Faith-based Approaches to Treating Hypertension and Colon Cancer Prevention
NCT ID: NCT01405638
Last Updated: 2015-11-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
451 participants
INTERVENTIONAL
2011-03-31
2015-06-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SCREENING
NONE
Study Groups
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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.
Motivational Interviewing
One-on-one client-centered counseling for lifestyle changes related to blood pressure control
Patient Navigation
The use of a patient navigation intervention to guide participants through the process of getting screened for colorectal cancer.
Patient Navigation
One-on-one navigation to guide participants through the process of being screened for colorectal cancer.
PLUS
This group receives both the motivational interviewing intervention and the patient navigation intervention.
Motivational Interviewing
One-on-one client-centered counseling for lifestyle changes related to blood pressure control
Patient Navigation
One-on-one navigation to guide participants through the process of being screened for colorectal cancer.
Interventions
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Motivational Interviewing
One-on-one client-centered counseling for lifestyle changes related to blood pressure control
Patient Navigation
One-on-one navigation to guide participants through the process of being screened for colorectal cancer.
Eligibility Criteria
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Inclusion Criteria
* 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
50 Years
MALE
No
Sponsors
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National Heart, Lung, and Blood Institute (NHLBI)
NIH
NYU Langone Health
OTHER
Responsible Party
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Principal Investigators
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Joseph Ravenell, MD, MS
Role: PRINCIPAL_INVESTIGATOR
NYU Langone Health
Locations
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New York University School of Medicine
New York, New York, United States
Countries
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Other Identifiers
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10-00427
Identifier Type: -
Identifier Source: org_study_id
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