Cardiovascular DiseasesNCT05031377
Effects of Cardiovascular Health Education Program on Community-dwelling Older Adults at Risk of ASCVD
A study testing HE programme in people with Cardiovascular Diseases and Healthy Lifestyle, run by The Hong Kong Polytechnic University.
Trial summary
Despite older adults being exposed to an increased risk of atherosclerotic cardiovascular disease (ASCVD), they are generally underrepresented in cardiovascular prevention programmes. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases, Healthy Lifestyle, Health Education
- What is being tested?
- HE programme
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2021to 1 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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.
- Conditions
- Cardiovascular Diseases, Healthy Lifestyle, Health Education
- Being tested
- HE programme, Usual care
- Keywords
- Older Adults, Physical Activity, Atherosclerotic Cardiovascular Disease, Lifestyle Modification, Health Education
- Medical subject headings
- Cardiovascular Diseases, Health Education, Motor Activity, Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HE programmeBehavioural
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.
Usual careBehavioural
Participants will receive usual care which primarily includes an education talk on basic health issues. Governmental health education leaflets will be provided for reference.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Arm: Integrated Intervention | Experimental | Receive an integrated exercise and cardiovascular health education programme (HE programme) Receives: Behavioral: HE programme |
| Control | Sham comparator | Receive usual care Receives: Behavioral: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical activity level (total score)
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.
Measured: At baseline, at Week 6, and at Week 12
Physical activity level (classification of physical activity level)
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.
Measured: At baseline, at Week 6, and at Week 12
Secondary outcomes (17)
Exercise self-efficacy
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.
Measured: At baseline, at Week 6, and at Week 12
ASCVD risk profiles (Blood pressure, weight, height, BMI & waist circumference, heart rate)
The ASCVD risk profiles will be assessed by physical evaluations carried out by blinded, trained outcome assessors.
Measured: At baseline, at Week 6, and at Week 12
ASCVD risk profiles (2-minute walk test)
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.
Measured: At screening stage, at Week 6, and at Week 12
Acceptability of the program to participants
It will be measured by a self-developed questionnaire
Measured: At Week 12
Acceptability of the program to outcome assessors
It will be measured by a self-developed questionnaire completed by outcome assessors
Measured: After the outcome assessors have finished their duties
Acceptability of the program to lecture deliverers
It will be measured by a self-developed questionnaire completed by lecture deliverers
Measured: After the lecture deliverers have finished their duties
Adverse events throughout the program
Unfavorable or unintended events regarding the programme reported by participants throughout the study period.
Measured: Throughout the study period
Program safety evaluated by participants
It will be measured via a self-developed questionnaire completed by participants
Measured: At Week 12
Eligibility rate
The number of eligible potential participants divided by the number of screened people
Measured: At baseline
Recruitment rate
The percentage of participants who consent to join the study and being recruited
Measured: At baseline
Retention rate
The percentage of participants remaining in the study
Measured: At baseline, at Week 6 and at Week 12
Lecture attendance rate
- 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
Measured: Immediately after education session
Adherence to intervention
- 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
Measured: At Week 6 and at Week 12
Attendance rate to data collection
- 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
Measured: At baseline, at Week 6 and at Week 12
Questionnaire completion rate
The number of participants who complete the questionnaire divided by the number of distributed questionnaires
Measured: At baseline, at Week 6 and at Week 12
Missing data
The percentage of missing data
Measured: At baseline, at Week 6 and at Week 12
Structured questionnaire
The questionnaire will primarily include patient demographics, medical history, lifestyle patterns, medication use and physical fitness evaluation data, etc.
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2021
- Study start1 Sep 2021 (estimated)
- Primary completion1 Sep 2024 (estimated)
- Study completion1 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by The Hong Kong Polytechnic UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Eva Ho, The Hong Kong Polytechnic University
- Investigators
- Ka Yan Ho, PhD, Study director, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05031377
- Sponsor's protocol ID
- ASCVD_OlderAudlts
- Status last verified
- Aug 2021
- First submitted
- 19 Aug 2021
- Last updated
- 1 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of a Cardiovascular Health Education Program on Community-dwelling Older Adults at Risk of Atherosclerotic Cardiovascular Diseases: A Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05031377
- Acronym / sponsor ID
- ASCVD_OlderAudlts
- Conditions
- Cardiovascular Diseases, Healthy Lifestyle, Health Education
- Keywords
- Older Adults, Physical Activity, Atherosclerotic Cardiovascular Disease, Lifestyle Modification, Health Education
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- 1 Sep 2021 (estimated)
- Primary completion
- 1 Sep 2024 (estimated)
- Study completion
- 1 Sep 2024 (estimated)
- First posted
- 1 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Arm: Integrated Intervention | Experimental | Behavioral: HE programmeReceive an integrated exercise and cardiovascular health education programme (HE programme) |
| Control | Sham comparator | Behavioral: Usual careReceive usual care |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HE programmeParticipants 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. | Behavioural | Experimental Arm: Integrated Intervention |
| Usual careParticipants will receive usual care which primarily includes an education talk on basic health issues. Governmental health education leaflets will be provided for reference. | Behavioural | Control |
Primary outcome
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.
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.
17 secondary outcomes
Exercise self-efficacy
Time frame: 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
ASCVD risk profiles (2-minute walk test)
Time frame: At screening stage, at Week 6, and at Week 12
Acceptability of the program to participants
Time frame: At Week 12
Acceptability of the program to outcome assessors
Time frame: 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
Adverse events throughout the program
Time frame: Throughout the study period
Program safety evaluated by participants
Time frame: At Week 12
Eligibility rate
Time frame: At baseline
Recruitment rate
Time frame: At baseline
Retention rate
Time frame: At baseline, at Week 6 and at Week 12
Lecture attendance rate
Time frame: Immediately after education session
Adherence to intervention
Time frame: At Week 6 and at Week 12
Attendance rate to data collection
Time frame: At baseline, at Week 6 and at Week 12
Questionnaire completion rate
Time frame: At baseline, at Week 6 and at Week 12
Missing data
Time frame: At baseline, at Week 6 and at Week 12
Structured questionnaire
Time frame: At baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ka Yan Ho, PhD study director
The Hong Kong Polytechnic University
Questions about this trial
What is this clinical trial studying?
A study testing HE programme in people with Cardiovascular Diseases and Healthy Lifestyle, run by The Hong Kong Polytechnic University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ka Yan Ho, PhD (27666417, kyeva.ho@polyu.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical activity level (total score) (time frame: At baseline, at Week 6, and at Week 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2021.