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

Rheumatic Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00803491
• Other study ID #: FOUS08001
• Status: Active, not recruiting
• Phase: N/A
• First received: December 4, 2008
• Last updated: August 17, 2010
• Start date: December 2008
• Est. completion date: February 2013

Study information

• Verified date: August 2010
• Source: Spenshult Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: February 2013
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Rheumatic Diseases

Intervention

Other:
• Problem based learning
Group sessions under supervision from a nurse. Each group including 8 subjects. 10 occasions during a period of one year.
• Traditional rheumatology care.
Individually base.

Locations

Country	Name	City	State
Sweden	Spenshult Hospital	Oskarström

Sponsors (3)

Lead Sponsor	Collaborator
Spenshult Hospital	County Council of Halland, Sweden, The Swedish Rheumatism Ass

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Health related quality of life as measured by SF-36		Baseline, after intervention and six, twelve and thirtysix months after	No
Secondary	Empowerment as measured by ASES-S		Baseline, after intervention and six, twelve and thirtysix months after	No
Secondary	Empowerment measured by SWE-RES-23.		Baseline, after intervention and six, twelve and thirtysix months after	No
Secondary	Self-care ability measured by ASA-A.		Baseline, after intervention and six, twelve and thirtysix months after	No
Secondary	Sense of coherence (SOC).		Baseline, after intervention and six, twelve and thirtysix months after	No