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

Cardiovascular Diseases Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05031377
• Other study ID #: ASCVD_OlderAudlts
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 1, 2021
• Est. completion date: September 1, 2024

Study information

• Verified date: August 2021
• Source: The Hong Kong Polytechnic University
• Contact: Ka Yan Ho, PhD
• Phone: 27666417
• Email: kyeva.ho[@]polyu.edu.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: September 1, 2024
• Est. primary completion date: September 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Health Education
• Healthy Lifestyle

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
The Hong Kong Polytechnic University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	Acceptability of the program to participants	It will be measured by a self-developed questionnaire	At Week 12
Secondary	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
Secondary	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
Secondary	Adverse events throughout the program	Unfavorable or unintended events regarding the programme reported by participants throughout the study period.	Throughout the study period
Secondary	Program safety evaluated by participants	It will be measured via a self-developed questionnaire completed by participants	At Week 12
Secondary	Eligibility rate	The number of eligible potential participants divided by the number of screened people	At baseline
Secondary	Recruitment rate	The percentage of participants who consent to join the study and being recruited	At baseline
Secondary	Retention rate	The percentage of participants remaining in the study	At baseline, at Week 6 and at Week 12
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Missing data	The percentage of missing data	At baseline, at Week 6 and at Week 12
Secondary	Structured questionnaire	The questionnaire will primarily include patient demographics, medical history, lifestyle patterns, medication use and physical fitness evaluation data, etc.	At baseline