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Tailored Case Management for Diabetes and Hypertension (TEACH-DM)

This study is currently recruiting participants.
Verified June 2011 by Duke University
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT00978835
First received: September 15, 2009
Last updated: November 9, 2012
Last verified: June 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Diabetes
Hypertension
 Behavioral: Tailored telephone-based case management
Behavioral: Nurse Education
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Tailored Case Management for Diabetes and Hypertension

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Duke University:

Primary Outcome Measures:
  • Blood Pressure [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Hemoglobin A1c [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 400
Study Start Date: May 2008
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
 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.
Active Comparator: Nurse Education
Didactic, non-interactive education by a nurse on general health topics.
 Behavioral: Nurse Education
Didactic, non-interactive education by a nurse on general health topics. Calls are made every two months.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00978835

Contacts
Contact: Amy C Harris, AB 919-668-7205 harri063@mc.duke.edu

Locations
United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27705
Principal Investigator: David Edelman, MD            
Sponsors and Collaborators
Duke University
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  More Information

No publications provided

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00978835     History of Changes
Other Study ID Numbers: Pro00002325 (DK74672), 1R01DK074672
Study First Received: September 15, 2009
Last Updated: November 9, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Duke University:
Diabetes
Hypertension
Physical Activity
Diet
Medication Adherence

Additional relevant MeSH terms:
Diabetes Mellitus
Hypertension
Glucose Metabolism Disorders
Metabolic Diseases
 Endocrine System Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 22, 2013