My Symptoms - Feasibility Study

NCT ID: NCT05287087

Last Updated: 2024-02-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-31
• Study Completion Date: 2023-06-30

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.

Conditions

Persistent Physical Symptoms

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

My Symptoms 1 (MySt-1)

GPs will receive an introduction to the overall content of the eHealth programme MySt-1. The information will be given to participating GPs and their staff during a 1½-hour session in the practice. The research assistant will go through the logistics of the patient recruitment and evaluation step-by-step and GPs and relevant staff will subsequently have access to the programme.

The patients will get access to a basic eHealth programme (My Symptoms 1). The programme is an internet-delivered self-help programme supporting patients' selfefficacy and behavioural changes. The programme is activated by the patient after prescription by the GP.

Group Type: ACTIVE_COMPARATOR

My Symptoms 1 (MySt-1)

Intervention Type: BEHAVIORAL

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

1. A questionnaire including the BDS checklist

2. A brief introductory animation about how to understand symptoms in general

3. Basic information on symptom in general and on six common symptoms: headache, fatigue, dizziness, pain, dyspepsia and abdominal unease.

4. 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)

GPs will attend a one-day training course of 7 hours including: in depth insight into the My Symptoms 2 eHealth programme, comprehensive understanding of PPS, training of communication skills and the use of contextual (non-specific/common psychological) factors. The training programme has been developed in cooperation with the national GP association offering CME (PLO-e). Lecturers and trainers will be GPs and psychologists from the research team.

The patients will get access to an advanced eHealth programme (My Symptoms 2). The programme is an internet-delivered self-help programme supporting patients' selfefficacy and behavioural changes. The programme is activated by the patient after prescription by the GP.

Group Type: EXPERIMENTAL

My Symptoms 2 (MySt-2)

Intervention Type: BEHAVIORAL

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

1. A questionnaire including the BDS checklist

2. A brief introductory animation about how to understand symptoms in general

3. Basic information on symptom in general and on six common symptoms: headache, fatigue, dizziness, pain, dyspepsia and abdominal unease.

4. A brief animation about the interaction of body and mind.

5. Thorough symptom explanations

6. Physical energy (focus on sleep, diet and activity)

7. Values and choices (focus on meaning and existential issues)

8. Emotional health (focus on emotion regulation)

9. Mental energy (focus on stress regulation and thinking)

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

Interventions

My Symptoms 1 (MySt-1)

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

1. A questionnaire including the BDS checklist

2. A brief introductory animation about how to understand symptoms in general

3. Basic information on symptom in general and on six common symptoms: headache, fatigue, dizziness, pain, dyspepsia and abdominal unease.

4. A brief animation about the interaction of body and mind.

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

Intervention Type: BEHAVIORAL

My Symptoms 2 (MySt-2)

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

1. A questionnaire including the BDS checklist

2. A brief introductory animation about how to understand symptoms in general

3. Basic information on symptom in general and on six common symptoms: headache, fatigue, dizziness, pain, dyspepsia and abdominal unease.

4. A brief animation about the interaction of body and mind.

5. Thorough symptom explanations

6. Physical energy (focus on sleep, diet and activity)

7. Values and choices (focus on meaning and existential issues)

8. Emotional health (focus on emotion regulation)

9. Mental energy (focus on stress regulation and thinking)

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

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Aarhus University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Marianne Rosendal

Senior researcher, PhD, General Practitioner

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Aarhus University Hospital

Aarhus, , Denmark

Countries

Denmark

Related Links

https://mine-symptomer.dk/

Program access for patients

Other Identifiers

1-10-72-372-21

Identifier Type: -

Identifier Source: org_study_id