Effects of Integrated Cardiovascular Health Education Program on Older Adults at Risk of ASCVD

NCT ID: NCT05434273

Last Updated: 2022-06-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

190 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-28

Study Completion Date

2025-11-30

Brief Summary

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Despite older adults being exposed to an increased risk of atherosclerotic cardiovascular disease (ASCVD), they are generally underrepresented in cardiovascular prevention programmes. The aim of this study is to examine the effects of an integrated exercise and cardiovascular health education programme (HE programme) on community-dwelling older adults at risk of ASCVD.

Detailed Description

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The study is a two-arm randomized controlled trial. (1) The control group will mainly receive a basic lifestyle modification talk, a lecture video and governmental education leaflets. (2) The experimental group will receive an integrated exercise and health education programme (HE programme) based on self-efficacy theory. Physical activity level, exercise self-efficacy and ASCVD risk profile including blood pressure, cardiac endurance, fasting blood glucose, fasting blood lipids, and anthropometric outcomes will be investigated via physiological assessments, medical history-taking or questionnaires at baseline, Week 12, Week 24 and Week 36.

Conditions

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Cardiovascular Diseases Healthy Lifestyle Health Education

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Experimental Arm: Integrated Intervention

Receive an integrated exercise and cardiovascular health education programme (HE programme)

Group Type EXPERIMENTAL

HE programme

Intervention Type BEHAVIORAL

Participants will receive a 12-week integrated exercise and cardiovascular health education programme (HE programme) which is constructed based on self-efficacy theory. A booster intervention in the form of SMS messaging will be given from Week 1 to Week 12.

Control

Receive usual care

Group Type SHAM_COMPARATOR

Usual care

Intervention Type BEHAVIORAL

Participants will receive usual care which primarily includes an education talk on basic health issues. A governmental health education leaflet and a lecture video will be provided for reference.

Interventions

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HE programme

Participants will receive a 12-week integrated exercise and cardiovascular health education programme (HE programme) which is constructed based on self-efficacy theory. A booster intervention in the form of SMS messaging will be given from Week 1 to Week 12.

Intervention Type BEHAVIORAL

Usual care

Participants will receive usual care which primarily includes an education talk on basic health issues. A governmental health education leaflet and a lecture video will be provided for reference.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Chinese adults ≧60 years old
* Having at least one ASCVD risk factor
* Pass the cardiovascular fitness evaluation
* Able to write and read Chinese, and communicate in Cantonese;
* Possess a mobile phone and able to make use of the phone in reading short messages

Exclusion Criteria

* Visually impaired, hearing impaired, or suffer from cognitive, psychiatric, or muscular disorder
* Having a history of attending similar cardiovascular prevention program
* Having a previous history of coronary heart disease or stroke
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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The Hong Kong Polytechnic University

OTHER

Sponsor Role lead

Responsible Party

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Dr Eva Ho

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ka Yan Ho

Role: STUDY_DIRECTOR

The Hong Kong Polytechnic University

Locations

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The Hong Kong Polytechnic University

Hong Kong, , Hong Kong

Site Status

Countries

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Hong Kong

Central Contacts

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Ka Yan Ho

Role: CONTACT

References

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Lo FMW, Wong EML, Ho KY. The effects of an integrated exercise and cardiovascular health education programme on community-dwelling older adults at risk of atherosclerotic cardiovascular diseases: A study protocol for a randomised controlled trial. PLoS One. 2023 May 24;18(5):e0286181. doi: 10.1371/journal.pone.0286181. eCollection 2023.

Reference Type DERIVED
PMID: 37224162 (View on PubMed)

Other Identifiers

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ASCVD_OlderAdult_Full

Identifier Type: -

Identifier Source: org_study_id

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