Controlling Hypertension in Diabetes- Feasibility Study

Not Applicable

Completed

• Conditions: Type 2 Diabetes; Hypertension; Hyperlipidemia
• Interventions: Behavioral: home health/primary care collaboration

• Registration Number: NCT01145742
• Lead Sponsor: Albert Einstein College of Medicine

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-11
• Primary Completion: 2009-09
• Study Completion: 2009-09
• Study First Submitted: 2010-06-15
• Study First Submitted QC: 2010-06-16
• Study First Posted: 2010-06-17
• Status Verified: 2018-12
• Last Update Submitted: 2018-12-10
• Last Update Posted: 2018-12-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
self-management support and BP telemonitoring	home health/primary care collaboration	collaborative intervention involving home BP monitoring, home behavior change counseling to enhance self management, and intensification of treatment by primary care doctors

Primary Outcome Measures

Name	Time	Method
Blood pressure	baseline and 6 months	Change in blood pressure, measured at partipants' homes, between baseline and 6 months

Secondary Outcome Measures

Name	Time	Method
LDL Cholesterol	baseline and 6 months	Change in LDL cholesterol from baseline to 6 months
Hemoglobin A1c	baseline and 6 months	Change in A1c from baseline to 6 months

Trial Locations

Locations (1)

Albert Einstein College of Medicine; 🇺🇸 Bronx, New York, United States