Advance Health Mobile APP for the Self Management of Diabetes Type2

September 23, 2024 updated by: Arshed Muhammad, Universiti Putra Malaysia

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

1600

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention arm
Ae mobile application tailored for patients with Type 2 diabetes, aiming to enhance their self-management practices will be used for the intervention arm. The app includes features such as medication tracking, appointment scheduling, patient data storage, advice for treatment and follow-ups, health education and promotion, and real-time health monitoring.
Behavioral: Diabetes self management @ click
A mobile application tailored for patients with Type 2 diabetes, aiming to enhance their self-management practices will be used for the intervention arm. The app includes features such as medication tracking, appointment scheduling, patient data storage, advice for treatment and follow-ups, health education and promotion, and real-time health monitoring.
No Intervention: Control arm
The control arm will be given no intervention except usual care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6- months from baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hemoglobin A1C
Time Frame: 6- months from baseline
Hemoglobin A1C will be measured by taking blood samples.
6- months from baseline
Adherence to medication
Time Frame: 6- months from baseline
SEAMS URDU VERSION WILL BE USED FOR SEAMS Urdu version. It is of 13 questions with a score ranging from 13-39. Higher scores show better adherence
6- months from baseline
Health related quality of life
Time Frame: 6- months from baseline
Health-related quality of life will be assessed by EQ 5D3L. The EQ-5D-3L Index score summarizes each possible health state on a numerical scale ranging from -0.594 to 1, where a score of 1 indicates full health and scores of 0 and less than 0 indicate a state equivalent to being dead, and a state
6- months from baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universiti Putra Malaysia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 5, 2024

Primary Completion (Estimated)

May 15, 2025

Study Completion (Estimated)

June 10, 2025

Study Registration Dates

First Submitted

September 23, 2024

First Submitted That Met QC Criteria

September 23, 2024

First Posted (Actual)

September 26, 2024

Study Record Updates

Last Update Posted (Actual)

September 26, 2024

Last Update Submitted That Met QC Criteria

September 23, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BMU

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Only study protocol, statistical plan, and results will be shared by publications in peer reviewed journals

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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