Health Related Quality of Life After a Self-promoting Learning Program for People With Rheumatic Diseases

Study Overview
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Brief Summary
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Randomized controlled trial including 200 subjects with rheumatic diseases. Subjects will be randomized to either a self-promoting problem based learning (PBL) program or a control group with traditional care. The hypothesis is that a PBL program will improve health-related quality of life, empowerment and self-care ability.

Official Title
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Health Related Quality of Life After a Self-promoting Problem-based Learning Program for People With Rheumatic Diseases: a Randomized Controlled Trial

Conditions
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Rheumatic Diseases

Intervention / Treatment
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* Other: Problem based learning
* Other: Traditional rheumatology care.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects should have one or several rheumatic diseases diagnosed more than a year. Subjects should have musculoskeletal pain, sleep disturbances and fatigue, overwhelming number of days during the last three months. Subjects should be registered on the waiting list to the rheumatologic clinic. Exclusion Criteria: Subjects with difficulties speaking and/or read Swedish. Subjects with difficulties travelling to the clinic.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Problem based learning program<br>PBL intervention - a self-promoting PBL program for patients with rheumatic diseases. | Other: Problem based learning<br>* Group sessions under supervision from a nurse. Each group including 8 subjects. 10 occasions during a period of one year.<br>|
| Active Comparator: Control group<br>Traditional rheumatological care. | Other: Traditional rheumatology care.<br>* Individually base.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health related quality of life as measured by SF-36 |  | Baseline, after intervention and six, twelve and thirtysix months after | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Empowerment as measured by ASES-S |  | Baseline, after intervention and six, twelve and thirtysix months after | 
| Empowerment measured by SWE-RES-23. |  | Baseline, after intervention and six, twelve and thirtysix months after | 
| Self-care ability measured by ASA-A. |  | Baseline, after intervention and six, twelve and thirtysix months after | 
| Sense of coherence (SOC). |  | Baseline, after intervention and six, twelve and thirtysix months after | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rheumatic diseases, Problem based learning, Health-related quality of life, Empowerment, Self-care