Rheumatic DiseasesNCT00803491
Health Related Quality of Life After a Self-promoting Learning Program for People With Rheumatic Diseases
A study testing Problem based learning and Traditional rheumatology care. in people with Rheumatic Diseases, run by Spenshult Hospital at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Rheumatic Diseases
- What is being tested?
- Problem based learning and Traditional rheumatology care.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteSweden
- Study dates
- Dec 2008to Feb 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Subjects with difficulties speaking and/or read Swedish.
- Subjects with difficulties travelling to the clinic.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Rheumatic Diseases
- Being tested
- Problem based learning, Traditional rheumatology care.
- Keywords
- Rheumatic diseases, Problem based learning, Health-related quality of life, Empowerment, Self-care
- Medical subject headings
- Rheumatic Diseases, Empowerment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Problem based learningOther
Group sessions under supervision from a nurse. Each group including 8 subjects. 10 occasions during a period of one year.
Traditional rheumatology care.Other
Individually base.
| Study group | Role | What they receive |
|---|---|---|
| Problem based learning program | Experimental | PBL intervention - a self-promoting PBL program for patients with rheumatic diseases. Receives: Other: Problem based learning |
| Control group | Active comparator | Traditional rheumatological care. Receives: Other: Traditional rheumatology care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health related quality of life as measured by SF-36
Measured: Baseline, after intervention and six, twelve and thirtysix months after
Secondary outcomes (4)
Empowerment as measured by ASES-S
Measured: Baseline, after intervention and six, twelve and thirtysix months after
Empowerment measured by SWE-RES-23.
Measured: Baseline, after intervention and six, twelve and thirtysix months after
Self-care ability measured by ASA-A.
Measured: Baseline, after intervention and six, twelve and thirtysix months after
Sense of coherence (SOC).
Measured: Baseline, after intervention and six, twelve and thirtysix months after
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2008 (estimated)
- Study startDec 2008
- Primary completionFeb 2010 (estimated)
- Study completionFeb 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatic DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Spenshult Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The Swedish Rheumatism Ass, County Council of Halland, Sweden
- Investigators
- Susann Arvidsson, PhD-student, Principal investigator, R&D-centre SpenshultStefan Bergman, MD, PhD, Study director, R&D-centre SpenshultBarbro Arvidsson, Professor, Study chair, R&D-centre SpenshultBengt Fridlund, Professor, Study chair, University of Jönköping, SwedenPia Tingström, PhD, Study chair, University of Linköping
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00803491
- Sponsor's protocol ID
- FOUS08001
- Status last verified
- Aug 2010
- First submitted
- 4 Dec 2008
- Last updated
- 18 Aug 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health Related Quality of Life After a Self-promoting Problem-based Learning Program for People With Rheumatic Diseases: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT00803491
- Acronym / sponsor ID
- FOUS08001
- Conditions
- Rheumatic Diseases
- Keywords
- Rheumatic diseases, Problem based learning, Health-related quality of life, Empowerment, Self-care
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Spenshult HospitalUniversity, hospital or other
- Collaborators
- The Swedish Rheumatism Ass, County Council of Halland, Sweden
- Study start
- Dec 2008
- Primary completion
- Feb 2010 (estimated)
- Study completion
- Feb 2013 (estimated)
- First posted
- 5 Dec 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Problem based learning program | Experimental | Other: Problem based learningPBL intervention - a self-promoting PBL program for patients with rheumatic diseases. |
| Control group | Active comparator | Other: Traditional rheumatology care.Traditional rheumatological care. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- Subjects with difficulties speaking and/or read Swedish.
- Subjects with difficulties travelling to the clinic.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Problem based learningGroup sessions under supervision from a nurse. Each group including 8 subjects. 10 occasions during a period of one year. | Other | Problem based learning program |
| Traditional rheumatology care.Individually base. | Other | Control group |
Primary outcome
Health related quality of life as measured by SF-36
Time frame: Baseline, after intervention and six, twelve and thirtysix months after
4 secondary outcomes
Empowerment as measured by ASES-S
Time frame: 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
Self-care ability measured by ASA-A.
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susann Arvidsson, PhD-student principal investigator
R&D-centre Spenshult
Stefan Bergman, MD, PhD study director
R&D-centre Spenshult
Barbro Arvidsson, Professor study chair
R&D-centre Spenshult
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Problem based learning and Traditional rheumatology care. in people with Rheumatic Diseases, run by Spenshult Hospital at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Aug 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health related quality of life as measured by SF-36 (time frame: Baseline, after intervention and six, twelve and thirtysix months after). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2010.