Effectiveness of an mHealth Mobile App

NCT ID: NCT06387433

Last Updated: 2024-04-30

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-20
• Study Completion Date: 2025-08-31

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

Conditions

Type II Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

mobile app users

Group Type: EXPERIMENTAL

mobile app use

Intervention Type: BEHAVIORAL

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

mobile app non-users

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

Dow University of Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Maria Atif

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Maria Atif

Role: PRINCIPAL_INVESTIGATOR

Dow University of Health Sciences

Locations

National Institute of Diabetes and Endocrinology

Karachi, Sindh, Pakistan

Countries

Pakistan

Other Identifiers

SG-222/R3-05/RDC/DUHS/1478

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

mHealth

Identifier Type: -

Identifier Source: org_study_id