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CompletedNCT06185712Updated Dec 29, 2023

Patient Education in Ankylosing Spondylitis

An interventional study of Nurse-led disease management education in Ankylosing Spondylitis, sponsored by Zeliha Tülek. Completed at 1 site in Turkey. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-12-29.

Sponsored by Zeliha Tülek · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 3 years 4 months after the study started (first participant enrolled Aug 2020, registered Dec 2023).
Phase
Not applicable
Study type
Interventional
Enrollment
122
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Ankylosing Spondylitis

Keywords

  • Patient Education
  • Nursing
  • Rheumatology
03

In context

Spondylitis

623 studies on the registry are indexed under Spondylitis; 83 are open to participants now.

This study's enrollment of 122 is above the median of 92 across 349 interventional studies indexed under Spondylitis.

Browse Spondylitis studies →

Lead sponsor

This is the only study on the registry with Zeliha Tülek as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Communication difficulties
  • Illiterates
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
122 participants (actual)

Study arms

  • 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

  • No intervention
    Control Group

    No interventions were performed other than routine clinical procedures.

Interventions

  • BehavioralNurse-led disease management education

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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 12 weeks

  2. 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.

    Time frame: 12 weeks

  3. 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.

    Time frame: 12 weeks

  4. 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.

    Time frame: 12 weeks

  5. 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.

    Time frame: 12 weeks

07

Study locations

1 site
  • Istanbul University-Cerrahpasa Cerrahpasa Medical Faculty Hospital
    Istanbul, Turkey
08

References and documents

Publications

  • 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. PubMed 23765201 ↗
  • 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. PubMed 7699630 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 29, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06185712
Lead sponsor
Zeliha Tülek
Responsible party
Zeliha Tülek (RN, Prof, Istanbul University - Cerrahpasa) — Sponsor-investigator
First posted
Dec 29, 2023
Start date
Aug 1, 2020
Primary completion
Jun 30, 2021
Completion
Jun 30, 2021
Last update
Dec 29, 2023

Study contacts

Ayten Dağ, RN, PhD
principal investigator · Istanbul University - Cerrhapasa
Zeliha Tulek, RN, Prof
study director · Istanbul University - Cerrhapasa
Emire Seyahi, MD, Prof
study chair · Istanbul University - Cerrhapasa

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.

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