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

Primary Purpose

Rheumatic Diseases

Status

Unknown status

Phase

Not Applicable

Locations

Sweden

Study Type

Interventional

Intervention

Problem based learning

Traditional rheumatology care.

About this trial

This is an interventional supportive care trial for Rheumatic Diseases focused on measuring Rheumatic diseases, Problem based learning, Health-related quality of life, Empowerment, Self-care

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Spenshult Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Problem based learning program

Control group

Arm Description

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

Traditional rheumatological care.

Outcomes

Primary Outcome Measures

Health related quality of life as measured by SF-36

Secondary Outcome Measures

Empowerment as measured by ASES-S

Empowerment measured by SWE-RES-23.

Self-care ability measured by ASA-A.

Sense of coherence (SOC).

Full Information

NCT ID

NCT00803491

First Posted

December 4, 2008

Last Updated

August 17, 2010

Sponsor

Spenshult Hospital

Collaborators

The Swedish Rheumatism Ass, County Council of Halland, Sweden

1. Study Identification

Unique Protocol Identification Number

NCT00803491

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2010

Overall Recruitment Status

Unknown status

Study Start Date

December 2008 (undefined)

Primary Completion Date

February 2010 (Anticipated)

Study Completion Date

February 2013 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Spenshult Hospital

Collaborators

The Swedish Rheumatism Ass, County Council of Halland, Sweden

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Rheumatic Diseases

Keywords

Rheumatic diseases, Problem based learning, Health-related quality of life, Empowerment, Self-care

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Problem based learning program

Arm Type

Experimental

Arm Description

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

Arm Title

Control group

Arm Type

Active Comparator

Arm Description

Traditional rheumatological care.

Intervention Type

Other

Intervention Name(s)

Problem based learning

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Traditional rheumatology care.

Intervention Description

Individually base.

Primary Outcome Measure Information:

Title

Health related quality of life as measured by SF-36

Time Frame

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

Secondary Outcome Measure Information:

Title

Empowerment as measured by ASES-S

Time Frame

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

Title

Empowerment measured by SWE-RES-23.

Time Frame

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

Title

Self-care ability measured by ASA-A.

Time Frame

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

Title

Sense of coherence (SOC).

Time Frame

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

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials: