Trial Using Motivational Interviewing Positive Affect and Self-Affirmation in Hypertension (TRIUMPH)

Not Applicable

Completed

• Conditions: Hypertension
• Interventions: Behavioral: Positive Affect/Self-Affirmation/Motivational Interviewing; Behavioral: Educational and Behavioral

• Registration Number: NCT01024933
• Lead Sponsor: Weill Medical College of Cornell University

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%.

Study Timeline

• Study First Submitted: 2009-12-01
• Study First Submitted QC: 2009-12-02
• Study First Posted: 2009-12-03
• Study Start: 2010-01
• Primary Completion: 2014-04
• Study Completion: 2014-04
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-17
• Last Update Posted: 2017-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 238

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PASA group-intervention	Positive Affect/Self-Affirmation/Motivational Interviewing	The PASA group (Positive Affect/Self-Affirmation/Motivational Interviewing) will receive a positive-affect and self-affirmation intervention with motivational interviewing.These patients will also receive an educational workbook and behavioral contract. This is the intervention.
Educational and Behavioral	Educational and Behavioral	The Education and Behavioral Contract (Control group) will receive an educational workbook and behavioral contract. Each patient will receive a home blood pressure device for self-monitoring, and will be called every two months.

Primary Outcome Measures

Name	Time	Method
The primary outcome is the blood pressure control.	12 months

Secondary Outcome Measures

Name	Time	Method
The secondary outcome is within-patient change in Systolic Blood Pressure and Diastolic Blood Pressure.	12 months

Trial Locations

Locations (1)

Lincoln Medical and Mental Health Center; 🇺🇸 Bronx, New York, United States