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NCT Number: NCT06614283

Advance Health Mobile APP for the Self Management of Diabetes type2

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.

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Key information

Conditions

Diabetes Mellitus Type 2 Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Diabetes self management @ click

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.

Primary outcomes

  1. 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

  1. Hemoglobin A1C

    Time frame: 6- months from baseline

    Hemoglobin A1C will be measured by taking blood samples.

  2. 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

  3. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Dr. Muhammad Raashed Research coordinator, MPHIL

CONTACT

[email protected]

00923137774464

Sponsors and collaborators

Lead sponsor

Universiti Putra Malaysia

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 26, 2024
Registry last updated
Sep 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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