Tailored Case Management for Diabetes and Hypertension (TEACH-DM)

Duke University

Status: Completed

Conditions: Hypertension; Diabetes

Treatments: Behavioral: Tailored telephone-based case management; Behavioral: Nurse Education

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00978835

Pro00002325

1R01DK074672 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 377 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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%

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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377 participants in 2 patient groups

Nurse case management

Experimental group

Description:

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.

Treatment:

Behavioral: Tailored telephone-based case management

Nurse Education

Active Comparator group

Description:

Didactic, non-interactive education by a nurse on general health topics.

Treatment:

Behavioral: Nurse Education