Tailored Case Management for Diabetes and Hypertension

Hypertension Clinical Trial

— TEACH-DM  

Official title:

Tailored Case Management for Diabetes and Hypertension

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00978835
• Other study ID #: Pro00002325
• Secondary ID: 1R01DK074672
• Status: Completed
• Phase: N/A
• First received: September 15, 2009
• Last updated: July 14, 2014
• Start date: May 2008
• Est. completion date: July 2013

Study information

• Verified date: July 2014
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 377
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes
• Hypertension

Intervention

Behavioral:
• 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.
• Nurse Education
Didactic, non-interactive education by a nurse on general health topics. Calls are made every two months.

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	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		2 years	No
Secondary	Hemoglobin A1c		2 years	No