Rheumatic DiseasesNCT01071447
Nurse-led Clinic for Patients With Rheumatic Diseases and Biological Treatment
A study testing Nurse-led clinic vs rheumatologist-led clinic in people with Rheumatic Diseases, run by Spenshult Hospital at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Rheumatic Diseases
- What is being tested?
- Nurse-led clinic vs rheumatologist-led clinic
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSweden
- Study dates
- Oct 2009to Oct 2012
- 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 with rheumatologic diseases and biological treatment with a DAS28 of 3.2 or less
Who cannot join
- The subjects should not have problems with infections due to treatment
- Subjects with difficulties speaking and/or reading swedish
Trial locations and contacts
1 site in 1 country.
Sweden1 site, 1 recruiting
- Recruiting
Spenshult Hospital
Oskarström, Oskarström, S-31392
Stefan Bergman, MD, PhD, +46-35 2635050, stefan.bergman@spenshult.se
Ingrid Larsson, RN, PhD-stud, +46-35 2635253, ingrid.larsson@spenshult.se
About this study
Official title: Nurse-led Clinic for Patients With Rheumatic Diseases and Biological Treatment:a Randomized Controlled Trial Comparing Nurse-led Clinic Versus Rheumatologist Clinic
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.
Read the 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.
- Conditions
- Rheumatic Diseases
- Being tested
- Nurse-led clinic vs rheumatologist-led clinic
- Keywords
- Rheumatic diseases, Biologic treatment, Nurse-led
- Medical subject headings
- Rheumatic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nurse-led clinic vs rheumatologist-led clinicOther
Also called Nurse-led clinic, 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.
| Study group | Role | What they receive |
|---|---|---|
| Rheumatologist-led clinic | Active comparator | 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 Receives: Other: Nurse-led clinic vs rheumatologist-led clinic |
| Nurse-led clinic | Experimental | 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. Receives: Other: Nurse-led clinic vs rheumatologist-led clinic |
What is being measured
The primary outcome is the main question the study is designed to answer.
DAS28 and costs for the clinics respectively.
Measured: Baseline at 0 months, 6 months, 12 months
Secondary outcomes (1)
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.
Measured: Baseline at 0 months, 6 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2010 (estimated)
- Study startOct 2009
- Primary completionOct 2011 (estimated)
- Study completionOct 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 100 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
- Ingrid Larsson, RN, PhD-stud, Principal investigator, R&D-centre SpenshultStefan Bergman, MD, PhD, Study director, R&D-centre SpenshultBarbro Arvidsson, RNT, prof, Study chair, R&D-centre SpenshultBengt Fridlund, RNT, prof, Study chair, University of Jönköping, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01071447
- Sponsor's protocol ID
- FoUS09001
- Status last verified
- Aug 2010
- First submitted
- 8 Oct 2009
- Last updated
- 18 Aug 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Larsson I, Fridlund B, Arvidsson B, Teleman A, Svedberg P, Bergman S. A nurse-led rheumatology clinic versus rheumatologist-led clinic in monitoring of patients with chronic inflammatory arthritis undergoing biological therapy: a cost comparison study in a randomised controlled trial. BMC Musculoskelet Disord. 2015 Nov 16;16:354. doi: 10.1186/s12891-015-0817-6.
PubMed 26573936
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
- Nurse-led Clinic for Patients With Rheumatic Diseases and Biological Treatment:a Randomized Controlled Trial Comparing Nurse-led Clinic Versus Rheumatologist Clinic
- ClinicalTrials.gov ID
- NCT01071447
- Acronym / sponsor ID
- FoUS09001
- Conditions
- Rheumatic Diseases
- Keywords
- Rheumatic diseases, Biologic treatment, Nurse-led
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Spenshult HospitalUniversity, hospital or other
- Collaborators
- The Swedish Rheumatism Ass, County Council of Halland, Sweden
- Study start
- Oct 2009
- Primary completion
- Oct 2011 (estimated)
- Study completion
- Oct 2012 (estimated)
- First posted
- 19 Feb 2010 (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 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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rheumatologist-led clinic | Active comparator | Other: Nurse-led clinic vs rheumatologist-led clinicRheumatologist-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 | Experimental | Other: Nurse-led clinic vs rheumatologist-led clinicThe 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Subjects with rheumatologic diseases and biological treatment with a DAS28 of 3.2 or less
Key exclusion criteria (2 listed)
- The subjects should not have problems with infections due to treatment
- Subjects with difficulties speaking and/or reading swedish
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 |
|---|---|---|
| Nurse-led clinic vs rheumatologist-led clinicAlso: Nurse-led clinic, Rheumatologist-led clinicThe 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 | Nurse-led clinic, Rheumatologist-led clinic |
Primary outcome
DAS28 and costs for the clinics respectively.
Time frame: Baseline at 0 months, 6 months, 12 months
1 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.
Time frame: Baseline at 0 months, 6 months, 12 months
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.
- Derived from this study: PubMed 26573936Larsson I, Fridlund B, Arvidsson B, Teleman A, Svedberg P, Bergman S. A nurse-led rheumatology clinic versus rheumatologist-led clinic in monitoring of patients with chronic inflammatory arthritis undergoing biological therapy: a cost comparison study in a randomised controlled trial. BMC Musculoskelet Disord. 2015 Nov 16;16:354. doi: 10.1186/s12891-015-0817-6.
- Related InfoLink provided by the sponsor.
Related trials for Rheumatic Diseases
RecruitingPhase 2
Study of PTC844 in Participants With Active Rheumatoid Arthritis
Rheumatoid Arthritis
Not yet recruitingPhase 1
An Ascending Dose Study of DKB903 in Participants With Rheumatoid Arthritis (RA) and Participants With Systemic Lupus Erythematosus (SLE)
Rheumatoid Arthritis and Systemic Lupus Erythematosus
Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Not yet recruitingPhase 1
R-2487 in Patients With Sjogren's Syndrome (SjD)
Sjogren's Syndrome, Sjögren
Active, not recruiting
Effectiveness of Therapeutic Exercises on Spinopelvic Mobility
Osteoarthritis (OA) of the Hip
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.
Ingrid Larsson, RN, PhD-stud principal investigator
R&D-centre Spenshult
Stefan Bergman, MD, PhD study director
R&D-centre Spenshult
Barbro Arvidsson, RNT, prof 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 Nurse-led clinic vs rheumatologist-led clinic 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 1 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?
Contact Stefan Bergman, MD, PhD (+46-35 2635250, stefan.bergman@spenshult.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DAS28 and costs for the clinics respectively. (time frame: Baseline at 0 months, 6 months, 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01071447, which also lists 1 linked publication.
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.