Tailored Case Management for Diabetes and Hypertension

NCT ID: NCT00978835

Last Updated: 2014-07-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 377 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-05-31
• Study Completion Date: 2013-07-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Nurse 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.

Group Type: EXPERIMENTAL

Tailored telephone-based case management

Intervention Type: 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 Education

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

Group Type: ACTIVE_COMPARATOR

Nurse Education

Intervention Type: BEHAVIORAL

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

Interventions

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.

Intervention Type: BEHAVIORAL

Nurse Education

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

NIH

Sponsor Role: collaborator

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Duke University Medical Center

Durham, North Carolina, United States

Countries

United States

Other Identifiers

1R01DK074672

Identifier Type: NIH

Identifier Source: secondary_id

View Link

Pro00002325

Identifier Type: -

Identifier Source: org_study_id