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Interactive Multirisk-Factor Intervention for Hypertension (HTN) Blacks

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boston Medical Center
ClinicalTrials.gov Identifier:
NCT00207194
First received: September 12, 2005
Last updated: February 21, 2013
Last verified: June 2011
History of Changes
  Purpose

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

Condition Intervention
Hypertension
 Behavioral: Automated Telephone Program

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Interactive Multirisk-Factor Intervention for HTN Blacks

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Boston Medical Center:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Outcomes were assessed at baseline, 4 months, 8 months (the end of the study intervention) and 12 months.


Secondary Outcome Measures:
  • 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 [ Time Frame: 8 months ] [ Designated as safety issue: No ]
    Outcomes were assessed at baseline, 4 months, 8 months (the end of the study intervention) and 12 months.


Enrollment: 337
Study Start Date: October 2001
Study Completion Date: August 2007
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Automated Telephone Program
The intervention was a totally automated, computer-based, interactive telephone counseling system called Telephone- Linked-Care, designed to monitor, educate, and counsel African-American adults with hypertension and to provide summary data regularly to the patient's primary care provider.
 Behavioral: Automated Telephone Program
The intervention incorporated principles of social cognitive theory, the transtheoretical model of behavioral change, and motivational interviewing, and was tailored to the user's values. Content was also adapted to cultural characteristics of culturally African-American adults (i.e., not Caribbean-American, Black-Hispanic, etc.).
Placebo Comparator: Health Behavior Education
The comparator group received health education relating to the management of hypertension. Members of this group also received standard primary medical care.

  Eligibility

Ages Eligible for Study:   35 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00207194

Locations
United States, Massachusetts
Medical Information Systems Unit/Boston Medical Center
Boston, Massachusetts, United States, 02118
Sponsors and Collaborators
Boston Medical Center
Investigators
Principal Investigator: Robert Friedman, MD Boston Medical Center
Study Director: Jeffrey Migneault, PhD Boston University
  More Information

Publications:

Responsible Party: Boston Medical Center
ClinicalTrials.gov Identifier: NCT00207194     History of Changes
Other Study ID Numbers: HL 69395
Study First Received: September 12, 2005
Last Updated: February 21, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 21, 2013