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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Experimental Arm: Integrated Intervention
Receive an integrated exercise and cardiovascular health education programme (HE programme)
Behavioral: 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
Behavioral: 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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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
  • The number of participants in the control group who attend the education talk divided by the number of participants who are randomized into the control group
  • The number of participants in the experimental group who attend the education session divided by the number of participants who are randomized into the experimental group
  • The number of participants in the two groups who attend the education session divided by the number of randomized participants
Immediately after education session
Adherence to intervention
Time Frame: At Week 6 and at Week 12
  • The number of participants in the experimental group who practice the tailor-made exercise learned during the intervention divided by the number of participants in the experimental group
  • Experimental group's frequency in performing tailor-made exercise related to the recommended exercise dosage
At Week 6 and at Week 12
Attendance rate to data collection
Time Frame: At baseline, at Week 6 and at Week 12
  • The number of participants in the control group who attend the data collection divided by the number of participants who are randomized into the control group
  • The number of participants in the experimental group who attend the data collection divided by the number of participants who are randomized into the experimental group
  • The number of participants who attend the data collection divided by the number of randomized participants
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The Hong Kong Polytechnic University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2024

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 19, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 26, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 1, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 1, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 26, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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