Patient Education in Ankylosing Spondylitis

NCT06185712 | Completed

• 1 other identifier: Disease management in AS
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 1

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.

Conditions

Ankylosing Spondylitis

Keywords

Patient Education; Nursing; Rheumatology

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (2)

Nurse-led disease management education

EXPERIMENTAL

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

Control Group

NO INTERVENTION

No interventions were performed other than routine clinical procedures.

Interventions

Nurse-led disease management education BEHAVIORAL

Nurse-led disease management education was applied to the intervention group

Nurse-led disease management education

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Communication difficulties
• Illiterates

Sponsors & Collaborators

• Zeliha Tülek: lead

Study Sites (1)

Istanbul University-Cerrahpasa Cerrahpasa Medical Faculty Hospital

Istanbul, Turkey (Türkiye)

Location

Related Publications (2)

• 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.

  PMID: 23765201 BACKGROUND

• 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.

  PMID: 7699630 BACKGROUND

MeSH Terms

Conditions

Spondylitis, Ankylosing

Condition Hierarchy (Ancestors)

Axial Spondyloarthritis; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Ankylosis; Joint Diseases; Arthritis

Study Officials

• Ayten Dağ, RN, PhD

  Istanbul University - Cerrhapasa

  PRINCIPAL INVESTIGATOR

• Zeliha Tulek, RN, Prof

  Istanbul University - Cerrhapasa

  STUDY DIRECTOR

• Emire Seyahi, MD, Prof

  Istanbul University - Cerrhapasa

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: RN, Prof

Study Record Dates

• First Submitted: December 7, 2023
• First Posted: December 29, 2023
• Study Start: August 1, 2020
• Primary Completion: June 30, 2021
• Study Completion: June 30, 2021
• Last Updated: December 29, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)