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Faith-based Approaches to Treating Hypertension and Colon Cancer Prevention (FAITH-CRC)
This study has been completed.
Sponsor:
New York University School of Medicine
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
New York University School of Medicine
ClinicalTrials.gov Identifier:
NCT01405638
First received: July 27, 2011
Last updated: November 11, 2015
Last verified: November 2015
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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.
| Condition | Intervention |
|---|---|
| Blood Pressure Colorectal Cancer | 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 ]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.
| Enrollment: | 451 |
| Study Start Date: | March 2011 |
| Study Completion Date: | June 2015 |
| Primary Completion Date: | June 2015 (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.
|
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.
Eligibility| Ages Eligible for Study: | 50 Years and older (Adult, Senior) |
| Sexes 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01405638
Please refer to this study by its ClinicalTrials.gov identifier: NCT01405638
Locations
| United States, New York | |
| New York University School of Medicine | |
| New York, New York, United States, 10010 | |
Sponsors and Collaborators
New York University School of Medicine
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
| Principal Investigator: | Joseph Ravenell, MD, MS | New York University School of Medicine |
More Information
| Responsible Party: | New York University School of Medicine |
| ClinicalTrials.gov Identifier: | NCT01405638 History of Changes |
| Other Study ID Numbers: |
10-00427 1R01HL096946-01A2 ( US NIH Grant/Contract Award Number ) |
| Study First Received: | July 27, 2011 |
| Last Updated: | November 11, 2015 |
Additional relevant MeSH terms:
|
Hypertension Colorectal Neoplasms Colonic Neoplasms Vascular Diseases Cardiovascular Diseases Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms |
Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases |
ClinicalTrials.gov processed this record on June 23, 2017