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OpenTrials
Completed

NCT Number: NCT00978835

Tailored Case Management for Diabetes and Hypertension

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.

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Key information

Conditions

Diabetes Behavior Cardiovascular Diseases Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Health Behavior Hypertension Medication Adherence Metabolic Diseases Motor Activity Nutritional and Metabolic Diseases Patient Acceptance of Health Care Patient Compliance Treatment Adherence and Compliance Vascular Diseases

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke University Medical Center

Durham, North Carolina, 27705, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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 education

Behavioral

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

Primary outcomes

  1. Blood Pressure

    Time frame: 2 years

Secondary outcomes

  1. Hemoglobin A1c

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

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

Registry information

Acronym: TEACH-DM

Important dates

Study start
2008
Primary completion
2013
Study completion
2013
First posted
Sep 17, 2009
Registry last updated
Jul 15, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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