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Completed

NCT Number: NCT06185712

Patient Education in Ankylosing Spondylitis

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul University-Cerrahpasa Cerrahpasa Medical Faculty Hospital

Istanbul, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nurse-led disease management education

Behavioral

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

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Sponsors and collaborators

Lead sponsor

Zeliha Tülek

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Dec 29, 2023
Registry last updated
Dec 29, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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