Clinical trial NCT06163014: My Symptoms: an eHealth and GP Assisted Programme for Persistent Symptoms in Primary Care
Official title: My Symptoms: a Before-After Evaluation of an eHealth and GP Assisted Programme for Persistent Symptoms in Primary Care (eASY)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Persistent Physical Symptoms
Lead sponsor: Aarhus University Hospital
Sponsor class: OTHER
First posted: 2023-12-08
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.

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.

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

Primary outcomes:
measure: Change in symptom intensity
timeFrame: Baseline to end of treatment (week 8)
measure: Change in symptom interference
timeFrame: Baseline to end of treatment (week 8)
Secondary outcomes:
measure: Change in symptom intensity
timeFrame: Baseline to 3 months after end of treatment
measure: Change in symptom interference
timeFrame: Baseline to 3 months after end of treatment
measure: Change in symptom burden
timeFrame: Baseline to end of treatment (week 8)
measure: Change in symptom burden
timeFrame: Baseline to 3 months after end of treatment
measure: Bodily Distress Syndrome
timeFrame: Baseline
measure: Bodily Distress Syndrome
timeFrame: End of treatment (week 8)
measure: Bodily Distress Syndrome
timeFrame: 3 months after end of treatment
measure: Change in illness perception
timeFrame: Baseline to end of treatment (week 8)
measure: Change in illness perception
timeFrame: Baseline to 3 months after end of treatment
measure: Change in illness worry
timeFrame: Baseline to end of treatment (week 8)
measure: Change in illness worry
timeFrame: Baseline to 3 months after end of treatment
measure: Anxiety
timeFrame: Baseline
measure: Anxiety
timeFrame: End of treatment (week 8)
measure: Anxiety
timeFrame: 3 months after end of treatment
measure: Depression
timeFrame: Baseline
measure: Depression
timeFrame: End of treatment (week 8)
measure: Depression
timeFrame: 3 months after end of treatment
measure: Distress
timeFrame: Baseline
measure: Distress
timeFrame: End of treatment (week 8)
measure: Distress
timeFrame: 3 months after end of treatment
measure: Change of hope
timeFrame: Baseline to end of treatment (week 8)
measure: Change of hope
timeFrame: Baseline to 3 months after end of treatment
measure: Change in stress
timeFrame: Baseline to end of treatment (week 8)
measure: Change in stress
timeFrame: Baseline to 3 months after end of treatment
measure: Change in limiting behaviour
timeFrame: Baseline to end of treatment (week 8)
measure: Change in limiting behaviour
timeFrame: Baseline to 3 months after end of treatment
measure: Change in all or nothing behaviour
timeFrame: Baseline to end of treatment (week 8)
measure: Change in all or nothing behaviour
timeFrame: Baseline to 3 months after end of treatment
measure: Change in confidence in performing activities in the context of PPS
timeFrame: Baseline to end of treatment (week 8)
measure: Change in confidence in performing activities in the context of PPS
timeFrame: Baseline to 3 months after end of treatment
measure: Change in health-related quality of life
timeFrame: Baseline to end of treatment (week 8)
measure: Change in health-related quality of life
timeFrame: Baseline to 3 months after end of treatment
measure: Health-related quality of life
timeFrame: Baseline
measure: Health-related quality of life
timeFrame: End of treatment (week 8)
measure: Health-related quality of life
timeFrame: 3 months after end of treatment
measure: Credibility related to the eHealth programme
timeFrame: Baseline
measure: Expectancy related to the eHealth programme
timeFrame: Baseline
measure: Evaluation of the referral consultation
timeFrame: Baseline
measure: Evaluation of the eHealth programme
timeFrame: End of treatment (week 8)
measure: Recommendation of the eHealth programme
timeFrame: End of treatment (week 8)
measure: Evaluation of the follow up consultation
timeFrame: End of treatment (week 8)
measure: Self-rated global health change
timeFrame: End of treatment (week 8)
measure: Self-rated global health change
timeFrame: 3 months after end of treatment
measure: Adverse events
timeFrame: End of treatment (week 8)
measure: Adverse events
timeFrame: 3 months after end of treatment
measure: Quality-adjusted life year (QALY)
timeFrame: 6 months after end of treatment
measure: Changes in health care use
timeFrame: 6 months before baseline compared to 6 months after end of treatment
measure: Changes in productivity costs
timeFrame: 6 months before baseline compared to 6 months after end of treatment
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
Study officials:
References: