My Symptoms: an eHealth and GP Assisted Programme for Persistent Symptoms in Primary Care

Persistent Physical Symptoms Clinical Trial

— eASY  

Official title:

My Symptoms: a Before-After Evaluation of an eHealth and GP Assisted Programme for Persistent Symptoms in Primary Care (eASY)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06163014
• Other study ID #: 1-10-72-222-22
• Status: Recruiting
• Start date: December 1, 2023
• Est. completion date: December 2025

Study information

• Verified date: February 2024
• Source: Aarhus University Hospital
• Contact: Marianne Rosendal, PhD
• Phone: +4521476826
• Email: marose[@]rm.dk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The project 'My Symptoms' is part of a large research programme: eHealth and GP-assisted self-help interventions for persistent physical symptoms (eASY). See www.mine-symptomer.dk. The research programme is an ambitious and dedicated effort aiming at improvement of functioning and quality of life for individuals with persistent physical symptoms (PPS) and prevention of the development of chronic functional disorders and associated loss of working capacity and high use of health care. At present, access to specialized treatment of PPS is very limited and treatment capacity in general practice is restricted to brief consultations - often with poor opportunity to make a treatment plan for symptoms. As part of the research programme, the investigators have developed a web-based self-help programme for patient with PPS. This treatment programme is prescribed by the patient's general practitioner (GP). Only GPs who have participated in a short introduction course will be allowed for prescriptions. The investigators have applied a high degree of user involvement (GPs and patients) in the development process but there is a need to evaluate how the new treatment programme is in fact adopted by GPs and patients. With this study, the investigators wish to follow the national implementation using a before-after study design describing uptake and effects on GPs, patients and the health care system.

Description:

The project aims to evaluate the uptake and effects of the new self-help programme for PPS, the My Symptoms programme, prescribed and followed up by GPs. Specific objectives are to: 1. Describe the use of the programme during routine care. This includes 1. Determination of the number of patients per GP who access the programme after prescription from their GPs (adoption) 2. A description of how often the follow-up consultation is completed according to the patients. 2. Explore patient characteristics (appropriateness) 3. Describe patients' engagement with the programme with regard to time and frequency of access to modules and tools (fidelity) 4. Evaluate effects on patients' health, quality of life, functioning and satisfaction with care 5. Estimate effects on patients' use of health care services 6. Estimate effects on patients' work productivity 7. Estimate possible effects on health care costs provided the intervention is fully disseminated nationally.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Age 18-65 (target population for the programme)
• The consultation targets symptom complaints
• Listed with participating practice.

Exclusion Criteria:

• Symptoms are acute (not persistent) and there is no need for this intervention
• Symptoms must primarily be treated by medicine or surgery
• Patient severely affected by other disease
• Not eligible due to language or cognitive problems

Related Conditions & MeSH terms

• Persistent Physical Symptoms

Intervention

Behavioral:
• My Symptoms eHealth programme
My Symptoms supports patients' self-efficacy and behavioural changes. The programme is activated by the patient after prescription by the GP. The patient is free to choose relevant tasks corresponding to wishes, needs/requirements and own perspectives. Summary of content: Symptom explanations and facts about frequent symptoms including brief animated explanations Physical energy (sleep, diet and activity) Working with resources and strain in everyday life Values and choices (meaning and existential issues) Thoughts Feelings (emotion regulation) Self-care (attention incl. mindfulness and audio exercises) Preparation for a follow-up visit with the GP and relapse prevention. The above modules connect to four general tools: symptom registration, 'don't break the chain', goal setting staircase and notebook. After 6 weeks: Voluntary GP follow-up consultation. After 8 weeks: End-of-treatment.

Locations

Country	Name	City	State
Denmark	Aarhus University Hospital	Aarhus

Sponsors (1)

Lead Sponsor	Collaborator
Aarhus University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in symptom intensity	Symptom intensity measured by a numeric rating scale (0-10)	Baseline to end of treatment (week 8)
Primary	Change in symptom interference	Symptom interference measured by a numeric rating scale (0-10)	Baseline to end of treatment (week 8)
Secondary	Change in symptom intensity	Symptom intensity measured by a numeric rating scale (0-10)	Baseline to 3 months after end of treatment
Secondary	Change in symptom interference	Symptom interference measured by a numeric rating scale (0-10)	Baseline to 3 months after end of treatment
Secondary	Change in symptom burden	Bodily Distress Syndrome (BDS) Checklist measuring symptom burden (0-100)	Baseline to end of treatment (week 8)
Secondary	Change in symptom burden	Bodily Distress Syndrome (BDS) Checklist measuring symptom burden (0-100)	Baseline to 3 months after end of treatment
Secondary	Bodily Distress Syndrome	Bodily Distress Syndrome (BDS) Checklist measuring BDS (0/1)	Baseline
Secondary	Bodily Distress Syndrome	Bodily Distress Syndrome (BDS) Checklist measuring BDS (0/1)	End of treatment (week 8)
Secondary	Bodily Distress Syndrome	Bodily Distress Syndrome (BDS) Checklist measuring BDS (0/1)	3 months after end of treatment
Secondary	Change in illness perception	Brief Illness Perception Questionnaire (B-IPQ). Sum score (min 0; max 70). Lower scores indicate more positive illness perceptions.	Baseline to end of treatment (week 8)
Secondary	Change in illness perception	Brief Illness Perception Questionnaire (B-IPQ). Sum score (min 0; max 70). Lower scores indicate more positive illness perceptions.	Baseline to 3 months after end of treatment
Secondary	Change in illness worry	The revised version of the six-item Whiteley Index (WI-6-R). Sum score (min 0; max 24). Higher scores indicate higher illness worry.	Baseline to end of treatment (week 8)
Secondary	Change in illness worry	The revised version of the six-item Whiteley Index (WI-6-R). Sum score (min 0; max 24). Higher scores indicate higher illness worry.	Baseline to 3 months after end of treatment
Secondary	Anxiety	Symptom Checklist Anxiety (SCL-ANX4). Sum score (min 0; max 16). Higher scores indicate higher impairment.	Baseline
Secondary	Anxiety	Symptom Checklist Anxiety (SCL-ANX4). Sum score (min 0; max 16). Higher scores indicate higher impairment by anxiety.	End of treatment (week 8)
Secondary	Anxiety	Symptom Checklist Anxiety (SCL-ANX4). Sum score (min 0; max 16). Higher scores indicate higher impairment by anxiety.	3 months after end of treatment
Secondary	Depression	Symptom Checklist Depression (SCL-DEP6). Sum score (min 0; max 24). Higher scores indicate higher impairment by depression.	Baseline
Secondary	Depression	Symptom Checklist Depression (SCL-DEP6). Sum score (min 0; max 24). Higher scores indicate higher impairment by depression.	End of treatment (week 8)
Secondary	Depression	Symptom Checklist Depression (SCL-DEP6). Sum score (min 0; max 24). Higher scores indicate higher impairment by depression.	3 months after end of treatment
Secondary	Distress	Symptom Checklist Distress (SCL-Distress8). Sum score (min 0; max 32). Higher scores indicate higher impairment by distress.	Baseline
Secondary	Distress	Symptom Checklist Distress (SCL-Distress8). Sum score (min 0; max 32). Higher scores indicate higher impairment by distress.	End of treatment (week 8)
Secondary	Distress	Symptom Checklist Distress (SCL-Distress8). Sum score (min 0; max 32). Higher scores indicate higher impairment by distress.	3 months after end of treatment
Secondary	Change of hope	One item from the Symptom Checklist (SCL)-90. Response categories ranging from 'not at all' (0) to 'very much' (4) (min 0; max 4). Higher scores indicate higher impairment by hopelessness.	Baseline to end of treatment (week 8)
Secondary	Change of hope	One item from the Symptom Checklist (SCL)-90. Response categories ranging from 'not at all' (0) to 'very much' (4) (min 0; max 4). Higher scores indicate higher impairment by hopelessness.	Baseline to 3 months after end of treatment
Secondary	Change in stress	Perceived Stress Scale 10-item version (PSS-10). Sum score (min 0; max 40). Higher scores indicate higher stress levels.	Baseline to end of treatment (week 8)
Secondary	Change in stress	Perceived Stress Scale 10-item version (PSS-10). Sum score (min 0; max 40). Higher scores indicate higher stress levels.	Baseline to 3 months after end of treatment
Secondary	Change in limiting behaviour	Behaviour Related to Illness Questionnaire (BRIQ), subscale. Sum score (min 0; max 24). Lower scores indicate a more adaptive symptom behaviour.	Baseline to end of treatment (week 8)
Secondary	Change in limiting behaviour	Behaviour Related to Illness Questionnaire (BRIQ), subscale. Sum score (min 0; max 24). Lower scores indicate a more adaptive symptom behaviour.	Baseline to 3 months after end of treatment
Secondary	Change in all or nothing behaviour	Behaviour Related to Illness Questionnaire (BRIQ), subscale. Sum score (min 0; max 28). Lower scores indicate a more adaptive symptom behaviour.	Baseline to end of treatment (week 8)
Secondary	Change in all or nothing behaviour	Behaviour Related to Illness Questionnaire (BRIQ), subscale. Sum score (min 0; max 28). Lower scores indicate a more adaptive symptom behaviour.	Baseline to 3 months after end of treatment
Secondary	Change in confidence in performing activities in the context of PPS	Adapted version of the Pain Self-Efficacy Questionnaire (PSEQ). Sum score (min 0; max 60). Higher scores indicate better self-efficacy.	Baseline to end of treatment (week 8)
Secondary	Change in confidence in performing activities in the context of PPS	Adapted version of the Pain Self-Efficacy Questionnaire (PSEQ). Sum score (min 0; max 60). Higher scores indicate better self-efficacy.	Baseline to 3 months after end of treatment
Secondary	Change in health-related quality of life	36-Item Short Form Health Survey (SF-36) (subscales and the physical (PCS) and mental (MCS) component summary scores). PCS and MCS will be transformed into scales ranging from 0 to 100 by the following expression: (patient raw score-lowest possible score)/(highest possible score-lowest possible score)×100. Higher scores express better health.	Baseline to end of treatment (week 8)
Secondary	Change in health-related quality of life	36-Item Short Form Health Survey (SF-36) (subscales and the physical (PCS) and mental (MCS) component summary scores). PCS and MCS will be transformed into scales ranging from 0 to 100 by the following expression: (patient raw score-lowest possible score)/(highest possible score-lowest possible score)×100. Higher scores express better health.	Baseline to 3 months after end of treatment
Secondary	Health-related quality of life	The EuroQoL 5-domain 5-level (EQ-5D-5L). EQ-5D-5L health states will be summarised by a single summary number (index value), which reflects how good or bad the health state is according to the preferences of the general population. Index values will be derived according to the EuroQol Research Foundation manual for EQ-5D-5L.	Baseline
Secondary	Health-related quality of life	The EuroQoL 5-domain 5-level (EQ-5D-5L). EQ-5D-5L health states will be summarised by a single summary number (index value), which reflects how good or bad the health state is according to the preferences of the general population. Index values will be derived according to the EuroQol Research Foundation manual for EQ-5D-5L.	End of treatment (week 8)
Secondary	Health-related quality of life	The EuroQoL 5-domain 5-level (EQ-5D-5L). EQ-5D-5L health states will be summarised by a single summary number (index value), which reflects how good or bad the health state is according to the preferences of the general population. Index values will be derived according to the EuroQol Research Foundation manual for EQ-5D-5L.	3 months after end of treatment
Secondary	Credibility related to the eHealth programme	One item measuring credibility. A scale ranging from 'not meaningful at all' (1) to 'highly meaningful' (10) is provided.	Baseline
Secondary	Expectancy related to the eHealth programme	One item measuring expectancy. A scale ranging from 'not efficient at all' (1) to 'highly efficient' (10) is provided.	Baseline
Secondary	Evaluation of the referral consultation	Questionnaire comprising 6 items. The items are scored on a five-point Likert-type scale ranging from 'bad' (1) to 'excellent' (5).	Baseline
Secondary	Evaluation of the eHealth programme	Questionnaire comprising 12 items. The items are scored on a five-point Likert-type scale representing the extent to which the patient find the programme easy to use or has experienced benefit. The scale ranges from 'not at all' (0) to 'to a very great extent' (4).	End of treatment (week 8)
Secondary	Recommendation of the eHealth programme	One item. The patient is asked to indicate whether he or she would recommend the treatment programme to a friend with similar problems. A VAS scale (0 ('not at all') - 10 ('highly recommend') is provided.	End of treatment (week 8)
Secondary	Evaluation of the follow up consultation	One item measuring satisfaction. The item is scored on a five-point Likert-type scale ranging from 'bad' (1) to 'excellent' (5).	End of treatment (week 8)
Secondary	Self-rated global health change	Patient Global Impression of Change (PGIC) scale. One item scored on a five point Likert-type scale ranging from 'Much worse' (1) to 'Much better' health (5).	End of treatment (week 8)
Secondary	Self-rated global health change	Patient Global Impression of Change (PGIC) scale. One item scored on a five point Likert-type scale ranging from 'Much worse' (1) to 'Much better' health (5).	3 months after end of treatment
Secondary	Adverse events	Dichotomous outcome measure (0/1). Defined as a 50% worsening of symptoms as measured by the numeric rating scale (NRS) for symptom intensity	End of treatment (week 8)
Secondary	Adverse events	Dichotomous outcome measure (0/1). Defined as a 50% worsening of symptoms as measured by the numeric rating scale (NRS) for symptom intensity	3 months after end of treatment
Secondary	Quality-adjusted life year (QALY)	QALY is a single reported value based on the change in patient's health-related quality of life measured with the EuroQoL 5-domain 5-level (EQ-5D-5L) and valued using Danish QALY-weights.	6 months after end of treatment
Secondary	Changes in health care use	Estimation of effects on patients' changes in use of health care services using Danish registers from a before-vs-after approach	6 months before baseline compared to 6 months after end of treatment
Secondary	Changes in productivity costs	Changes in productivity costs i.e., the change in lost production due to changes in sick leaves and absence from work	6 months before baseline compared to 6 months after end of treatment

External Links

•   Project website