The Effect of Mobile Application on Anti-TNF Drug Adherence of Ankylosing Spondylitis Patients: Pilot Study

Ankylosing Spondylitis Clinical Trial

Official title:

Research Asistant in Deparment of Nursing

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04301128
• Other study ID #: 80558721/261
• Secondary ID: AZ142
• Status: Completed
• Phase: N/A
• Start date: December 27, 2017
• Est. completion date: December 31, 2019

Study information

• Verified date: September 2020
• Source: Eskisehir Osmangazi University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study was carried out to develop mobile application on the android platform for the subcutaneous anti-TNF drug adherence of ankylosing spondylitis patients and to evaluate the effect of this application on drug compliance.

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 June 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 Adherence Questionnaire.

Description:

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 mobile application on the android platform for the subcutaneous anti-TNF drug adherence of ankylosing spondylitis patients and to evaluate the effect of this application on drug compliance.

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 June 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 Adherence Questionnaire.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Ankylosing Spondylitis
• Spondylitis
• Spondylitis, Ankylosing

Intervention

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

Locations

Country	Name	City	State
Turkey	Eskisehir Osmangazi University Faculty of Health Sciences	Eskisehir

Sponsors (2)

Lead Sponsor	Collaborator
Eskisehir Osmangazi University	Koç University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	subcutaneous anti TNF-a drug adherence was assesed by "Subcutaneous Anti-TNF-a Treatment Adherence Questionnaire"	In this questionnaire, It is expected from patients to answer "no" to these questions: "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?"; The drug adherence of the patients who answered "no" to these questions is considered evaluated as good, and those who answered "yes" to these questions the drug compliance is considered as poor.	4 times in 6 months