NCT06466837

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
184

participants targeted

Target at P50-P75 for not_applicable diabetes

Timeline
Completed

Started Sep 2024

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 14, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 20, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2024

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2026

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2026

Completed
Last Updated

September 15, 2025

Status Verified

September 1, 2025

Enrollment Period

1.4 years

First QC Date

June 14, 2024

Last Update Submit

September 8, 2025

Conditions

Keywords

telecareolder adultsdiabetes

Outcome Measures

Primary Outcomes (2)

  • Change in HbA1c

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

    baseline, three-month, and six-month

  • Diabetic self-management behaviour

    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

    baseline, three-month, and six-month

Secondary Outcomes (5)

  • Change in quality of life

    baseline, three-month, and six-month

  • Change in medication adherence

    baseline, three-month, and six-month

  • Change in health service utilization

    baseline, three-month, and six-month

  • Cost

    three-month, and six-month

  • satisfaction with the JITAIs, as well as usability and technical problems

    three-month

Study Arms (2)

Just-in-time Intervention

EXPERIMENTAL

They will receive just-in-time intervention and 3 monthly nursing consultations.

Behavioral: Just-in-time intervention

Active Control

ACTIVE COMPARATOR

They will receive 6 bi-weekly nursing consultations.

Behavioral: Active control

Interventions

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

Just-in-time Intervention
Active controlBEHAVIORAL

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

Active Control

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

District Health Center

Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Conditions

Diabetes MellitusSelf-Control

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesSocial BehaviorBehavior

Study Officials

  • Arkers Wong, PhD

    The Hong Kong Polytechnic University

    PRINCIPAL INVESTIGATOR
  • Arkers NR Wong

    The Hong Kong Polytechnic University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The research assistant, who will be responsible for data collection, will be masked for the group allocation during the whole process.
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: Single-blinded, two-armed, randomized controlled trial.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

June 14, 2024

First Posted

June 20, 2024

Study Start

September 1, 2024

Primary Completion

February 1, 2026

Study Completion

March 1, 2026

Last Updated

September 15, 2025

Record last verified: 2025-09

Locations