Clinical trial NCT06185712: Patient Education in Ankylosing Spondylitis
Official title: The Impact of Nurse-led Disease Management Education on Outcomes of Patients With Ankylosing Spondylitis: Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ankylosing Spondylitis
Keywords: Patient Education
Nursing
Rheumatology
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
First posted: 2023-12-29
Enrollment: 122
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Change in scores Bath Ankylosing Spondylitis Disease Activity Index
timeFrame: 12 weeks
measure: Change in scores Bath Ankylosing Spondylitis Functional Index
timeFrame: 12 weeks
measure: Change in scores Compliance Questionnaire on Rheumatology
timeFrame: 12 weeks
measure: Change in scores Ankylosing Spondylitis Quality of Life Scale
timeFrame: 12 weeks
measure: Change in scores Tampa Scale for Kinesiophobia
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University-Cerrahpasa Cerrahpasa Medical Faculty Hospital
Study officials:
affiliation: Istanbul University - Cerrhapasa
name: Ayten Dağ, RN, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Istanbul University - Cerrhapasa
name: Zeliha Tulek, RN, Prof
role: STUDY_DIRECTOR
affiliation: Istanbul University - Cerrhapasa
name: Emire Seyahi, MD, Prof
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.