Clinical trial NCT05031377: Effects of Cardiovascular Health Education Program on Community-dwelling Older Adults at Risk of ASCVD
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cardiovascular Diseases
Healthy Lifestyle
Health Education
Keywords: Older Adults
Physical Activity
Atherosclerotic Cardiovascular Disease
Lifestyle Modification
Health Education
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2021-09-01
Enrollment: 80
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Physical activity level (total score)
timeFrame: At baseline, at Week 6, and at Week 12
measure: Physical activity level (classification of physical activity level)
timeFrame: At baseline, at Week 6, and at Week 12
Secondary outcomes:
measure: Exercise self-efficacy
timeFrame: At baseline, at Week 6, and at Week 12
measure: ASCVD risk profiles (Blood pressure, weight, height, BMI & waist circumference, heart rate)
timeFrame: At baseline, at Week 6, and at Week 12
measure: ASCVD risk profiles (2-minute walk test)
timeFrame: At screening stage, at Week 6, and at Week 12
measure: Acceptability of the program to participants
timeFrame: At Week 12
measure: Acceptability of the program to outcome assessors
timeFrame: After the outcome assessors have finished their duties
measure: Acceptability of the program to lecture deliverers
timeFrame: After the lecture deliverers have finished their duties
measure: Adverse events throughout the program
timeFrame: Throughout the study period
measure: Program safety evaluated by participants
timeFrame: At Week 12
measure: Eligibility rate
timeFrame: At baseline
measure: Recruitment rate
timeFrame: At baseline
measure: Retention rate
timeFrame: At baseline, at Week 6 and at Week 12
measure: Lecture attendance rate
timeFrame: Immediately after education session
measure: Adherence to intervention
timeFrame: At Week 6 and at Week 12
measure: Attendance rate to data collection
timeFrame: At baseline, at Week 6 and at Week 12
measure: Questionnaire completion rate
timeFrame: At baseline, at Week 6 and at Week 12
measure: Missing data
timeFrame: At baseline, at Week 6 and at Week 12
measure: Structured questionnaire
timeFrame: At baseline
Other outcomes:
Locations:
Study officials:
affiliation: The Hong Kong Polytechnic University
name: Ka Yan Ho, PhD
role: STUDY_DIRECTOR
References: