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The proposed project 'My Symptoms' is part of a large research programme: eHealth and GP-assisted self-help interventions for persistent physical symptoms (eASY). See www.minesymptomer.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. In order to improve health care for patients with PPS, the investigators have developed a web-based selfhelp programme for symptoms. As part of the intervention, this programme is prescribed by the patient's general practitioner (GP). 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 and how it affects GPs in routine care and patients in daily life. With this study, the investigators wish to take the first step towards a comprehensive and rigorous evaluation. Results from this feasibility study will both qualify a subsequent randomised controlled trial (RCT) in a larger pilot study and provide information for a potential national dissemination.
Drawing on existing evidence about symptoms, functional disorders and eHealth interventions combined with user involvement, the investigators have developed a web-based self-help programme for PPS: "My Symptoms". The programme builds on the bio-psycho-socialexistential illness model and enhanced cognitive behavioural theory. Seven treatment modules focus on psychoeducation, lifestyle intervention, self-regulation and graded exercise delivered through text, videos, animations and audio files (see overview of content in table 1). Furthermore, it includes a 1-day course for GPs and a mandatory follow-up appointment between patient and GP at the programme closure. The training course for the GPs will focus on patient identification, positive reinforcement and familiarity with the content of the programme. The programme must be prescribed by GPs and is recommended to use for 6 weeks.
The objectives with the present feasibility study are: 1) to test and refine the GP training course, 2) to explore the planned logistics for patient recruitment, 3) to evaluate GP and patient questionnaires, and 4) to evaluate patients' use of the programme and 5) follow-up consultations with their GP.
With regard to 2-5, the following questions will be adressed and explored:
Alongside this part of the feasibility study, the investigators will conduct a separate in-depth qualitative study (field study observations and interviews) on GP and patient interactions with the intervention. A separate protocol has been developed for this part of the feasibility study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| My Symptoms 1 (MySt-1) | Active Comparator | GPs will receive an introduction to the overall content of the eHealth programme MySt-1. The information will be given to participating GPs and their staff during a 1½-hour session in the practice. The research assistant will go through the logistics of the patient recruitment and evaluation step-by-step and GPs and relevant staff will subsequently have access to the programme. The patients will get access to a basic eHealth programme (My Symptoms 1). The programme is an internet-delivered self-help programme supporting patients' selfefficacy and behavioural changes. The programme is activated by the patient after prescription by the GP. |
|
| My Symptoms 2 (MySt-2) | Experimental | GPs will attend a one-day training course of 7 hours including: in depth insight into the My Symptoms 2 eHealth programme, comprehensive understanding of PPS, training of communication skills and the use of contextual (non-specific/common psychological) factors. The training programme has been developed in cooperation with the national GP association offering CME (PLO-e). Lecturers and trainers will be GPs and psychologists from the research team. The patients will get access to an advanced eHealth programme (My Symptoms 2). The programme is an internet-delivered self-help programme supporting patients' selfefficacy and behavioural changes. The programme is activated by the patient after prescription by the GP. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| My Symptoms 1 (MySt-1) | Behavioral | The patients will get access to an eHealth programme consisting of:
These four provisions are identical to the first part of the MySt-2. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients in the target age group visiting the practice | Recruitment (Week 1) | |
| Number of patients refusing participation | Recruitment (Week 1) | |
| Number of patients fulfilling the inclusion criteria | Recruitment (Week 1) | |
| Number of patients excluded by the GPs and reasons for this | Recruitment and/or referral consultation (Week 1-3 expectedly) | |
| Number of patients not accepting the invitation for intervention despite consent to participate in the project (drop-outs) | Invitation for referral consultation/at referral consultation (Week 1-3 expectedly) | |
| Number of patients who do not log into the programme within 2 weeks from referral or only log into the programme once (drop-outs) | 2 weeks after referral consultation (Week 4-5 expectedly) |
| Measure | Description | Time Frame |
|---|---|---|
| Symptoms | Bodily Distress Syndrome checklist | Recruitment (screening), programme login (baseline), end of treatment |
| Symptom intensity and interference | Recruitment (screening), programme login (baseline), end of treatment |
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Inclusion Criteria:
Exclusion Criteria:
Criteria for stratification:
- Long-term sick leave, i.e. more than 8 weeks, will be a criterion for stratification in order to enable analyses on the target group of patients with PPS without chronicity
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aarhus University Hospital | Aarhus | 8000 | Denmark |
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| Label | URL |
|---|---|
| Program access for patients | View source |
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| ID | Term |
|---|---|
| D050881 | E1A-Associated p300 Protein |
| ID | Term |
|---|---|
| D050880 | p300-CBP Transcription Factors |
| D051548 | Histone Acetyltransferases |
| D000070837 | Lysine Acetyltransferases |
| D000123 | Acetyltransferases |
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We will inform GPs about the possibility of being assigned to one of two interventions expected to have each their advantages and disadvantages, hence being of equal value to patients. The GPs will know the content of their assignment but will not be informed about the specific content of the other intervention. Enrolled patients will only be informed whether they are to use the programme My Symptoms 1 or My Symptoms 2 accessed via a website.
Outcome assessment and data analyses in this feasibility study conducted by the project researchers will not be blinded.
|
| My Symptoms 2 (MySt-2) | Behavioral | The patients will get access to an eHealth programme consisting of:
After 4-6 weeks, the patient will see the GP for a follow-up consultation. |
|
| Illness perception | Illness Perception Questionnaire | Recruitment (screening), programme login (baseline), end of treatment |
| Anxiety and Depression | Symptom Checklist (SCL)-13 | Recruitment (screening), programme login (baseline), end of treatment |
| Health anxiety | Whiteley-6R | Recruitment (screening), programme login (baseline), end of treatment |
| Global health | One item from SF-36 | Recruitment (screening), programme login (baseline), end of treatment |
| Evaluation of GP at referral consultation | 6 items | Programme login (baseline) |
| Program expectations | 2 items adapted from the Credibility Expectancy Questionnaire | Programme login (baseline) |
| Quality of life | SF-36 | Programme login (baseline), end of treatment |
| Quality of life | EQ-5D-5L (EuroQol) | Programme login (baseline), end of treatment |
| Pain self-efficacy | Pain Self-Efficacy Questionnaire | Programme login (baseline), end of treatment |
| Illness behavior | The Behavioural Responses to Illness Questionnaire | Programme login (baseline), end of treatment |
| Productivity Costs | Productivity Costs Questionnaire (IMTA) | Programme login (baseline), end of treatment |
| Health care utilization | Medical Consumption Questionnaire (IMTA) | Programme login (baseline), end of treatment |
| Program evaluation | 13 items | End of treatment |
| Global impression of change | 1 item | End of treatment |
| Evaluation of GP at referral consultation | 2 items | End of treatment |
| D000217 | Acyltransferases |
| D014166 | Transferases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D014157 | Transcription Factors |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |