Faith-based Approaches to Treating Hypertension and Colon Cancer Prevention

Not Applicable

Completed

• Conditions: Colorectal Cancer; Blood Pressure
• Interventions: Behavioral: Patient Navigation; Behavioral: Motivational Interviewing

• Registration Number: NCT01405638
• Lead Sponsor: NYU Langone Health

Brief Summary

Primary Aim: 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.

Hypotheses: Among black men, aged \> 50 years with uncontrolled HTN and in need of CRC screening:

1. Hyp. 1: those randomized to the lifestyle intervention will have lower BP compared to those randomized to the patient navigation intervention at 6 months.

2. Hyp. 2: those randomized to the patient navigation intervention will have higher CRC screening rates compared to those randomized to the lifestyle intervention at 6 months.

Detailed Description

The primary outcomes will be (1) within-patient change in systolic and diastolic BP from baseline to 6 months and (2) CRC screening rates as determined by colonoscopy report or fecal immunochemical test (FIT) result from the primary care provider at 6 months. Blood pressure will be assessed with an automated digital BP monitor based on American Heart Association guidelines.1 CRC screening will be assessed by self-report and verified with medical records and/or the actual colonoscopy or FIT report from participants' providers.

Study Timeline

• Study Start: 2011-03
• Study First Submitted: 2011-07-27
• Study First Submitted QC: 2011-07-28
• Study First Posted: 2011-07-29
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-11
• Last Update Posted: 2015-11-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 451

Inclusion Criteria

• Participants must be age 50 years or older
• Participants must have a working telephone (a necessary criterion since much of the interventions are telephone based)
• Self-identified as a black or African American and male
• Have uncontrolled hypertension defined as SBP>135 mmHg or DBP>85 mmHg and SBP >130 mmHg or DBP >80 mmHg (in those with diabetes) at the screening
• Have a need for CRC screening defined as: 1) no colonoscopy in the last 10 years; 2) no Flexible sigmoidoscopy, Digital Contrast Barium Enema or CT-colonoscopy in the last 5 years, or 3) no Fecal Immunochemical Test or Fecal Occult Blood Test in the last 12 months.
• All participants must be fluent in English. Certain measures used have not been verified in other languages.

Exclusion Criteria

• 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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patient Navigation	Patient Navigation	The use of a patient navigation intervention to guide participants through the process of getting screened for colorectal cancer.
PLUS	Motivational Interviewing	This group receives both the motivational interviewing intervention and the patient navigation intervention.
PLUS	Patient Navigation	This group receives both the motivational interviewing intervention and the patient navigation intervention.
Motivational Interviewing	Motivational Interviewing	The use of a one-on-one motivational interviewing counseling intervention, 4 visits over 5 months, focusing on changes to behavior related to blood pressure control.

Primary Outcome Measures

Name	Time	Method
Blood Pressure	6-months	The primary outcomes will be (1) within-patient change in systolic and diastolic BP from baseline to 6 months and (2) CRC screening rates as determined by colonoscopy report or fecal immunochemical test (FIT) result from the primary care provider at 6 months. Blood pressure will be assessed with an automated digital BP monitor based on American Heart Association guidelines.1 CRC screening will be assessed by self-report and verified with medical records and/or the actual colonoscopy or FIT report from participants' providers.
Colorectal Cancer Screening	6M	The primary outcomes will be (1) within-patient change in systolic and diastolic BP from baseline to 6 months and (2) CRC screening rates as determined by colonoscopy report or fecal immunochemical test (FIT) result from the primary care provider at 6 months. Blood pressure will be assessed with an automated digital BP monitor based on American Heart Association guidelines.1 CRC screening will be assessed by self-report and verified with medical records and/or the actual colonoscopy or FIT report from participants' providers.

Trial Locations

Locations (1)

New York University School of Medicine; 🇺🇸 New York, New York, United States