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Completed

NCT Number: NCT05287087

My Symptoms - Feasibility Study

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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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aarhus University Hospital

Aarhus, 8000, Denmark

About this study

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:

  • Which modifications are needed to the predefined procedures for consecutive patient enrolment?
  • 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?)
  • To what extent do patients accept and engage with the baseline research questionnaires?
  • When do included patients engage with the programme after enrolment (delay in time)?
  • 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?
  • How many patients consult the GP for a follow-up consultation and when does this consultation take place?
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

My Symptoms 1 (MySt-1)

Behavioral

The patients will get access to an eHealth programme consisting of:

  • A questionnaire including the BDS checklist
  • A brief introductory animation about how to understand symptoms in general
  • Basic information on symptom in general and on six common symptoms: headache, fatigue, dizziness, pain, dyspepsia and abdominal unease.
  • A brief animation about the interaction of body and mind.

These four provisions are identical to the first part of the MySt-2.

My Symptoms 2 (MySt-2)

Behavioral

The patients will get access to an eHealth programme consisting of:

  • A questionnaire including the BDS checklist
  • A brief introductory animation about how to understand symptoms in general
  • Basic information on symptom in general and on six common symptoms: headache, fatigue, dizziness, pain, dyspepsia and abdominal unease.
  • A brief animation about the interaction of body and mind.
  • Thorough symptom explanations
  • Physical energy (focus on sleep, diet and activity)
  • Values and choices (focus on meaning and existential issues)
  • Emotional health (focus on emotion regulation)
  • Mental energy (focus on stress regulation and thinking)

After 4-6 weeks, the patient will see the GP for a follow-up consultation.

Primary outcomes

  1. Number of patients in the target age group visiting the practice

    Time frame: Recruitment (Week 1)

  2. Number of patients refusing participation

    Time frame: Recruitment (Week 1)

  3. Number of patients fulfilling the inclusion criteria

    Time frame: Recruitment (Week 1)

  4. Number of patients excluded by the GPs and reasons for this

    Time frame: Recruitment and/or referral consultation (Week 1-3 expectedly)

  5. Number of patients not accepting the invitation for intervention despite consent to participate in the project (drop-outs)

    Time frame: Invitation for referral consultation/at referral consultation (Week 1-3 expectedly)

  6. Number of patients who do not log into the programme within 2 weeks from referral or only log into the programme once (drop-outs)

    Time frame: 2 weeks after referral consultation (Week 4-5 expectedly)

Secondary outcomes

  1. Symptoms

    Time frame: Recruitment (screening), programme login (baseline), end of treatment

    Bodily Distress Syndrome checklist

  2. Symptom intensity and interference

    Time frame: Recruitment (screening), programme login (baseline), end of treatment

  3. Illness perception

    Time frame: Recruitment (screening), programme login (baseline), end of treatment

    Illness Perception Questionnaire

  4. Anxiety and Depression

    Time frame: Recruitment (screening), programme login (baseline), end of treatment

    Symptom Checklist (SCL)-13

  5. Health anxiety

    Time frame: Recruitment (screening), programme login (baseline), end of treatment

    Whiteley-6R

  6. Global health

    Time frame: Recruitment (screening), programme login (baseline), end of treatment

    One item from SF-36

  7. Evaluation of GP at referral consultation

    Time frame: Programme login (baseline)

    6 items

  8. Program expectations

    Time frame: Programme login (baseline)

    2 items adapted from the Credibility Expectancy Questionnaire

  9. Quality of life

    Time frame: Programme login (baseline), end of treatment

    SF-36

  10. Quality of life

    Time frame: Programme login (baseline), end of treatment

    EQ-5D-5L (EuroQol)

  11. Pain self-efficacy

    Time frame: Programme login (baseline), end of treatment

    Pain Self-Efficacy Questionnaire

  12. Illness behavior

    Time frame: Programme login (baseline), end of treatment

    The Behavioural Responses to Illness Questionnaire

  13. Productivity Costs

    Time frame: Programme login (baseline), end of treatment

    Productivity Costs Questionnaire (IMTA)

  14. Health care utilization

    Time frame: Programme login (baseline), end of treatment

    Medical Consumption Questionnaire (IMTA)

  15. Program evaluation

    Time frame: End of treatment

    13 items

  16. Global impression of change

    Time frame: End of treatment

    1 item

  17. Evaluation of GP at referral consultation

    Time frame: End of treatment

    2 items

Sponsors and collaborators

Lead sponsor

Aarhus University Hospital

Other

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Mar 18, 2022
Registry last updated
Feb 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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