Effectiveness of an mHealth Mobile App (mHealth)

Assessing the Effectiveness of an mHealth Intervention Versus the Usual Standard of Care for Improving Medication Adherence and Self-management Among Type II Diabetics in Pakistan: A Randomized Controlled Trial

Type II diabetes is a serious challenge for Pakistan. Not using medications properly increases healthcare costs and diabetes-related deaths. A mobile app in local language can improve medication adherence and self-management among diabetics. Therefore, in this 18 months long study researchers will develop a diabetes-related mobile application in Urdu, and will conduct a trial to assess whether it improves medication compliance and self-management, and how much economical this app would be compared to the usual standard of care for type II diabetics in Pakistan. This trial will be conducted at the National Institute of Diabetes and Endocrinology Karachi. The study participants will be divided in two groups. Only one group will use this application. Researchers will measure medication compliance and self-management through diabetes-specific blood test and self-reporting questionnaires between two groups. Researchers will also determine how much economic costs would be saved by using this app to improve medication compliance

Study Overview

• Status: Active, not recruiting
• Conditions: Type II Diabetes
• Intervention / Treatment: Behavioral: mobile app use

Detailed Description

Type II diabetes continues to be a challenge for the resource-constrained healthcare system in Pakistan. Non-adherence to medications increases healthcare costs and disease-related mortality. Mobile health (mHealth), especially in local language, can improve medication adherence and self-management among diabetics. However, there are currently no validated diabetes-related apps available in Urdu for Pakistani population The objective of this study is to develop an android-compatible mobile application in Urdu, to assess its effectiveness in improving medication adherence and self-management, and to conduct an economic evaluation of this app against the usual standard of care for type II diabetics in Pakistan. This 18 months long randomized controlled trial will be conducted at the National Institute of Diabetes and Endocrinology Karachi. This bi-phasic study will involve the development and pilot testing of an android-compatible app, followed by an RCT to assess the effectiveness of this mobile app in improving medication adherence and self-management among type II diabetics in Pakistan. Medication adherence will be measured by the HbA1c levels and self-reported Morisky Medication Adherence Scale (Urdu version), while self- management will be assessed by Diabetes Self-Management Questionnaire (Urdu version). All outcomes will be assessed at 3 and 6 months. Intervention usability will be evaluated by the Mobile App Rating Scale (MARS) and economic effectiveness will be evaluated by EQ-5D-3L (Urdu version) to measure Quality Adjusted Life Years.

The expected outcome is the production of scientific evidence for the effectiveness and economic viability of a locally-validated mobile application for diabetes care and management in Pakistan

• Study Type: Interventional
• Enrollment (Estimated): 160
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Sindh
    • Karachi, Sindh, Pakistan
      • National Institute of Diabetes and Endocrinology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Adults
• HbA1c more than or equal to 8.0 on most recent lab report within last 3 months
• able to comprehend Urdu language

Exclusion Criteria:

• type I diabetics,
• patients on continuous glucose monitoring,
• patients with severe mental or physical impairment,
• pregnant
• do not have access to smart phone

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: mobile app users	Behavioral: mobile app use; The experimental group will use the mobile application while controlled group will not use mobile application. Investigators will assess the effectiveness of mobile application in ensuring medication adherence and self-management among diabetics in Pakistan
No Intervention: mobile app non-users

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
adherence to medication	measured by Morisky Medication Adherence Scale .For Morisky Medication Adherence Scale, a score of less than 6 will be considered low adherence and higher scores will indicate better adherence	baseline, 3 and 6 months
self-management among diabetics	measured by Diabetes self-management questionnaire. This questionnaire has a scale from 0 to 10, with the score of 10 indicating the most effective self-care behaviour.	baseline, 3 and 6 months
effective management of diabetes	Adherence to treatment will also be assessed by the HbA1c levelsHbA1c levels of 8% or more will be considered diabetic, with higher score indicating poor control of diabetes	baseline, 3 and 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intervention usability	measured through Mobile Application Rating Scale. In this scale all points are rated on 5 point scale from 1 indicating 'inadequate' and 5 indicating 'excellent'	measured at 6 months following intervention
economic effectiveness of the app	measured through EQ-5D-3L. calculated by subtracting the values of the descriptive EQ-5D system from the numerical value 1. This corresponds to the best possible health status, while an index value of <0 represents the worst possible health status.	measured at 6 months following intervention

Collaborators and Investigators

• Sponsor: Dow University of Health Sciences
• Collaborators: National Institutes of Health (NIH)
• Investigators: Principal Investigator: Maria Atif, Dow University of Health Sciences

Study record dates

Study Major Dates

• Study Start (Actual): March 20, 2024
• Primary Completion (Estimated): August 1, 2025
• Study Completion (Estimated): August 1, 2025

Study Registration Dates

• First Submitted: April 15, 2024
• First Submitted That Met QC Criteria: April 24, 2024
• First Posted (Actual): April 29, 2024

Study Record Updates

• Last Update Posted (Actual): April 30, 2024
• Last Update Submitted That Met QC Criteria: April 26, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: mobile applications; diabetes mellitus; Pakistan
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: mHealth; SG-222/R3-05/RDC/DUHS/1478 (Other Grant/Funding Number: National Institutes of Health Pakistan)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No