NCT05422729

Brief Summary

A randomised controlled trial to evaluate the effects of a personalised mHealth-supported coach programme in the middle-aged group with stroke risk.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
164

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 8, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 16, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

September 5, 2022

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 4, 2024

Completed
Last Updated

August 21, 2023

Status Verified

August 1, 2023

Enrollment Period

1.8 years

First QC Date

June 8, 2022

Last Update Submit

August 18, 2023

Conditions

Heart Disease Risk Factors

Keywords

Primary Health Care

Outcome Measures

Primary Outcomes (2)

  • Health-promoting behaviours

    Four subscales, including health responsibility, nutrition, physical activity and stress management, of the Health Promoting Lifestyle Profile II. The possible score range from 34 to 136, with a higher score meaning healthier lifestyles were adopted.

    3-month post-allocation

  • Health-promoting behaviours

    Four subscales, including health responsibility, nutrition, physical activity and stress management, of the Health Promoting Lifestyle Profile II. The possible score range from 34 to 136, with a higher score meaning healthier lifestyles were adopted.

    6-month post-allocation

Secondary Outcomes (18)

  • Self-efficacy of adopting health-promoting behaviours

    3-month post-allocation

  • Self-efficacy

    6-month post-allocation

  • INTERHEART risk score

    3-month post-allocation

  • INTERHEART risk score

    6-month post-allocation

  • automatic retinal image analysis

    3-month post-allocation

  • +13 more secondary outcomes

Study Arms (2)

Personalised mHeatlh-supported coaching programme

EXPERIMENTAL

Three monthly individual consultation session, supported with a specific mobile application.

Behavioral: mHealth-supported coaching

Traditional in-person health coaching programme

ACTIVE COMPARATOR

Three monthly individual consultation sessions.

Behavioral: Conventional Health coaching

Interventions

mHealth-supported coachingBEHAVIORAL

The intervention includes two components. Three individual consultation sessions based on a health coaching protocol developed by a multidisciplinary team. A mobile application provides educational information about healthy lifestyles, knowledge quizzes, telemonitoring function and virtual platform for sharing.

Personalised mHeatlh-supported coaching programme
Conventional Health coachingBEHAVIORAL

Three individual consultation sessions delivered by a nurse.

Traditional in-person health coaching programme

Eligibility Criteria

Age40 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Chinese ethnic
  • able to read Chinese and communicate in Cantonese/Mandarin
  • with non-laboratory IHRS score 10 or higher

You may not qualify if:

  • mentally incompetent
  • previously diagnosed with stroke, TIA, MI, coronary heart disease, heart failure or atrial fibrillation
  • with eye or retinal disease
  • with terminal disease with an expected life expectancy less than six months
  • being pregnant
  • have enrolled in other lifestyle-based or exercise-based projects
  • do have mobile devices or internet service to access the mobile application

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Chinese University of Hong Kong

Hong Kong, 00000, Hong Kong

RECRUITING

Study Officials

  • Helen Y Chan, Ph.D

    Chinese University of Hong Kong

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Helen Y Chan, Ph.D

CONTACT

+85239438099helencyl@cuhk.edu.hk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor (Dr)

Study Record Dates

First Submitted

June 8, 2022

First Posted

June 16, 2022

Study Start

September 5, 2022

Primary Completion

June 30, 2024

Study Completion

September 4, 2024

Last Updated

August 21, 2023

Record last verified: 2023-08

Locations

HK(1)