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Controlling Hypertension in Diabetes- Feasibility Study (COACH-D)

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ClinicalTrials.gov Identifier: NCT01145742
Recruitment Status : Completed
First Posted : June 17, 2010
Last Update Posted : June 22, 2010
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by:
Albert Einstein College of Medicine, Inc.

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.

Condition or disease Intervention/treatment
Type 2 Diabetes Hypertension Hyperlipidemia Behavioral: home health/primary care collaboration

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Primary Purpose: Health Services Research
Official Title: A Collaborative Approach to Control Hypertension in Diabetes
Study Start Date : November 2006
Primary Completion Date : September 2009
Estimated Study Completion Date : September 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: self-management support and BP telemonitoring
collaborative intervention involving home BP monitoring, home behavior change counseling to enhance self management, and intensification of treatment by primary care doctors
Behavioral: home health/primary care collaboration
self-management support and telemonitoring of BP and blood glucose
No Intervention: usual care
usual primary care management of BP. lipids, and glucose

Primary Outcome Measures :
  1. Blood pressure [ Time Frame: baseline and 6 months ]
    Change in blood pressure, measured at partipants' homes, between baseline and 6 months

Secondary Outcome Measures :
  1. Hemoglobin A1c [ Time Frame: baseline and 6 months ]
    Change in A1c from baseline to 6 months

  2. LDL Cholesterol [ Time Frame: baseline and 6 months ]
    Change in LDL cholesterol from baseline to 6 months

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Ages Eligible for Study:   30 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01145742

United States, New York
Albert Einstein College of Medicine
Bronx, New York, United States, 10705
Sponsors and Collaborators
Albert Einstein College of Medicine, Inc.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Principal Investigator: Melissa Diane McKee, MD, MS Albert Einstein College of Medicine, Inc.

Responsible Party: M. Diane McKee, MD, MS, Albert Einstein College of Medicine
ClinicalTrials.gov Identifier: NCT01145742     History of Changes
Other Study ID Numbers: 2006-232
First Posted: June 17, 2010    Key Record Dates
Last Update Posted: June 22, 2010
Last Verified: June 2010

Keywords provided by Albert Einstein College of Medicine, Inc.:
Type 2 diabetes
Health services research
Health disparities
Behavior change

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Vascular Diseases
Cardiovascular Diseases
Lipid Metabolism Disorders