Just-In-Time Adaptive Interventions for Diabetic Patients
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60+
SponsorThe Hong Kong Polytechnic University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
With a confirmed DM diagnosis for one year or more than one year
Using governmental mhealth App
Living in an area with Internet coverage
Disqualifiers
Already engaged in other mHealth programmes
Physical and cognitive limitations
Trial design
Design model
Parallel
Treatments tested in this trial
Just-in-time intervention
BehavioralThe intervention group participants will receive just-in-time intervention from a developed app for healthy behavior reminder
Active control
BehavioralThe control group participants will receive six nursing consultations during the 3-month program period.
Treatment groups
184 Participants
are divided into 2 treatment groupsGroup A: Just-in-time InterventionExperimental treatment 1 intervention
Group B: Active ControlActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in HbA1c
Measured using the A1C Now device, with blood drawn from the subjects' finger
Time frame
baseline, three-month, and six-month2
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
Time frame
baseline, three-month, and six-monthSecondary outcomes
1
Change in quality of life
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
Time frame
baseline, three-month, and six-month2
Change in medication adherence
Measure this by using the Adherence to Refills and Medications Scale. Scores from 12 to 48, higher score better medication adherence.
Time frame
baseline, three-month, and six-month3
Change in health service utilization
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
Time frame
baseline, three-month, and six-month4
Cost
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.
Time frame
three-month, and six-monthSponsors and contacts
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Source ClinicalTrials.gov