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

Study Overview
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Brief Summary
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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.

Detailed Description
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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: Describe the use of the programme during routine care. This includes Determination of the number of patients per GP who access the programme after prescription from their GPs (adoption) A description of how often the follow-up consultation is completed according to the patients. Explore patient characteristics (appropriateness) Describe patients' engagement with the programme with regard to time and frequency of access to modules and tools (fidelity) Evaluate effects on patients' health, quality of life, functioning and satisfaction with care Estimate effects on patients' use of health care services Estimate effects on patients' work productivity Estimate possible effects on health care costs provided the intervention is fully disseminated nationally.

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

Conditions
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Persistent Physical Symptoms

Intervention / Treatment
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* Behavioral: My Symptoms eHealth programme


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients<br>Patients with persistent physical symptoms consulting their GP and referred to the My Symptoms eHealth programme. | Behavioral: My Symptoms eHealth programme<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in symptom intensity | Symptom intensity measured by a numeric rating scale (0-10) | Baseline to end of treatment (week 8) | 
| Change in symptom interference | Symptom interference measured by a numeric rating scale (0-10) | Baseline to end of treatment (week 8) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in symptom intensity | Symptom intensity measured by a numeric rating scale (0-10) | Baseline to 3 months after end of treatment | 
| Change in symptom interference | Symptom interference measured by a numeric rating scale (0-10) | Baseline to 3 months after end of treatment | 
| Change in symptom burden | Bodily Distress Syndrome (BDS) Checklist measuring symptom burden (0-100) | Baseline to end of treatment (week 8) | 
| Change in symptom burden | Bodily Distress Syndrome (BDS) Checklist measuring symptom burden (0-100) | Baseline to 3 months after end of treatment | 
| Bodily Distress Syndrome | Bodily Distress Syndrome (BDS) Checklist measuring BDS (0/1) | Baseline | 
| Bodily Distress Syndrome | Bodily Distress Syndrome (BDS) Checklist measuring BDS (0/1) | End of treatment (week 8) | 
| Bodily Distress Syndrome | Bodily Distress Syndrome (BDS) Checklist measuring BDS (0/1) | 3 months after end of treatment | 
| 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) | 
| 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 | 
| 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) | 
| 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 | 
| Anxiety | Symptom Checklist Anxiety (SCL-ANX4). Sum score (min 0; max 16). Higher scores indicate higher impairment. | Baseline | 
| Anxiety | Symptom Checklist Anxiety (SCL-ANX4). Sum score (min 0; max 16). Higher scores indicate higher impairment by anxiety. | End of treatment (week 8) | 
| 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 | 
| Depression | Symptom Checklist Depression (SCL-DEP6). Sum score (min 0; max 24). Higher scores indicate higher impairment by depression. | Baseline | 
| Depression | Symptom Checklist Depression (SCL-DEP6). Sum score (min 0; max 24). Higher scores indicate higher impairment by depression. | End of treatment (week 8) | 
| 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 | 
| Distress | Symptom Checklist Distress (SCL-Distress8). Sum score (min 0; max 32). Higher scores indicate higher impairment by distress. | Baseline | 
| Distress | Symptom Checklist Distress (SCL-Distress8). Sum score (min 0; max 32). Higher scores indicate higher impairment by distress. | End of treatment (week 8) | 
| 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 | 
| 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) | 
| 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 | 
| 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) | 
| 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 | 
| 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) | 
| 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 | 
| 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) | 
| 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 | 
| 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) | 
| 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 | 
| 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) | 
| 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 | 
| 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 | 
| 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) | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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 | 
| 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) | 
| 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 | 
| 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 | 
| 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 | 
| 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 |