Effectiveness of an mHealth Mobile App

Not Applicable

Active, not recruiting

• Conditions: Type II Diabetes
• Interventions: Behavioral: mobile app use

• Registration Number: NCT06387433
• Lead Sponsor: Dow University of Health Sciences

Brief Summary

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

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 Timeline

• Study Start: 2024-03-20
• Status Verified: 2024-04
• Study First Submitted: 2024-04-15
• Study First Submitted QC: 2024-04-24
• Last Update Submitted: 2024-04-26
• Study First Posted: 2024-04-29
• Last Update Posted: 2024-04-30
• Primary Completion: 2025-08
• Study Completion: 2025-08

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 160

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
mobile app users	mobile app use	-

Primary Outcome Measures

Name	Time	Method
self-management among diabetics	baseline, 3 and 6 months	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.
effective management of diabetes	baseline, 3 and 6 months	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
adherence to medication	baseline, 3 and 6 months	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

Secondary Outcome Measures

Name	Time	Method
economic effectiveness of the app	measured at 6 months following intervention	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.
Intervention usability	measured at 6 months following intervention	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'

Trial Locations

Locations (1)

National Institute of Diabetes and Endocrinology; 🇵🇰 Karachi, Sindh, Pakistan