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

NCT06163014 | Recruiting

• 1 other identifier: 1-10-72-222-22
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Persistent Physical Symptoms

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (48)

• Change in symptom intensity

  Baseline to 3 months after end of treatment

• Change in symptom interference

  Baseline to 3 months after end of treatment

• Change in symptom burden

  Baseline to end of treatment (week 8)

• Change in symptom burden

  Baseline to 3 months after end of treatment

• Bodily Distress Syndrome

  Baseline

Study Arms (1)

Patients

Patients with persistent physical symptoms consulting their GP and referred to the My Symptoms eHealth programme.

Behavioral: My Symptoms eHealth programme

Interventions

My Symptoms eHealth programme BEHAVIORAL

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.

Patients

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Only patients who consult their GP will be eligible for participation. Patients will need a referral from their GP to be able to access the 'My Symptoms' programme using a specific code. All patients who consent to participate and login to the programme will be included in the present study. The GP will assess whether prescription of the 'My Symptoms' programme is relevant. As a guide for this assessment, the GP will be provided with the inclusion and exclusion criteria during their training programme.

You may qualify if:

• Age 18-65 (target population for the programme)
• The consultation targets symptom complaints
• Listed with participating practice.

You may not qualify if:

• 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

Sponsors & Collaborators

• Aarhus University Hospital: lead

Study Sites (1)

Aarhus University Hospital

Aarhus, Denmark

RECRUITING

Related Links

• Project website

Central Study Contacts

Marianne Rosendal, PhD

CONTACT

+4521476826; marose@rm.dk

Lisbeth Frostholm, PhD

CONTACT

lisfro@rm.dk

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, senior researcher, MD, PhD

Study Record Dates

• First Submitted: June 8, 2023
• First Posted: December 8, 2023
• Study Start: December 1, 2023
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 13, 2025

Record last verified: 2025-02

Locations

DK (1)