Clinical trial NCT04301128: The Effect of Mobile Application on Subcutaneous Anti-TNF Drug Administration:Ankylosing Spondylitis Patients
Official title: Research Asistant in Deparment of Nursing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ankylosing Spondylitis
Spondylitis, Ankylosing
Keywords: anti-TNF
mobile application
nursing
ankylosing Spondylitis
drug administration
Lead sponsor: Eskisehir Osmangazi University
Sponsor class: OTHER
Collaborators: name: Koç University
First posted: 2020-03-10
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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 .

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 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.

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

Primary outcomes:
measure: subcutaneous anti TNF-α drug administration was assesed by "Subcutaneous Anti-TNF Treatment Questionnaire "
timeFrame: 4 times in 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Eskişehir
country: Turkey
facility: Eskişehir Osmangazi University Faculty of Health Sciences
Study officials:
affiliation: Eskisehir Osmangazi University
name: Ayşe Özkaraman
role: STUDY_DIRECTOR
References: