Aarhus University Hospital
Aarhus, 8000, Denmark
NCT Number: NCT05287087
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.
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Notify Me18 year–65 year
All sexes
Interventional
Not applicable
Aarhus, 8000, Denmark
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:
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Criteria for stratification:
The patients will get access to an eHealth programme consisting of:
These four provisions are identical to the first part of the MySt-2.
The patients will get access to an eHealth programme consisting of:
After 4-6 weeks, the patient will see the GP for a follow-up consultation.
Time frame: Recruitment (Week 1)
Time frame: Recruitment (Week 1)
Time frame: Recruitment (Week 1)
Time frame: Recruitment and/or referral consultation (Week 1-3 expectedly)
Time frame: Invitation for referral consultation/at referral consultation (Week 1-3 expectedly)
Time frame: 2 weeks after referral consultation (Week 4-5 expectedly)
Time frame: Recruitment (screening), programme login (baseline), end of treatment
Bodily Distress Syndrome checklist
Time frame: Recruitment (screening), programme login (baseline), end of treatment
Time frame: Recruitment (screening), programme login (baseline), end of treatment
Illness Perception Questionnaire
Time frame: Recruitment (screening), programme login (baseline), end of treatment
Symptom Checklist (SCL)-13
Time frame: Recruitment (screening), programme login (baseline), end of treatment
Whiteley-6R
Time frame: Recruitment (screening), programme login (baseline), end of treatment
One item from SF-36
Time frame: Programme login (baseline)
6 items
Time frame: Programme login (baseline)
2 items adapted from the Credibility Expectancy Questionnaire
Time frame: Programme login (baseline), end of treatment
SF-36
Time frame: Programme login (baseline), end of treatment
EQ-5D-5L (EuroQol)
Time frame: Programme login (baseline), end of treatment
Pain Self-Efficacy Questionnaire
Time frame: Programme login (baseline), end of treatment
The Behavioural Responses to Illness Questionnaire
Time frame: Programme login (baseline), end of treatment
Productivity Costs Questionnaire (IMTA)
Time frame: Programme login (baseline), end of treatment
Medical Consumption Questionnaire (IMTA)
Time frame: End of treatment
13 items
Time frame: End of treatment
1 item
Time frame: End of treatment
2 items
Aarhus University Hospital
Other
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
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