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Effect of Patient Education in Rheumatic Diseases

Primary Purpose

Polyarthritis

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Patient education with individual nurse consultations
Sponsored by
Norwegian University of Science and Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Polyarthritis focused on measuring Patient education, Nurse consultation, Arthritis, Wellbeing, Coping, Health related quality of life

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Polyarthritis
  • 18-80 years
  • native Norwegian speaking
  • able to understand and participate in the PE program

Exclusion Criteria:

  • Participated in a patient educational program the latest 12 months

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

1

2

Arm Description

Patient education

Usual care

Outcomes

Primary Outcome Measures

Self efficacy
Well being (Arizona Integrative Outcomes Scale)

Secondary Outcome Measures

Arthritis Impact Measurement Scale 2 (affect, symptoms, social interaction, role)
The Hospital Anxiety and Depression Scale
Educational Needs Assessment Tools
Modified Health Assessment Questionnaire
DAS 28 score (Disease activity score)
Patient Activation Measurement (PAM)
Cost- benefit
Physical activity
Use of medications
fatigue (VAS scale)
Pain (VAS scale)

Full Information

First Posted
February 12, 2008
Last Updated
April 7, 2015
Sponsor
Norwegian University of Science and Technology
Collaborators
The Research Council of Norway
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1. Study Identification

Unique Protocol Identification Number
NCT00623922
Brief Title
Effect of Patient Education in Rheumatic Diseases
Official Title
The Effect of Patient Education on Coping and Well Being in Patients With Arthritis.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
February 2008 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
March 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Norwegian University of Science and Technology
Collaborators
The Research Council of Norway

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
There has been a rather long tradition of PE for patients with arthritis. A recent systematic review found that PE had small short-term effects on disability, joint counts, patient global assessment, psychological status and depression, but this effect disappeared on the latest time of follow up (3-14 months). A recent large British study also failed to show an effect on pain, physical functioning, or contact with primary care after 12 months, but found a significant effect on anxiety and improved the participants' perceived self efficacy. This indicates that the present forms of interventions fails to show a long term effect. One possible reason for the lack of long term effect might be that these interventions are given to groups only. Patients seem to prefer one-to-one interaction regarding information about the disease and its treatment together with emotional aspects, while education in groups are preferred for physical training and relational topics.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polyarthritis
Keywords
Patient education, Nurse consultation, Arthritis, Wellbeing, Coping, Health related quality of life

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
141 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Patient education
Arm Title
2
Arm Type
No Intervention
Arm Description
Usual care
Intervention Type
Behavioral
Intervention Name(s)
Patient education with individual nurse consultations
Intervention Description
3 group meetings followed by 1-2 individual nurse consultations.
Primary Outcome Measure Information:
Title
Self efficacy
Time Frame
Baseline, 4 and 12 months
Title
Well being (Arizona Integrative Outcomes Scale)
Time Frame
Baseline, 4 and 12 months
Secondary Outcome Measure Information:
Title
Arthritis Impact Measurement Scale 2 (affect, symptoms, social interaction, role)
Time Frame
Baseline, 4 and 12 months
Title
The Hospital Anxiety and Depression Scale
Time Frame
Baseline, 4 and 12 months
Title
Educational Needs Assessment Tools
Time Frame
Baseline, 4 and 12 months
Title
Modified Health Assessment Questionnaire
Time Frame
Baseline, 4 and 12 months
Title
DAS 28 score (Disease activity score)
Time Frame
Baseline, 4 and 12 months
Title
Patient Activation Measurement (PAM)
Time Frame
Baseline, 4 and 12 months
Title
Cost- benefit
Time Frame
Baseline, 4 and 12 months
Title
Physical activity
Time Frame
Baseline, 4 and 12 months
Title
Use of medications
Time Frame
Baseline, 4 and 12 months
Title
fatigue (VAS scale)
Time Frame
Baseline, 4 and 12 months
Title
Pain (VAS scale)
Time Frame
Baseline, 4 and 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Polyarthritis 18-80 years native Norwegian speaking able to understand and participate in the PE program Exclusion Criteria: Participated in a patient educational program the latest 12 months
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aslak Steinsbekk
Organizational Affiliation
Norwegian University of Science and Technology
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kjersti Grønning
Organizational Affiliation
Norwegian University of Science and Technology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Norwegian University of Science and Technology and St. Olavs Hospital HF
City
Trondheim
ZIP/Postal Code
7489
Country
Norway

12. IPD Sharing Statement

Citations:
PubMed Identifier
15593105
Citation
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.
Results Reference
background
PubMed Identifier
22277625
Citation
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.
Results Reference
result
PubMed Identifier
23875718
Citation
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.
Results Reference
result
PubMed Identifier
27147905
Citation
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.
Results Reference
derived

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Effect of Patient Education in Rheumatic Diseases

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