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

NCT04301128 | Completed

• 2 other identifiers: 80558721/261AZ142
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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 .

Conditions

Ankylosing Spondylitis; Spondylitis, Ankylosing

Keywords

anti-TNF; mobile application; nursing; ankylosing Spondylitis; drug administration

Outcome Measures

Primary Outcomes (1)

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

  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.

  4 times in 6 months

Study Arms (2)

EXPERIMENTAL GROUP

EXPERIMENTAL

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 Subcutaneous Anti-TNF Treatment Questionnaire , BASDAI, ASQoL, BASFI scales.

Other: Experimental

BOOKLET GROUP

ACTIVE COMPARATOR

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 Subcutaneous Anti-TNF Treatment Questionnaire , BASDAI, ASQoL, BASFI scales. At the end of the study (twenty forth week) was applied to all patients.

Other: control

Interventions

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.

EXPERIMENTAL GROUP

control OTHER

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

BOOKLET GROUP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Eskisehir Osmangazi University: lead
• Koç University: collaborator

Study Sites (1)

Eskişehir Osmangazi University Faculty of Health Sciences

Eskişehir, Eskişehir, 26480, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Spondylitis, Ankylosing

Condition Hierarchy (Ancestors)

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

Study Officials

• Ayşe Özkaraman

  Eskisehir Osmangazi University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Study Record Dates

• First Submitted: February 27, 2020
• First Posted: March 10, 2020
• Study Start: December 27, 2017
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: October 28, 2024

Record last verified: 2020-09

Locations

TU (1)