The Impact of Person Centred Care (PCC) in Grave's Disease

Graves Disease Clinical Trial

Official title:

The Impact of Person Centred Care (PCC) on Mental Outcome and Work Ability in Graves' Disease - the GRAves CarE (GRACE) PCC Project

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06309316
• Other study ID #: Grace-PCC
• Status: Recruiting
• Phase: N/A
• Start date: March 25, 2024
• Est. completion date: December 30, 2028

Study information

• Verified date: January 2024
• Source: Vastra Gotaland Region
• Contact: Agneta Lindo
• Phone: +46766185481
• Email: agneta.lindo[@]vgregion.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Mental fatigue (MF) is prevalent after Graves' disease (GD), which is the most common form of hyperthyroidism. We have reported that 38% of patients, compared to 11% of control subjects, suffer from MF more than 1 year after successfully reversing of their hyperthyroidism and that MF is an entity of its own, separated from MF combined with anxiety or depression. The brain pathophysiology is unknown and there is no medical treatment, which requires patients to simply adapt to the situation. In the new national guideline for hyperthyroidism (Jan 2023), rehabilitation is recommended, but currently rarely offered to these patients. The problem is significant for patients, as illustrated by frequent media appeals. In this project, we hypothesise that person-centred care (PCC), which promotes positive coping strategies and increases self-efficacy by engaging patients as partners in their own care, improves MF, reduces sick leave, and lowers the recurrence rate of GD. In two work packages (WP), we will: WP1 Evaluate the effect of PCC eHealth intervention (telephone and digital platform) as an add-on to usual care vs usual care alone in a randomized controlled trial (RCT) of 220 patients on self-efficacy, days of sick-leave (composite score as primary outcome), MF, recurrence rate of disease, coping strategies, perceived stress, quality of life (QoL) and personality. WP2 Investigate the cost-effectiveness of the intervention Patients with GD have impaired long-term QoL. PCC could improve long-term outcomes of this autoimmune disease and may apply to other patient groups. This is in line with the societal aim to reduce mental illness.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 220
• Est. completion date: December 30, 2028
• Est. primary completion date: September 30, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Age 18-65 years
• First time Graves' diseases with elevated FT4 and/or FT3 and positive TSH receptor antibody (TRAb)

Exclusion Criteria:

• Patients that cannot attend to the protocol
• Patients with moderate-severe/ severe Graves' eye disease

Related Conditions & MeSH terms

• Graves Disease

Intervention

Behavioral:
• Person-centred care (PCC)
In addition to usual care, patients will receive PCC through physical visits, telephone and through a web-based platform for 15-months. Primary outcome is after 3 month (we expect the need of support is largest in the beginning) but the intervention will continue for the period of care 12-18 months, increasing transferability to regular care.

Locations

Country	Name	City	State
Sweden	Agneta Lindo	Göteborg

Sponsors (1)

Lead Sponsor	Collaborator
Vastra Gotaland Region

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite score of changes	A patient is classified as improved, deteriorated or unchanged: A patient is classified as improved if: at 3 months increased general self-efficacy by = 5 units and reduced sick leave percentage (or unchanged if no sick-leave at baseline) at 3 months follow-up; A patient is classified as deteriorated if: at 3 months reduced general self-efficacy by = 5 units or increased sick-leave percentage (or unchanged if on full-time sick leave at inclusion) Those who have neither improved or deteriorated are classified as unchanged	Change from baseline examined at 3 months follow-up.
Secondary	General Self-Efficacy Scale (GSE)	Evaluated by the validated questionnaire General Self-Efficacy. Scores are compared between the intervention and the control group. The total score ranges between 10 and 40, with a higher score indicating more self-efficacy.	Change from baseline examined at 6 weeks follow-up.
Secondary	General Self-Efficacy Scale (GSE)	Evaluated by the validated questionnaire General Self-Efficacy. Scores are compared between the intervention and the control group. The total score ranges between 10 and 40, with a higher score indicating more self-efficacy.	Change from baseline examined at 3 months follow-up.
Secondary	General Self-Efficacy Scale (GSE)	Evaluated by the validated questionnaire General Self-Efficacy. Scores are compared between the intervention and the control group. The total score ranges between 10 and 40, with a higher score indicating more self-efficacy.	Change from baseline examined at 6 months follow-up.
Secondary	General Self-Efficacy Scale (GSE)	Evaluated by the validated questionnaire General Self-Efficacy. Scores are compared between the intervention and the control group. The total score ranges between 10 and 40, with a higher score indicating more self-efficacy.	Change from baseline examined at 15 months follow-up.
Secondary	Days of sick-leave	Evaluated sick leave days between the intervention and the control group.	Change from baseline examined at 6 weeks follow-up.
Secondary	Days of sick-leave	Evaluated sick leave days between the intervention and the control group.	Change from baseline examined at 3 months follow-up.
Secondary	Days of sick-leave	Evaluated sick leave days between the intervention and the control group.	Change from baseline examined at 6 months follow-up.
Secondary	Days of sick-leave	Evaluated sick leave days between the intervention and the control group.	Change from baseline examined at 15 months follow-up.
Secondary	Mental fatigue score	Scores at the Mental Fatigue Scale are compared between the intervention and the control group. Scores is between 0-42 and higher scores mean more brain fatigue.	Change from baseline examined at 6 weeks follow-up.
Secondary	Mental fatigue score	Scores at the Mental Fatigue Scale are compared between the intervention and the control group. Scores is between 0-42 and higher scores mean more brain fatigue.	Change from baseline examined at 3 months follow-up.
Secondary	Mental fatigue score	Scores at the Mental Fatigue Scale are compared between the intervention and the control group. Scores is between 0-42 and higher scores mean more brain fatigue.	Change from baseline examined at 6 months follow-up.
Secondary	Mental fatigue score	Scores at the Mental Fatigue Scale are compared between the intervention and the control group. Scores is between 0-42 and higher scores mean more brain fatigue.	Change from baseline examined at 15 months follow-up.
Secondary	Coping Orientations to Problems Experienced (Brief cope)	Evaluated by the validated questionnaire Brief cope. The Brief COPE is a shorter version of the COPE Inventory composed of 28-items rated on a 4-point ordinal scale that measure 14 subscales of coping style (2-items each). The overall mean is calculated with more than three being worse outcome. Coping strategies are compared between the intervention and the control group.	Change from baseline examined at 6 weeks follow-up.
Secondary	Coping Orientations to Problems Experienced (Brief cope)	Evaluated by the validated questionnaire Brief cope. The Brief COPE is a shorter version of the COPE Inventory composed of 28-items rated on a 4-point ordinal scale that measure 14 subscales of coping style (2-items each). The overall mean is calculated with more than three being worse outcome. Coping strategies are compared between the intervention and the control group.	Change from baseline examined at 3 months follow-up.
Secondary	Coping Orientations to Problems Experienced (Brief cope)	Evaluated by the validated questionnaire Brief cope. The Brief COPE is a shorter version of the COPE Inventory composed of 28-items rated on a 4-point ordinal scale that measure 14 subscales of coping style (2-items each). The overall mean is calculated with more than three being worse outcome. Coping strategies are compared between the intervention and the control group.	Change from baseline examined at 6 months follow-up.
Secondary	Coping Orientations to Problems Experienced (Brief cope)	Evaluated by the validated questionnaire Brief cope. The Brief COPE is a shorter version of the COPE Inventory composed of 28-items rated on a 4-point ordinal scale that measure 14 subscales of coping style (2-items each). The overall mean is calculated with more than three being worse outcome. Coping strategies are compared between the intervention and the control group.	Change from baseline examined at 15 months follow-up.
Secondary	Perceived Stress Scale (PSS-14)	Evaluated by the validated questionnaire Perceived Stress Scale (PSS-14). Scores are compared between the intervention and the control group. The total score ranges between 0 and 56, with a higher score indicate more symptoms of stress.	Change from baseline examined at 6 weeks follow-up.
Secondary	Perceived Stress Scale (PSS-14)	Evaluated by the validated questionnaire Perceived Stress Scale (PSS-14). Scores are compared between the intervention and the control group. The total score ranges between 0 and 56, with a higher score indicate more symptoms of stress.	Change from baseline examined at 3 months follow-up.
Secondary	Perceived Stress Scale (PSS-14)	Evaluated by the validated questionnaire Perceived Stress Scale (PSS-14). Scores are compared between the intervention and the control group. The total score ranges between 0 and 56, with a higher score indicate more symptoms of stress.	Change from baseline examined at 6 months follow-up.
Secondary	Perceived Stress Scale (PSS-14)	Evaluated by the validated questionnaire Perceived Stress Scale (PSS-14). Scores are compared between the intervention and the control group. The total score ranges between 0 and 56, with a higher score indicate more symptoms of stress.	Change from baseline examined at 15 months follow-up.
Secondary	Personality Assessment Guardian NEO-FFI-3	The NEO Five Factor Inventory-3 (NEO-FFI-3) is a measure of the five domains of personality: neuroticism, extraversion, openness to experience, agreeableness, and conscientiousness.	Change from baseline examined at 6 weeks follow-up.
Secondary	Personality Assessment Guardian NEO-FFI-3	The NEO Five Factor Inventory-3 (NEO-FFI-3) is a measure of the five domains of personality: neuroticism, extraversion, openness to experience, agreeableness, and conscientiousness.	Change from baseline examined at 3 months follow-up.
Secondary	Personality Assessment Guardian NEO-FFI-3	The NEO Five Factor Inventory-3 (NEO-FFI-3) is a measure of the five domains of personality: neuroticism, extraversion, openness to experience, agreeableness, and conscientiousness.	Change from baseline examined at 6 months follow-up.
Secondary	Personality Assessment Guardian NEO-FFI-3	The NEO Five Factor Inventory-3 (NEO-FFI-3) is a measure of the five domains of personality: neuroticism, extraversion, openness to experience, agreeableness, and conscientiousness.	Change from baseline examined at 15 months follow-up.
Secondary	Comprehensive psychopathological rating questionnaire (CPRS)	Evaluated by the validated questionnaire the Comprehensive Psychopathological Rating Scale (CPRS). Scores are compared between the intervention and the control group. Higher scores at the Comprehensive Psychopathological Rating Scale mean more symptoms of anxiety and depression. The Scores for anxiety is between 0-27 and for depression is between 0-27.	Change from baseline examined at 6 weeks follow-up.
Secondary	Comprehensive psychopathological rating questionnaire (CPRS)	Evaluated by the validated questionnaire the Comprehensive Psychopathological Rating Scale (CPRS). Scores are compared between the intervention and the control group. Higher scores at the Comprehensive Psychopathological Rating Scale mean more symptoms of anxiety and depression. The Scores for anxiety is between 0-27 and for depression is between 0-27.	Change from baseline examined at 3 months follow-up.
Secondary	Comprehensive psychopathological rating questionnaire (CPRS)	Evaluated by the validated questionnaire the Comprehensive Psychopathological Rating Scale (CPRS). Scores are compared between the intervention and the control group. Higher scores at the Comprehensive Psychopathological Rating Scale mean more symptoms of anxiety and depression. The Scores for anxiety is between 0-27 and for depression is between 0-27.	Change from baseline examined at 6 months follow-up.
Secondary	Comprehensive psychopathological rating questionnaire (CPRS)	Evaluated by the validated questionnaire the Comprehensive Psychopathological Rating Scale (CPRS). Scores are compared between the intervention and the control group. Higher scores at the Comprehensive Psychopathological Rating Scale mean more symptoms of anxiety and depression. The Scores for anxiety is between 0-27 and for depression is between 0-27.	Change from baseline examined at 15 months follow-up.
Secondary	Thyroid-specific Patient-Reported Outcome short-form (ThyPro 39)	Evaluated by the validated questionnaire Thyroid-specific Patient-Reported Outcome short-form (ThyPro 39). Scores are compared between the intervention and the control group. ThyPRO scales is scored as a summary score and linearly transformed to range 0- 100. Higher scores at the Thyroid-specific Patient-Reported Outcome short-form means worse quality of life.	Change from baseline examined at 6 weeks follow-up.
Secondary	Thyroid-specific Patient-Reported Outcome short-form (ThyPro 39)	Evaluated by the validated questionnaire Thyroid-specific Patient-Reported Outcome short-form (ThyPro 39). Scores are compared between the intervention and the control group. ThyPRO scales is scored as a summary score and linearly transformed to range 0- 100. Higher scores at the Thyroid-specific Patient-Reported Outcome short-form means worse quality of life.	Change from baseline examined at 3 months follow-up.
Secondary	Thyroid-specific Patient-Reported Outcome short-form (ThyPro 39)	Evaluated by the validated questionnaire Thyroid-specific Patient-Reported Outcome short-form (ThyPro 39). Scores are compared between the intervention and the control group. ThyPRO scales is scored as a summary score and linearly transformed to range 0- 100. Higher scores at the Thyroid-specific Patient-Reported Outcome short-form means worse quality of life.	Change from baseline examined at 6 months follow-up.
Secondary	Thyroid-specific Patient-Reported Outcome short-form (ThyPro 39)	Evaluated by the validated questionnaire Thyroid-specific Patient-Reported Outcome short-form (ThyPro 39). Scores are compared between the intervention and the control group. ThyPRO scales is scored as a summary score and linearly transformed to range 0- 100. Higher scores at the Thyroid-specific Patient-Reported Outcome short-form means worse quality of life.	Change from baseline examined at 15 months follow-up.
Secondary	Graves' Ophthalmopathy Quality of Life Questionnaire (GO QoL).	Evaluated by the validated questionnaire the Graves' Ophthalmopathy Quality of Life Questionnaire (GO QoL). Scores are compared between the intervention and the control group. The range of each score is from 0 to 100, higher scores indicating better health.	Change from baseline examined at 6 weeks follow-up
Secondary	Graves' Ophthalmopathy Quality of Life Questionnaire (GO QoL).	Evaluated by the validated questionnaire the Graves' Ophthalmopathy Quality of Life Questionnaire (GO QoL). Scores are compared between the intervention and the control group. The range of each score is from 0 to 100, higher scores indicating better health.	Change from baseline examined at 3 months follow-up
Secondary	Graves' Ophthalmopathy Quality of Life Questionnaire (GO QoL).	Evaluated by the validated questionnaire the Graves' Ophthalmopathy Quality of Life Questionnaire (GO QoL). Scores are compared between the intervention and the control group. The range of each score is from 0 to 100, higher scores indicating better health.	Change from baseline examined at 6 months follow-up
Secondary	Graves' Ophthalmopathy Quality of Life Questionnaire (GO QoL).	Evaluated by the validated questionnaire the Graves' Ophthalmopathy Quality of Life Questionnaire (GO QoL). Scores are compared between the intervention and the control group. The range of each score is from 0 to 100, higher scores indicating better health.	Change from baseline examined at 15 months follow-up
Secondary	EuroQol- health questionnaire (EQ-5D)	Evaluated by the validated questionnaire EuroQol- health (EQ-5D). Scores are compared between the intervention and the control group. Each question may have 1 of 3-level answers, and a visual analog scale (VAS) on which patients can mark their current health state. The EQ-5D-3L index is calculated by subtracting the values of the descriptive EQ-5D system from the numerical value 1. This corresponds to the best possible health status, while an index value of <0 represents the worst possible health status.	Change from baseline examined at 6 weeks follow-up
Secondary	EuroQol- health questionnaire (EQ-5D)	Evaluated by the validated questionnaire EuroQol- health (EQ-5D). Scores are compared between the intervention and the control group. Each question may have 1 of 3-level answers, and a visual analog scale (VAS) on which patients can mark their current health state. The EQ-5D-3L index is calculated by subtracting the values of the descriptive EQ-5D system from the numerical value 1. This corresponds to the best possible health status, while an index value of <0 represents the worst possible health status.	Change from baseline examined at 3 months follow-up
Secondary	EuroQol- health questionnaire (EQ-5D)	Evaluated by the validated questionnaire EuroQol- health (EQ-5D). Scores are compared between the intervention and the control group. Each question may have 1 of 3-level answers, and a visual analog scale (VAS) on which patients can mark their current health state. The EQ-5D-3L index is calculated by subtracting the values of the descriptive EQ-5D system from the numerical value 1. This corresponds to the best possible health status, while an index value of <0 represents the worst possible health status.	Change from baseline examined at 6 months follow-up
Secondary	EuroQol- health questionnaire (EQ-5D)	Evaluated by the validated questionnaire EuroQol- health (EQ-5D). Scores are compared between the intervention and the control group. Each question may have 1 of 3-level answers, and a visual analog scale (VAS) on which patients can mark their current health state. The EQ-5D-3L index is calculated by subtracting the values of the descriptive EQ-5D system from the numerical value 1. This corresponds to the best possible health status, while an index value of <0 represents the worst possible health status.	Change from baseline examined at 15 months follow-up
Secondary	Frenchay Activities Index (FAI)	Evaluated by the validated Frenchay Activities Index (FAI). Compare function and work ability between the intervention and the control group. Questionnaire consisting of 15 items on frequency of social everyday activities and the score is based on the frequency with which an activity has been performed during the previous 3 or 6 months. The total score ranges from 0 (inactive) to 45 (very active).	Change from baseline examined at 6 weeks follow-up
Secondary	Frenchay Activities Index (FAI)	Evaluated by the validated Frenchay Activities Index (FAI). Compare function and work ability between the intervention and the control group. Questionnaire consisting of 15 items on frequency of social everyday activities and the score is based on the frequency with which an activity has been performed during the previous 3 or 6 months. The total score ranges from 0 (inactive) to 45 (very active).	Change from baseline examined at 3 months follow-up
Secondary	Frenchay Activities Index (FAI)	Evaluated by the validated Frenchay Activities Index (FAI). Compare function and work ability between the intervention and the control group. Questionnaire consisting of 15 items on frequency of social everyday activities and the score is based on the frequency with which an activity has been performed during the previous 3 or 6 months. The total score ranges from 0 (inactive) to 45 (very active).	Change from baseline examined at 6 months follow-up
Secondary	Frenchay Activities Index (FAI)	Evaluated by the validated Frenchay Activities Index (FAI). Compare function and work ability between the intervention and the control group. Questionnaire consisting of 15 items on frequency of social everyday activities and the score is based on the frequency with which an activity has been performed during the previous 3 or 6 months. The total score ranges from 0 (inactive) to 45 (very active).	Change from baseline examined at 15 months follow-up
Secondary	Work Productivity and Activity Impairment questionnaire (WPAI). Productivity and Activity Impairment questionnaire (WPAI)	Evaluated by the validated Work Productivity and Activity Impairment questionnaire (WPAI). Compare Work Productivity and Activity between the intervention and the control group.; Four main outcomes can be generated from the WPAI-GH and expressed in percentages by multiplying the following scores by 100: 1) percent work time missed due to health = Q2/(Q2 + Q4) for those who were currently employed; 2) percent impairment while working due to health = Q5/10 for those who were currently employed and actually worked in the past seven days; 3) percent overall work impairment due to health Q2/(Q2 + Q4) + ((1 - Q2/(Q2 + Q4)) × (Q5/10)) for those who were currently employed; 4) percent activity impairment due to health Q6/10 for all respondents.	Change from baseline examined at 6 weeks follow-up
Secondary	Work Productivity and Activity Impairment questionnaire (WPAI). Productivity and Activity Impairment questionnaire (WPAI)	Evaluated by the validated Work Productivity and Activity Impairment questionnaire (WPAI). Compare Work Productivity and Activity between the intervention and the control group.; Four main outcomes can be generated from the WPAI-GH and expressed in percentages by multiplying the following scores by 100: 1) percent work time missed due to health = Q2/(Q2 + Q4) for those who were currently employed; 2) percent impairment while working due to health = Q5/10 for those who were currently employed and actually worked in the past seven days; 3) percent overall work impairment due to health Q2/(Q2 + Q4) + ((1 - Q2/(Q2 + Q4)) × (Q5/10)) for those who were currently employed; 4) percent activity impairment due to health Q6/10 for all respondents.	Change from baseline examined at 3 months follow-up
Secondary	Work Productivity and Activity Impairment questionnaire (WPAI). Productivity and Activity Impairment questionnaire (WPAI)	Evaluated by the validated Work Productivity and Activity Impairment questionnaire (WPAI). Compare Work Productivity and Activity between the intervention and the control group.; Four main outcomes can be generated from the WPAI-GH and expressed in percentages by multiplying the following scores by 100: 1) percent work time missed due to health = Q2/(Q2 + Q4) for those who were currently employed; 2) percent impairment while working due to health = Q5/10 for those who were currently employed and actually worked in the past seven days; 3) percent overall work impairment due to health Q2/(Q2 + Q4) + ((1 - Q2/(Q2 + Q4)) × (Q5/10)) for those who were currently employed; 4) percent activity impairment due to health Q6/10 for all respondents.	Change from baseline examined at 6 months follow-up
Secondary	Work Productivity and Activity Impairment questionnaire (WPAI). Productivity and Activity Impairment questionnaire (WPAI)	Evaluated by the validated Work Productivity and Activity Impairment questionnaire (WPAI). Compare Work Productivity and Activity between the intervention and the control group.; Four main outcomes can be generated from the WPAI-GH and expressed in percentages by multiplying the following scores by 100: 1) percent work time missed due to health = Q2/(Q2 + Q4) for those who were currently employed; 2) percent impairment while working due to health = Q5/10 for those who were currently employed and actually worked in the past seven days; 3) percent overall work impairment due to health Q2/(Q2 + Q4) + ((1 - Q2/(Q2 + Q4)) × (Q5/10)) for those who were currently employed; 4) percent activity impairment due to health Q6/10 for all respondents.	Change from baseline examined at 15 months follow-up
Secondary	Levels of thyroid autoantibodies	Levels of thyroid autoantibodies, analysed with the standard method of the laboratory at Sahlgrenska University Hospital, compared between the intervention and the control group.	Change from baseline examined at 6 weeks follow-up
Secondary	Levels of thyroid autoantibodies	Levels of thyroid autoantibodies, analysed with the standard method of the laboratory at Sahlgrenska University Hospital, compared between the intervention and the control group.	Change from baseline examined at 3 months follow-up
Secondary	Levels of thyroid autoantibodies	Levels of thyroid autoantibodies, analysed with the standard method of the laboratory at Sahlgrenska University Hospital, compared between the intervention and the control group.	Change from baseline examined at 6 months follow-up
Secondary	Levels of thyroid autoantibodies	Levels of thyroid autoantibodies, analysed with the standard method of the laboratory at Sahlgrenska University Hospital, compared between the intervention and the control group.	Change from baseline examined at 15 months follow-up
Secondary	Levels of thyroid hormones	Levels of thyroid hormones, analysed with the standard method of the laboratory at Sahlgrenska University Hospital, compared between the intervention and the control group.	Change from baseline examined at 6 weeks follow-up
Secondary	Levels of thyroid hormones	Levels of thyroid hormones, analysed with the standard method of the laboratory at Sahlgrenska University Hospital, compared between the intervention and the control group.	Change from baseline examined at 3 months follow-up
Secondary	Levels of thyroid hormones	Levels of thyroid hormones, analysed with the standard method of the laboratory at Sahlgrenska University Hospital, compared between the intervention and the control group.	Change from baseline examined at 6 months follow-up
Secondary	Levels of thyroid hormones	Levels of thyroid hormones, analysed with the standard method of the laboratory at Sahlgrenska University Hospital, compared between the intervention and the control group.	Change from baseline examined at 15 months follow-up
Secondary	Clinical Activity Score (CAS)	Comparison of Clinical Activity Score (a composite measure of ophthalmological signs and symptoms) between the intervention and the control group. Scores can be between 0-10 and higher scores mean more eye symptoms.	Change from baseline examined at 6 weeks follow-up
Secondary	Clinical Activity Score (CAS)	Comparison of Clinical Activity Score (a composite measure of ophthalmological signs and symptoms) between the intervention and the control group. Scores can be between 0-10 and higher scores mean more eye symptoms.	Change from baseline examined at 3 months follow-up
Secondary	Clinical Activity Score (CAS)	Comparison of Clinical Activity Score (a composite measure of ophthalmological signs and symptoms) between the intervention and the control group. Scores can be between 0-10 and higher scores mean more eye symptoms.	Change from baseline examined at 6 months follow-up
Secondary	Clinical Activity Score (CAS)	Comparison of Clinical Activity Score (a composite measure of ophthalmological signs and symptoms) between the intervention and the control group. Scores can be between 0-10 and higher scores mean more eye symptoms.	Change from baseline examined at 15 months follow-up
Secondary	Severity score	Comparison of Severity score (a composite measure of ophthalmological signs and symptoms) between the intervention and the control group. Scores can be between 0-29 and higher scores mean more eye symptoms.	Change from baseline examined at 6 weeks follow-up
Secondary	Severity score	Comparison of Severity score (a composite measure of ophthalmological signs and symptoms) between the intervention and the control group. Scores can be between 0-29 and higher scores mean more eye symptoms.	Change from baseline examined at 3 months follow-up
Secondary	Severity score	Comparison of Severity score (a composite measure of ophthalmological signs and symptoms) between the intervention and the control group. Scores can be between 0-29 and higher scores mean more eye symptoms.	Change from baseline examined at 6 months follow-up
Secondary	Severity score	Comparison of Severity score (a composite measure of ophthalmological signs and symptoms) between the intervention and the control group. Scores can be between 0-29 and higher scores mean more eye symptoms.	Change from baseline examined at 15 months follow-up
Secondary	Saltin-Grimby Physical Activity Scale (SGPAS)	Physical activity level, 1-4 (4 highest activity level).	Change from baseline examined at 6 weeks follow-up
Secondary	Saltin-Grimby Physical Activity Scale (SGPAS)	Physical activity level, 1-4 (4 highest activity level).	Change from baseline examined at 3 months follow-up
Secondary	Saltin-Grimby Physical Activity Scale (SGPAS)	Physical activity level, 1-4 (4 highest activity level).	Change from baseline examined at 6 months follow-up
Secondary	Saltin-Grimby Physical Activity Scale (SGPAS)	Physical activity level, 1-4 (4 highest activity level).	Change from baseline examined at 15 months follow-up
Secondary	Composite score of changes	A patient is classified as improved, deteriorated or unchanged: A patient is classified as improved if: at 3 months increased general self-efficacy by = 5 units and reduced sick leave percentage (or unchanged if no sick-leave at baseline) at 3 months follow-up; A patient is classified as deteriorated if: at 3 months reduced general self-efficacy by = 5 units or increased sick-leave percentage (or unchanged if on full-time sick leave at inclusion) Those who have neither improved or deteriorated are classified as unchanged	Change from 6weeks examined at 3 months follow-up.