Efficacy of a Phone Application on Treatment Adherence in Asthmatic Patients in Upper Egypt

January 22, 2024 updated by: Entsar Hsanen, Assiut University
asthma adherence is mandatory for disease control

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Asthma is a chronic and common disease of the airways that affects more than 339 million people globally [1]. According to WHO estimates, there were 417,918 deaths due to asthma at the global level and 24.8 million disability-adjusted life years (DALYs) attributable to Asthma [2, 3]. There is much evidence that self-care by patients with asthma has beneficial outcomes, including reduced hospital stays, reduced symptoms, and general compliance with treatments [4-6]. One of the approaches for promoting self-care skills in patients with asthma is to provide self-care services (i.e., providing basic information about the nature of asthma, avoiding exposure to allergens and triggers, treating with drugs, providing alerts and reminders to patients, and how to use the therapeutic tools [7]) through information technology tools (e.g. the Internet, mobile phones, and computer software). Given the increasing worldwide use of smartphones, mobile health (mHealth) technologies can work as promising tools to improve self-care in patients with asthma by providing support services such as communication information, providing learning materials, and sending reminders for behavior change [8, 9]. mHealth, as a component of electronic health, is related to the use of mobile phones and other wireless technologies to improve the provision of health-related services. Moreover, ease of use, portability, and ubiquity in all regions are the potential benefits of mHealth tools for the prevention, diagnosis, treatment, and care of diseases also increasing access to health services and reducing the costs incurred [10]. This study aims to evaluate the role of a mobile application in reminding the patient to take his treatment and its reflection on asthma control and quality of life.

Study Type

Interventional

Enrollment (Estimated)

180

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 Contact

Study Contact Backup

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

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Doctor-diagnosed asthma. On at least Global Initiative for Asthma (GINA) step 3 which means they will be on regular inhaled steroids.

No change in regular asthma treatment in the last 1 month Sufficient English-language ability to understand the text in mobile phone-delivered interventions The education level required will be at least a high school diploma.

Exclusion Criteria:

GINA step 5 asthma (complex issues, too unstable). Recent changes to asthma treatment within the last month Another chronic health condition (eg diabetes, congenital heart disease, cystic fibrosis) Patients without mobile device skills

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Application
intervention group that will download the Medisafe android application (https://www.medisafe.com). This mobile application uses simple English language and figures to remind the patient about the dose
Behavioral: the Medisafe android application (https://www.medisafe.com).
software for Android mobile phones that can remind the patient of his treatment on time
Other Names:
  • mobile application
  • Artificial intelligence
  • phone application
No Intervention: control
control group with Standard Care and Medication Monitoring

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Asthma control after 3 months
Time Frame: 3 months
asthma control test after 3 months
3 months

Collaborators and Investigators

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

Sponsor

Assiut University

Investigators

  • Principal Investigator: Entsar H Mohamed, Lecturer, Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • 1.Vos T, Abajobir AA, Abate KH, et al. Global, regional, and national incidence, prevalence, and years lived with disability for 328 diseases and injuries for 195 countries, 1990-2016: a systematic analysis for the Global Burden of Disease Study 2016. The Lancet. 2017;390(10100):1211-59. 2.World Health Organisation. Global health estimates 2016: deaths by cause, age, sex, by country and by region, 2000-2016. Geneva: World Health Organization; 2018a. 3.World Health Organisation. Global health estimates 2016: disease burden by cause, age, sex, by country and by region, 2000-2016. Geneva: World Health Organization; 2018b. 4.Levy M, Andrews R, Buckingham R, et al. Why asthma still kills: the National Review of Asthma Deaths (NRAD). London: Royal College of Physcians; 2014. 5.James DR, Lyttle MD. British guideline on the management of asthma: SIGN Clinical Guideline 141, 2014. Arch Dis Child Educ Pract. 2016;101(6):319-22.

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 (Estimated)

February 1, 2024

Primary Completion (Estimated)

February 1, 2025

Study Completion (Estimated)

March 1, 2025

Study Registration Dates

First Submitted

January 12, 2024

First Submitted That Met QC Criteria

January 22, 2024

First Posted (Actual)

January 31, 2024

Study Record Updates

Last Update Posted (Actual)

January 31, 2024

Last Update Submitted That Met QC Criteria

January 22, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • asthma adherence phone

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Study Data/Documents

  1. Individual Participant Data Set

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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