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

Official Title: “Trial Using Motivational Interviewing Positive Affect and Self-Affirmation in Hypertension (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.)

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%.

Intervention(s) in this Clinical Trial

• 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.
• 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.

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 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. Each patient will also receive a home blood pressure device for self-monitoring. In addition, during follow ups they will receive a positive-affect and self-affirmation intervention with motivational interviewing.

Primary Measures

• The primary outcome is the blood pressure control.
  • Time Frame: 12 months
    Safety Issue?: No

Secondary Measures

• The secondary outcome is within-patient change in Systolic Blood Pressure and Diastolic Blood Pressure.
  • Time Frame: 12 months
    Safety Issue?: No

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Weill Medical College of Cornell University Other

Overall Clinical Trial Officials and Contacts

Carla Boutin-Foster, MD Principal Investigator Weill Medical College of Cornell University  

Overall Contact: Carla Boutin-Foster, MD 212-746-1607 cboutin@med.cornell.edu

Information obtained from ClinicalTrials.gov on February 09, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT01024933

Study ID Number: Triumph

ClinicalTrials.gov Identifier: NCT01024933

Health Authority: United States: Institutional Review Board