Expired Study
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Bronx, New York 10705


Purpose:

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.


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


Study is Available At:


Original ID:

2006-232


NCT ID:

NCT01145742


Secondary ID:


Study Acronym:

COACH-D


Brief Title:

Controlling Hypertension in Diabetes- Feasibility Study


Official Title:

A Collaborative Approach to Control Hypertension in Diabetes


Overall Status:

Completed


Study Phase:

N/A


Genders:

N/A


Minimum Age:

30 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Albert Einstein College of Medicine


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

56


Enrollment Type:

Actual


Overall Contact Information

Official Name:Melissa Diane McKee, MD, MS
Principal Investigator
Albert Einstein College of Medicine

Study Dates

Start Date:November 2006
Completion Date:September 2009
Completion Type:Actual
Primary Completion Date:September 2009
Primary Completion Type:Actual
Verification Date:December 2018
Last Changed Date:December 10, 2018
First Received Date:June 15, 2010

Study Outcomes

Outcome Type:Primary Outcome
Measure:Blood pressure
Time Frame:baseline and 6 months
Safety Issues:False
Description:Change in blood pressure, measured at partipants' homes, between baseline and 6 months
Outcome Type:Secondary Outcome
Measure:Hemoglobin A1c
Time Frame:baseline and 6 months
Safety Issues:False
Description:Change in A1c from baseline to 6 months
Outcome Type:Secondary Outcome
Measure:LDL Cholesterol
Time Frame:baseline and 6 months
Safety Issues:False
Description:Change in LDL cholesterol from baseline to 6 months

Study Interventions

Intervention Type:Behavioral
Name:home health/primary care collaboration
Description:self-management support and telemonitoring of BP and blood glucose
Arm Name:self-management support and BP telemonitoring

Study Arms

Study Arm Type:No Intervention
Arm Name:usual care
Description:usual primary care management of BP. lipids, and glucose
Study Arm Type:Experimental
Arm Name:self-management support and BP telemonitoring
Description:collaborative intervention involving home BP monitoring, home behavior change counseling to enhance self management, and intensification of treatment by primary care doctors

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Albert Einstein College of Medicine
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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