Tailored Case Management for Diabetes and Hypertension

Study Overview
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Brief Summary
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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.

Official Title
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Tailored Case Management for Diabetes and Hypertension

Conditions
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Diabetes, Hypertension

Intervention / Treatment
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* Behavioral: Tailored telephone-based case management
* Behavioral: Nurse Education


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nurse case management<br>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<br>* 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.<br>|
| Active Comparator: Nurse Education<br>Didactic, non-interactive education by a nurse on general health topics. | Behavioral: Nurse Education<br>* Didactic, non-interactive education by a nurse on general health topics. Calls are made every two months.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood Pressure |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemoglobin A1c |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes, Hypertension, Physical Activity, Diet, Medication Adherence