Faith-based Approaches to Treating Hypertension and Colon Cancer Prevention

NCT01405638 | Completed DMC

• 2 other identifiers: 10-004271R01HL096946-01A2
• Study Type: interventional
• Target: 451
• Locations: 1 country
• Sites: 1

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:

1. 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. 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.

Conditions

Blood Pressure; Colorectal Cancer

Outcome Measures

Primary Outcomes (2)

• Blood Pressure

  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.

  6-months

• Colorectal Cancer Screening

  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.

  6M

Study Arms (3)

Motivational Interviewing

EXPERIMENTAL

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

Patient Navigation

EXPERIMENTAL

The use of a patient navigation intervention to guide participants through the process of getting screened for colorectal cancer.

Behavioral: Patient Navigation

PLUS

EXPERIMENTAL

This group receives both the motivational interviewing intervention and the patient navigation intervention.

Behavioral: Motivational Interviewing; Behavioral: Patient Navigation

Interventions

Motivational Interviewing BEHAVIORAL

One-on-one client-centered counseling for lifestyle changes related to blood pressure control

Motivational Interviewing; PLUS

Patient Navigation BEHAVIORAL

One-on-one navigation to guide participants through the process of being screened for colorectal cancer.

PLUS; Patient Navigation

Eligibility Criteria

• Age: 50 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Inability to comply with the study protocol (either self-selected or by indicating during screening that he could not complete all requested tasks).

Sponsors & Collaborators

• NYU Langone Health: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

New York University School of Medicine

New York, New York, 10010, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Motivational Interviewing; Patient Navigation

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Directive Counseling; Counseling; Mental Health Services; Behavioral Disciplines and Activities; Health Services; Health Care Facilities Workforce and Services; Patient-Centered Care; Primary Health Care; Comprehensive Health Care; Patient Care Management; Health Services Administration

Study Officials

• Joseph Ravenell, MD, MS

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2011
• First Posted: July 29, 2011
• Study Start: March 1, 2011
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: November 13, 2015

Record last verified: 2015-11

Locations

US (1)