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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
Blood Pressure; Colorectal Cancer	Behavioral: Motivational Interviewing; Behavioral: Patient Navigation	Not Applicable

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 Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	451 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Screening
Official Title:	Faith-based Approaches to Treating Hypertension and Colon Cancer Prevention
Study Start Date :	March 2011
Actual Primary Completion Date :	June 2015
Actual Study Completion Date :	June 2015

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Experimental: 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.	Behavioral: Motivational Interviewing; One-on-one client-centered counseling for lifestyle changes related to blood pressure control
Experimental: Patient Navigation; The use of a patient navigation intervention to guide participants through the process of getting screened for colorectal cancer.	Behavioral: Patient Navigation; One-on-one navigation to guide participants through the process of being screened for colorectal cancer.
Experimental: PLUS; This group receives both the motivational interviewing intervention and the patient navigation intervention.	Behavioral: Motivational Interviewing; One-on-one client-centered counseling for lifestyle changes related to blood pressure control Behavioral: Patient Navigation; One-on-one navigation to guide participants through the process of being screened for colorectal cancer.

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Blood Pressure [ Time Frame: 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.
2. Colorectal Cancer Screening [ Time Frame: 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.

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	50 Years and older (Adult, Senior)
Sexes Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

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).

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

United States, New York
New York University School of Medicine
New York, New York, United States, 10010

Sponsors and Collaborators

New York University School of Medicine

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

Principal Investigator:	Joseph Ravenell, MD, MS	New York University School of Medicine

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	New York University School of Medicine
ClinicalTrials.gov Identifier:	NCT01405638 History of Changes
Other Study ID Numbers:	10-00427; 1R01HL096946-01A2 ( U.S. NIH Grant/Contract )
First Posted:	July 29, 2011
Last Update Posted:	November 13, 2015
Last Verified:	November 2015

Additional relevant MeSH terms:

Hypertension; Colorectal Neoplasms; Colonic Neoplasms; Vascular Diseases; Cardiovascular Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms	Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases