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OpenTrials
Completed

NCT Number: NCT00623922

Effect of Patient Education in Rheumatic Diseases

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.

Completed

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Trondheim, 7489, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Patient education with individual nurse consultations

Behavioral

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

Primary outcomes

  1. Self efficacy

    Time frame: Baseline, 4 and 12 months

  2. Well being (Arizona Integrative Outcomes Scale)

    Time frame: Baseline, 4 and 12 months

Secondary outcomes

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

    Time frame: Baseline, 4 and 12 months

  2. The Hospital Anxiety and Depression Scale

    Time frame: Baseline, 4 and 12 months

  3. Educational Needs Assessment Tools

    Time frame: Baseline, 4 and 12 months

  4. Modified Health Assessment Questionnaire

    Time frame: Baseline, 4 and 12 months

  5. DAS 28 score (Disease activity score)

    Time frame: Baseline, 4 and 12 months

  6. Patient Activation Measurement (PAM)

    Time frame: Baseline, 4 and 12 months

  7. Cost- benefit

    Time frame: Baseline, 4 and 12 months

  8. Physical activity

    Time frame: Baseline, 4 and 12 months

  9. Use of medications

    Time frame: Baseline, 4 and 12 months

  10. fatigue (VAS scale)

    Time frame: Baseline, 4 and 12 months

  11. Pain (VAS scale)

    Time frame: Baseline, 4 and 12 months

Sponsors and collaborators

Lead sponsor

Norwegian University of Science and Technology

Other

Collaborators

  • The Research Council of Norway

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Feb 26, 2008
Registry last updated
Apr 8, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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