My Symptoms - Feasibility Study

NCT05287087 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2024-02-23

No results posted yet for this study

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

Interventions

BEHAVIORAL

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.

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.

Sponsors & Collaborators

  • Aarhus University Hospital

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-31
Primary Completion
2022-09-30
Completion
2023-06-30

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05287087 on ClinicalTrials.gov