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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Albert Einstein College of Medicine of Yeshiva University
ClinicalTrials.gov Identifier:
NCT01145742
First received: June 15, 2010
Last updated: June 17, 2010
Last verified: June 2010
  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.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Primary Purpose: Health Services Research
Official Title: A Collaborative Approach to Control Hypertension in Diabetes

Resource links provided by NLM:


Further study details as provided by Albert Einstein College of Medicine of Yeshiva University:

Primary Outcome Measures:
  • Blood pressure [ Time Frame: baseline and 6 months ] [ Designated as safety issue: No ]
    Change in blood pressure, measured at partipants' homes, between baseline and 6 months


Secondary Outcome Measures:
  • Hemoglobin A1c [ Time Frame: baseline and 6 months ] [ Designated as safety issue: No ]
    Change in A1c from baseline to 6 months

  • LDL Cholesterol [ Time Frame: baseline and 6 months ] [ Designated as safety issue: No ]
    Change in LDL cholesterol from baseline to 6 months


Enrollment: 56
Study Start Date: November 2006
Estimated Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01145742

Locations
United States, New York
Albert Einstein College of Medicine
Bronx, New York, United States, 10705
Sponsors and Collaborators
Albert Einstein College of Medicine of Yeshiva University
Investigators
Principal Investigator: Melissa Diane McKee, MD, MS Albert Einstein College of Medicine of Yeshiva University
  More Information

No publications provided

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
Study First Received: June 15, 2010
Last Updated: June 17, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Albert Einstein College of Medicine of Yeshiva University:
Type 2 diabetes
Hypertension
Health services research
Health disparities
Behavior change

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

ClinicalTrials.gov processed this record on April 14, 2014