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Clinical Trials/NCT06614283
NCT06614283
Not yet recruiting
Not Applicable

Effectiveness of Advance Health Mobile APP for the Self Management of Diabetes Type2 in a Resource-constrained Setting, a Randomized Control Trial

Universiti Putra Malaysia1 site in 1 country1,600 target enrollmentOctober 5, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Diabetes Mellitus Type 2
Sponsor
Universiti Putra Malaysia
Enrollment
1600
Locations
1
Primary Endpoint
Diabetes Self-Management
Status
Not yet recruiting
Last Updated
last year

Overview

Brief Summary

Digital health using mobile health (mHealth) tools, such as telehealth and text messaging, and or mobile Apps can improve blood glucose levels in patients with type 2 diabetes. This intervention is designed to improve self-management of diabetes and blood glucose levels in diabetic patients.

Detailed Description

Patients with type 2 diabetes may experience improvements in their blood glucose levels thanks to mHealth technologies like mobile apps and telehealth text messaging. The goal of this intervention is to help diabetic people better control their blood glucose levels and diabetes. The intervention arm will employ a smartphone application designed specifically for individuals with Type 2 diabetes, with the goal of improving their self-management behaviors. Features of the app include real-time health monitoring, appointment scheduling, medication tracking, patient data storage, treatment and follow-up recommendations, and health education and promotion.

Registry
clinicaltrials.gov
Start Date
October 5, 2024
End Date
June 10, 2025
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Arshed Muhammad

PhD

Universiti Putra Malaysia

Eligibility Criteria

Inclusion Criteria

  • The presence of T2D and at least 1 recorded HbA1c level of 8.0% or higher in the past 6 months
  • Age between ages 21 and 85 years,
  • Receiving primary care at the clinical site
  • Having fluency in English/ Urdu in reading and writing
  • Having a smartphone
  • Agreeing to take part in the study

Exclusion Criteria

  • Planning to move away from the study site
  • Being pregnant or in lactation, (6) being unable to send or read text messages on a mobile phone,
  • Having a history of receiving or planning surgery.

Outcomes

Primary Outcomes

Diabetes Self-Management

Time Frame: 6- months from baseline

DSMQ-R will assess Diabetes self-management. The DSMQ-R is a multidimensional questionnaire with 27 items regarding essential self-management practices for T1D and T2D (including diabetes-adjusted eating, glucose testing/monitoring, medication taking, physical activity, and cooperation with the diabetes team). 4 Subscales: * 'Glucose Management' (GM), 11 items: 1, 4, 6, 10, 12, 21, 22, 23, 24, 26, 27 (10 and 12 must be inverted). * 'Dietary Control' (DC), 7 items: 2, 5, 9, 13, 17, 18, 25 (5, 13 and 18 must be inverted). * 'Physical Activity' (PA), 3 items: 8, 11, 15 (11 and 15 must be inverted). * 'Health-Care Use' (HU), 4 items: 3, 7, 14, 19 (7 and 14 must be inverted). SCALE SCORE = ACTUAL SUM OF ITEMS / MAXIMUM POSSIBLE SUM OF ITEMS x 10

Secondary Outcomes

  • Hemoglobin A1C(6- months from baseline)
  • Adherence to medication(6- months from baseline)
  • Health related quality of life(6- months from baseline)

Study Sites (1)

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