NCT00803491

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2008

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

December 4, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 5, 2008

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2010

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
Last Updated

August 18, 2010

Status Verified

August 1, 2010

Enrollment Period

1.2 years

First QC Date

December 4, 2008

Last Update Submit

August 17, 2010

Conditions

Rheumatic Diseases

Keywords

Rheumatic diseasesProblem based learningHealth-related quality of lifeEmpowermentSelf-care

Outcome Measures

Primary Outcomes (1)

  • Health related quality of life as measured by SF-36

    Baseline, after intervention and six, twelve and thirtysix months after

Secondary Outcomes (4)

  • 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

Study Arms (2)

Problem based learning program

EXPERIMENTAL

PBL intervention - a self-promoting PBL program for patients with rheumatic diseases.

Other: Problem based learning

Control group

ACTIVE COMPARATOR

Traditional rheumatological care.

Other: Traditional rheumatology care.

Interventions

Problem based learningOTHER

Group sessions under supervision from a nurse. Each group including 8 subjects. 10 occasions during a period of one year.

Problem based learning program
Traditional rheumatology care.OTHER

Individually base.

Control group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Subjects with difficulties speaking and/or read Swedish.
  • Subjects with difficulties travelling to the clinic.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Spenshult Hospital

Oskarström, SE-313 92, Sweden

Location

MeSH Terms

Conditions

Rheumatic DiseasesEmpowerment

Condition Hierarchy (Ancestors)

Musculoskeletal DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesSocial BehaviorBehavior

Study Officials

  • Susann Arvidsson, PhD-student

    R&D-centre Spenshult

    PRINCIPAL INVESTIGATOR

  • Stefan Bergman, MD, PhD

    R&D-centre Spenshult

    STUDY DIRECTOR

  • 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 CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 4, 2008

First Posted

December 5, 2008

Study Start

December 1, 2008

Primary Completion

February 1, 2010

Study Completion

February 1, 2013

Last Updated

August 18, 2010

Record last verified: 2010-08

Locations

SE(1)