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

September 12, 2005
February 21, 2013
October 2001
August 2007   (final data collection date for primary outcome measure)
  • 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.
  • 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
  • 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
  • 3-adherence to CDC-ACSM recommendations for moderate intensity physical activity at the end of the intervention period
  • 4- patients receiving TLC-HTN-AA will be more likely to become adherent to all 3 target regimens (above) than patients in the control group
Complete list of historical versions of study NCT00207194 on ClinicalTrials.gov Archive Site
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.
  • 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
  • 2-The effects of TLC-HTN-AA on adherence of patients to their regiments and on blood pressure will be sustained during a 4-month maintenance period during which patients will not be exposed to the intervention
  • 3-TLC-HTN-AA's effects on blood pressure will be mediated, in part, through improved adherence of patients to their treatment regimens
  • 4-TLC-HTN-AA will be perceived by patients and professionals as an acceptable, useable, and useful health care service
  • 5-Improvements in behavioral variables such as intention and self-efficacy, among, others, will mediate improvement in regimen adherence
Not Provided
Not Provided
 
Interactive Multirisk-Factor Intervention for Hypertension (HTN) Blacks
Interactive Multirisk-Factor Intervention for HTN Blacks

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
Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Hypertension
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.).
  • 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.
    Intervention: Behavioral: Automated Telephone Program
  • 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.
Migneault JP, Dedier JJ, Wright JA, Heeren T, Campbell MK, Morisky DE, Rudd P, Friedman RH. A culturally adapted telecommunication system to improve physical activity, diet quality, and medication adherence among hypertensive African-Americans: a randomized controlled trial. Ann Behav Med. 2012 Feb;43(1):62-73. doi: 10.1007/s12160-011-9319-4.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
337
August 2007
August 2007   (final data collection date for primary outcome measure)

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
Both
35 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00207194
HL 69395
Yes
Boston Medical Center
Boston Medical Center
Not Provided
Principal Investigator: Robert Friedman, MD Boston Medical Center
Study Director: Jeffrey Migneault, PhD Boston University
Boston Medical Center
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP