NCT00403676

Brief Summary

Evaluate the effectiveness and acceptability of care given by nurse specialists in out patient clinics, through a randomized controlled study.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2005

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2005

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

November 24, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 27, 2006

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2008

Completed
Last Updated

June 28, 2012

Status Verified

June 1, 2012

Enrollment Period

2.9 years

First QC Date

November 24, 2006

Last Update Submit

June 27, 2012

Conditions

Arthritis

Keywords

nurse practitionerrheumatology careoutpatient clinicpatient satisfaction

Outcome Measures

Primary Outcomes (1)

  • patient satisfaction

    12 mnths and 24 mnths

Secondary Outcomes (3)

  • Health related quality of life

    12 mnths and 24 mnths

  • Disease activity

    12 mnths and 24 mnths

  • coping

    12 mnths and 24 mnths

Study Arms (2)

Follow up by nurse

EXPERIMENTAL

Patient randomized for follow-up by a nurse

Other: Follow up bu a nurse

follow up by medical doctor

EXPERIMENTAL

Patients randomized for follow up by a medical doctor

Other: Follow up by a medical doctor

Interventions

Follow up bu a nurseOTHER

Follow up bu a nurse

Follow up by nurse
Follow up by a medical doctorOTHER

Follow up by a medical doctor

follow up by medical doctor

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with inflammatory arthropathies monitored after starting disease modifying antirheumatic drugs.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Olavs Hospital

Trondheim, 7020, Norway

Location

Related Publications (1)

  • 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.

    PMID: 23393144DERIVED

MeSH Terms

Conditions

ArthritisPatient Satisfaction

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Kåre Birger Hagen, PhD

    Diakonhjemmet Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Nurse

Study Record Dates

First Submitted

November 24, 2006

First Posted

November 27, 2006

Study Start

September 1, 2005

Primary Completion

August 1, 2008

Study Completion

August 1, 2008

Last Updated

June 28, 2012

Record last verified: 2012-06

Locations

NO(1)