Clinical trial NCT00207194: Interactive Multirisk-Factor Intervention for Hypertension (HTN) Blacks
Official title: Interactive Multirisk-Factor Intervention for HTN Blacks
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Lead sponsor: Boston Medical Center
Sponsor class: OTHER
First posted: 2005-09-21
Enrollment: 337
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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

Primary outcomes:
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
timeFrame: 8 months
measure: 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
timeFrame: 8 months
measure: 3-adherence to CDC-ACSM recommendations for moderate intensity physical activity at the end of the intervention period
timeFrame: 8 months
Secondary outcomes:
measure: 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
timeFrame: 8 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Medical Information Systems Unit/Boston Medical Center
state: Massachusetts
Study officials:
affiliation: Boston Medical Center
name: Robert Friedman, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Boston University
name: Jeffrey Migneault, PhD
role: STUDY_DIRECTOR
References:
citation: 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.