Tailored Case Management for Diabetes and Hypertension

NCT00978835 | Completed DMC

• 2 other identifiers: Pro000023251R01DK074672
• Study Type: interventional
• Target: 377
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes; Hypertension

Keywords

Diabetes; Hypertension; Physical Activity; Diet; Medication Adherence

Outcome Measures

Primary Outcomes (1)

• Blood Pressure

  2 years

Secondary Outcomes (1)

• Hemoglobin A1c

  2 years

Study Arms (2)

Nurse case management

EXPERIMENTAL

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.

Behavioral: Tailored telephone-based case management

Nurse Education

ACTIVE COMPARATOR

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

Behavioral: Nurse Education

Interventions

Tailored telephone-based case management BEHAVIORAL

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 case management

Nurse Education BEHAVIORAL

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

Nurse Education

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27705, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus; Hypertension; Motor Activity; Medication Adherence

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases; Behavior; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2009
• First Posted: September 17, 2009
• Study Start: May 1, 2008
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: July 15, 2014

Record last verified: 2014-07

Locations

US (1)