Faith-based Approaches to Treating Hypertension and Colon Cancer Prevention
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Blood Pressure
- Sponsor
- NYU Langone Health
- Enrollment
- 451
- Locations
- 1
- Primary Endpoint
- Blood Pressure
- Status
- Completed
- Last Updated
- 10 years ago
Overview
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.
Investigators
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).
Outcomes
Primary Outcomes
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.