Patient Education in Ankylosing Spondylitis

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

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.

Study Overview

• Status: Completed
• Conditions: Ankylosing Spondylitis
• Intervention / Treatment: Behavioral: Nurse-led disease management education

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.

• Study Type: Interventional
• Enrollment (Actual): 122
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey
    • Istanbul University-Cerrahpasa Cerrahpasa Medical Faculty Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Nurse-led disease management education; Individual patient education was provided, and patients were followed up by telephone at two-week intervals beginning the week after their clinic visit.	Behavioral: Nurse-led disease management education; Nurse-led disease management education was applied to the intervention group
No Intervention: Control Group; No interventions were performed other than routine clinical procedures.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in scores Bath Ankylosing Spondylitis Disease Activity Index	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.	12 weeks
Change in scores Bath Ankylosing Spondylitis Functional Index	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.	12 weeks
Change in scores Compliance Questionnaire on Rheumatology	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.	12 weeks
Change in scores Ankylosing Spondylitis Quality of Life Scale	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.	12 weeks
Change in scores Tampa Scale for Kinesiophobia	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.	12 weeks

Collaborators and Investigators

• Sponsor: Zeliha Tülek
• Investigators: Principal Investigator: Ayten Dağ, RN, PhD, Istanbul University - Cerrhapasa; Study Director: Zeliha Tulek, RN, Prof, Istanbul University - Cerrhapasa; Study Chair: Emire Seyahi, MD, Prof, Istanbul University - Cerrhapasa

Publications and helpful links

General Publications

• Garrett S, Jenkinson T, Kennedy LG, Whitelock H, Gaisford P, Calin A. A new approach to defining disease status in ankylosing spondylitis: the Bath Ankylosing Spondylitis Disease Activity Index. J Rheumatol. 1994 Dec;21(12):2286-91.
• Duruoz MT, Doward L, Turan Y, Cerrahoglu L, Yurtkuran M, Calis M, Tas N, Ozgocmen S, Yoleri O, Durmaz B, Oncel S, Tuncer T, Sendur O, Birtane M, Tuzun F, Bingol U, Kirnap M, Celik Erturk G, Ardicoglu O, Memis A, Atamaz F, Kizil R, Kacar C, Gurer G, Uzunca K, Sari H. Translation and validation of the Turkish version of the Ankylosing Spondylitis Quality of Life (ASQOL) questionnaire. Rheumatol Int. 2013 Nov;33(11):2717-22. doi: 10.1007/s00296-013-2796-y. Epub 2013 Jun 14.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2020
• Primary Completion (Actual): June 30, 2021
• Study Completion (Actual): June 30, 2021

Study Registration Dates

• First Submitted: December 7, 2023
• First Submitted That Met QC Criteria: December 14, 2023
• First Posted (Actual): December 29, 2023

Study Record Updates

• Last Update Posted (Actual): December 29, 2023
• Last Update Submitted That Met QC Criteria: December 14, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Nursing; Patient Education; Rheumatology
• Additional Relevant MeSH Terms: Infections; Joint Diseases; Musculoskeletal Diseases; Arthritis; Spinal Diseases; Bone Diseases; Spondylarthropathies; Bone Diseases, Infectious; Ankylosis; Axial Spondyloarthritis; Spondylitis; Spondylarthritis; Spondylitis, Ankylosing
• Other Study ID Numbers: Disease management in AS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No