Trial Using Motivational Interviewing Positive Affect and Self-Affirmation in Hypertension (TRIUMPH) (Triumph)
|Hypertension||Behavioral: Positive Affect/Self-Affirmation/Motivational Interviewing Behavioral: Educational and Behavioral|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||Trial Using Motivational Interviewing Positive Affect and Self-Affirmation in Hypertension (TRIUMPH)|
- 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 ]
|Study Start Date:||January 2010|
|Study Completion Date:||April 2014|
|Primary Completion Date:||April 2014 (Final data collection date for primary outcome measure)|
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.
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%.
Please refer to this study by its ClinicalTrials.gov identifier: 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|