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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by New York University School of Medicine
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Joseph E. Ravenell, MD, MS, New York University School of Medicine
ClinicalTrials.gov Identifier:
NCT01405638
First received: July 27, 2011
Last updated: November 12, 2013
Last verified: November 2013
  Purpose

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.

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.


Condition Intervention
Blood Pressure
Colorectal Cancer Screening
Behavioral: Motivational Interviewing
Behavioral: Patient Navigation

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Screening
Official Title: Faith-based Approaches to Treating Hypertension and Colon Cancer Prevention

Resource links provided by NLM:


Further study details as provided by New York University School of Medicine:

Primary Outcome Measures:
  • Blood Pressure [ Time Frame: 6-months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 6M ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 720
Study Start Date: March 2011
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01405638

Contacts
Contact: Helen V Cole, MPH 646-501-2593 helen.cole@nyumc.org
Contact: Tania Bouzy, MPH 646-501-2609 tania.bouzy@nyumc.org

Locations
United States, New York
New York University School of Medicine Recruiting
New York, New York, United States, 10010
Contact: Joseph Ravenell, MD, MS    212-263-4243    joseph.ravenell@nyumc.org   
Sub-Investigator: Hayley Thompson, PhD         
Sponsors and Collaborators
New York University School of Medicine
Investigators
Principal Investigator: Joseph Ravenell, MD, MS New York University School of Medicine
  More Information

No publications provided

Responsible Party: Joseph E. Ravenell, MD, MS, Assistant Professor, New York University School of Medicine
ClinicalTrials.gov Identifier: NCT01405638     History of Changes
Other Study ID Numbers: 10-00427, 1R01HL096946-01A2
Study First Received: July 27, 2011
Last Updated: November 12, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Colonic Neoplasms
Colorectal Neoplasms
Hypertension
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 01, 2014