Effect of Patient Education in Rheumatic Diseases - Full Text View

Sponsors and Collaborators:	Norwegian University of Science and Technology The Research Council of Norway
Information provided by:	Norwegian University of Science and Technology
ClinicalTrials.gov Identifier:	NCT00623922

Purpose

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.

Condition	Intervention
Polyarthritis	Behavioral: Patient education with individual nurse consultations

Study Type:	Interventional
Study Design:	Health Services Research, Randomized, Open Label, Parallel Assignment, Efficacy Study
Official Title:	The Effect of Patient Education on Coping and Well Being in Patients With Arthritis.

Further study details as provided by Norwegian University of Science and Technology:

Primary Outcome Measures:

Self efficacy [ Time Frame: Baseline, 4 and 12 months ] [ Designated as safety issue: No ]
Well being (Arizona Integrative Outcomes Scale) [ Time Frame: Baseline, 4 and 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Arthritis Impact Measurement Scale 2 (affect, symptoms, social interaction, role) [ Time Frame: Baseline, 4 and 12 months ] [ Designated as safety issue: No ]
The Hospital Anxiety and Depression Scale [ Time Frame: Baseline, 4 and 12 months ] [ Designated as safety issue: No ]
Educational Needs Assessment Tools [ Time Frame: Baseline, 4 and 12 months ] [ Designated as safety issue: No ]
Modified Health Assessment Questionnaire [ Time Frame: Baseline, 4 and 12 months ] [ Designated as safety issue: No ]
DAS 28 score (Disease activity score) [ Time Frame: Baseline, 4 and 12 months ] [ Designated as safety issue: No ]
Patient Activation Measurement (PAM) [ Time Frame: Baseline, 4 and 12 months ] [ Designated as safety issue: No ]
Cost- benefit [ Time Frame: Baseline, 4 and 12 months ] [ Designated as safety issue: No ]
Physical activity [ Time Frame: Baseline, 4 and 12 months ] [ Designated as safety issue: No ]
Use of medications [ Time Frame: Baseline, 4 and 12 months ] [ Designated as safety issue: No ]
fatigue (VAS scale) [ Time Frame: Baseline, 4 and 12 months ] [ Designated as safety issue: No ]
Pain (VAS scale) [ Time Frame: Baseline, 4 and 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	140
Study Start Date:	February 2008
Estimated Study Completion Date:	February 2010
Estimated Primary Completion Date:	February 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Patient education	Behavioral: Patient education with individual nurse consultations 3 group meetings followed by 1-2 individual nurse consultations.
2: No Intervention Usual care

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.

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00623922

Locations

Norway
Norwegian University of Science and Technology and St. Olavs Hospital HF
Trondheim, Norway, 7489

Sponsors and Collaborators

Norwegian University of Science and Technology

The Research Council of Norway

Investigators

Principal Investigator:	Aslak Steinsbekk	Norwegian University of Science and Technology
Principal Investigator:	Kjersti Grønning	Norwegian University of Science and Technology

More Information

Publications:

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

Responsible Party:	Norwegian University of Science and Technology ( Kjersti Grønning )
Study ID Numbers:	4.2007.2472, NSD 17975
Study First Received:	February 12, 2008
Last Updated:	June 16, 2009
ClinicalTrials.gov Identifier:	NCT00623922 History of Changes
Health Authority:	Norway: Norwegian Social Science Data Services

Keywords provided by Norwegian University of Science and Technology:

Patient education
Nurse consultation
Arthritis

Wellbeing
Coping
Health related quality of life

Study placed in the following topic categories:

Musculoskeletal Diseases
Joint Diseases
Arthritis

Quality of Life
Rheumatic Diseases
Polyarthritis

Additional relevant MeSH terms:

Musculoskeletal Diseases
Joint Diseases
Arthritis

ClinicalTrials.gov processed this record on September 03, 2009