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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01405638
First Posted: July 29, 2011
Last Update Posted: November 13, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
New York University School of Medicine
July 27, 2011
July 29, 2011
November 13, 2015
March 2011
June 2015   (Final data collection date for primary outcome measure)
  • 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.
  • 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.
Same as current
Complete list of historical versions of study NCT01405638 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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.
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
  • Blood Pressure
  • Colorectal Cancer
  • 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.
 
Completed
451
June 2015
June 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).
Sexes Eligible for Study: Male
50 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01405638
10-00427
1R01HL096946-01A2 ( U.S. NIH Grant/Contract )
Yes
Not Provided
Not Provided
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 2015

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