Interactive Multirisk-Factor Intervention for Hypertension (HTN) Blacks

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

337 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-10-31

Study Completion Date

2007-08-31

Brief Summary

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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

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Detailed Description

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Conditions

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Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Automated Telephone Program

Intervention Type BEHAVIORAL

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.). These participants also received the same health behavior education those in the control condition received.

Health Behavior Education

Intervention Type BEHAVIORAL

Participants received a 75-page resource manual that described hypertension, listed dietary recommendations, heart healthy food recipes, and local resources for exercise, and provided information to support antihypertensive medication adherence. They received a 20-min education session based on the content of this manual, and were given a pedometer and a digital weight scale (Healthometer, model # HDR900KD01).

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.

Group Type PLACEBO_COMPARATOR

Health Behavior Education

Intervention Type BEHAVIORAL

Participants received a 75-page resource manual that described hypertension, listed dietary recommendations, heart healthy food recipes, and local resources for exercise, and provided information to support antihypertensive medication adherence. They received a 20-min education session based on the content of this manual, and were given a pedometer and a digital weight scale (Healthometer, model # HDR900KD01).

Interventions

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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.). These participants also received the same health behavior education those in the control condition received.

Intervention Type BEHAVIORAL

Health Behavior Education

Participants received a 75-page resource manual that described hypertension, listed dietary recommendations, heart healthy food recipes, and local resources for exercise, and provided information to support antihypertensive medication adherence. They received a 20-min education session based on the content of this manual, and were given a pedometer and a digital weight scale (Healthometer, model # HDR900KD01).

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No