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

Primary Purpose

Ankylosing Spondylitis, Spondylitis, Ankylosing

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Experimental
control
Sponsored by
Eskisehir Osmangazi University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Ankylosing Spondylitis focused on measuring anti-TNF, drug adherence, mobile application, nursing, ankylosing Spondylitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Eskişehir Osmangazi University Faculty of Health Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

EXPERIMENTAL GROUP

CONTROL GROUP

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
February 27, 2020
Last Updated
September 24, 2020
Sponsor
Eskisehir Osmangazi University
Collaborators
Koç University
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1. Study Identification

Unique Protocol Identification Number
NCT04301128
Brief Title
The Effect of Mobile Application on Anti-TNF Drug Adherence of Ankylosing Spondylitis Patients: Pilot Study
Official Title
Research Asistant in Deparment of Nursing
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
December 27, 2017 (Actual)
Primary Completion Date
December 31, 2019 (Actual)
Study Completion Date
December 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Eskisehir Osmangazi University
Collaborators
Koç University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ankylosing Spondylitis, Spondylitis, Ankylosing
Keywords
anti-TNF, drug adherence, mobile application, nursing, ankylosing Spondylitis

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
EXPERIMENTAL GROUP
Arm Type
Experimental
Arm Description
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.
Arm Title
CONTROL GROUP
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Experimental
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
control
Intervention Description
Patients in the control group were informed same informations verbally and given an education book.
Primary Outcome Measure Information:
Title
subcutaneous anti TNF-α drug adherence was assesed by "Subcutaneous Anti-TNF-α Treatment Adherence Questionnaire"
Description
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.
Time Frame
4 times in 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ayşe Özkaraman
Organizational Affiliation
Eskisehir Osmangazi University
Official's Role
Study Director
Facility Information:
Facility Name
Eskişehir Osmangazi University Faculty of Health Sciences
City
Eskişehir
ZIP/Postal Code
26480
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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