Interactive Multirisk-Factor Intervention for Hypertensio... | NCT00207194

NCT00207194

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Oversight Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Automated Telephone Program	Active Comparator	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 Behavioral: Health Behavior Education
Health Behavior Education	Placebo Comparator	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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

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 Outcomes

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

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Robert Friedman, MD	Boston Medical Center	Principal Investigator
Jeffrey Migneault, PhD	Boston University	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Medical Information Systems Unit/Boston Medical Center		Boston	Massachusetts	02118	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
22246660	Result	Migneault JP, Dedier JJ, Wright JA, Heeren T, Campbell MK, Morisky DE, Rudd P, Friedman RH. A culturally adapted telecommunication system to improve physical activity, diet quality, and medication adherence among hypertensive African-Americans: a randomized controlled trial. Ann Behav Med. 2012 Feb;43(1):62-73. doi: 10.1007/s12160-011-9319-4.

Condition Browse Module

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases