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NCT Number: NCT06466837

Just-In-Time Adaptive Interventions for Diabetic Patients

The addition of proactive nurse consultations was useful to older adults with diabetes mellitus in facilitating their chronic disease self-management. However, the service is time and resource-intensive. With the support of advanced technology, mhealth App seems to be a convenient way to support patients in managing diabetes.

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Key information

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

District Health Center

Hong Kong

Location status: Recruiting

Location contact

Stella Au, MSc

CONTACT

+85234003805

About this study

This study examines the effectiveness of mhealth App plus nurse consultations in promoting self-management behaviours for diabetic patients.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • With a confirmed DM diagnosis for one year or more than one year
  • Using governmental mhealth App
  • Living in an area with Internet coverage

Exclusion criteria

  • Already engaged in other mHealth programmes
  • Physical and cognitive limitations

Treatment and study plan

Just-in-time intervention

Behavioral

The intervention group participants will receive just-in-time intervention from a developed app for healthy behavior reminder

Active Control

Behavioral

The control group participants will receive six nursing consultations during the 3-month program period.

Primary outcomes

  1. Change in HbA1c

    Time frame: baseline, three-month, and six-month

    Measured using the A1C Now device, with blood drawn from the subjects' finger

  2. Diabetic self-management behaviour

    Time frame: baseline, three-month, and six-month

    measured using the Summary of Diabetes Self-care. Total scores range from 0 to 42, with higher scores representing better self-management performance. Activities questionnaire

Secondary outcomes

  1. Change in quality of life

    Time frame: baseline, three-month, and six-month

    By using the Chinese version of the 12-item Short Form Health Survey. Total score ranges from 0 to 100, higher the better.

    version 2

  2. Change in medication adherence

    Time frame: baseline, three-month, and six-month

    Measure this by using the Adherence to Refills and Medications Scale. Scores from 12 to 48, higher score better medication adherence.

  3. Change in health service utilization

    Time frame: baseline, three-month, and six-month

    Measure the total number of unscheduled visits to general out-patient departments, general practitioners, emergency departments, and hospitals, and the total frequency of health service attendance

  4. Cost

    Time frame: three-month, and six-month

    The cost of the app, including development of new features and maintenance costs, will be estimated from the provider and societal perspectives, including the subjects' travelling costs and time. An ingredient approach will be adopted to estimate the cost.

  5. satisfaction with the JITAIs, as well as usability and technical problems

    Time frame: three-month

    using semi-structured group interviews with the intervention group participants

Study contacts

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

Arkers Wong, PhD

CONTACT

[email protected]

852 3400 3805

Sponsors and collaborators

Lead sponsor

The Hong Kong Polytechnic University

Other

Registry information

Official study title

Promoting Self-management Behaviours Among Older Adults With Diabetes Mellitus by Integrating Just-In-Time Adaptive Interventions in Mobile Health Applications: A Randomized Controlled Trial

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jun 20, 2024
Registry last updated
Sep 15, 2025

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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