Interactive Multirisk-Factor Intervention for Hypertension (HTN) Blacks

Not Applicable

Completed

• Conditions: Hypertension

• 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

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