Interactive Multirisk-Factor Intervention for Hypertension (HTN) Blacks

Study Overview
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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: TLC-HTN-AA use will improve medication regiment adherence TLC-HTN-AA will improve adherence to 3 healthy diet recommendations TLC-HTN-AA will improve levels of regular exercise Patients receiving TLC-HTN-AA will be more likely to become adherent to all 3 target regiments than patients in the control group

Official Title
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Interactive Multirisk-Factor Intervention for HTN Blacks

Conditions
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Hypertension

Intervention / Treatment
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* Behavioral: Automated Telephone Program
* Behavioral: Health Behavior Education


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Automated Telephone Program<br>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. | Behavioral: Automated Telephone Program<br>* 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.<br>Behavioral: Health Behavior Education<br>* 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).<br>|
| Placebo Comparator: Health Behavior Education<br>The comparator group received health education relating to the management of hypertension. Members of this group also received standard primary medical care. | Behavioral: Health Behavior Education<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Outcomes were assessed at baseline, 4 months, 8 months (the end of the study intervention) and 12 months. | 8 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 | Outcomes were assessed at baseline, 4 months, 8 months (the end of the study intervention) and 12 months. | 8 months | 
| 3-adherence to CDC-ACSM recommendations for moderate intensity physical activity at the end of the intervention period | Outcomes were assessed at baseline, 4 months, 8 months (the end of the study intervention) and 12 months. | 8 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Outcomes were assessed at baseline, 4 months, 8 months (the end of the study intervention) and 12 months. | 8 months |