Ignite Creation Date:
2024-05-06 @ 8:27 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06387433
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-04-30
First Post:
2024-04-15
Brief Title:
Effectiveness of an mHealth Mobile App
Sponsor:
Dow University of Health Sciences
Organization:
Dow University of Health Sciences
Study Overview
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
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
mHealth
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| SG-222R3-05RDCDUHS1478 | OTHER_GRANT | National Institutes of Health Pakistan | None |