Controlling Hypertension in Diabetes- Feasibility Study (COACH-D)
Primary Purpose
Type 2 Diabetes, Hypertension, Hyperlipidemia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
home health/primary care collaboration
Sponsored by
About this trial
This is an interventional health services research trial for Type 2 Diabetes focused on measuring Type 2 diabetes, Hypertension, Health services research, Health disparities, Behavior change
Eligibility Criteria
Inclusion Criteria:
- type 2 diabetes,
- BP above 140/90 on two health center visits,
- home touch tone phone
Exclusion Criteria:
- dementia,
- homelessness,
- language other than English or Spanish
Sites / Locations
- Albert Einstein College of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
self-management support and BP telemonitoring
usual care
Arm Description
collaborative intervention involving home BP monitoring, home behavior change counseling to enhance self management, and intensification of treatment by primary care doctors
usual primary care management of BP. lipids, and glucose
Outcomes
Primary Outcome Measures
Blood pressure
Change in blood pressure, measured at partipants' homes, between baseline and 6 months
Secondary Outcome Measures
Hemoglobin A1c
Change in A1c from baseline to 6 months
LDL Cholesterol
Change in LDL cholesterol from baseline to 6 months
Full Information
NCT ID
NCT01145742
First Posted
June 15, 2010
Last Updated
December 10, 2018
Sponsor
Albert Einstein College of Medicine
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
1. Study Identification
Unique Protocol Identification Number
NCT01145742
Brief Title
Controlling Hypertension in Diabetes- Feasibility Study
Acronym
COACH-D
Official Title
A Collaborative Approach to Control Hypertension in Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
November 2006 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
September 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Albert Einstein College of Medicine
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Many primary care patients, especially in inner-city settings, do not achieve targets for blood pressure and glycemic control. There is an urgent need to enhance treatment for those who do not reach goals within the usual clinical care system. We propose to develop a multi-component intervention grounded in the Chronic Care Model, and sustainable in resource-challenged settings. Through collaboration with home health nursing and with the use of home telemetry for feedback and intensification of therapy, we will augment usual clinical services to improve health outcomes for diabetes patients who have not been able to reach therapeutic goals. There are three specific aims. First, we will establish a feasible, practical and sustainable collaborative model between the primary care sites of our practice-based research network (NYC RING), clinical researchers at the Diabetes Research and Training Center, and The Montefiore Home Health Organization, integrating the unique expertise of each of the partners and defining the roles and responsibilities of each. Second, we will develop and refine the components of the intervention, to include training primary care providers and home health nurses to integrate the technical, psychosocial and communication processes for implementation of the intervention. Third, we will assess the feasibility of the collaborative intervention by implementing the intervention for 25 primary care patients and obtain preliminary estimates of effectiveness by comparing outcomes to 25 patients receiving usual care. Our proposal includes plans to develop feasible procedures for data collection, with qualitative and quantitative methods of assessing process and outcome measures. We will use these preliminary data to revise the intervention and prepare an R18 application to further develop and test the intervention in multiple inner-city primary care sites serving low-income diabetes patients. This proposal is for secondary prevention of diabetes complications, targeting a population known for health disparities and a high burden from this chronic disease.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes, Hypertension, Hyperlipidemia
Keywords
Type 2 diabetes, Hypertension, Health services research, Health disparities, Behavior change
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Allocation
Randomized
Enrollment
56 (Actual)
8. Arms, Groups, and Interventions
Arm Title
self-management support and BP telemonitoring
Arm Type
Experimental
Arm Description
collaborative intervention involving home BP monitoring, home behavior change counseling to enhance self management, and intensification of treatment by primary care doctors
Arm Title
usual care
Arm Type
No Intervention
Arm Description
usual primary care management of BP. lipids, and glucose
Intervention Type
Behavioral
Intervention Name(s)
home health/primary care collaboration
Intervention Description
self-management support and telemonitoring of BP and blood glucose
Primary Outcome Measure Information:
Title
Blood pressure
Description
Change in blood pressure, measured at partipants' homes, between baseline and 6 months
Time Frame
baseline and 6 months
Secondary Outcome Measure Information:
Title
Hemoglobin A1c
Description
Change in A1c from baseline to 6 months
Time Frame
baseline and 6 months
Title
LDL Cholesterol
Description
Change in LDL cholesterol from baseline to 6 months
Time Frame
baseline and 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
type 2 diabetes,
BP above 140/90 on two health center visits,
home touch tone phone
Exclusion Criteria:
dementia,
homelessness,
language other than English or Spanish
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Melissa Diane McKee, MD, MS
Organizational Affiliation
Albert Einstein College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Albert Einstein College of Medicine
City
Bronx
State/Province
New York
ZIP/Postal Code
10705
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Controlling Hypertension in Diabetes- Feasibility Study
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