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Controlling Hypertension in Diabetes- Feasibility Study

NCT ID: NCT01145742

Last Updated: 2018-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-11-30

Study Completion Date

2009-09-30

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.

Detailed Description

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Conditions

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Type 2 Diabetes Hypertension Hyperlipidemia

Keywords

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Type 2 diabetes Hypertension Health services research Health disparities Behavior change

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Study Groups

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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

Group Type EXPERIMENTAL

home health/primary care collaboration

Intervention Type BEHAVIORAL

self-management support and telemonitoring of BP and blood glucose

usual care

usual primary care management of BP. lipids, and glucose

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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home health/primary care collaboration

self-management support and telemonitoring of BP and blood glucose

Intervention Type BEHAVIORAL

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
Minimum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role collaborator

Albert Einstein College of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Diane Mckee

Prof., Dept Family and Social Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Melissa Diane McKee, MD, MS

Role: PRINCIPAL_INVESTIGATOR

Albert Einstein College of Medicine

Locations

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Albert Einstein College of Medicine

The Bronx, New York, United States

Site Status

Countries

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United States

Other Identifiers

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2006-232

Identifier Type: -

Identifier Source: org_study_id