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CompletedNCT00978835TEACH-DMUpdated Jul 15, 2014

Tailored Case Management for Diabetes and Hypertension

An interventional study of Tailored telephone-based case management and Nurse Education in Diabetes and Hypertension, sponsored by Duke University. Completed at 1 site in United States. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2014-07-15.

Sponsored by Duke University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
377
Allocation
Randomized
Ages
21 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Diabetes
  • Hypertension

Keywords

  • Diabetes
  • Hypertension
  • Physical Activity
  • Diet
  • Medication Adherence
03

In context

Hypertension

6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.

This study's enrollment of 377 is above the median of 90 across 4,995 interventional studies indexed under Hypertension.

Browse Hypertension studies →

Lead sponsor

Duke University is the lead sponsor of 2,025 studies on the registry; 275 are open to participants now.

Of its 194 completed or terminated interventional studies of FDA-regulated products, 159 (82%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
377 participants (actual)

Study arms

  • 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

  • Active comparator
    Nurse Education

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

    Behavioral: Nurse Education

Interventions

  • BehavioralTailored 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.

  • BehavioralNurse Education

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

06

What researchers measure

Primary outcomes

  1. Blood Pressure

    Time frame: 2 years

Secondary outcomes

  1. Hemoglobin A1c

    Time frame: 2 years

07

Study locations

1 site
  • Duke University Medical Center
    Durham, North Carolina 27705, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 15, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00978835
Lead sponsor
Duke University
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Responsible party
Sponsor
First posted
Sep 17, 2009
Start date
May 2008
Primary completion
Jul 2013
Completion
Jul 2013
Last update
Jul 15, 2014

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2014. You cannot join it, but the record below documents what was studied.

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