Nurse-led Clinic for Patients With Rheumatic Diseases and Biological Treatment
Recruitment status was Recruiting
| Tracking Information | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Received Date ICMJE | October 8, 2009 | ||||||||||||||||
| Last Updated Date | August 17, 2010 | ||||||||||||||||
| Start Date ICMJE | October 2009 | ||||||||||||||||
| Estimated Primary Completion Date | October 2011 (final data collection date for primary outcome measure) | ||||||||||||||||
| Current Primary Outcome Measures ICMJE |
DAS28 and costs for the clinics respectively. [ Time Frame: Baseline at 0 months, 6 months, 12 months ] [ Designated as safety issue: No ] | ||||||||||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||||||||||
| Change History | Complete list of historical versions of study NCT01071447 on ClinicalTrials.gov Archive Site | ||||||||||||||||
| Current Secondary Outcome Measures ICMJE |
HAQ (Health Assessment Questionnaire), VAS-pain (Visual Analog Scale), VAS-global health, VAS-satisfaction, VAS-security/trust, Tender joints, swollen joints, Quality of life-EQ5D, Effective consumer survey 17, Inflammatory parameters in blood. [ Time Frame: Baseline at 0 months, 6 months, 12 months ] [ Designated as safety issue: No ] | ||||||||||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||||||||||
| Descriptive Information | |||||||||||||||||
| Brief Title ICMJE | Nurse-led Clinic for Patients With Rheumatic Diseases and Biological Treatment | ||||||||||||||||
| Official Title ICMJE | Nurse-led Clinic for Patients With Rheumatic Diseases and Biological Treatment:a Randomized Controlled Trial Comparing Nurse-led Clinic Versus Rheumatologist Clinic | ||||||||||||||||
| Brief Summary | Randomized controlled trial including 100 subjects with rheumatic diseases and biological treatment with a 28 point-Disease Activity Score(DAS28)3.2 or less. The subjects will be randomized to either nurse-led clinic or rheumatologist-led clinic. The hypothesis is that there will be no difference in DAS28 between the two groups after 1 year follow-up. |
||||||||||||||||
| Detailed Description | Aim To compare nurse-led clinic and rheumatologist-led clinic regarding results of treatment, and health economic costs. Intervention Rheumatologist-led clinic: The subjects are seeing a rheumatologist after six months and after 12-months of intervention and have the possibility to contact the rheumatology clinic. Nurse-led clinic: The subjects are seeing a rheumatology nurse after six months and a rheumatologist after 12 months of intervention and have the possibility to contact the rheumatology nurse during the intervention. Outcome measures: Main outcome: DAS28 and costs for the clinics respectively. Secondary outcome: HAQ (Health Assessment Questionnaire), VAS-pain (Visual Analog Scale), VAS-global health, VAS-satisfaction, VAS-security/trust, Tender joints, swollen joints, Quality of life-EQ5D, Effective consumer survey 17, Inflammatory parameters in blood. |
||||||||||||||||
| Study Type ICMJE | Interventional | ||||||||||||||||
| Study Phase | Not Provided | ||||||||||||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Supportive Care |
||||||||||||||||
| Condition ICMJE | Rheumatic Diseases | ||||||||||||||||
| Intervention ICMJE | Other: Nurse-led clinic vs rheumatologist-led clinic
The subjects are seeing a rheumatology nurse (experimental arm)instead of a rheumatologist (active comparator arm) after six months. Subjects in both arms are seeing a rheumatologist after 12 months and have the possibility to contact the rheumatology nurse.
Other Names:
|
||||||||||||||||
| Study Arm (s) |
|
||||||||||||||||
| Publications * | Not Provided | ||||||||||||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||||||||||||||
| Recruitment Information | |||||||||||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||||||||||
| Estimated Enrollment ICMJE | 100 | ||||||||||||||||
| Estimated Completion Date | October 2012 | ||||||||||||||||
| Estimated Primary Completion Date | October 2011 (final data collection date for primary outcome measure) | ||||||||||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||||||||||||||
| Gender | Both | ||||||||||||||||
| Ages | Not Provided | ||||||||||||||||
| Accepts Healthy Volunteers | No | ||||||||||||||||
| Contacts ICMJE |
|
||||||||||||||||
| Location Countries ICMJE | Sweden | ||||||||||||||||
| Administrative Information | |||||||||||||||||
| NCT Number ICMJE | NCT01071447 | ||||||||||||||||
| Other Study ID Numbers ICMJE | FoUS09001 | ||||||||||||||||
| Has Data Monitoring Committee | Yes | ||||||||||||||||
| Responsible Party | Stefan Bergman, Research Director, R&D-centre Spenshult Hospital | ||||||||||||||||
| Study Sponsor ICMJE | Spenshult Hospital | ||||||||||||||||
| Collaborators ICMJE |
|
||||||||||||||||
| Investigators ICMJE |
|
||||||||||||||||
| Information Provided By | Spenshult Hospital | ||||||||||||||||
| Verification Date | August 2010 | ||||||||||||||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||||||||||||||