Faith-based Approaches to Treating Hypertension and Colon Cancer Prevention (FAITH-CRC)

NYU Langone Health

Status: Completed

Conditions: Blood Pressure; Colorectal Cancer

Treatments: Behavioral: Patient Navigation; Behavioral: Motivational Interviewing

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01405638

10-00427

1R01HL096946-01A2 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 451 patients

Sex: Male

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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451 participants in 3 patient groups

Motivational Interviewing

Experimental group

Description:

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.

Treatment:

Behavioral: Motivational Interviewing

Patient Navigation

Experimental group

Description:

The use of a patient navigation intervention to guide participants through the process of getting screened for colorectal cancer.

Treatment:

Behavioral: Patient Navigation

PLUS

Experimental group

Description:

This group receives both the motivational interviewing intervention and the patient navigation intervention.

Treatment:

Behavioral: Motivational Interviewing

Behavioral: Patient Navigation