Trial Using Motivational Interviewing Positive Affect and Self-Affirmation in Hypertension (TRIUMPH) (Triumph)
|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.|
|ClinicalTrials.gov Identifier: NCT01024933|
Recruitment Status : Completed
First Posted : December 3, 2009
Last Update Posted : February 23, 2017
|Condition or disease||Intervention/treatment||Phase|
|Hypertension||Behavioral: Positive Affect/Self-Affirmation/Motivational Interviewing Behavioral: Educational and Behavioral||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||238 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Trial Using Motivational Interviewing Positive Affect and Self-Affirmation in Hypertension (TRIUMPH)|
|Study Start Date :||January 2010|
|Actual Primary Completion Date :||April 2014|
|Actual Study Completion Date :||April 2014|
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.
- The primary outcome is the blood pressure control. [ Time Frame: 12 months ]
- The secondary outcome is within-patient change in Systolic Blood Pressure and Diastolic Blood Pressure. [ Time Frame: 12 months ]
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
|United States, New York|
|Lincoln Medical and Mental Health Center|
|Bronx, New York, United States, 10451|
|Principal Investigator:||Carla Boutin-Foster, MD||Weill Medical College of Cornell University|