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Faith-based Approaches to Treating Hypertension and Colon Cancer Prevention


N/A
50 Years
N/A
Open (Enrolling)
Male
Blood Pressure, Colorectal Cancer Screening

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Trial Information

Faith-based Approaches to Treating Hypertension and Colon Cancer Prevention


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).

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Screening

Outcome Measure:

Blood Pressure

Outcome 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.

Outcome Time Frame:

6-months

Safety Issue:

No

Principal Investigator

Joseph Ravenell, MD, MS

Investigator Role:

Principal Investigator

Investigator Affiliation:

New York University School of Medicine

Authority:

United States: Institutional Review Board

Study ID:

10-00427

NCT ID:

NCT01405638

Start Date:

March 2011

Completion Date:

June 2015

Related Keywords:

  • Blood Pressure
  • Colorectal Cancer Screening
  • Colonic Neoplasms
  • Colorectal Neoplasms
  • Hypertension

Name

Location
New York University School of Medicine New York, New York  10016