Effectiveness of an mHealth Mobile App

NCT06387433 | Active Not Recruiting

• 2 other identifiers: mHealthSG-222/R3-05/RDC/DUHS/1478
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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

Conditions

Type II Diabetes

Keywords

diabetes mellitus; mobile applications; Pakistan

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Intervention usability

  measured at 6 months following intervention

• economic effectiveness of the app

  measured at 6 months following intervention

Study Arms (2)

mobile app users

EXPERIMENTAL

Behavioral: mobile app use

mobile app non-users

NO INTERVENTION

Interventions

mobile app use 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 users

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Dow University of Health Sciences: lead
• National Institutes of Health (NIH): collaborator

Study Sites (1)

National Institute of Diabetes and Endocrinology

Karachi, Sindh, Pakistan

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Maria Atif

  Dow University of Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 15, 2024
• First Posted: April 29, 2024
• Study Start: March 20, 2024
• Primary Completion: August 1, 2025
• Study Completion: August 1, 2025
• Last Updated: April 30, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)