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

NCT ID: NCT00803491

Last Updated: 2010-08-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-12-31

Study Completion Date

2013-02-28

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.

Detailed Description

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Conditions

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Rheumatic Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Problem based learning program

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

Group Type EXPERIMENTAL

Problem based learning

Intervention Type OTHER

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

Control group

Traditional rheumatological care.

Group Type ACTIVE_COMPARATOR

Traditional rheumatology care.

Intervention Type OTHER

Individually base.

Interventions

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Problem based learning

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

Intervention Type OTHER

Traditional rheumatology care.

Individually base.

Intervention Type OTHER

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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Swedish Rheumatism Ass

OTHER

Sponsor Role collaborator

County Council of Halland, Sweden

OTHER_GOV

Sponsor Role collaborator

Spenshult Hospital

OTHER

Sponsor Role lead

Responsible Party

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R&D-centre Spenshult Hospital

Principal Investigators

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Susann Arvidsson, PhD-student

Role: PRINCIPAL_INVESTIGATOR

R&D-centre Spenshult

Stefan Bergman, MD, PhD

Role: STUDY_DIRECTOR

R&D-centre Spenshult

Barbro Arvidsson, Professor

Role: STUDY_CHAIR

R&D-centre Spenshult

Bengt Fridlund, Professor

Role: STUDY_CHAIR

University of Jönköping, Sweden

Pia Tingström, PhD

Role: STUDY_CHAIR

University of Linköping

Locations

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Spenshult Hospital

Oskarström, , Sweden

Site Status

Countries

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Sweden

Other Identifiers

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FOUS08001

Identifier Type: -

Identifier Source: org_study_id

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