My Symptoms: an eHealth and GP Assisted Programme for Persistent Symptoms in Primary Care
NCT ID: NCT06163014
Last Updated: 2025-02-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
120 participants
OBSERVATIONAL
2023-12-01
2026-12-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Patients
Patients with persistent physical symptoms consulting their GP and referred to the My Symptoms eHealth programme.
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:
1. Symptom explanations and facts about frequent symptoms including brief animated explanations
2. Physical energy (sleep, diet and activity)
3. Working with resources and strain in everyday life
4. Values and choices (meaning and existential issues)
5. Thoughts
6. Feelings (emotion regulation)
7. Self-care (attention incl. mindfulness and audio exercises)
8. 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.
Interventions
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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:
1. Symptom explanations and facts about frequent symptoms including brief animated explanations
2. Physical energy (sleep, diet and activity)
3. Working with resources and strain in everyday life
4. Values and choices (meaning and existential issues)
5. Thoughts
6. Feelings (emotion regulation)
7. Self-care (attention incl. mindfulness and audio exercises)
8. 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.
Eligibility Criteria
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Inclusion Criteria
* The consultation targets symptom complaints
* Listed with participating practice.
Exclusion Criteria
* Symptoms must primarily be treated by medicine or surgery
* Patient severely affected by other disease
* Not eligible due to language or cognitive problems
18 Years
65 Years
ALL
No
Sponsors
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Aarhus University Hospital
OTHER
Responsible Party
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Marianne Rosendal
Principal Investigator, senior researcher, MD, PhD
Locations
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Aarhus University Hospital
Aarhus, , Denmark
Countries
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Central Contacts
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Facility Contacts
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Related Links
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Project website
Other Identifiers
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1-10-72-222-22
Identifier Type: -
Identifier Source: org_study_id
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