Clinical trial NCT01024933: Trial Using Motivational Interviewing Positive Affect and Self-Affirmation in Hypertension (TRIUMPH)
Official title: Trial Using Motivational Interviewing Positive Affect and Self-Affirmation in Hypertension (TRIUMPH)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Keywords: Hypertension
High Blood Pressure
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
Collaborators: name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2009-12-03
Enrollment: 238
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary aim of this study is to evaluate whether an intervention that combines positive affect and self-affirmation with motivational interviewing (TRIUMPH) improves blood pressure control compared to an educational/behavioral contract intervention at 12 months. We hypothesize that a greater proportion of participants in the experimental arm of TRIUMPH will have adequate blood pressure control as defined by Seventh Joint National Committee on Detection, Evaluation and Treatment of Hypertension (JNC-7.)

Detailed description: TRIUMPH is designed to build on the findings of our previous studies by combining positive affect and self affirmation with motivational interviewing in order to increase blood pressure control in community based practices that care for large numbers of hypertensive black patients. Patients in both the educational and behavioral contract control group and would receive a workbook, would make a behavioral contract, and a home blood pressure monitor. The positive affect/self-affirmation group would receive the same components as the control group. In addition the experimental group would receive a positive affect/self-affirmation induction and motivational interviewing.

Both the control group and the experimental group would be followed at 2 month intervals. The outcome blood pressure control in this group will be contrasted to the knowledge/behavioral contract group. We hypothesize that we can increase the percent of patients who have blood pressure control to 75%.

Eligibility criteria: Inclusion Criteria:

* 18 years or older.
* Must be receiving care within the Renaissance Health Network for at least one year.
* Must have uncontrolled HTN defined as an average SBP\>140 mmHg or DBP\>90 mmHg on at least two previous visits in the past year and be taking at least one antihypertensive medication.
* Must self-identify as Black, or African American.
* Must have patient's physician to participate in the study.

Exclusion Criteria:

* Being deemed unable to comply with the study protocol (either self-selected or by indicating during screening that he/she could not complete all requested tasks).
* Participation in other clinical trials.
* Diagnosis of cognitive dysfunction or significant psychiatric comorbidity.

Primary outcomes:
measure: The primary outcome is the blood pressure control.
timeFrame: 12 months
Secondary outcomes:
measure: The secondary outcome is within-patient change in Systolic Blood Pressure and Diastolic Blood Pressure.
timeFrame: 12 months
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Lincoln Medical and Mental Health Center
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Carla Boutin-Foster, MD
role: PRINCIPAL_INVESTIGATOR
References: