CardiovascularNCT04866732
Physical Activity Program for Cardiac Health Among Older African American Populations
A study testing Physical Activity Cardiac Health Program in people with Cardiovascular and Disease, run by University of Alabama, Tuscaloosa.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older, women only
- Conditions the study is for
- Cardiovascular, Disease
- What is being tested?
- Physical Activity Cardiac Health Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Jul 2021to 30 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- Women only
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Physical Activity Program for Cardiac Health Among Older African American Populations Living in Rural Alabama: Needs Assessment and Initial Development
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.
Read the 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.
- Conditions
- Cardiovascular, Disease
- Being tested
- Physical Activity Cardiac Health Program
- Keywords
- Cardiovascular, African American, Older, Women, Rural
- Medical subject headings
- Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical Activity Cardiac Health ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: Physical Activity Cardiac Health Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2021
- Study startJul 2021 (estimated)
- Primary completion30 Jun 2022 (estimated)
- Study completion30 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for CardiovascularStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This project involves a mixed methods study with sequential design.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alabama, Tuscaloosa
- Sponsor type
- University, hospital or other
- Collaborators
- University of Alabama at Birmingham
- Responsible party
- Sponsor
- Investigators
- Mudasir Andrabi, Ph D, Principal investigator, The University of AlabamaRobert Motl, Ph D, Study director, The University of Alabama at BirminghamKarlene Ball, Ph D, Study director, The University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04866732
- Sponsor's protocol ID
- 000526161
- Status last verified
- Apr 2021
- First submitted
- 20 Apr 2021
- Last updated
- 30 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 29941776Abu 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.
PubMed 20677967Agrell 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.
PubMed 2772980Andrawes 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.
PubMed 16245959Angermayr 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.
PubMed 20652464Bellet 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.
PubMed 23122432Cho 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.
PubMed 30776919Colantonio 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.
PubMed 30746585Der 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.
PubMed 30388803Ferdinand 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.
PubMed 31863786Garatachea 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.
PubMed 20449530
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Activity Program for Cardiac Health Among Older African American Populations Living in Rural Alabama: Needs Assessment and Initial Development
- ClinicalTrials.gov ID
- NCT04866732
- Acronym / sponsor ID
- 000526161
- Conditions
- Cardiovascular, Disease
- Keywords
- Cardiovascular, African American, Older, Women, Rural
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of Alabama, TuscaloosaUniversity, hospital or other
- Collaborators
- University of Alabama at Birmingham
- Study start
- Jul 2021 (estimated)
- Primary completion
- 30 Jun 2022 (estimated)
- Study completion
- 30 Jul 2022 (estimated)
- First posted
- 30 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This project involves a mixed methods study with sequential design.
| Arm | Type | Receives |
|---|---|---|
| Needs assessment and feasibility group | Experimental | Behavioral: Physical Activity Cardiac Health ProgramBased 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 |
Who may qualify
- Ages
- 65 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical Activity Cardiac Health ProgramThe 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. | Behavioural | Needs assessment and feasibility group |
Primary outcome
Physical Activity
Time frame: 12 Weeks
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2021.
- Results publication: PubMed 29941776Abbott 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.
- Results publication: PubMed 20677967Abu 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.
- Results publication: PubMed 2772980Agrell 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.
- Results publication: PubMed 16245959Andrawes 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.
- Results publication: PubMed 20652464Angermayr 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.
- Results publication: PubMed 23122432Bellet 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.
- Results publication: PubMed 30776919Cho 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.
- Results publication: PubMed 30746585Colantonio 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.
- Results publication: PubMed 30388803Der 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.
- Results publication: PubMed 31863786Ferdinand 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.
- Results publication: PubMed 20449530Garatachea 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.
- Individual participant dataSharing planned: Yes. 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.
Related trials for Cardiovascular
Active, not recruitingPhase 3
ENDOTHELION Study Group: Effect of Bosentan in NAION Patients
Ischemic Optic Neuropathy
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Not yet recruitingPhase 2
Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma (RRMM)
RecruitingPhase 2
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
Multiple Myeloma
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mudasir Andrabi, Ph D principal investigator
The University of Alabama
Robert Motl, Ph D study director
The University of Alabama at Birmingham
Karlene Ball, Ph D study director
The University of Alabama at Birmingham
Questions about this trial
What is this clinical trial studying?
A study testing Physical Activity Cardiac Health Program in people with Cardiovascular and Disease, run by University of Alabama, Tuscaloosa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mudasir Andrabi, Ph D (4432045623, MANDRABI@UA.EDU), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical Activity (time frame: 12 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04866732, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2021.