My Symptoms - Feasibility Study

Persistent Physical Symptoms Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05287087
• Other study ID #: 1-10-72-372-21
• Status: Completed
• Phase: N/A
• Start date: March 31, 2022
• Est. completion date: June 30, 2023

Study information

• Verified date: February 2024
• Source: Aarhus University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: June 30, 2023
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Persistent Physical Symptoms

Intervention

Behavioral:
• My Symptoms 1 (MySt-1)
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)
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.

Locations

Country	Name	City	State
Denmark	Aarhus University Hospital	Aarhus

Sponsors (1)

Lead Sponsor	Collaborator
Aarhus University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients in the target age group visiting the practice		Recruitment (Week 1)
Primary	Number of patients refusing participation		Recruitment (Week 1)
Primary	Number of patients fulfilling the inclusion criteria		Recruitment (Week 1)
Primary	Number of patients excluded by the GPs and reasons for this		Recruitment and/or referral consultation (Week 1-3 expectedly)
Primary	Number of patients not accepting the invitation for intervention despite consent to participate in the project (drop-outs)		Invitation for referral consultation/at referral consultation (Week 1-3 expectedly)
Primary	Number of patients who do not log into the programme within 2 weeks from referral or only log into the programme once (drop-outs)		2 weeks after referral consultation (Week 4-5 expectedly)
Secondary	Symptoms	Bodily Distress Syndrome checklist	Recruitment (screening), programme login (baseline), end of treatment
Secondary	Symptom intensity and interference		Recruitment (screening), programme login (baseline), end of treatment
Secondary	Illness perception	Illness Perception Questionnaire	Recruitment (screening), programme login (baseline), end of treatment
Secondary	Anxiety and Depression	Symptom Checklist (SCL)-13	Recruitment (screening), programme login (baseline), end of treatment
Secondary	Health anxiety	Whiteley-6R	Recruitment (screening), programme login (baseline), end of treatment
Secondary	Global health	One item from SF-36	Recruitment (screening), programme login (baseline), end of treatment
Secondary	Evaluation of GP at referral consultation	6 items	Programme login (baseline)
Secondary	Program expectations	2 items adapted from the Credibility Expectancy Questionnaire	Programme login (baseline)
Secondary	Quality of life	SF-36	Programme login (baseline), end of treatment
Secondary	Quality of life	EQ-5D-5L (EuroQol)	Programme login (baseline), end of treatment
Secondary	Pain self-efficacy	Pain Self-Efficacy Questionnaire	Programme login (baseline), end of treatment
Secondary	Illness behavior	The Behavioural Responses to Illness Questionnaire	Programme login (baseline), end of treatment
Secondary	Productivity Costs	Productivity Costs Questionnaire (IMTA)	Programme login (baseline), end of treatment
Secondary	Health care utilization	Medical Consumption Questionnaire (IMTA)	Programme login (baseline), end of treatment
Secondary	Program evaluation	13 items	End of treatment
Secondary	Global impression of change	1 item	End of treatment
Secondary	Evaluation of GP at referral consultation	2 items	End of treatment

External Links

•   Program access for patients