Faith-based Approaches to Treating Hypertension and Colon Cancer Prevention

Study 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.

Official Title
-----------------
Faith-based Approaches to Treating Hypertension and Colon Cancer Prevention

Conditions
-----------------
Blood Pressure, Colorectal Cancer

Intervention / Treatment
-----------------
* Behavioral: Motivational Interviewing
* Behavioral: Patient Navigation


Participation Criteria
=================
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).

Ages Eligible for Study
-----------------
Minimum Age: 50 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Motivational Interviewing<br>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<br>* One-on-one client-centered counseling for lifestyle changes related to blood pressure control<br>|
| Experimental: Patient Navigation<br>The use of a patient navigation intervention to guide participants through the process of getting screened for colorectal cancer. | Behavioral: Patient Navigation<br>* One-on-one navigation to guide participants through the process of being screened for colorectal cancer.<br>|
| Experimental: PLUS<br>This group receives both the motivational interviewing intervention and the patient navigation intervention. | Behavioral: Motivational Interviewing<br>* One-on-one client-centered counseling for lifestyle changes related to blood pressure control<br>Behavioral: Patient Navigation<br>* One-on-one navigation to guide participants through the process of being screened for colorectal cancer.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |