Advance Health Mobile APP for the Self Management of Diabetes Type2

NCT ID: NCT06614283

Last Updated: 2024-09-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

1600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-05

Study Completion Date

2025-06-10

Brief Summary

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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

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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.

Conditions

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Diabetes Mellitus Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Two-arm randomized control trial
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

DOUBLE

Participants Investigators
Participants and Investigators are blinded.

Study Groups

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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.

Group Type EXPERIMENTAL

Diabetes self management @ click

Intervention Type BEHAVIORAL

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.

Control arm

The control arm will be given no intervention except usual care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universiti Putra Malaysia

OTHER

Sponsor Role lead

Responsible Party

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Arshed Muhammad

PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Said Mitha Hospital

Lahore, Punjab Province, Pakistan

Site Status

Countries

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Pakistan

Central Contacts

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Dr. Muhammad Raashed Research coordinator, MPHIL

Role: CONTACT

00923137774464

Facility Contacts

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Dr. MUHAMMAD ARSHED

Role: primary

03337474464

References

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Nelson LA, Greevy RA, Spieker A, Wallston KA, Elasy TA, Kripalani S, Gentry C, Bergner EM, LeStourgeon LM, Williamson SE, Mayberry LS. Effects of a Tailored Text Messaging Intervention Among Diverse Adults With Type 2 Diabetes: Evidence From the 15-Month REACH Randomized Controlled Trial. Diabetes Care. 2021 Jan;44(1):26-34. doi: 10.2337/dc20-0961. Epub 2020 Nov 5.

Reference Type BACKGROUND
PMID: 33154039 (View on PubMed)

Saydah S, Cowie C, Eberhardt MS, De Rekeneire N, Narayan KM. Race and ethnic differences in glycemic control among adults with diagnosed diabetes in the United States. Ethn Dis. 2007 Summer;17(3):529-35.

Reference Type BACKGROUND
PMID: 17985509 (View on PubMed)

Choudhry NK, Isaac T, Lauffenburger JC, Gopalakrishnan C, Lee M, Vachon A, Iliadis TL, Hollands W, Elman S, Kraft JM, Naseem S, Doheny S, Lee J, Barberio J, Patel L, Khan NF, Gagne JJ, Jackevicius CA, Fischer MA, Solomon DH, Sequist TD. Effect of a Remotely Delivered Tailored Multicomponent Approach to Enhance Medication Taking for Patients With Hyperlipidemia, Hypertension, and Diabetes: The STIC2IT Cluster Randomized Clinical Trial. JAMA Intern Med. 2018 Sep 1;178(9):1182-1189. doi: 10.1001/jamainternmed.2018.3189.

Reference Type BACKGROUND
PMID: 30083727 (View on PubMed)

American College of Clinical Pharmacy; McBane SE, Dopp AL, Abe A, Benavides S, Chester EA, Dixon DL, Dunn M, Johnson MD, Nigro SJ, Rothrock-Christian T, Schwartz AH, Thrasher K, Walker S. Collaborative drug therapy management and comprehensive medication management-2015. Pharmacotherapy. 2015 Apr;35(4):e39-50. doi: 10.1002/phar.1563.

Reference Type BACKGROUND
PMID: 25884536 (View on PubMed)

Other Identifiers

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BMU

Identifier Type: -

Identifier Source: org_study_id

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