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

NCT01024933 | Completed DMC

• 2 other identifiers: Triumph1P60MD003421-01
• Study Type: interventional
• Target: 238
• Locations: 1 country
• Sites: 1

Brief Summary

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.)

Conditions

Hypertension

Keywords

Hypertension; High Blood Pressure

Outcome Measures

Primary Outcomes (1)

• The primary outcome is the blood pressure control.

  12 months

Secondary Outcomes (1)

• The secondary outcome is within-patient change in Systolic Blood Pressure and Diastolic Blood Pressure.

  12 months

Study Arms (2)

Educational and Behavioral

PLACEBO COMPARATOR

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

PASA group-intervention

EXPERIMENTAL

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

Interventions

Positive Affect/Self-Affirmation/Motivational Interviewing BEHAVIORAL

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.

PASA group-intervention

Educational and Behavioral 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.

Educational and Behavioral

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator

Study Sites (1)

Lincoln Medical and Mental Health Center

The Bronx, New York, 10451, United States

Location

MeSH Terms

Conditions

Hypertension

Interventions

Motivational Interviewing

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Directive Counseling; Counseling; Mental Health Services; Behavioral Disciplines and Activities; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Carla Boutin-Foster, MD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2009
• First Posted: December 3, 2009
• Study Start: January 1, 2010
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: February 23, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)