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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Research Asistant in Deparment of Nursing

Conditions
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Ankylosing Spondylitis, Spondylitis, Ankylosing

Intervention / Treatment
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* Other: Experimental
* Other: control


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EXPERIMENTAL GROUP<br>Patients in the experimental group were able to install and set up mobile application on android phones via Bluetooth and were informed about the sick android application. Patients were reminded and guided by subcutaneous anti-TNF drug treatments from mobile application. Both groups of patients were then assessed using face-to-face interviews for 6 months, 6 weeks after using the Sub Cutan Anti-Tnf-α Therapy Questionnaire, BASDAI, ASQoL, BASFI scales. | Other: Experimental<br>* 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.<br>|
| Active Comparator: CONTROL GROUP<br>An anti-TNF drug administration training booklet were given to patients in the control group and were required to take advantage of the booklet on subcutaneous anti-TNF drug production. Both groups of patients were then assessed using face-to-face interviews for 6 months, 6 weeks after using the Sub Cutan Anti-Tnf-α Therapy Questionnaire, BASDAI, ASQoL, BASFI scales. At the end of the study (twenty forth week) was applied to all patients. | Other: control<br>* Patients in the control group were informed same informations verbally and given an education book.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| subcutaneous anti TNF-α drug adherence was assesed by Subcutaneous Anti-TNF-α 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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anti-TNF, drug adherence, mobile application, nursing, ankylosing Spondylitis