Effects of Cardiovascular Health Education Program on Community-dwelling Older Adults at Risk of ASCVD

Study Overview
=================
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.

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

Conditions
-----------------
Cardiovascular Diseases, Healthy Lifestyle, Health Education

Intervention / Treatment
-----------------
* Behavioral: HE programme
* Behavioral: Usual care


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental Arm: Integrated Intervention<br>Receive an integrated exercise and cardiovascular health education programme (HE programme) | Behavioral: HE programme<br>* 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.<br>|
| Sham Comparator: Control<br>Receive usual care | Behavioral: Usual care<br>* Participants will receive usual care which primarily includes an education talk on basic health issues. Governmental health education leaflets will be provided for reference.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | At baseline, at Week 6, and at Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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 | At Week 12 | 
| Acceptability of the program to outcome assessors | 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 | It will be measured by a self-developed questionnaire completed by lecture deliverers | 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. | Throughout the study period | 
| Program safety evaluated by participants | It will be measured via a self-developed questionnaire completed by participants | At Week 12 | 
| Eligibility rate | The number of eligible potential participants divided by the number of screened people | At baseline | 
| Recruitment rate | The percentage of participants who consent to join the study and being recruited | At baseline | 
| Retention rate | The percentage of participants remaining in the study | 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 | 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 | 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 | 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 | At baseline, at Week 6 and at Week 12 | 
| Missing data | The percentage of missing data | 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. | At baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Older Adults, Physical Activity, Atherosclerotic Cardiovascular Disease, Lifestyle Modification, Health Education