Interactive Multirisk-Factor Intervention for Hypertension (HTN) Blacks

Boston Medical Center (BMC)

Status: Completed

Conditions: Hypertension

Treatments: Behavioral: Automated Telephone Program; Behavioral: Health Behavior Education

Study type: Interventional

Funder types: Other

Identifiers

NCT00207194

HL 69395

Details and patient eligibility

About

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

Enrollment: 337 patients

Sex: All

Ages: 35+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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337 participants in 2 patient groups, including a placebo group

Automated Telephone Program

Active Comparator group

Description:

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.

Treatment:

Behavioral: Health Behavior Education

Behavioral: Automated Telephone Program

Health Behavior Education

Placebo Comparator group

Description:

The comparator group received health education relating to the management of hypertension. Members of this group also received standard primary medical care.

Treatment:

Behavioral: Health Behavior Education