Tailored Case Management for Diabetes and Hypertension

Not Applicable

Completed

• Conditions: Hypertension; Diabetes
• Interventions: Behavioral: Nurse Education; Behavioral: Tailored telephone-based case management

• Registration Number: NCT00978835
• Lead Sponsor: Duke University

Brief Summary

Diabetes and hypertension co-exist in approximately 10 million people in the USA and constitute severe risk factors for the development of such complications as heart and kidney disease. The investigators propose a randomized controlled trial in patients of community primary care practices to study a tailored telephone-administered behavioral intervention to improve control of blood pressure and blood sugar in patients with both hypertension and diabetes. The investigators hypothesize that 20% more patients talking to a nurse every other month about ways to improve blood pressure and blood sugar control will bring their blood pressure under control when compared to patients who talk with the nurse only about general health issues. If successful in improving control of these diseases this intervention can easily be adopted in other community primary care practices to lessen the burden of diabetes and hypertension in the USA.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2008-05
• Study First Submitted: 2009-09-15
• Study First Submitted QC: 2009-09-16
• Study First Posted: 2009-09-17
• Primary Completion: 2013-07
• Study Completion: 2013-07
• Status Verified: 2014-07
• Last Update Submitted: 2014-07-14
• Last Update Posted: 2014-07-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 377

Inclusion Criteria

• Enrolled and receiving primary care at one of 9 participating clinics in North Carolina
• Diagnosis of diabetes as determined by billing data
• Taking medication for diabetes
• Diagnosis of hypertension as determined by billing data
• Taking medication for hypertension
• Most recent (within one year) Hemoglobin A1c >= 7.5%

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Exclusion Criteria

• Active psychosis
• Hospitalization for stroke, myocardial infarction (MI), or coronary artery revascularization in the past 6 months
• Type I diabetes
• Does not speak English
• No access to a telephone
• Institution-dwelling or receiving comprehensive professional home health care
• Hearing or speech inadequate for long interactive phone conversations
• Terminal illness or active treatment for cancer
• Cognitive impairment too severe to understand instructions

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nurse Education	Nurse Education	Didactic, non-interactive education by a nurse on general health topics.
Nurse case management	Tailored telephone-based case management	Telephone calls by a nurse every two months to assess adherence to diet, physical activity, and pill-taking regimens. The nurse will then identify barriers to adherence to these recommendations and use motivational interviewing approaches to offer solutions to the barriers identified. No changes to medication are made.

Primary Outcome Measures

Name	Time	Method
Blood Pressure	2 years

Secondary Outcome Measures

Name	Time	Method
Hemoglobin A1c	2 years

Trial Locations

Locations (1)

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States