NCT00623922

Brief Summary

The purpose of this study is to explore the effect of patient education (PE) in patients with arthritis. PE has become a task that is dictated by law in Norway, and is increasingly used as an element in the treatment of patients with chronic complaints. Our hypothesis is that \- PE delivered as group education, followed by an individual nurse consultation increases the patients wellbeing an ability to cope with the disease.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
141

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2008

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

February 1, 2008

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

February 12, 2008

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 26, 2008

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
Last Updated

April 8, 2015

Status Verified

April 1, 2015

Enrollment Period

2.1 years

First QC Date

February 12, 2008

Last Update Submit

April 7, 2015

Conditions

Polyarthritis

Keywords

Patient educationNurse consultationArthritisWellbeingCopingHealth related quality of life

Outcome Measures

Primary Outcomes (2)

  • Self efficacy

    Baseline, 4 and 12 months

  • Well being (Arizona Integrative Outcomes Scale)

    Baseline, 4 and 12 months

Secondary Outcomes (11)

  • Arthritis Impact Measurement Scale 2 (affect, symptoms, social interaction, role)

    Baseline, 4 and 12 months

  • The Hospital Anxiety and Depression Scale

    Baseline, 4 and 12 months

  • Educational Needs Assessment Tools

    Baseline, 4 and 12 months

  • Modified Health Assessment Questionnaire

    Baseline, 4 and 12 months

  • DAS 28 score (Disease activity score)

    Baseline, 4 and 12 months

  • +6 more secondary outcomes

Study Arms (2)

1

EXPERIMENTAL

Patient education

Behavioral: Patient education with individual nurse consultations

2

NO INTERVENTION

Usual care

Interventions

Patient education with individual nurse consultationsBEHAVIORAL

3 group meetings followed by 1-2 individual nurse consultations.

1

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Polyarthritis
  • years
  • native Norwegian speaking
  • able to understand and participate in the PE program

You may not qualify if:

  • Participated in a patient educational program the latest 12 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Norwegian University of Science and Technology and St. Olavs Hospital HF

Trondheim, Trondheim, 7489, Norway

Location

Related Publications (4)

  • Riemsma RP, Taal E, Kirwan JR, Rasker JJ. Systematic review of rheumatoid arthritis patient education. Arthritis Rheum. 2004 Dec 15;51(6):1045-59. doi: 10.1002/art.20823. No abstract available.

    PMID: 15593105BACKGROUND

  • Gronning K, Skomsvoll JF, Rannestad T, Steinsbekk A. The effect of an educational programme consisting of group and individual arthritis education for patients with polyarthritis--a randomised controlled trial. Patient Educ Couns. 2012 Jul;88(1):113-20. doi: 10.1016/j.pec.2011.12.011. Epub 2012 Jan 23.

    PMID: 22277625RESULT

  • Gronning K, Rannestad T, Skomsvoll JF, Rygg LO, Steinsbekk A. Long-term effects of a nurse-led group and individual patient education programme for patients with chronic inflammatory polyarthritis - a randomised controlled trial. J Clin Nurs. 2014 Apr;23(7-8):1005-17. doi: 10.1111/jocn.12353. Epub 2013 Jul 22.

    PMID: 23875718RESULT

  • Gronning K, Midttun L, Steinsbekk A. Patients' confidence in coping with arthritis after nurse-led education; a qualitative study. BMC Nurs. 2016 May 4;15:28. doi: 10.1186/s12912-016-0150-x. eCollection 2016.

    PMID: 27147905DERIVED

MeSH Terms

Conditions

Arthritis

Interventions

Patient Education as Topic

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Health EducationPreventive Health ServicesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Aslak Steinsbekk

    Norwegian University of Science and Technology

    PRINCIPAL INVESTIGATOR

  • Kjersti Grønning

    Norwegian University of Science and Technology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 12, 2008

First Posted

February 26, 2008

Study Start

February 1, 2008

Primary Completion

March 1, 2010

Study Completion

March 1, 2010

Last Updated

April 8, 2015

Record last verified: 2015-04

Locations

NO(1)