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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01024933
First Posted: December 3, 2009
Last Update Posted: February 23, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute on Minority Health and Health Disparities (NIMHD)
Information provided by (Responsible Party):
Weill Medical College of Cornell University
  Purpose
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.)

Condition Intervention
Hypertension Behavioral: Positive Affect/Self-Affirmation/Motivational Interviewing Behavioral: Educational and Behavioral

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Trial Using Motivational Interviewing Positive Affect and Self-Affirmation in Hypertension (TRIUMPH)

Further study details as provided by Weill Medical College of Cornell University:

Primary Outcome Measures:
  • The primary outcome is the blood pressure control. [ Time Frame: 12 months ]

Secondary Outcome Measures:
  • The secondary outcome is within-patient change in Systolic Blood Pressure and Diastolic Blood Pressure. [ Time Frame: 12 months ]

Enrollment: 238
Study Start Date: January 2010
Study Completion Date: April 2014
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01024933


Locations
United States, New York
Lincoln Medical and Mental Health Center
Bronx, New York, United States, 10451
Sponsors and Collaborators
Weill Medical College of Cornell University
National Institute on Minority Health and Health Disparities (NIMHD)
Investigators
Principal Investigator: Carla Boutin-Foster, MD Weill Medical College of Cornell University
  More Information

Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT01024933     History of Changes
Other Study ID Numbers: Triumph
1P60MD003421-01 ( U.S. NIH Grant/Contract )
First Submitted: December 1, 2009
First Posted: December 3, 2009
Last Update Posted: February 23, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: there is no plan to share

Keywords provided by Weill Medical College of Cornell University:
Hypertension
High Blood Pressure

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases