DiabetesMHHINCT01152957
Miami Healthy Heart Initiative a Behavioral Study on Cardiovascular Risk Factors
A study testing CARIÑO Project in people with Diabetes and Heart Disease, run by University of Miami at 1 site in United States.
Trial summary
A study to examine the effectiveness of a multilevel Community Health Workers intervention as an adjunct to routine primary care in reducing CVD risk factors among diabetic Latinos in Miami. Read more about this study
- Who is it for?
- Ages 35 to 70 years
- Conditions the study is for
- Diabetes, Heart Disease, Hypertension
- What is being tested?
- CARIÑO Project
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2010to Nov 2013
- 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 35 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients age 35-70 years
- Receiving care at ACC clinic (2 visits with a primary care provider in the previous year)
- Living in Miami-Dade county (based on zip codes)
- Had a hemoglobin A1C done within the past year, with the latest value being >=8.0
Who cannot join
- Patients whose Primary Doctor believes are not appropriate candidates for participation
- Type 1 diabetics (identified by Primary Doctor or those with diabetes diagnosed when under age 25).
- Patients who do not self identify as Hispanic
- Any life-threatening or extreme medical comorbidity
- Having a diabetes diagnosis for less than a year
- Planning to move out of the neighborhood during the next year
- Participation in any other CVD or diabetes intervention study
- Arm circumference of greater than 47 cm (oscillometric cuffs do not give accurate readings)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Miami Healthy Heart Initiative (MHHI) a Randomized Study of Behavioral Risk Factors for Cardiovascular Disease in Latino and Hispanic Patients With Poorly Controlled Diabetes
A study to examine the effectiveness of a multilevel Community Health Workers intervention as an adjunct to routine primary care in reducing CVD risk factors among diabetic Latinos in Miami.
Read the detailed description
Disparities in the epidemiology of cardiovascular disease (CVD) risk factors among Latinos have been extensively described; however, traditional medical models of CVD risk reduction have not been very effective in Latinos. One promising strategy is the use of community-based community health workers (CHWs). CHWs have long been used in Latin-America as an integral part of their health care delivery system. Further, preliminary data from our prior pilot diabetes self-management CHW program have shown improvements in lipids. However, because of a lack of effectiveness data from studies using rigorous experimental designs, the adoption of the CHW model has been quite limited both locally and nationally. In MHHI, our goal is to examine the effectiveness of a CHW intervention in CVD risk reduction among Latinos.
The investigators propose to examine the effectiveness of a multilevel CHW intervention as an adjunct to routine primary care in reducing CVD risk factors among diabetic Latinos Miami. The UM Jay Weiss Center which has substantial experience in Community Health Worker Program will take the lead role in the development and implementation intervention of the CHW program.
The study design is a randomized controlled trial (RCT) of 300 Latino patients ages 35-70 with poorly controlled diabetes (AIC >=8.0) followed at the Ambulatory Care Clinic (ACC) of Jackson Memorial Hospital (JMH).
Primary Objective: To determine if the CHW intervention results in lowering of CVD risk factors including blood pressure, LDL cholesterol, and diabetes control (AIC) as measured by the Total Framingham Risk Score (FRS).
Secondary Objectives: To determine if the CHW intervention results in improvements in the following putative mechanisms that may influence the FRS:
- Medication adherence (measured by validated instruments)
- Improvements in diet and exercise (as measured by validated instruments);
Hypotheses: Among patients receiving care at the ACC we hypothesize that as compared to those in enhanced usual care, patients randomized to the CHW intervention at 18 months will have:
- Greater reductions in blood pressure and low density lipoprotein (LDL)
- Improved glycemic control
- Greater rates of medication adherence (taking >80% of specified medication doses)
- Increases in physical activity (kcal/week)
- Increases in mean number of daily vegetables consumed
The CHW intervention will involve 4 or more (as required) home visits, 10 group sessions, an 10 follow-up phone calls per subject over a 12-month time period. The primary outcome is a HgA1C; secondary outcomes include LDL levels, and systolic and diastolic blood pressure. Baseline and follow-up data on medication adherence, medication intensification, diet and exercise will also be collected.
The control group will continue to receive usual care from their primary care physician. We will enhance the usual care that these patients receive by providing them with three sets of educational materials published by the NIH.
- Conditions
- Diabetes, Heart Disease, Hypertension
- Being tested
- CARIÑO Project, Enhanced Usual Care
- Keywords
- diabetes, cardiovascular, chronic, Community Health Workers, behavioral, social, diet, exercise, patient, cholesterol, A1C, blood pressure
- Medical subject headings
- Diabetes Mellitus, Heart Diseases, Hypertension, Bronchiolitis Obliterans Syndrome, Behavior, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CARIÑO ProjectBehavioural
Care Attention Resources Information Nutrition \& Optimism Project (CARIÑO) is a CHW intervention that will involve 4 or more (as required) home visits, 10 group sessions, and 10 follow-up phone calls per subject over a 12-month period. The primary outcome is lower HgA1C levels. The secondary outcomes are to lower LDL levels, and systolic and diastolic blood pressure, medication adherence and improved diet and exercise. CARIÑO Project will provide outreach support services to patients with poorly controlled diabetes, such as health education, lifestyle changes, home visits, follow-up phone calls, support groups, one on one counseling and coaching, and assistance with resource referrals.
Enhanced Usual CareBehavioural
Usual care plus 4 health education brochures
| Study group | Role | What they receive |
|---|---|---|
| Community Health Worker Model | Experimental | Care, Attention, Resources, Information, Nutrition and Optimism Project (CARIÑO Project) will provide outreach support services to patients with poorly controlled diabetes, such as health education, lifestyle changes, home visits, follow-up phone calls, support groups, one on one counseling and coaching, and assistance with resource referrals. Receives: Behavioral: CARIÑO Project |
| Enhanced Usual Care | Active comparator | Usual Care and mailing of 4 health education brochures over the year. Receives: Behavioral: Enhanced Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycemic Control
A1C
Measured: 12 months.
Secondary outcomes (2)
Blood Pressure
SBP
Measured: 12 months
Cholesterol
LDL
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2010 (estimated)
- Study startJul 2010
- Primary completionNov 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by University of MiamiThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Olveen Carrasquillo, University of Miami
- Investigators
- Olveen Carrasquillo, MD, MPH, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01152957
- Sponsor's protocol ID
- 20090751
- Other IDs
- 7R01HL083857-02
- Acronym
- MHHI
- Status last verified
- Oct 2018
- First submitted
- 28 Jun 2010
- Last updated
- 17 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: Contact PI
Publications
Carrasquillo O, Patberg E, Alonzo Y, Li H, Kenya S. Rationale and design of the Miami Healthy Heart Initiative: a randomized controlled study of a community health worker intervention among Latino patients with poorly controlled diabetes. Int J Gen Med. 2014 Feb 27;7:115-26. doi: 10.2147/IJGM.S56250. eCollection 2014.
PubMed 24600243Kenya S, Lebron CN, Chang AY, Li H, Alonzo YA, Carrasquillo O. A profile of Latinos with poorly controlled diabetes in South Florida. J Community Hosp Intern Med Perspect. 2015 Apr 1;5(2):26586. doi: 10.3402/jchimp.v5.26586. eCollection 2015.
PubMed 25846350Lebron CN, Reyes-Arrechea E, Castillo A, Carrasquillo O, Kenya S. Tales from the Miami Healthy Heart Initiative: the experiences of two community health workers. J Health Care Poor Underserved. 2015 May;26(2):453-62. doi: 10.1353/hpu.2015.0033.
PubMed 25913343Chang A, Kenya S, Ilangovan K, Li H, Koru-Sengul T, Alonzo Y, Carrasquillo O. Is greater acculturation associated with an increased prevalence of cardiovascular risk factors among Latinos in South Florida? Med Care. 2015 May;53(5):417-22. doi: 10.1097/MLR.0000000000000337.
PubMed 25793266Carrasquillo O, Lebron C, Alonzo Y, Li H, Chang A, Kenya S. Effect of a Community Health Worker Intervention Among Latinos With Poorly Controlled Type 2 Diabetes: The Miami Healthy Heart Initiative Randomized Clinical Trial. JAMA Intern Med. 2017 Jul 1;177(7):948-954. doi: 10.1001/jamainternmed.2017.0926.
PubMed 28459925Chang A, Patberg E, Cueto V, Li H, Singh B, Kenya S, Alonzo Y, Carrasquillo O. Community Health Workers, Access to Care, and Service Utilization Among Florida Latinos: A Randomized Controlled Trial. Am J Public Health. 2018 Sep;108(9):1249-1251. doi: 10.2105/AJPH.2018.304542. Epub 2018 Jul 19.
PubMed 30024805
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Miami Healthy Heart Initiative (MHHI) a Randomized Study of Behavioral Risk Factors for Cardiovascular Disease in Latino and Hispanic Patients With Poorly Controlled Diabetes
- ClinicalTrials.gov ID
- NCT01152957
- Acronym / sponsor ID
- MHHI / 20090751
- Conditions
- Diabetes, Heart Disease, Hypertension
- Keywords
- diabetes, cardiovascular, chronic, Community Health Workers, behavioral, social, diet, exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Jul 2010
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 29 Jun 2010 (estimated)
- 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.
A study to examine the effectiveness of a multilevel Community Health Workers intervention as an adjunct to routine primary care in reducing CVD risk factors among diabetic Latinos in Miami.
Detailed description
Disparities in the epidemiology of cardiovascular disease (CVD) risk factors among Latinos have been extensively described; however, traditional medical models of CVD risk reduction have not been very effective in Latinos. One promising strategy is the use of community-based community health workers (CHWs). CHWs have long been used in Latin-America as an integral part of their health care delivery system. Further, preliminary data from our prior pilot diabetes self-management CHW program have shown improvements in lipids. However, because of a lack of effectiveness data from studies using rigorous experimental designs, the adoption of the CHW model has been quite limited both locally and nationally. In MHHI, our goal is to examine the effectiveness of a CHW intervention in CVD risk reduction among Latinos.
The investigators propose to examine the effectiveness of a multilevel CHW intervention as an adjunct to routine primary care in reducing CVD risk factors among diabetic Latinos Miami. The UM Jay Weiss Center which has substantial experience in Community Health Worker Program will take the lead role in the development and implementation intervention of the CHW program.
The study design is a randomized controlled trial (RCT) of 300 Latino patients ages 35-70 with poorly controlled diabetes (AIC >=8.0) followed at the Ambulatory Care Clinic (ACC) of Jackson Memorial Hospital (JMH).
Primary Objective: To determine if the CHW intervention results in lowering of CVD risk factors including blood pressure, LDL cholesterol, and diabetes control (AIC) as measured by the Total Framingham Risk Score (FRS).
Secondary Objectives: To determine if the CHW intervention results in improvements in the following putative mechanisms that may influence the FRS:
- Medication adherence (measured by validated instruments)
- Improvements in diet and exercise (as measured by validated instruments);
Hypotheses: Among patients receiving care at the ACC we hypothesize that as compared to those in enhanced usual care, patients randomized to the CHW intervention at 18 months will have:
- Greater reductions in blood pressure and low density lipoprotein (LDL)
- Improved glycemic control
- Greater rates of medication adherence (taking >80% of specified medication doses)
- Increases in physical activity (kcal/week)
- Increases in mean number of daily vegetables consumed
The CHW intervention will involve 4 or more (as required) home visits, 10 group sessions, an 10 follow-up phone calls per subject over a 12-month time period. The primary outcome is a HgA1C; secondary outcomes include LDL levels, and systolic and diastolic blood pressure. Baseline and follow-up data on medication adherence, medication intensification, diet and exercise will also be collected.
The control group will continue to receive usual care from their primary care physician. We will enhance the usual care that these patients receive by providing them with three sets of educational materials published by the NIH.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Community Health Worker Model | Experimental | Behavioral: CARIÑO ProjectCare, Attention, Resources, Information, Nutrition and Optimism Project (CARIÑO Project) will provide outreach support services to patients with poorly controlled diabetes, such as health education, lifestyle changes, home visits, follow-up phone calls, support groups, one on one counseling and coaching, and assistance with resource referrals. |
| Enhanced Usual Care | Active comparator | Behavioral: Enhanced Usual CareUsual Care and mailing of 4 health education brochures over the year. |
Who may qualify
- Ages
- 35 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult patients age 35-70 years
- Receiving care at ACC clinic (2 visits with a primary care provider in the previous year)
- Living in Miami-Dade county (based on zip codes)
- Had a hemoglobin A1C done within the past year, with the latest value being >=8.0
Key exclusion criteria (8 listed)
- Patients whose Primary Doctor believes are not appropriate candidates for participation
- Type 1 diabetics (identified by Primary Doctor or those with diabetes diagnosed when under age 25).
- Patients who do not self identify as Hispanic
- Any life-threatening or extreme medical comorbidity
- Having a diabetes diagnosis for less than a year
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 |
|---|---|---|
| CARIÑO ProjectCare Attention Resources Information Nutrition \& Optimism Project (CARIÑO) is a CHW intervention that will involve 4 or more (as required) home visits, 10 group sessions, and 10 follow-up phone calls per subject over a 12-month period. The primary outcome is lower HgA1C levels. The secondary outcomes are to lower LDL levels, and systolic and diastolic blood pressure, medication adherence and improved diet and exercise. CARIÑO Project will provide outreach support services to patients with poorly controlled diabetes, such as health education, lifestyle changes, home visits, follow-up phone calls, support groups, one on one counseling and coaching, and assistance with resource referrals. | Behavioural | Community Health Worker Model |
| Enhanced Usual CareUsual care plus 4 health education brochures | Behavioural | Enhanced Usual Care |
Primary outcome
Glycemic Control
Time frame: 12 months.
A1C
2 secondary outcomes
Blood Pressure
Time frame: 12 months
Cholesterol
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2018.
- Background: PubMed 24600243Carrasquillo O, Patberg E, Alonzo Y, Li H, Kenya S. Rationale and design of the Miami Healthy Heart Initiative: a randomized controlled study of a community health worker intervention among Latino patients with poorly controlled diabetes. Int J Gen Med. 2014 Feb 27;7:115-26. doi: 10.2147/IJGM.S56250. eCollection 2014.
- Background: PubMed 25846350Kenya S, Lebron CN, Chang AY, Li H, Alonzo YA, Carrasquillo O. A profile of Latinos with poorly controlled diabetes in South Florida. J Community Hosp Intern Med Perspect. 2015 Apr 1;5(2):26586. doi: 10.3402/jchimp.v5.26586. eCollection 2015.
- Background: PubMed 25913343Lebron CN, Reyes-Arrechea E, Castillo A, Carrasquillo O, Kenya S. Tales from the Miami Healthy Heart Initiative: the experiences of two community health workers. J Health Care Poor Underserved. 2015 May;26(2):453-62. doi: 10.1353/hpu.2015.0033.
- Background: PubMed 25793266Chang A, Kenya S, Ilangovan K, Li H, Koru-Sengul T, Alonzo Y, Carrasquillo O. Is greater acculturation associated with an increased prevalence of cardiovascular risk factors among Latinos in South Florida? Med Care. 2015 May;53(5):417-22. doi: 10.1097/MLR.0000000000000337.
- Results publication: PubMed 28459925Carrasquillo O, Lebron C, Alonzo Y, Li H, Chang A, Kenya S. Effect of a Community Health Worker Intervention Among Latinos With Poorly Controlled Type 2 Diabetes: The Miami Healthy Heart Initiative Randomized Clinical Trial. JAMA Intern Med. 2017 Jul 1;177(7):948-954. doi: 10.1001/jamainternmed.2017.0926.
- Results publication: PubMed 30024805Chang A, Patberg E, Cueto V, Li H, Singh B, Kenya S, Alonzo Y, Carrasquillo O. Community Health Workers, Access to Care, and Service Utilization Among Florida Latinos: A Randomized Controlled Trial. Am J Public Health. 2018 Sep;108(9):1249-1251. doi: 10.2105/AJPH.2018.304542. Epub 2018 Jul 19.
- Individual participant dataSharing planned: No. Contact PI
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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.
Olveen Carrasquillo, MD, MPH principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CARIÑO Project in people with Diabetes and Heart Disease, run by University of Miami at 1 site in United States.
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 4 inclusion and 8 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: finished, as of the sponsor's last update on 17 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glycemic Control (time frame: 12 months.). 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 NCT01152957, which also lists 6 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 17 Oct 2018.