Controlling Hypertension in Diabetes- Feasibility Study

Hypertension Clinical Trial

— COACH-D  

Official title:

A Collaborative Approach to Control Hypertension in Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01145742
• Other study ID #: 2006-232
• Status: Completed
• Phase: N/A
• Start date: November 2006
• Est. completion date: September 2009

Study information

• Verified date: December 2018
• Source: Albert Einstein College of Medicine, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Hyperlipidemia
• Hyperlipidemias
• Hyperlipoproteinemias
• Hypertension
• Type 2 Diabetes

Intervention

Behavioral:
• home health/primary care collaboration
self-management support and telemonitoring of BP and blood glucose

Locations

Country	Name	City	State
United States	Albert Einstein College of Medicine	Bronx	New York

Sponsors (2)

Lead Sponsor	Collaborator
Albert Einstein College of Medicine, Inc.	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood pressure	Change in blood pressure, measured at partipants' homes, between baseline and 6 months	baseline and 6 months
Secondary	Hemoglobin A1c	Change in A1c from baseline to 6 months	baseline and 6 months
Secondary	LDL Cholesterol	Change in LDL cholesterol from baseline to 6 months	baseline and 6 months