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

September 24, 2020 updated by: Fusun Uzgor, Eskisehir Osmangazi University

Research Asistant in Deparment of Nursing

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Eskişehir, Turkey, 26480
        • Eskişehir Osmangazi University Faculty of Health Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: EXPERIMENTAL GROUP
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
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.
Active Comparator: CONTROL GROUP
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
Patients in the control group were informed same informations verbally and given an education book.

What is the study measuring?

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"
Time Frame: 4 times in 6 months

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eskisehir Osmangazi University

Collaborators

Koç University

Investigators

  • Study Director: Ayşe Özkaraman, Eskisehir Osmangazi University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 27, 2017

Primary Completion (Actual)

December 31, 2019

Study Completion (Actual)

December 31, 2019

Study Registration Dates

First Submitted

February 27, 2020

First Submitted That Met QC Criteria

March 5, 2020

First Posted (Actual)

March 10, 2020

Study Record Updates

Last Update Posted (Actual)

September 28, 2020

Last Update Submitted That Met QC Criteria

September 24, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 80558721/261
  • AZ142 (Other Identifier: Eskisehir Osmnagazi University)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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