ArthritisNCT00403676
Nursing Consultation in Out-patient Clinics for Patients With Inflammatory Rheumatic Disease
A study testing Follow up bu a nurse and Follow up by a medical doctor in people with Arthritis, run by Diakonhjemmet Hospital at 1 site in Norway.
Trial summary
Evaluate the effectiveness and acceptability of care given by nurse specialists in out patient clinics, through a randomized controlled study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthritis
- What is being tested?
- Follow up bu a nurse and Follow up by a medical doctor
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteNorway
- Study dates
- Sep 2005to Aug 2008
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with inflammatory arthropathies monitored after starting disease modifying antirheumatic drugs.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Evaluate the effectiveness and acceptability of care given by nurse specialists in out patient clinics, through a randomized controlled study.
Read the detailed description
This study is part of a national multicenter study (NOR-DMARD) that aims to measure the longterm safety and effectiveness of disease modifying therapies in inflammatory arthropathies. The Nor-Dmard study is a comparative, phase IV, longitudinal, observational study. All patients starting a DMARD regime are enrolled. Patients from two clinics (different parts of Norway) will be randomised to receive follow-up care from either a clinical nurse or a rheumatologist.
The primary outcome measure is patient satisfaction measured by Leeds Satisfaction Questionnaire.
The secondary outcome is effectiveness measured by Coping (CORS),Health related quality of life (SF-36) and Disease activity (MHAQ, DAS-28).
- Conditions
- Arthritis
- Being tested
- Follow up bu a nurse, Follow up by a medical doctor
- Keywords
- nurse practitioner, rheumatology care, outpatient clinic, patient satisfaction
- Medical subject headings
- Arthritis, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Follow up bu a nurseOther
Follow up bu a nurse
Follow up by a medical doctorOther
Follow up by a medical doctor
| Study group | Role | What they receive |
|---|---|---|
| Follow up by nurse | Experimental | Patient randomized for follow-up by a nurse Receives: Other: Follow up bu a nurse |
| follow up by medical doctor | Experimental | Patients randomized for follow up by a medical doctor Receives: Other: Follow up by a medical doctor |
What is being measured
The primary outcome is the main question the study is designed to answer.
patient satisfaction
Measured: 12 mnths and 24 mnths
Secondary outcomes (3)
Health related quality of life
Measured: 12 mnths and 24 mnths
Disease activity
Measured: 12 mnths and 24 mnths
coping
Measured: 12 mnths and 24 mnths
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2006 (estimated)
- Study startSep 2005
- Primary completionAug 2008
- Study completionAug 2008
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 ArthritisStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Diakonhjemmet Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- St. Olavs Hospital
- Responsible party
- Principal investigator, Hege Svean Koksvik, Diakonhjemmet Hospital
- Investigators
- Kåre Birger Hagen, PhD, Study chair, Diakonhjemmet Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00403676
- Sponsor's protocol ID
- DiakonhjemmetS
- Status last verified
- Jun 2012
- First submitted
- 24 Nov 2006
- Last updated
- 28 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Koksvik HS, Hagen KB, Rodevand E, Mowinckel P, Kvien TK, Zangi HA. Patient satisfaction with nursing consultations in a rheumatology outpatient clinic: a 21-month randomised controlled trial in patients with inflammatory arthritides. Ann Rheum Dis. 2013 Jun;72(6):836-43. doi: 10.1136/annrheumdis-2012-202296. Epub 2013 Feb 7.
PubMed 23393144
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nursing Consultation in Out-patient Clinics for Patients With Inflammatory Rheumatic Disease
- ClinicalTrials.gov ID
- NCT00403676
- Acronym / sponsor ID
- DiakonhjemmetS
- Conditions
- Arthritis
- Keywords
- nurse practitioner, rheumatology care, outpatient clinic, patient satisfaction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Diakonhjemmet HospitalUniversity, hospital or other
- Collaborators
- St. Olavs Hospital
- Study start
- Sep 2005
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 27 Nov 2006 (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.
Evaluate the effectiveness and acceptability of care given by nurse specialists in out patient clinics, through a randomized controlled study.
Detailed description
This study is part of a national multicenter study (NOR-DMARD) that aims to measure the longterm safety and effectiveness of disease modifying therapies in inflammatory arthropathies. The Nor-Dmard study is a comparative, phase IV, longitudinal, observational study. All patients starting a DMARD regime are enrolled. Patients from two clinics (different parts of Norway) will be randomised to receive follow-up care from either a clinical nurse or a rheumatologist.
The primary outcome measure is patient satisfaction measured by Leeds Satisfaction Questionnaire.
The secondary outcome is effectiveness measured by Coping (CORS),Health related quality of life (SF-36) and Disease activity (MHAQ, DAS-28).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Follow up by nurse | Experimental | Other: Follow up bu a nursePatient randomized for follow-up by a nurse |
| follow up by medical doctor | Experimental | Other: Follow up by a medical doctorPatients randomized for follow up by a medical doctor |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with inflammatory arthropathies monitored after starting disease modifying antirheumatic drugs.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Follow up bu a nurseFollow up bu a nurse | Other | Follow up by nurse |
| Follow up by a medical doctorFollow up by a medical doctor | Other | follow up by medical doctor |
Primary outcome
patient satisfaction
Time frame: 12 mnths and 24 mnths
3 secondary outcomes
Health related quality of life
Time frame: 12 mnths and 24 mnths
Disease activity
Time frame: 12 mnths and 24 mnths
coping
Time frame: 12 mnths and 24 mnths
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2012.
- Derived from this study: PubMed 23393144Koksvik HS, Hagen KB, Rodevand E, Mowinckel P, Kvien TK, Zangi HA. Patient satisfaction with nursing consultations in a rheumatology outpatient clinic: a 21-month randomised controlled trial in patients with inflammatory arthritides. Ann Rheum Dis. 2013 Jun;72(6):836-43. doi: 10.1136/annrheumdis-2012-202296. Epub 2013 Feb 7.
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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.
Kåre Birger Hagen, PhD study chair
Diakonhjemmet Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Follow up bu a nurse and Follow up by a medical doctor in people with Arthritis, run by Diakonhjemmet Hospital at 1 site in Norway.
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 0 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: finished, as of the sponsor's last update on 28 Jun 2012. 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 Norway. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
patient satisfaction (time frame: 12 mnths and 24 mnths). 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 NCT00403676, 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 28 Jun 2012.