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RecruitingNCT06163014

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

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

Status
Recruiting
Phase
Study type
Observational
Enrollment
120 (estimated)
Sponsor
Aarhus University Hospital · Academic / Other
Sex
All
Age
18 Years – 65 Years
Healthy volunteers
Not accepted

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.

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALMy Symptoms eHealth programmeMy 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.

Timeline

Start date
2023-12-01
Primary completion
2026-09-01
Completion
2026-12-01
First posted
2023-12-08
Last updated
2025-02-13

Locations

1 site across 1 country: Denmark

Source: ClinicalTrials.gov record NCT06163014. Inclusion in this directory is not an endorsement.