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

Primary Purpose

Blood Pressure, Colorectal Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Motivational Interviewing
Patient Navigation
Sponsored by
NYU Langone Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Blood Pressure

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)MaleDoes not accept 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).

Sites / Locations

  • New York University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Motivational Interviewing

Patient Navigation

PLUS

Arm 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.

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

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

Outcomes

Primary Outcome Measures

Blood Pressure
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
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.

Secondary Outcome Measures

Full Information

First Posted
July 27, 2011
Last Updated
November 11, 2015
Sponsor
NYU Langone Health
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
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1. Study Identification

Unique Protocol Identification Number
NCT01405638
Brief Title
Faith-based Approaches to Treating Hypertension and Colon Cancer Prevention
Acronym
FAITH-CRC
Official Title
Faith-based Approaches to Treating Hypertension and Colon Cancer Prevention
Study Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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: Hyp. 1: those randomized to the lifestyle intervention will have lower BP compared to those randomized to the patient navigation intervention at 6 months. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Blood Pressure, Colorectal Cancer

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
451 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Motivational Interviewing
Arm Type
Experimental
Arm 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.
Arm Title
Patient Navigation
Arm Type
Experimental
Arm Description
The use of a patient navigation intervention to guide participants through the process of getting screened for colorectal cancer.
Arm Title
PLUS
Arm Type
Experimental
Arm Description
This group receives both the motivational interviewing intervention and the patient navigation intervention.
Intervention Type
Behavioral
Intervention Name(s)
Motivational Interviewing
Intervention Description
One-on-one client-centered counseling for lifestyle changes related to blood pressure control
Intervention Type
Behavioral
Intervention Name(s)
Patient Navigation
Intervention Description
One-on-one navigation to guide participants through the process of being screened for colorectal cancer.
Primary Outcome Measure Information:
Title
Blood Pressure
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.
Time Frame
6-months
Title
Colorectal Cancer Screening
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.
Time Frame
6M

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph Ravenell, MD, MS
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York University School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10010
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Faith-based Approaches to Treating Hypertension and Colon Cancer Prevention

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