Clinical trial NCT04866732: Physical Activity Program for Cardiac Health Among Older African American Populations
Official title: Physical Activity Program for Cardiac Health Among Older African American Populations Living in Rural Alabama: Needs Assessment and Initial Development
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cardiovascular
Disease
Keywords: Cardiovascular
African American
Older
Women
Rural
Lead sponsor: University of Alabama, Tuscaloosa
Sponsor class: OTHER
Collaborators: name: University of Alabama at Birmingham
First posted: 2021-04-30
Enrollment: 30
Sex: FEMALE
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This project involves a mixed methods study with sequential design.
Primary purpose: PREVENTION

Brief summary: Cardiovascular Diseases (CVD) are the leading cause of morbidity and mortality globally, and older African Americans (AAs) living in rural areas are disproportionately affected by this healthcare problem. The investigators propose conducting a mixed-methods study to gain information about CVD-related knowledge, perceptions regarding CVD-related healthcare needs, preferences and access barriers, and cultural aspects within this population. The information will be used in tailoring an existing intervention to meet those needs and preferences and evaluate its feasibility among older AAs living in rural Alabama. This study will lay a foundation for developing a federal grant application and a line of independent research by this early-stage investigator.

Detailed description: Cardiovascular diseases (CVD) are a leading cause of morbidity and mortality. Older populations are inherently more vulnerable to such conditions. Older African American (AA) populations living in rural areas are disproportionately affected by CVD, which has been shown to cause an increased risk for mortality in this population. Evidence suggests using lifestyle Physical activity programs to prevent CVD risk factors, which can decrease the morbidity and mortality rates associated with these health conditions. There are limited resources and healthcare services available to these populations, especially those living in Alabama's black belt. Therefore, this research project proposes conducting a phased mixed-methods study to collect data from rural AA older adults. These data are the critical first step towards developing a culturally sensitive, accessible, and acceptable intervention that addresses their needs and risk factors, incorporates their preferences, and mitigates identified barriers, which will be tested for feasibility and acceptability in this pilot study. The aims for this study are Aim 1: Through survey and interviews, assess: i) the knowledge and perceptions of AA older adults living in rural Alabama regarding CVD-related risk factors; ii) the needs/existing resources and access barriers for a community-based physical activity program; iii) the perceptions about a proposed intervention and its components, method of delivery, time/effort, and incentives; and iv) the cultural preferences regarding recruitment strategies, treatment strategies, and incentives. Aim2a: Based on the findings of Aim 1, develop a PA program for improving CVD-related risk factors among older AA populations living in rural Alabama. Aim2b: To examine the feasibility and acceptability of delivering a PA program (developed in Aim 2a) among the older AA populations living in rural Alabama. The enhanced program would enable AA older populations to prevent and manage CVD-related risk factors. It will also help in filling the gap of health disparity between AAs and other ethnicities.

Eligibility criteria: Inclusion Criteria:

* AA women above 65 years of age
* residing in a community setting of rural Alabama
* diagnosis of CVD
* two or more CVD-related risk factors
* able to speak and understand English
* physically inactive (engaging in no structured ambulatory/walking based lifestyle physical activity),
* able to understand and participate in basic elements (informed consent, components of intervention) of the study.

Exclusion Criteria:

* medical co-morbidity or any acute illness or frailty that would prevent their participation in the physical activity component,
* history of more than two falls in the last two months
* suicidal ideation
* scoring below 22 on Mini-Mental Status Examination Scale
* lack of transportation to the research sites
* concurrent participation in any other heart health or Physical activity intervention study.
* engaged in any kind of ambulatory/walking-based lifestyle physical activity

Primary outcomes:
measure: Physical Activity
timeFrame: 12 Weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: The University of Alabama
name: Mudasir Andrabi, Ph D
role: PRINCIPAL_INVESTIGATOR
affiliation: The University of Alabama at Birmingham
name: Robert Motl, Ph D
role: STUDY_DIRECTOR
affiliation: The University of Alabama at Birmingham
name: Karlene Ball, Ph D
role: STUDY_DIRECTOR
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