Clinical trial NCT06614283: Advance Health Mobile APP for the Self Management of Diabetes Type2
Official title: Effectiveness of Advance Health Mobile APP for the Self Management of Diabetes Type2 in a Resource-constrained Setting, a Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Diabetes Mellitus Type 2
Lead sponsor: Universiti Putra Malaysia
Sponsor class: OTHER
First posted: 2024-09-26
Enrollment: 1600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two-arm randomized control trial
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Primary outcomes:
measure: Diabetes Self-Management
timeFrame: 6- months from baseline
Secondary outcomes:
measure: Hemoglobin A1C
timeFrame: 6- months from baseline
measure: Adherence to medication
timeFrame: 6- months from baseline
measure: Health related quality of life
timeFrame: 6- months from baseline
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Said Mitha Hospital
state: Punjab
Study officials:
References:
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