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Completed

NCT Number: NCT00207194

Interactive Multirisk-Factor Intervention for Hypertension (HTN) Blacks

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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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

35 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical Information Systems Unit/Boston Medical Center

Boston, Massachusetts, 02118, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Automated Telephone Program

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

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).

Primary outcomes

  1. 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

    Time frame: 8 months

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

  2. 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

    Time frame: 8 months

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

  3. 3-adherence to CDC-ACSM recommendations for moderate intensity physical activity at the end of the intervention period

    Time frame: 8 months

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

Secondary outcomes

  1. 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

    Time frame: 8 months

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

Sponsors and collaborators

Lead sponsor

Boston Medical Center

Other

Registry information

Official study title

Interactive Multirisk-Factor Intervention for HTN Blacks

Important dates

Study start
2001
Primary completion
2007
Study completion
2007
First posted
Sep 21, 2005
Registry last updated
Jun 16, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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