Clinical trial NCT05287087: My Symptoms - Feasibility Study
Official title: My Symptoms - Feasibility Study: Feasibility of Intervention and Evaluation of an eHealth and GP Assisted Programme for Persistent Symptoms in Primary Care for Persistent Symptoms in Primary Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Persistent Physical Symptoms
Lead sponsor: Aarhus University Hospital
Sponsor class: OTHER
First posted: 2022-03-18
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The proposed project 'My Symptoms' is part of a large research programme: eHealth and GP-assisted self-help interventions for persistent physical symptoms (eASY). See www.minesymptomer.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. In order to improve health care for patients with PPS, the investigators have developed a web-based selfhelp programme for symptoms. As part of the intervention, this programme is prescribed by the patient's general practitioner (GP). 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 and how it affects GPs in routine care and patients in daily life. With this study, the investigators wish to take the first step towards a comprehensive and rigorous evaluation. Results from this feasibility study will both qualify a subsequent randomised controlled trial (RCT) in a larger pilot study and provide information for a potential national dissemination.

Detailed description: Drawing on existing evidence about symptoms, functional disorders and eHealth interventions combined with user involvement, the investigators have developed a web-based self-help programme for PPS: "My Symptoms". The programme builds on the bio-psycho-socialexistential illness model and enhanced cognitive behavioural theory. Seven treatment modules focus on psychoeducation, lifestyle intervention, self-regulation and graded exercise delivered through text, videos, animations and audio files (see overview of content in table 1). Furthermore, it includes a 1-day course for GPs and a mandatory follow-up appointment between patient and GP at the programme closure. The training course for the GPs will focus on patient identification, positive reinforcement and familiarity with the content of the programme. The programme must be prescribed by GPs and is recommended to use for 6 weeks.

The objectives with the present feasibility study are: 1) to test and refine the GP training course, 2) to explore the planned logistics for patient recruitment, 3) to evaluate GP and patient questionnaires, and 4) to evaluate patients' use of the programme and 5) follow-up consultations with their GP.

With regard to 2-5, the following questions will be adressed and explored:

1. Which modifications are needed to the predefined procedures for consecutive patient enrolment?
2. What are the results of patient enrolment with respect to recruitment rates and patient characteristics? (Patients are asked and screened consecutively, but how many accept participation and fulfil inclusion criteria? What characterises enrolled patients compared to refusers?)
3. To what extent do patients accept and engage with the baseline research questionnaires?
4. When do included patients engage with the programme after enrolment (delay in time)?
5. How much do included patients interact with the intervention, i.e. how many patients log into the program, which modules and pages are accessed, and how many tools are used?
6. How many patients consult the GP for a follow-up consultation and when does this consultation take place?
7. How many contacts do the patients have to participating practices during their use of the programme?

Alongside this part of the feasibility study, the investigators will conduct a separate in-depth qualitative study (field study observations and interviews) on GP and patient interactions with the intervention. A separate protocol has been developed for this part of the feasibility study.

Eligibility criteria: Inclusion Criteria:

* Listed with participating practice
* Giving informed consent to participation in the study
* Consulting a GP or GP supervised staff
* Multiple symptoms, i.e. 4 or more symptoms within the past 4 weeks, according to the Bodily Distress Syndrome checklist (a validated symptom checklist with 25 items)

Exclusion Criteria:

* Not consulting for symptoms
* Symptoms are due to acute disease
* Symptoms must primarily be treated by medicine or surgery
* Not eligible due to language or cognitive problems
* Patient severely affected by other disease
* Other, GP assessment/statement (e.g.: All symptoms are with recent onset and I see no need for intervention at present, I do not believe the patient will benefit the least bit from participation in the eHealth programme at this time)
* Patient declines to use the eHealth program despite GP recommendation
* Patient has not accessed the programme within 2 weeks from referral from the GP

Criteria for stratification:

- Long-term sick leave, i.e. more than 8 weeks, will be a criterion for stratification in order to enable analyses on the target group of patients with PPS without chronicity

Primary outcomes:
measure: Number of patients in the target age group visiting the practice
timeFrame: Recruitment (Week 1)
measure: Number of patients refusing participation
timeFrame: Recruitment (Week 1)
measure: Number of patients fulfilling the inclusion criteria
timeFrame: Recruitment (Week 1)
measure: Number of patients excluded by the GPs and reasons for this
timeFrame: Recruitment and/or referral consultation (Week 1-3 expectedly)
measure: Number of patients not accepting the invitation for intervention despite consent to participate in the project (drop-outs)
timeFrame: Invitation for referral consultation/at referral consultation (Week 1-3 expectedly)
measure: Number of patients who do not log into the programme within 2 weeks from referral or only log into the programme once (drop-outs)
timeFrame: 2 weeks after referral consultation (Week 4-5 expectedly)
Secondary outcomes:
measure: Symptoms
timeFrame: Recruitment (screening), programme login (baseline), end of treatment
measure: Symptom intensity and interference
timeFrame: Recruitment (screening), programme login (baseline), end of treatment
measure: Illness perception
timeFrame: Recruitment (screening), programme login (baseline), end of treatment
measure: Anxiety and Depression
timeFrame: Recruitment (screening), programme login (baseline), end of treatment
measure: Health anxiety
timeFrame: Recruitment (screening), programme login (baseline), end of treatment
measure: Global health
timeFrame: Recruitment (screening), programme login (baseline), end of treatment
measure: Evaluation of GP at referral consultation
timeFrame: Programme login (baseline)
measure: Program expectations
timeFrame: Programme login (baseline)
measure: Quality of life
timeFrame: Programme login (baseline), end of treatment
measure: Quality of life
timeFrame: Programme login (baseline), end of treatment
measure: Pain self-efficacy
timeFrame: Programme login (baseline), end of treatment
measure: Illness behavior
timeFrame: Programme login (baseline), end of treatment
measure: Productivity Costs
timeFrame: Programme login (baseline), end of treatment
measure: Health care utilization
timeFrame: Programme login (baseline), end of treatment
measure: Program evaluation
timeFrame: End of treatment
measure: Global impression of change
timeFrame: End of treatment
measure: Evaluation of GP at referral consultation
timeFrame: End of treatment
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
Study officials:
References: