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

NCT05031377 | Unknown

• 1 other identifier: ASCVD_OlderAudlts
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cardiovascular Diseases; Healthy Lifestyle; Health Education

Keywords

Older Adults; Physical Activity; Atherosclerotic Cardiovascular Disease; Lifestyle Modification; Health Education

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (17)

• Exercise self-efficacy

  At baseline, at Week 6, and at Week 12

• ASCVD risk profiles (Blood pressure, weight, height, BMI & waist circumference, heart rate)

  At baseline, at Week 6, and at Week 12

• ASCVD risk profiles (2-minute walk test)

  At screening stage, at Week 6, and at Week 12

• Acceptability of the program to participants

  At Week 12

• Acceptability of the program to outcome assessors

  After the outcome assessors have finished their duties

Study Arms (2)

Experimental Arm: Integrated Intervention

EXPERIMENTAL

Receive an integrated exercise and cardiovascular health education programme (HE programme)

Behavioral: HE programme

Control

SHAM COMPARATOR

Receive usual care

Behavioral: Usual care

Interventions

HE programme BEHAVIORAL

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.

Experimental Arm: Integrated Intervention

Usual care BEHAVIORAL

Participants will receive usual care which primarily includes an education talk on basic health issues. Governmental health education leaflets will be provided for reference.

Control

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead

MeSH Terms

Conditions

Cardiovascular Diseases; Health Education; Motor Activity; Atherosclerosis

Condition Hierarchy (Ancestors)

Adherence Interventions; Medication Adherence; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Ka Yan Ho, PhD

  The Hong Kong Polytechnic University

  STUDY DIRECTOR

Central Study Contacts

Ka Yan Ho, PhD

CONTACT

27666417; kyeva.ho@polyu.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 19, 2021
• First Posted: September 1, 2021
• Study Start: September 1, 2021
• Primary Completion: September 1, 2024
• Study Completion: September 1, 2024
• Last Updated: September 1, 2021

Record last verified: 2021-08