My Symptoms - Feasibility Study

NCT05287087 | Completed

• 1 other identifier: 1-10-72-372-21
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Persistent Physical Symptoms

Outcome Measures

Primary Outcomes (6)

• Number of patients in the target age group visiting the practice

  Recruitment (Week 1)

• Number of patients refusing participation

  Recruitment (Week 1)

• Number of patients fulfilling the inclusion criteria

  Recruitment (Week 1)

• Number of patients excluded by the GPs and reasons for this

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

• 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)

• 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 Outcomes (17)

• Symptoms

  Recruitment (screening), programme login (baseline), end of treatment

• Symptom intensity and interference

  Recruitment (screening), programme login (baseline), end of treatment

• Illness perception

  Recruitment (screening), programme login (baseline), end of treatment

• Anxiety and Depression

  Recruitment (screening), programme login (baseline), end of treatment

• Health anxiety

  Recruitment (screening), programme login (baseline), end of treatment

Study Arms (2)

My Symptoms 1 (MySt-1)

ACTIVE COMPARATOR

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.

Behavioral: My Symptoms 1 (MySt-1)

My Symptoms 2 (MySt-2)

EXPERIMENTAL

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.

Behavioral: My Symptoms 2 (MySt-2)

Interventions

My Symptoms 1 (MySt-1) 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 1 (MySt-1)

My Symptoms 2 (MySt-2) 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.

My Symptoms 2 (MySt-2)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Aarhus University Hospital: lead

Study Sites (1)

Aarhus University Hospital

Aarhus, 8000, Denmark

Location

Related Links

• Program access for patients

MeSH Terms

Interventions

E1A-Associated p300 Protein

Intervention Hierarchy (Ancestors)

p300-CBP Transcription Factors; Histone Acetyltransferases; Lysine Acetyltransferases; Acetyltransferases; Acyltransferases; Transferases; Enzymes; Enzymes and Coenzymes; Transcription Factors; Proteins; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: We will inform GPs about the possibility of being assigned to one of two interventions expected to have each their advantages and disadvantages, hence being of equal value to patients. The GPs will know the content of their assignment but will not be informed about the specific content of the other intervention. Enrolled patients will only be informed whether they are to use the programme My Symptoms 1 or My Symptoms 2 accessed via a website. Outcome assessment and data analyses in this feasibility study conducted by the project researchers will not be blinded.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior researcher, PhD, General Practitioner

Study Record Dates

• First Submitted: March 10, 2022
• First Posted: March 18, 2022
• Study Start: March 31, 2022
• Primary Completion: September 30, 2022
• Study Completion: June 30, 2023
• Last Updated: February 23, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)