Effect of Patient Education in Rheumatic Diseases

Polyarthritis Clinical Trial

Official title:

The Effect of Patient Education on Coping and Well Being in Patients With Arthritis.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00623922
• Other study ID #: 4.2007.2472
• Secondary ID: NSD 17975
• Status: Completed
• Phase: N/A
• First received: February 12, 2008
• Last updated: April 7, 2015
• Start date: February 2008
• Est. completion date: March 2010

Study information

• Verified date: April 2015
• Source: Norwegian University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Norwegian Social Science Data Services
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 141
• Est. completion date: March 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Polyarthritis

Intervention

Behavioral:
• Patient education with individual nurse consultations
3 group meetings followed by 1-2 individual nurse consultations.

Locations

Country	Name	City	State
Norway	Norwegian University of Science and Technology and St. Olavs Hospital HF	Trondheim

Sponsors (2)

Lead Sponsor	Collaborator
Norwegian University of Science and Technology	The Research Council of Norway

Country where clinical trial is conducted

Norway, 

References & Publications (3)

Grønning K, Rannestad T, Skomsvoll JF, Rygg LØ, 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( — View Citation

Grønning 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. d — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Self efficacy		Baseline, 4 and 12 months	No
Primary	Well being (Arizona Integrative Outcomes Scale)		Baseline, 4 and 12 months	No
Secondary	Arthritis Impact Measurement Scale 2 (affect, symptoms, social interaction, role)		Baseline, 4 and 12 months	No
Secondary	The Hospital Anxiety and Depression Scale		Baseline, 4 and 12 months	No
Secondary	Educational Needs Assessment Tools		Baseline, 4 and 12 months	No
Secondary	Modified Health Assessment Questionnaire		Baseline, 4 and 12 months	No
Secondary	DAS 28 score (Disease activity score)		Baseline, 4 and 12 months	No
Secondary	Patient Activation Measurement (PAM)		Baseline, 4 and 12 months	No
Secondary	Cost- benefit		Baseline, 4 and 12 months	No
Secondary	Physical activity		Baseline, 4 and 12 months	No
Secondary	Use of medications		Baseline, 4 and 12 months	No
Secondary	fatigue (VAS scale)		Baseline, 4 and 12 months	No
Secondary	Pain (VAS scale)		Baseline, 4 and 12 months	No