Effectiveness of an mHealth Mobile App

Type II Diabetes Clinical Trial

— mHealth  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06387433
• Other study ID #: mHealth
• Secondary ID: SG-222/R3-05/RDC
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 20, 2024
• Est. completion date: August 2025

Study information

• Verified date: April 2024
• Source: Dow University of Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 160
• Est. completion date: August 2025
• Est. primary completion date: August 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type II Diabetes

Intervention

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

Locations

Country	Name	City	State
Pakistan	National Institute of Diabetes and Endocrinology	Karachi	Sindh

Sponsors (2)

Lead Sponsor	Collaborator
Dow University of Health Sciences	National Institutes of Health (NIH)

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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