MISTER-B: Community-based Approaches to Treating Hypertension and Colon Cancer Prevention

Sponsor

NYU Langone Health (Other)

Overall Status

Completed

CT.gov ID

NCT01092078

Collaborator

Cornell University (Other), Wayne State University (Other)

740

Enrollment

Location

Arms

Duration (Months)

15.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Black men constitute the demographic group with the greatest burden of premature death and disability from hypertension (HTN) in the United States. But while the disproportionately high rate of hypertension-related morbidity and mortality is well documented, the epidemic of colorectal cancer (CRC) among black men is comparatively under-appreciated. For example, CRC is a leading cause of cancer death in black men with a death rate 50% higher than in white men. Low rates of screening for CRC in this population contribute significantly to this problem. The purpose of this randomized controlled trial (RCT) is to evaluate the effect of a lifestyle intervention delivered through telephone-based motivational interviewing (MINT) versus a patient navigation intervention on blood pressure reduction and CRC screening.

Condition or Disease	Intervention/Treatment	Phase
Hypertension Colon Cancer	Behavioral: MINT Behavioral: Patient Navigation	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

740 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Official Title:

Community-based Approaches to Treating Hypertension and Colon Cancer Prevention

Study Start Date :

May 1, 2010

Actual Primary Completion Date :

May 1, 2014

Actual Study Completion Date :

May 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Motivational Interviewing Individuals in the motivational interviewing (MINT) arm of the study will receive telephone-based lifestyle interviewing for 6-months. Counseling will be aimed at modifying diet and/or physical activity behaviors associated with decreasing blood pressure.	Behavioral: MINT Motivational interviewing for lifestyle changes associated with treating hypertension
Experimental: Patient Navigation Participants in the patient navigation arm will receive patient navigation for colonoscopy.	Behavioral: Patient Navigation Patient navigation for colonoscopy.
Experimental: PLUS Both patient navigation for colorectal cancer screening and motivational interviewing for blood pressure control	Behavioral: MINT Motivational interviewing for lifestyle changes associated with treating hypertension Behavioral: Patient Navigation Patient navigation for colonoscopy.

Arm

Intervention/Treatment

Experimental: Motivational Interviewing

Individuals in the motivational interviewing (MINT) arm of the study will receive telephone-based lifestyle interviewing for 6-months. Counseling will be aimed at modifying diet and/or physical activity behaviors associated with decreasing blood pressure.

Behavioral: MINT

Motivational interviewing for lifestyle changes associated with treating hypertension

Experimental: Patient Navigation

Participants in the patient navigation arm will receive patient navigation for colonoscopy.

Behavioral: Patient Navigation

Patient navigation for colonoscopy.

Experimental: PLUS

Both patient navigation for colorectal cancer screening and motivational interviewing for blood pressure control

Behavioral: MINT

Motivational interviewing for lifestyle changes associated with treating hypertension

Behavioral: Patient Navigation

Patient navigation for colonoscopy.

Outcome Measures

Primary Outcome Measures

Blood Pressure [Outcome is measured at 6-month follow-up]
Three blood pressure measures and the average of the three measures will be obtained at baseline and 6-month follow-up using a Welch Allyn Vital Signs automated blood pressure monitor.
Colon Cancer Screening Behavior [The outcome will be measured at 6-month follow-up]
Whether or not the participant was screened for colon cancer between baseline and 6-month follow-up will be assessed using self-report and patient medical records.

Secondary Outcome Measures

Medication Adherence [6-month follow-up]
Medication adherence will be assessed using the 4-item Morisky Medication Adherence scale.
Physical Activity [6-month follow-up]
Physical activity will be measured using the International Physical Activity Questionnaire (IPAQ).
Intrinsic Motivation to Exercise [6-month Follow-up]
Intrinsic motivation will be assessed using a 17-item questionnaire.
Self-Efficacy (Exercise) [6-month follow-up]
Self-efficacy related to exercise will be measured using a 12-iten questionnaire.
Dietary Intake [6-month follow-up]
Dietary intake will be assessed using the Food Frequency Questionnaire.
Intrinsic Motivation (Diet) [6-month follow-up]
Intrinsic motivation relating to diet will be assessed using a 17-item scale.
Self-efficacy (Diet) [6-month follow-up]
Self-efficacy relating to diet will be assessed using a 10-item scale.
Facilitators and Barriers to obtaining a colonoscopy [6-month follow-up]
Facilitators and barriers to obtaining a colonoscopy will be assessed using a self-reported scale.
Behavioral Intention relating to colon cancer screening [6-month follow-up]
Behavioral intention to screen for colon cancer will be assessed using a self-reported scale.
Social Influence relating to colon cancer screening [6-month follow-up]
Social influence relating to colon cancer screening will be assessed using a self-reported questionnaire.

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Inclusion Criteria:

Participants must be age 50 years or older,
Self-identify as a black or African American male,
Have uncontrolled hypertension as defined by systolic blood pressure (SBP) > 135 mmHg or diastolic blood pressure (DBP) > 85 mmHg and SBP > 130 or DBP > 80 mmHg (in those with diabetes at the screening).