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Not yet recruiting NCT06614283

Advance Health Mobile APP for the Self Management of Diabetes type2

No phase Interventional Diabetes Mellitus Type 2

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Diabetes self management @ click.
Who it may be relevant to
Registry conditions: Diabetes Mellitus Type 2. Basic parameters: 18 years — 85 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Pakistan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Effectiveness of Advance Health Mobile APP for the Self Management of Diabetes type2 in a Resource-constrained Setting, a Randomized Control Trial

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • Diabetes Self-Management [Time frame: 6- months from baseline]
Secondary outcome measures (3)
  • Hemoglobin A1C [Time frame: 6- months from baseline]
  • Adherence to medication [Time frame: 6- months from baseline]
  • Health related quality of life [Time frame: 6- months from baseline]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Health services research

Study locations

Pakistan · 1 center
  • Said Mitha Hospital — Lahore

Publications

  • 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. PMID 33154039
  • 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. PMID 17985509
  • 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 STIC PMID 30083727
  • 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. PMID 25884536

Identifiers

NCT: NCT06614283 · BMU

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗