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Clinical Trials/NCT06185712
NCT06185712
Completed
Not Applicable

The Impact of Nurse-led Disease Management Education on Outcomes of Patients With Ankylosing Spondylitis: Randomised Controlled Trial

Zeliha Tülek1 site in 1 country122 target enrollmentAugust 1, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Ankylosing Spondylitis
Sponsor
Zeliha Tülek
Enrollment
122
Locations
1
Primary Endpoint
Change in scores Bath Ankylosing Spondylitis Disease Activity Index
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

This study was carried out to investigate the effect of a nurse-led disease management education program in AS on patient compliance, disease activity, functional capacity, kinesiophobia, and quality of life. A total of 122 patients diagnosed with AS according to the modified New York criteria were included in the study. The intervention group received nurse-led individualized disease management education. In the control group, no interventions were performed other than routine clinical procedures.

Detailed Description

This study was carried out to investigate the effect of a nurse-led disease management education program in AS on patient compliance, disease activity, functional capacity, kinesiophobia, and quality of life. A total of 122 patients diagnosed with AS according to the modified New York criteria were included in the study. The intervention group received nurse-led individualized disease management education. After the education, the group was contacted by telephone six times for 12 weeks to monitor the results. Patient education was provided through booklets and videos. In the control group, no interventions were performed other than routine clinical procedures.Patients were assessed using the same scales at baseline and end of the week 12.

Registry
clinicaltrials.gov
Start Date
August 1, 2020
End Date
June 30, 2021
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Zeliha Tülek
Responsible Party
Sponsor Investigator
Principal Investigator

Zeliha Tülek

RN, Prof

Istanbul University - Cerrahpasa (IUC)

Eligibility Criteria

Inclusion Criteria

  • Age: 18 years
  • Have a clinical diagnosis AS according to the modified New York criteria
  • Receiving TNF-α inhibitor treatment.

Exclusion Criteria

  • Communication difficulties
  • Illiterates

Outcomes

Primary Outcomes

Change in scores Bath Ankylosing Spondylitis Disease Activity Index

Time Frame: 12 weeks

Disease Activity will be evaluated by Bath Ankylosing Spondylitis Disease Activity Index. There are 6 questions in the scale that examine the symptoms of joint pain, fatigue and morning stiffness. Using a visual analog scale, patients are asked to give points (0-10 points) for each question according to the severity of the symptoms (0 = no symptoms, 10 = very severe). The scale score is calculated by taking the average score of the last two questions regarding morning stiffness, adding the scores from the first four questions, and dividing the result by 5. An increase in the scale score is considered as an increase in disease activity, and a decrease in the score is considered as a decrease in disease activity.

Change in scores Ankylosing Spondylitis Quality of Life Scale

Time Frame: 12 weeks

Quality of life will be evaluated by Ankylosing Spondylitis Quality of Life Scale. In the scale where disease symptoms, functional status and concerns about the disease are questioned, one of the options "Yes" or "No" is selected for each question (Yes = 1, No = 0), and the scale score varies between 0-18 points. An increase in the score is considered as a decrease in the quality of life.

Change in scores Bath Ankylosing Spondylitis Functional Index

Time Frame: 12 weeks

Functional Status will be evaluated by Bath Ankylosing Spondylitis Functional Index. Patients are asked to rate how difficult they are doing each activity on a scale of 0-10 (0 = easy, 10 = impossible). Scale scoring is calculated by adding the scores of all questions and dividing by 10. An increase in the BASFI score is considered as a decrease in functional capacity.

Change in scores Compliance Questionnaire on Rheumatology

Time Frame: 12 weeks

Treatment compliance will be evaluated by Compliance Questionnaire on Rheumatology.It consists of 19 items. The scores obtained from the scale vary between 0-100 points, and higher scores indicate increased compliance, while lower scores indicate decreased compliance.

Change in scores Tampa Scale for Kinesiophobia

Time Frame: 12 weeks

Kinesiophobia will be evaluated by Tampa Scale for Kinesiophobia. The scale score is calculated by summing the scores from each question and varies between 17-68 points. An increase in the scale score is considered as an increase in the fear of movement / injury.

Study Sites (1)

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