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Clinical Trials/NCT00207194
NCT00207194
Completed
Not Applicable

Interactive Multirisk-Factor Intervention for HTN Blacks

Boston Medical Center1 site in 1 country337 target enrollmentOctober 2001
ConditionsHypertension

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hypertension
Sponsor
Boston Medical Center
Enrollment
337
Locations
1
Primary Endpoint
1-proportion of study subjects who achieve adequate adherence (greater than or equal to 80% of doses taken) at the end of the intervention period
Status
Completed
Last Updated
9 years ago

Overview

Brief Summary

The aim of this study is to assess the efficacy of Telephone-Linked_Care for Hypertension Regimen Adherence in an African American population (TLC-HTN-AA). TLC-HTN-AA is a computer-based telecommunication system that will monitor, educate and counsel African American adults with hypertension on adherence to medication, diet, and exercise. The primary hypotheses are:

  1. TLC-HTN-AA use will improve medication regiment adherence
  2. TLC-HTN-AA will improve adherence to 3 healthy diet recommendations
  3. TLC-HTN-AA will improve levels of regular exercise
  4. Patients receiving TLC-HTN-AA will be more likely to become adherent to all 3 target regiments than patients in the control group
Registry
clinicaltrials.gov
Start Date
October 2001
End Date
August 2007
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Julien Dedier

BUMC Faculty

Boston Medical Center

Eligibility Criteria

Inclusion Criteria

  • a patient with a primary care provider at one of Boston Medical Center's Adult Primary Care Medical Practices or one of three HealthNet health centers participating in the study
  • have a physician diagnosis of hypertension
  • be African American by self-report
  • be 35 years of age or older
  • be prescribed at least one medication for hypertension
  • have poorly controlled blood pressure
  • be non-adherent to at least one hypertensive medication
  • understand spoken English
  • have a home telephone

Exclusion Criteria

  • patients for whom a medication, diet or exercise regiment adherence improvement or maintenance program would be inappropriate
  • patients with a terminal illness
  • patients with severe medical or psychiatric illness
  • patients with cognitive difficulty

Outcomes

Primary Outcomes

1-proportion of study subjects who achieve adequate adherence (greater than or equal to 80% of doses taken) at the end of the intervention period

Time Frame: 8 months

Outcomes were assessed at baseline, 4 months, 8 months (the end of the study intervention) and 12 months.

2-consumption of more than 5 servings of fruits and vegetables a day, less than 30% of calories from fat, and less than 2400 mg of sodium a day at the end of the intervention period

Time Frame: 8 months

Outcomes were assessed at baseline, 4 months, 8 months (the end of the study intervention) and 12 months.

3-adherence to CDC-ACSM recommendations for moderate intensity physical activity at the end of the intervention period

Time Frame: 8 months

Outcomes were assessed at baseline, 4 months, 8 months (the end of the study intervention) and 12 months.

Secondary Outcomes

  • 1-TLC-HTN-AA use will reduce the mean blood pressure and the proportion of the treatment group having uncontrolled hypertension at the end of the intervention period(8 months)

Study Sites (1)

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