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Controlling Hypertension in Diabetes- Feasibility Study

A Collaborative Approach to Control Hypertension in Diabetes

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01145742
Acronym
COACH-D
Enrollment
56
Registered
2010-06-17
Start date
2006-11-30
Completion date
2009-09-30
Last updated
2018-12-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hyperlipidemia, Hypertension, Type 2 Diabetes

Keywords

Type 2 diabetes, Hypertension, Health services research, Health disparities, Behavior change

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.

Interventions

BEHAVIORALhome health/primary care collaboration

self-management support and telemonitoring of BP and blood glucose

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
CollaboratorNIH
Albert Einstein College of Medicine
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH

Eligibility

Sex/Gender
ALL
Age
30 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Blood pressurebaseline and 6 monthsChange in blood pressure, measured at partipants' homes, between baseline and 6 months

Secondary

MeasureTime frameDescription
Hemoglobin A1cbaseline and 6 monthsChange in A1c from baseline to 6 months
LDL Cholesterolbaseline and 6 monthsChange in LDL cholesterol from baseline to 6 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026