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

Research Asistant in Deparment of Nursing

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04301128
Enrollment
32
Registered
2020-03-10
Start date
2017-12-27
Completion date
2019-12-31
Last updated
2024-10-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ankylosing Spondylitis, Spondylitis, Ankylosing

Keywords

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

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.

Interventions

OTHERExperimental

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.

OTHERcontrol

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

Sponsors

Koç University
CollaboratorOTHER
Eskisehir Osmangazi University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
subcutaneous anti TNF-α drug administration was assesed by Subcutaneous Anti-TNF Treatment Questionnaire 4 times in 6 monthsIn 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.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026