Controlling Hypertension in Diabetes- Feasibility Study

Study Overview
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Brief Summary
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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.

Official Title
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A Collaborative Approach to Control Hypertension in Diabetes

Conditions
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Type 2 Diabetes, Hypertension, Hyperlipidemia

Intervention / Treatment
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* Behavioral: home health/primary care collaboration


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Single Group Assignment


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: self-management support and BP telemonitoring<br>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<br>* self-management support and telemonitoring of BP and blood glucose<br>|
| No Intervention: usual care<br>usual primary care management of BP. lipids, and glucose | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood pressure | Change in blood pressure, measured at partipants' homes, between baseline and 6 months | baseline and 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemoglobin A1c | Change in A1c from baseline to 6 months | baseline and 6 months | 
| LDL Cholesterol | Change in LDL cholesterol from baseline to 6 months | baseline and 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Type 2 diabetes, Hypertension, Health services research, Health disparities, Behavior change