NCT04866732

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2021

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 20, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 30, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

July 1, 2021

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2022

Completed
Last Updated

April 30, 2021

Status Verified

April 1, 2021

Enrollment Period

12 months

First QC Date

April 20, 2021

Last Update Submit

April 26, 2021

Conditions

CardiovascularDisease

Keywords

CardiovascularAfrican AmericanOlderWomenRural

Outcome Measures

Primary Outcomes (1)

  • Physical Activity

    The investigators will measure the leisure-time physical activity including walk. This will be measured by an accelerometer which gives more accurate information about the ambulation of a person. Scores can range between 0 and infinite. The higher the score, the better is the outcome.

    12 Weeks

Study Arms (1)

Needs assessment and feasibility group

EXPERIMENTAL

Based on our target population's needs/preferences, an existing Physical Activity (PA) program will be modified and tailored to the needs of the target population. We anticipate that this PA program will include the following components: a) PA component - ( duration of walk) from baseline to the end of the study; b) weekly informational sessions on various topics related to CVD risk factors prevention; c) daily diary to record if they are facing any barriers in completing various components of the intervention; d) problem-solving sessions

Behavioral: Physical Activity Cardiac Health Program

Interventions

Physical Activity Cardiac Health ProgramBEHAVIORAL

The investigators anticipate that the physical activity program will include the following components: a) physical activity component - the investigators propose an incremental physical activity component whereby participants will gradually increase their physical activity ( duration of walk) from baseline to the end of the study; b) weekly informational sessions on various topics related to Cardiovascular disease risk factors prevention; c) daily diary, which will be used to document record about any barriers for completing various components of the intervention; d) problem-solving sessions whereby participants will meet once a week with the investigators to talk about the barriers and facilitators of their weekly activity and any adherence issues.

Needs assessment and feasibility group

Eligibility Criteria

Age65 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsOnly those participants who identify themselves as female gender will be recruited.
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (11)

  • Abbott LS, Slate EH. Improving Cardiovascular Disease Knowledge among Rural Participants: The Results of a Cluster Randomized Trial. Healthcare (Basel). 2018 Jun 25;6(3):71. doi: 10.3390/healthcare6030071.

    PMID: 29941776RESULT

  • Abu Alhaija ES, Aldaikki A, Al-Omairi MK, Al-Khateeb SN. The relationship between personality traits, pain perception and attitude toward orthodontic treatment. Angle Orthod. 2010 Nov;80(6):1141-9. doi: 10.2319/012710-59.1.

    PMID: 20677967RESULT

  • Agrell B, Dehlin O. Comparison of six depression rating scales in geriatric stroke patients. Stroke. 1989 Sep;20(9):1190-4. doi: 10.1161/01.str.20.9.1190.

    PMID: 2772980RESULT

  • Andrawes WF, Bussy C, Belmin J. Prevention of cardiovascular events in elderly people. Drugs Aging. 2005;22(10):859-76. doi: 10.2165/00002512-200522100-00005.

    PMID: 16245959RESULT

  • Angermayr L, Melchart D, Linde K. Multifactorial lifestyle interventions in the primary and secondary prevention of cardiovascular disease and type 2 diabetes mellitus--a systematic review of randomized controlled trials. Ann Behav Med. 2010 Aug;40(1):49-64. doi: 10.1007/s12160-010-9206-4.

    PMID: 20652464RESULT

  • Bellet RN, Adams L, Morris NR. The 6-minute walk test in outpatient cardiac rehabilitation: validity, reliability and responsiveness--a systematic review. Physiotherapy. 2012 Dec;98(4):277-86. doi: 10.1016/j.physio.2011.11.003. Epub 2012 May 16.

    PMID: 23122432RESULT

  • Cho D, Nguyen NT, Strong LL, Wu IHC, John JC, Escoto KH, Wetter DW, McNeill LH. Multiple Health Behaviors Engagement in an African American Cohort: Clustering Patterns and Correlates. Health Educ Behav. 2019 Jun;46(3):506-516. doi: 10.1177/1090198119826207. Epub 2019 Feb 18.

    PMID: 30776919RESULT

  • Colantonio LD, Monda KL, Rosenson RS, Brown TM, Mues KE, Howard G, Safford MM, Yedigarova L, Farkouh ME, Muntner P. Characteristics and Cardiovascular Disease Event Rates among African Americans and Whites Who Meet the Further Cardiovascular Outcomes Research with PCSK9 Inhibition in Subjects with Elevated Risk (FOURIER) Trial Inclusion Criteria. Cardiovasc Drugs Ther. 2019 Apr;33(2):189-199. doi: 10.1007/s10557-019-06864-2.

    PMID: 30746585RESULT

  • Der Ananian C, Winham DM, Thompson SV, Tisue ME. Perceptions of Heart-Healthy Behaviors among African American Adults: A Mixed Methods Study. Int J Environ Res Public Health. 2018 Nov 1;15(11):2433. doi: 10.3390/ijerph15112433.

    PMID: 30388803RESULT

  • Ferdinand DP, Nedunchezhian S, Ferdinand KC. Hypertension in African Americans: Advances in community outreach and public health approaches. Prog Cardiovasc Dis. 2020 Jan-Feb;63(1):40-45. doi: 10.1016/j.pcad.2019.12.005. Epub 2019 Dec 19.

    PMID: 31863786RESULT

  • Garatachea N, Torres Luque G, Gonzalez Gallego J. Physical activity and energy expenditure measurements using accelerometers in older adults. Nutr Hosp. 2010 Mar-Apr;25(2):224-30.

    PMID: 20449530RESULT

MeSH Terms

Conditions

Disease

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Mudasir Andrabi, Ph D

    The University of Alabama

    PRINCIPAL INVESTIGATOR

  • Robert Motl, Ph D

    The University of Alabama at Birmingham

    STUDY DIRECTOR

  • Karlene Ball, Ph D

    The University of Alabama at Birmingham

    STUDY DIRECTOR

Central Study Contacts

Mudasir Andrabi, Ph D

CONTACT

4432045623MANDRABI@UA.EDU

Mercy Mumba, Ph D

CONTACT

2055305439MMUMBA@UA.EDU

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: This project involves a mixed methods study with sequential design.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 20, 2021

First Posted

April 30, 2021

Study Start

July 1, 2021

Primary Completion

June 30, 2022

Study Completion

July 30, 2022

Last Updated

April 30, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will share

The investigators expect that the results of the proposed study will be of great interest to the scientific community. Investigators will collect and analyze the data for the course of the study and allow one calendar year from the end of the budget period to complete data analysis and publication of results. In the interim, data will be presented at scientific meetings and shared with providers and clinicians, surrounding prevention and treatment centers, and appropriate councils and organizations, such as the Alabama Department of Public Health and academic institutions with a curriculum focused on Cardiovascular disease prevention education. The findings will be disseminated using peer-reviewed journals and presentations at local, national, and international conferences. All these avenues are instrumental in the successful dissemination of the research findings. The investigators will also ensure that the NIA has access to our data through clinicaltrials.gov.

Shared Documents
CSR
Time Frame
Immediately following publication- 36 months following publication
Access Criteria
Anyone who wish to access the data.