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

August 17, 2010 updated by: Spenshult Hospital

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Oskarström, Sweden, SE-313 92
        • Spenshult Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Problem based learning program
PBL intervention - a self-promoting PBL program for patients with rheumatic diseases.
Other: 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: Control group
Traditional rheumatological care.
Other: Traditional rheumatology care.
Individually base.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Empowerment as measured by ASES-S
Time Frame: Baseline, after intervention and six, twelve and thirtysix months after
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
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
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
Baseline, after intervention and six, twelve and thirtysix months after

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Spenshult Hospital

Collaborators

The Swedish Rheumatism Ass
County Council of Halland, Sweden

Investigators

  • Principal Investigator: Susann Arvidsson, PhD-student, R&D-centre Spenshult
  • Study Director: Stefan Bergman, MD, PhD, R&D-centre Spenshult
  • Study Chair: Barbro Arvidsson, Professor, R&D-centre Spenshult
  • Study Chair: Bengt Fridlund, Professor, University of Jönköping, Sweden
  • Study Chair: Pia Tingström, PhD, University of Linköping

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2008

Primary Completion (Anticipated)

February 1, 2010

Study Completion (Anticipated)

February 1, 2013

Study Registration Dates

First Submitted

December 4, 2008

First Submitted That Met QC Criteria

December 4, 2008

First Posted (Estimate)

December 5, 2008

Study Record Updates

Last Update Posted (Estimate)

August 18, 2010

Last Update Submitted That Met QC Criteria

August 17, 2010

Last Verified

August 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FOUS08001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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