Ignite Creation Date:
2024-05-06 @ 7:52 PM
Last Modification Date:
2024-10-26 @ 3:15 PM
Study NCT ID:
NCT06163014
Status:
RECRUITING
Last Update Posted:
2024-02-02
First Post:
2023-06-08
Brief Title:
My Symptoms an eHealth and GP Assisted Programme for Persistent Symptoms in Primary Care
Sponsor:
Aarhus University Hospital
Organization:
Aarhus University Hospital
Study Overview
Official Title:
My Symptoms a Before-After Evaluation of an eHealth and GP Assisted Programme for Persistent Symptoms in Primary Care eASY
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
eASY
Brief Summary:
The project My Symptoms is part of a large research programme eHealth and GP-assisted self-help interventions for persistent physical symptoms eASY See wwwmine-symptomerdk
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 As part of the research programme the investigators have developed a web-based self-help programme for patient with PPS This treatment programme is prescribed by the patients general practitioner GP Only GPs who have participated in a short introduction course will be allowed for prescriptions
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 by GPs and patients
With this study the investigators wish to follow the national implementation using a before-after study design describing uptake and effects on GPs patients and the health care system
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 As part of the research programme the investigators have developed a web-based self-help programme for patient with PPS This treatment programme is prescribed by the patients general practitioner GP Only GPs who have participated in a short introduction course will be allowed for prescriptions
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 by GPs and patients
With this study the investigators wish to follow the national implementation using a before-after study design describing uptake and effects on GPs patients and the health care system
Detailed Description:
The project aims to evaluate the uptake and effects of the new self-help programme for PPS the My Symptoms programme prescribed and followed up by GPs
Specific objectives are to
1 Describe the use of the programme during routine care This includes
1 Determination of the number of patients per GP who access the programme after prescription from their GPs adoption
2 A description of how often the follow-up consultation is completed according to the patients
2 Explore patient characteristics appropriateness
3 Describe patients engagement with the programme with regard to time and frequency of access to modules and tools fidelity
4 Evaluate effects on patients health quality of life functioning and satisfaction with care
5 Estimate effects on patients use of health care services
6 Estimate effects on patients work productivity
7 Estimate possible effects on health care costs provided the intervention is fully disseminated nationally
Specific objectives are to
1 Describe the use of the programme during routine care This includes
1 Determination of the number of patients per GP who access the programme after prescription from their GPs adoption
2 A description of how often the follow-up consultation is completed according to the patients
2 Explore patient characteristics appropriateness
3 Describe patients engagement with the programme with regard to time and frequency of access to modules and tools fidelity
4 Evaluate effects on patients health quality of life functioning and satisfaction with care
5 Estimate effects on patients use of health care services
6 Estimate effects on patients work productivity
7 Estimate possible effects on health care costs provided the intervention is fully disseminated nationally
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None