Faith-based Approaches to Treating Hypertension and Colon Cancer Prevention (FAITH-CRC)
This study is currently recruiting participants.
Verified March 2013 by New York University School of Medicine
Sponsor:
New York University School of Medicine
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: March 12, 2013
Last verified: March 2013
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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:
- 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.
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: | December 2014 (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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01405638
Contacts
| Contact: Helen V Cole, MPH | 212-263-4251 | helen.cole@nyumc.org |
| Contact: Jordan Plumhoff, MA | 212-263-4993 | jordan.plumhoff@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: | March 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 May 19, 2013