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

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.)

Study Overview

• Status: Completed
• Conditions: Hypertension
• Intervention / Treatment: Behavioral: Educational and Behavioral; Behavioral: Positive Affect/Self-Affirmation/Motivational Interviewing

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 Type: Interventional
• Enrollment (Actual): 238
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Bronx, New York, United States, 10451
      • Lincoln Medical and Mental Health Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: 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.	Behavioral: Educational and Behavioral; The Education and Behavioral Contract (Control group)will receive an educational workbook and behavioral contract. In addition, each patient will receive a home blood pressure device for self-monitoring, and will be called every two months.
Experimental: PASA group-intervention; 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.	Behavioral: Positive Affect/Self-Affirmation/Motivational Interviewing; The PASA group-intervention will receive small gifts one week prior to their scheduled follow up. The PASA intervention involves reminding participants to think about their proud and positive moments. The motivational interviewing intervention includes assessing the patient's motivation and confidence; elicit barriers and concerns; summarize in a non-threatening manner the 'pros' and 'cons' of patient's concerns, thereby eliciting positive self-motivational statements about the behavior. Follow up will be every two months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The primary outcome is the blood pressure control.	12 months

Secondary Outcome Measures

Outcome Measure	Time Frame
The secondary outcome is within-patient change in Systolic Blood Pressure and Diastolic Blood Pressure.	12 months

Collaborators and Investigators

• Sponsor: Weill Medical College of Cornell University
• Collaborators: National Institute on Minority Health and Health Disparities (NIMHD)
• Investigators: Principal Investigator: Carla Boutin-Foster, MD, Weill Medical College of Cornell University

Study record dates

Study Major Dates

• Study Start: January 1, 2010
• Primary Completion (Actual): April 1, 2014
• Study Completion (Actual): April 1, 2014

Study Registration Dates

• First Submitted: December 1, 2009
• First Submitted That Met QC Criteria: December 2, 2009
• First Posted (Estimate): December 3, 2009

Study Record Updates

• Last Update Posted (Actual): February 23, 2017
• Last Update Submitted That Met QC Criteria: February 17, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Keywords: Hypertension; High Blood Pressure
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: TRIUMPH; 1P60MD003421-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: there is no plan to share