- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05031377
Effects of Cardiovascular Health Education Program on Community-dwelling Older Adults at Risk of ASCVD
August 26, 2021 updated by: Dr Eva Ho, The Hong Kong Polytechnic University
The Effects of a Cardiovascular Health Education Program on Community-dwelling Older Adults at Risk of Atherosclerotic Cardiovascular Diseases: A Pilot Randomized Controlled Trial
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 assess the feasibility of implementing an integrated exercise and cardiovascular health education programme (HE programme) on older adults at risk of ASCVD.
Study Overview
Status
Not yet recruiting
Intervention / Treatment
Detailed Description
The study is a two-arm pilot randomized controlled trial.
(1) The control group will receive a basic lifestyle modification talk 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, and anthropometric outcomes will be investigated via physiological assessments, medical history-taking or questionnaires at baseline, Week 6, and Week 12.
Meanwhile, study feasibility will be primarily evaluated in terms of programme acceptability, intervention integrity, recruitment rate and retention rate throughout the process and at Week 12.
Study Type
Interventional
Enrollment (Anticipated)
80
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
60 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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 SMS
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Experimental Arm: Integrated Intervention
Receive an integrated exercise and cardiovascular health education programme (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.
|
Sham Comparator: Control
Receive usual care
|
Participants will receive usual care which primarily includes an education talk on basic health issues.
Governmental health education leaflets will be provided for reference.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Physical activity level (total score)
Time Frame: At baseline, at Week 6, and at Week 12
|
The physical activity level will be measured by the Chinese Version of Physical Activity Scale for the Elderly (PASE-C).
The total score (from zero to 400 or above) is quantified based on frequency values and weights for these activities.
The higher the score, the higher the level of physical activity.
|
At baseline, at Week 6, and at Week 12
|
Physical activity level (classification of physical activity level)
Time Frame: At baseline, at Week 6, and at Week 12
|
The physical activity level will be measured by the Chinese version of International Physical Activity Questionnaire-short form (IPAQ-C-short form).
Participants are classified into "inactive", "minimally active" or "health enhancing physical activity (HEPA) active" based on their physical activity levels.
|
At baseline, at Week 6, and at Week 12
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adverse events throughout the program
Time Frame: Throughout the study period
|
Unfavorable or unintended events regarding the programme reported by participants throughout the study period.
|
Throughout the study period
|
Eligibility rate
Time Frame: At baseline
|
The number of eligible potential participants divided by the number of screened people
|
At baseline
|
Recruitment rate
Time Frame: At baseline
|
The percentage of participants who consent to join the study and being recruited
|
At baseline
|
Structured questionnaire
Time Frame: At baseline
|
The questionnaire will primarily include patient demographics, medical history, lifestyle patterns, medication use and physical fitness evaluation data, etc.
|
At baseline
|
Exercise self-efficacy
Time Frame: At baseline, at Week 6, and at Week 12
|
Exercise self-efficacy will be measured via the Chinese version of Self-Efficacy for Exercise (SEE-C).
The total score ranges from 0 to 90.
The higher the score, the greater the exercise self-efficacy.
|
At baseline, at Week 6, and at Week 12
|
ASCVD risk profiles (Blood pressure, weight, height, BMI & waist circumference, heart rate)
Time Frame: At baseline, at Week 6, and at Week 12
|
The ASCVD risk profiles will be assessed by physical evaluations carried out by blinded, trained outcome assessors.
|
At baseline, at Week 6, and at Week 12
|
ASCVD risk profiles (2-minute walk test)
Time Frame: At screening stage, at Week 6, and at Week 12
|
2-minute walk test will be adopted to examine aerobic capacity and self-paced walking capacity by measuring the walking distance covered at two minutes.
It will be assessed by blinded, trained outcome assessors.
|
At screening stage, at Week 6, and at Week 12
|
Acceptability of the program to participants
Time Frame: At Week 12
|
It will be measured by a self-developed questionnaire
|
At Week 12
|
Acceptability of the program to outcome assessors
Time Frame: After the outcome assessors have finished their duties
|
It will be measured by a self-developed questionnaire completed by outcome assessors
|
After the outcome assessors have finished their duties
|
Acceptability of the program to lecture deliverers
Time Frame: After the lecture deliverers have finished their duties
|
It will be measured by a self-developed questionnaire completed by lecture deliverers
|
After the lecture deliverers have finished their duties
|
Program safety evaluated by participants
Time Frame: At Week 12
|
It will be measured via a self-developed questionnaire completed by participants
|
At Week 12
|
Retention rate
Time Frame: At baseline, at Week 6 and at Week 12
|
The percentage of participants remaining in the study
|
At baseline, at Week 6 and at Week 12
|
Lecture attendance rate
Time Frame: Immediately after education session
|
|
Immediately after education session
|
Adherence to intervention
Time Frame: At Week 6 and at Week 12
|
|
At Week 6 and at Week 12
|
Attendance rate to data collection
Time Frame: At baseline, at Week 6 and at Week 12
|
|
At baseline, at Week 6 and at Week 12
|
Questionnaire completion rate
Time Frame: At baseline, at Week 6 and at Week 12
|
The number of participants who complete the questionnaire divided by the number of distributed questionnaires
|
At baseline, at Week 6 and at Week 12
|
Missing data
Time Frame: At baseline, at Week 6 and at Week 12
|
The percentage of missing data
|
At baseline, at Week 6 and at Week 12
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Ka Yan Ho, PhD, The Hong Kong Polytechnic University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
September 1, 2021
Primary Completion (Anticipated)
September 1, 2024
Study Completion (Anticipated)
September 1, 2024
Study Registration Dates
First Submitted
August 19, 2021
First Submitted That Met QC Criteria
August 26, 2021
First Posted (Actual)
September 1, 2021
Study Record Updates
Last Update Posted (Actual)
September 1, 2021
Last Update Submitted That Met QC Criteria
August 26, 2021
Last Verified
August 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ASCVD_OlderAudlts
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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