Overview

This trial is active, not recruiting.

Condition rheumatic diseases
Treatments problem based learning, traditional rheumatology care.
Sponsor Spenshult Hospital
Collaborator The Swedish Rheumatism Ass
Start date December 2008
End date February 2010
Trial size 200 participants
Trial identifier NCT00803491, FOUS08001

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose supportive care
Arm
(Experimental)
PBL intervention - a self-promoting PBL program for patients with rheumatic diseases.
problem based learning
Group sessions under supervision from a nurse. Each group including 8 subjects. 10 occasions during a period of one year.
(Active Comparator)
Traditional rheumatological care.
traditional rheumatology care.
Individually base.

Primary Outcomes

Measure
Health related quality of life as measured by SF-36
time frame: Baseline, after intervention and six, twelve and thirtysix months after

Secondary Outcomes

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

Eligibility Criteria

Male or female participants of any age.

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.

Additional Information

Official title Health Related Quality of Life After a Self-promoting Problem-based Learning Program for People With Rheumatic Diseases: a Randomized Controlled Trial
Principal investigator Susann Arvidsson, PhD-student
Trial information was received from ClinicalTrials.gov and was last updated in August 2010.
Information provided to ClinicalTrials.gov by Spenshult Hospital.