Clinical trial NCT06387433: Effectiveness of an mHealth Mobile App
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Type II Diabetes
Keywords: diabetes mellitus
mobile applications
Pakistan
Lead sponsor: Dow University of Health Sciences
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2024-04-29
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

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

Primary outcomes:
measure: adherence to medication
timeFrame: baseline, 3 and 6 months
measure: self-management among diabetics
timeFrame: baseline, 3 and 6 months
measure: effective management of diabetes
timeFrame: baseline, 3 and 6 months
Secondary outcomes:
measure: Intervention usability
timeFrame: measured at 6 months following intervention
measure: economic effectiveness of the app
timeFrame: measured at 6 months following intervention
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: National Institute of Diabetes and Endocrinology
state: Sindh
Study officials:
affiliation: Dow University of Health Sciences
name: Maria Atif
role: PRINCIPAL_INVESTIGATOR
References: