Interactive Multirisk-Factor Intervention for Hypertension (HTN) Blacks

Not Applicable

Completed

• Conditions: Hypertension
• Interventions: Behavioral: Automated Telephone Program; Behavioral: Health Behavior Education

• Registration Number: NCT00207194
• Lead Sponsor: Boston Medical Center

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

Detailed Description

Not available

Study Timeline

• Study Start: 2001-10
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-21
• Primary Completion: 2007-08
• Study Completion: 2007-08
• Status Verified: 2016-06
• Last Update Submitted: 2016-06-15
• Last Update Posted: 2016-06-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 337

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Automated Telephone Program	Health Behavior Education	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.
Health Behavior Education	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.
Automated Telephone Program	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.

Primary Outcome Measures

Name	Time	Method
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	8 months	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	8 months	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	8 months	Outcomes were assessed at baseline, 4 months, 8 months (the end of the study intervention) and 12 months.

Secondary Outcome Measures

Name	Time	Method
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	8 months	Outcomes were assessed at baseline, 4 months, 8 months (the end of the study intervention) and 12 months.

Trial Locations

Locations (1)

Medical Information Systems Unit/Boston Medical Center; 🇺🇸 Boston, Massachusetts, United States