My Symptoms: an eHealth and GP Assisted Programme for Persistent Symptoms in Primary Care
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: My Symptoms eHealth programme.
- Who it may be relevant to
- Registry conditions: Persistent Physical Symptoms. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Denmark
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
My Symptoms: a Before-After Evaluation of an eHealth and GP Assisted Programme for Persistent Symptoms in Primary Care (eASY)
Overview
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
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.
Interventions
- 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: 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 (meanin
Primary outcome measures
- Change in symptom intensity [Time frame: Baseline to end of treatment (week 8)]
- Change in symptom interference [Time frame: Baseline to end of treatment (week 8)]
Secondary outcome measures (12)
- Change in symptom intensity [Time frame: Baseline to 3 months after end of treatment]
- Change in symptom interference [Time frame: Baseline to 3 months after end of treatment]
- Change in symptom burden [Time frame: Baseline to end of treatment (week 8)]
- Change in symptom burden [Time frame: Baseline to 3 months after end of treatment]
- Bodily Distress Syndrome [Time frame: Baseline]
- Bodily Distress Syndrome [Time frame: End of treatment (week 8)]
- Bodily Distress Syndrome [Time frame: 3 months after end of treatment]
- Change in illness perception [Time frame: Baseline to end of treatment (week 8)]
- Change in illness perception [Time frame: Baseline to 3 months after end of treatment]
- Change in illness worry [Time frame: Baseline to end of treatment (week 8)]
- Change in illness worry [Time frame: Baseline to 3 months after end of treatment]
- Anxiety [Time frame: Baseline]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
Denmark · 1 center
- Aarhus University Hospital — Aarhus
Identifiers
NCT: NCT06163014 · 1-10-72-222-22