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NCT Number: NCT04301128

The Effect of Mobile Application on Subcutaneous Anti-TNF Drug Administration:Ankylosing Spondylitis Patients

This study was carried out to develop an android mobile application for the subcutaneous (SC) anti-TNF drug administration of ankylosing spondylitis patients and to evaluate its effect on drug administration.

The universe of this experimental designed posttest control group research is consisted of patients prescribed subcutaneous anti-TNF drug due to ankylosing spondylitis in Eskişehir Osmangazi University Health, Application and Research Hospital Rheumatology Polyclinic between 15 December 2017 - 30 December 2019. The patients who constituted the sample of the study were assigned by lot to mobile application and the education booklet groups. The mobile application that includes follow-up and information related to disease information, anti-TNF drug application and management was transferred to mobile phones of patients in mobile application group via bluetooth technology and installed. The patients in the education booklet group were given an education booklet on disease information, antiTNF drug administration and management. In the study, patients were evaluated once before anti-TNF drug treatment and every 6 weeks during 6 months (4 times) after treatment. The data of the study were collected by means of an individual identification form, BASDAI, BASFI, ASQoL and Subcutaneous Anti-TNF Treatment Questionnaire .

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Eskişehir Osmangazi University Faculty of Health Sciences

Eskişehir, 26480, Turkey (Türkiye)

About this study

Ankylosing spondylitis is a chronic, inflammatory disease that affects the axial spine, causing progressive limitation on the spine and leading to a decrease in quality of life. Anti TNF drugs are frequently used in the treatment of ankylosing spondylitis and teaching activities in improving patient compliance and patient compliance are very important in the success of this treatment. This study was carried out to develop an android mobile application for the subcutaneous (SC) anti-TNF drug administration of ankylosing spondylitis patients and to evaluate its effect on drug administration.

The universe of this experimental designed posttest control group research is consisted of patients prescribed subcutaneous anti-TNF drug due to ankylosing spondylitis in Eskişehir Osmangazi University Health, Application and Research Hospital Rheumatology Polyclinic between 15 December 2017 - 30 December 2019. The patients who constituted the sample of the study were assigned by lot to mobile application and the education booklet groups. The mobile application that includes follow-up and information related to disease information, anti-TNF drug application and management was transferred to mobile phones of patients in mobile application group via bluetooth technology and installed. The patients in the education booklet group were given an education booklet on disease information, antiTNF drug administration and management. In the study, patients were evaluated once before anti-TNF drug treatment and every 6 weeks during 6 months (4 times) after treatment. The data of the study were collected by means of an individual identification form, BASDAI, BASFI, ASQoL and Subcutaneous Anti-TNF Treatment Questionnaire.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • are diagnosed with ankylosing spondylitis according to the New York modification criterias
  • administer anti-TNF agent for the first or second time
  • are 18 years old and had literacy
  • have an android phone,
  • can use the andriod phone,
  • agree to participate in the work

Exclusion criteria

  • refuse to participate in the study
  • be young than 18 years old
  • administer anti-TNF agent more than twice

Treatment and study plan

Experimental

Other

Patients in the experimental group were educated and followed with an android based mobile application which contains the informations related to the disease, treatment and its complications, monitoring and cure and provides side effect tracking.

Control

Other

Patients in the control group were informed same informations verbally and given an education book.

Primary outcomes

  1. subcutaneous anti TNF-α drug administration was assesed by "Subcutaneous Anti-TNF Treatment Questionnaire "

    Time frame: 4 times in 6 months

    In this questionnaire, It is expected from patients to answer "no" or "I always administered it myself" to these questions: "How often was your medication administered by someone else?", "In the last 6 weeks, did you ever miss or forget your dose of medication?" and "Did you ever skip implementing your medication dose thinking that your illness is under control?" Furthermore, the mean scores of "Overall difficulty level in continuing SC anti-TNF drug treatment" and "Satisfaction level with anti-TNF drug treatment in the last 6 weeks" are expected to be high.

Sponsors and collaborators

Lead sponsor

Eskisehir Osmangazi University

Other

Collaborators

  • Koç University

Registry information

Official study title

Research Asistant in Deparment of Nursing

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Mar 10, 2020
Registry last updated
Oct 28, 2024

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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