Community-based Approaches to Treating Hypertension and Colon Cancer Prevention

Hypertension Clinical Trial

— MISTER-B  

Official title:

Community-based Approaches to Treating Hypertension and Colon Cancer Prevention

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01092078
• Other study ID #: 09-0151
• Status: Completed
• Phase: N/A
• First received: March 18, 2010
• Last updated: April 20, 2015
• Start date: May 2010
• Est. completion date: May 2014

Study information

• Verified date: April 2015
• Source: New York University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 740
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

1. Participants must be age 50 years or older,

2. Self-identify as a black or African American male,

3. 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).

Exclusion Criteria:

1. Inability to comply with the study protocol (either self-selected or by indicating during screening that he could not complete all requested tasks).

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Colon Cancer
• Hypertension

Intervention

Behavioral:
• MINT
Motivational interviewing for lifestyle changes associated with treating hypertension
• Patient Navigation
Patient navigation for colonoscopy.

Locations

Country	Name	City	State
United States	NYU School of Medicine	New York	New York

Sponsors (3)

Lead Sponsor	Collaborator
New York University School of Medicine	Cornell University, Wayne State University

Country where clinical trial is conducted

United States, 

References & Publications (1)

Ravenell J, Thompson H, Cole H, Plumhoff J, Cobb G, Afolabi L, Boutin-Foster C, Wells M, Scott M, Ogedegbe G. A novel community-based study to address disparities in hypertension and colorectal cancer: a study protocol for a randomized control trial. Trials. 2013 Sep 8;14:287. doi: 10.1186/1745-6215-14-287. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood Pressure	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.	Outcome is measured at 6-month follow-up	No
Primary	Colon Cancer Screening Behavior	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.	The outcome will be measured at 6-month follow-up	No
Secondary	Medication Adherence	Medication adherence will be assessed using the 4-item Morisky Medication Adherence scale.	6-month follow-up	No
Secondary	Physical Activity	Physical activity will be measured using the International Physical Activity Questionnaire (IPAQ).	6-month follow-up	No
Secondary	Intrinsic Motivation to Exercise	Intrinsic motivation will be assessed using a 17-item questionnaire.	6-month Follow-up	No
Secondary	Self-Efficacy (Exercise)	Self-efficacy related to exercise will be measured using a 12-iten questionnaire.	6-month follow-up	No
Secondary	Dietary Intake	Dietary intake will be assessed using the Food Frequency Questionnaire.	6-month follow-up	No
Secondary	Intrinsic Motivation (Diet)	Intrinsic motivation relating to diet will be assessed using a 17-item scale.	6-month follow-up	No
Secondary	Self-efficacy (Diet)	Self-efficacy relating to diet will be assessed using a 10-item scale.	6-month follow-up	No
Secondary	Facilitators and Barriers to obtaining a colonoscopy	Facilitators and barriers to obtaining a colonoscopy will be assessed using a self-reported scale.	6-month follow-up	No
Secondary	Behavioral Intention relating to colon cancer screening	Behavioral intention to screen for colon cancer will be assessed using a self-reported scale.	6-month follow-up	No
Secondary	Social Influence relating to colon cancer screening	Social influence relating to colon cancer screening will be assessed using a self-reported questionnaire.	6-month follow-up	No