UNIVERSITY OF MIAMI
Best practices for prevention and management of diabetes are known but not fully implemented in clinical and community settings. Working with the University of Miami, the Health Foundation of South Florida, a community partner in this proposal, created the Healthy Aging Regional Collaborative (HARC) in response to the challenges of chronic disease prevention and management in the elderly. HARC provides health organizations (several lead agencies representing 78 partners) with the tools they need to guard against key health threats: lack of physical activity and inability to manage chronic diseases. With support from federal agencies, HARC seeks (2008-2013) to improve healthy behaviors, reduce healthcare costs, and improve quality of life in approximately 35,000 South Florida older adults.
Our study goal is to increase adoption of existing comparative effectiveness research (CER) evidence for prevention and management of diabetes in South Florida overweight/obese (OW/OB) older adults. We will implement findings from the Diabetes Prevention Program (DPP), which demonstrated a 4 year delay over a decade in the onset of diabetes among individuals with prediabetes that received lifestyle intervention, as well as guidelines from the American Diabetes Association for management of diabetes in older adults, which include data from the Veterans Affairs Diabetes Trial (VADT). Both DPP and VADT meet the CER Federal Coordinating Council definition and will be adopted in the HARC network of public and private health care institutions in Miami-Dade, Broward, and Monroe Counties.
Specifically, the proposed study will test the hypothesis that Peer-led Care alone (PC), or activated by technology (TechnAlert-Peer or TAP), is superior to traditional methods of information dissemination (Usual Care or UC) for adoption of CER on prevention and management of diabetes, leading to better self-efficacy and clinical outcomes.
We propose to conduct a 12-month randomized controlled trial in South Florida older adults with prediabetes or diabetes participating in the HARC with the following primary objectives:
1) Compare changes in self-efficacy between participants receiving peer-led care (with or without TAP intervention) and those receiving UC.
2) Compare changes in weight and hemoglobin A1c between participants receiving peer-led care (with or without TAP intervention) and those receiving UC.
In addition, we proposed the following secondary objectives on process and health outcomes:
a) Perform a needs assessment to elucidate ways older adults participating in the HARC seek information related to prevention and management of diabetes.
b) Assess the availability of peer-leaders and the role of technology to increase adoption of CER for prevention and management of diabetes.
c) Evaluate potential racial/ethnic disparities in the process of adoption of CER for prevention and management of diabetes.
d) Compare changes in blood pressure, lipids, physical function, and quality of life among treatment groups (UC, PC, and TAP).
e) Compare changes in health care utilization (physician visits, emergency visits, and days in hospital) among treatment groups (UC, PC, and TAP).
This proposal will be implemented over 3 years and is expected to accelerate the adoption of CER for diabetes prevention and management, addressing health and economic challenges of our aging society.
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| AWARD OVERVIEW |
| Award Number |
1R18AE000049-01 |
Funding Agency |
Department of Health and Human Services |
| Total Award Amount |
$2,869,929 |
Project Location - City |
Miami |
| Award Date |
09/13/2010 |
Project Location - State |
FL |
| Project Status |
More than 50% Completed |
Project Location - Zip |
33136-1000
|
| Jobs Reported |
11.49 |
Congressional District |
24 |
| Project Location - Country |
US |
|
|
Recipient Information
(Grants)
| Recipient Information (Grants) |
|
Recipient Name
|
UNIVERSITY OF MIAMI |
| Recipient DUNS Number |
052780918
|
| Recipient Address |
1400 NW 10 AVE RM 1007P |
| Recipient City |
MIAMI |
| Recipient State |
Florida |
| Recipient Zip |
33136-1002 |
| Recipient Congressional District |
24 |
| Recipient Country |
USA |
Required to Report Top 5
Highly Compensated Officials |
No |
Projects and Jobs Information
| Projects and Jobs Information |
| Project Title |
PEER-LED AND TELEHEALTH INTERVENTIONS TO INCREASE CER ADOPTION FOR PREVENTION AND MANAGEME |
| Project Status |
More than 50% Completed |
| Final Project Report Submitted |
No |
| Project Activities Description |
Research & Public Policy Analysis |
| Quarterly Activities/Project Description |
The following activities were conducted this quarter:
Administrative:
- Protocol amendments to include measurements of body composition and physical activity were submitted and approved by the VA-IRB. The new outcomes were added as part of an ancillary study to the original study. New personnel to complete this ancillary study will be hired using funds approved in a recently approved study rebudget.
- The quarterly progress report was submitted to and approved by the HHS/NIH program officer.
Study Implementation and Dissemination:
- Twelve month (final study) visits have been completed in 43% of the study participants (100% of all expected). The evaluations have been conducted in both Miami and Broward clinics following the approved protocol.
- All data for the 6-month visits were collected, saved on a password-protected database and analyzed by the study statistician.
- The research team started to plan for the study program evaluation.
- A new wellness application was installed in participants’ cell phones to improve adherence.
- Two focus groups with study participants and peer-leaders were conducted (Broward and Miami). The main purpose was to collect information regarding technology use. Results were analyzed and discussed with the research staff.
- Drafts of the Methods and Focus Groups papers were discussed with the research team.
- The abstract “Diabetes is Associated with Physical Function Decline in Older Veterans Enrolling in A Lifestyle Intervention Program” was approved for presentation in the 2013 American Geriatrics Society (AGS) meeting.
|
| Jobs Created |
11.49 |
| Description of Jobs Created |
Principal Investigator will have the ultimate responsibility for all aspects of the project and will supervise the entire study design, implementation of the strategies, analysis of the data, and writing/presentation of the data. His effort on the project is 78%.
Co-Investigator provides support in the overall design and implementation of the project, specifically on the telehealth approach. Her effort on the project is 100% of her UM time.
Co-Investigator, in collaboration with the PI, participates in the implementation of the proposed research and the interpretation of study findings, manuscript preparation, and dissemination of results and conclusions. His effort on the project is 24%.
Co-Investigator has assisted in the randomization of study participants and presentation of reports to the Data Safety Monitoring Board (DSMB). She conducts most statistical analysis assisted by the data manager/research assistant. Her effort on the project is 7%.
Research Assistant Professor is helping with the follow up of study participants in the study. Her effort in this project is 100%.
Sr. Research Associate oversees coordination of patient scheduling, monitor patient enrollment and compliance to the study guidelines and supervises data entry activities. She maintains contact with coordinators at HARC participating agencies and community partners to keep track of the progress, and conducts visits to participating HARC research sites, evaluating research data gathering. She also assists in data analysis and evaluation process. She has 100% effort in this project.
Data Entry Clerk is responsible for the update and preparation of data in the study forms assisting Investigators to keep track of study participant evaluations. Her effort in the study is 40%.
Co-Investigator is supervising the outcome measurements, particularly relevant biochemical and metabolic tests. His effort in the study is 100%.
A Research Associate at UM is helping with the evaluation of potential markers of longevity and healthy aging. She assists in protocol preparation and laboratory maintenance’s work. Her effort in the study is 100%.
Sub recipients funded 4 Research Coordinators and 1 HARC Coordinator. |
Purchaser Information
(Grants)
| Purchaser Information |
| Contracting Office ID |
Not Reported |
| Contracting Office Name |
Not Available |
| Contracting Office Region |
Not Available |
| TAS Major Program |
75-1701 |
| Award Information |
| Award Date |
09/13/2010 |
| Award Number |
1R18AE000049-01 |
| Order Number |
|
| Award Type |
Grants |
| Funding Agency ID |
75 |
| Funding Agency Name |
Department of Health and Human Services |
| Funding Office Name |
Not Available |
| Awarding Agency ID |
75 |
| Awarding Agency Name |
Department of Health and Human Services |
| Amount of Award |
$2,869,929 |
| Funds Invoiced/Received |
$1,746,686 |
| Expenditure Amount |
$1,814,082 |
| Infrastructure Expenditure Amount |
$0 |
| Infrastructure Purpose and Rationale |
N/A |
| Infrastructure Point of Contact Name |
Not Reported |
| Infrastructure Point of Contact Email |
Not Reported |
| Infrastructure Point of Contact Phone |
Not Reported |
| Infrastructure Point of Contact Address |
Not Reported |
| Infrastructure Point of Contact City |
Not Reported |
| Infrastructure Point of Contact State |
Not Reported |
| Infrastructure Point of Contact Zip |
Not Reported |
Product or Service Information
(Grants)
| Product or Service Information |
| Primary Activity Code |
**K |
| Activity Description |
Research & Public Policy Analysis |
| Sub-Awards Information |
| Sub-awards to Organizations |
3 |
| Sub-award Amounts to Organizations |
$1,168,709 |
| Sub-Awards to Individuals |
0 |
| Sub-Award Amounts to Individuals |
$0 |
| Number of Sub-awards less than $25,000/award |
0 |
| Amount of Sub-awards less than $25,000/award |
$0 |
| Number of payments to vendors greater than $25,000 |
0 |
| Total Amount of payments to vendors greater than $25,000/award |
$0 |
| Number of payments to vendors less than $25,000/award |
227 |
| Total Amount of payments to vendors less than $25,000/award |
$173,120 |
Sub-award 66737Na - HEALTH FOUNDATION OF SOUTH FLORIDA, INC.
| Sub-Award Amount |
$317,622 |
| Sub-Award Date |
12/20/2010 |
| Sub-Awards Disbursed |
$264,685.00 |
| Project Location - City |
Miami |
| Project Location - State |
FL |
| Project Location - Zip Code |
33131-1806 |
| Project Location - Congressional District |
24 |
| Sub-Recipient DUNS Number |
613995567
|
| Sub-Recipient Address |
2 S BISCAYNE BLVD STE 1710 |
| Sub-Recipient City |
MIAMI |
| Sub-Recipient State |
Florida |
| Sub-Recipient Zip Code |
33131-1804 |
| Sub-Recipient Congressional District |
24 |
Required To Report Top 5
Highly Compensated Officials |
No |
Sub-award 66737N - Sensei, Inc
| Sub-Award Amount |
$300,000 |
| Sub-Award Date |
11/15/2010 |
| Sub-Awards Disbursed |
$300,000.00 |
| Project Location - City |
Boca Raton |
| Project Location - State |
FL |
| Project Location - Zip Code |
33431-7312 |
| Project Location - Congressional District |
22 |
| Sub-Recipient DUNS Number |
196524297
|
| Sub-Recipient Address |
2300 Glades Rd Ste 220w |
| Sub-Recipient City |
Boca Raton |
| Sub-Recipient State |
Florida |
| Sub-Recipient Zip Code |
33431-8527 |
| Sub-Recipient Congressional District |
22 |
Required To Report Top 5
Highly Compensated Officials |
No |
Sub-award 66737Nb - SOUTH FLORIDA VA FOUNDATION FOR RESEARCH AND EDUCATION INC
| Sub-Award Amount |
$551,087 |
| Sub-Award Date |
05/01/2011 |
| Sub-Awards Disbursed |
$393,158.00 |
| Project Location - City |
Miami |
| Project Location - State |
FL |
| Project Location - Zip Code |
33125-1624 |
| Project Location - Congressional District |
24 |
| Sub-Recipient DUNS Number |
126026355
|
| Sub-Recipient Address |
1201 NW 16TH ST |
| Sub-Recipient City |
MIAMI |
| Sub-Recipient State |
Florida |
| Sub-Recipient Zip Code |
33125-0000 |
| Sub-Recipient Congressional District |
24 |
Required To Report Top 5
Highly Compensated Officials |
No |
| Location Information |
| Latitude, Longitude |
25º 47' 19",
-80º 12' 39" |
| Congressional District |
24 |
| Address 1 |
|
| Address 2 |
|
| City |
Miami |
| County |
Miami-Dade |
| State |
FL |
| Zip |
33136-1000 |
|
 |