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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:
NCT01024933
First received: December 1, 2009
Last updated: July 24, 2013
Last verified: July 2013
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Trial Using Motivational Interviewing Positive Affect and Self-Affirmation in Hypertension (TRIUMPH)

Resource links provided by NLM:


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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The secondary outcome is within-patient change in Systolic Blood Pressure and Diastolic Blood Pressure. [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 238
Study Start Date: January 2010
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 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: Positive Affect/Self-Affirmation/Motivational
The Positive Affect/Self-Affirmation/Motivational (experimental group) will receive an educational workbook and behavioral contract. This group will receive a positive-affect and self-affirmation intervention with motivational interviewing.These patients will also receive a educational workbook and behavioral contract.
Behavioral: Positive Affect/Self-Affirmation/Motivational Interviewing
The positive affect/self-affirmation intervention will receive small gifts one week prior to their scheduled follow up. Secondly, we will use a task that involves reminding people of their proud moments. The motivational interviewing intervention includes the following steps: 1) assess the patient's motivation and confidence in engaging in medication adherence; 2) elicit barriers and concerns about medication adherence; 3) summarize in a non-threatening manner the 'pros' and 'cons' of patient's concerns, thereby eliciting positive self-motivational statements about the behavior; 4) provide a menu of options to the patient based on the nature of barriers elicited from the patient; 5) assess the patient's values and goals, in order to help the patient link their current health behavior pattern to their core values and life goals; and finally, 6) each encounter will end with a global summary of what was discussed and a clarification of an agreed-upon action plan.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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
Investigators
Principal Investigator: Carla Boutin-Foster, MD Weill Medical College of Cornell University
  More Information

No publications provided

Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT01024933     History of Changes
Other Study ID Numbers: Triumph, 1P60MD003421-01
Study First Received: December 1, 2009
Last Updated: July 24, 2013
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 21, 2014