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

July 27, 2011
November 12, 2013
March 2011
May 2015   (final data collection date for primary outcome measure)
  • 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.
Same as current
Complete list of historical versions of study NCT01405638 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Faith-based Approaches to Treating Hypertension and Colon Cancer Prevention
Faith-based Approaches to Treating Hypertension and Colon Cancer Prevention

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.

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Interventional
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Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Screening
  • Blood Pressure
  • Colorectal Cancer Screening
  • 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.
  • 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.
    Intervention: Behavioral: Motivational Interviewing
  • Experimental: Patient Navigation
    The use of a patient navigation intervention to guide participants through the process of getting screened for colorectal cancer.
    Intervention: Behavioral: Patient Navigation
  • Experimental: PLUS
    This group receives both the motivational interviewing intervention and the patient navigation intervention.
    Interventions:
    • Behavioral: Motivational Interviewing
    • Behavioral: Patient Navigation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
720
June 2015
May 2015   (final data collection date for primary outcome measure)

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).
Male
50 Years and older
No
Contact: Helen V Cole, MPH 646-501-2593 helen.cole@nyumc.org
Contact: Tania Bouzy, MPH 646-501-2609 tania.bouzy@nyumc.org
United States
 
NCT01405638
10-00427, 1R01HL096946-01A2
No
Joseph E. Ravenell, MD, MS, New York University School of Medicine
New York University School of Medicine
National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigator: Joseph Ravenell, MD, MS New York University School of Medicine
New York University School of Medicine
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP