secondary	Trust in own know-how	What is the effect of interactive patient education in supervised study groups on participant trust in own know-how and ability related to improving health (measured as change in score in questions about trust in own know-how and ability to improving health from baseline to 3 months after baseline).	Change from base-line scores in questions about trust in own know-how and ability to improving health at 3 months
Secondary	Trust in own know-how	What is the effect of interactive patient education in supervised study groups on participant trust in own know-how and ability related to improving health (measured as change in score in questions about trust in own know-how and ability to improving health from baseline to 6 months after baseline).	Change from base-line scores in questions about trust in own know-how and ability to improving health at 6 months
Secondary	Trust in own know-how	What is the effect of interactive patient education in supervised study groups on participant trust in own know-how and ability related to improving health (measured as change in score in questions about trust in own know-how and ability to improving health from baseline to 12 months after baseline).	Change from base-line scores in questions about trust in own know-how and ability to improving health at 12 months
Secondary	Partners in health care	What is the effect of interactive patient education in supervised study groups on participants being informed as patients and being a partners in health care (measured as change in score in questions about informed as a patient and being a partner in health care from baseline to 3 months after baseline).	Change from base-line scores in questions about informed as a patient and being a partner in health care at 3 months
Secondary	Partners in health care	What is the effect of interactive patient education in supervised study groups on participants being informed as patients and being a partners in health care (measured as change in score in questions about informed as a patient and being a partner in health care from baseline to 6 months after baseline).	Change from base-line scores in questions about informed as a patient and being a partner in health care at 6 months
Secondary	Partners in health care	What is the effect of interactive patient education in supervised study groups on participants being informed as patients and being a partners in health care (measured as change in score in questions about informed as a patient and being a partner in health care from baseline to 12 months after baseline).	Change from base-line scores in questions about informed as a patient and being a partner in health care at 12 months
Secondary	Visits to primary health care	What is the effect of interactive patient education in supervised study groups on participant visits to primary health care (research subjects are asked at baseline if they had to visit the primary health care center during the preceding two months. The same question is asked at 3 months. The measurement is the change in proportion of research subjects who visited the primary health care center).	Change from base-line proportion if they had to visit the primary health care center during the preceding two months, at 3 months
Secondary	Visits to primary health care	What is the effect of interactive patient education in supervised study groups on participant visits to primary health care (research subjects are asked at baseline if they had to visit the primary health care center during the preceding two months. The same question is asked at 6 months. The measurement is the change in proportion of research subjects who visited the primary health care center).	Change from base-line proportion if they had to visit the primary health care center during the preceding two months, at 6 months
Secondary	Visits to primary health care	What is the effect of interactive patient education in supervised study groups on participant visits to primary health care (research subjects are asked at baseline if they had to visit the primary health care center during the preceding two months. The same question is asked at 12 months. The measurement is the change in proportion of research subjects who visited the primary health care center).	Change from base-line proportion if they had to visit the primary health care center during the preceding two months, at 12 months