- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01092078
Community-based Approaches to Treating Hypertension and Colon Cancer Prevention (MISTER-B)
20. april 2015 opdateret af: Joseph E. Ravenell, MD, MS, NYU Langone Health
Black men constitute the demographic group with the greatest burden of premature death and disability from hypertension (HTN) in the United States.
But while the disproportionately high rate of hypertension-related morbidity and mortality is well documented, the epidemic of colorectal cancer (CRC) among black men is comparatively under-appreciated.
For example, CRC is a leading cause of cancer death in black men with a death rate 50% higher than in white men.
Low rates of screening for CRC in this population contribute significantly to this problem.
The purpose of this randomized controlled trial (RCT) is 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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
740
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
New York
-
New York, New York, Forenede Stater, 10010
- NYU School of Medicine
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
50 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Han
Beskrivelse
Inclusion Criteria:
- Participants must be age 50 years or older,
- Self-identify as a black or African American male,
- Have uncontrolled hypertension as defined by systolic blood pressure (SBP) > 135 mmHg or diastolic blood pressure (DBP) > 85 mmHg and SBP > 130 or DBP > 80 mmHg (in those with diabetes at the screening).
Exclusion Criteria:
1. Inability to comply with the study protocol (either self-selected or by indicating during screening that he could not complete all requested tasks).
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: Motivational Interviewing
Individuals in the motivational interviewing (MINT) arm of the study will receive telephone-based lifestyle interviewing for 6-months.
Counseling will be aimed at modifying diet and/or physical activity behaviors associated with decreasing blood pressure.
|
Motivational interviewing for lifestyle changes associated with treating hypertension
|
Eksperimentel: Patient Navigation
Participants in the patient navigation arm will receive patient navigation for colonoscopy.
|
Patient navigation for colonoscopy.
|
Eksperimentel: PLUS
Both patient navigation for colorectal cancer screening and motivational interviewing for blood pressure control
|
Motivational interviewing for lifestyle changes associated with treating hypertension
Patient navigation for colonoscopy.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Blood Pressure
Tidsramme: Outcome is measured at 6-month follow-up
|
Three blood pressure measures and the average of the three measures will be obtained at baseline and 6-month follow-up using a Welch Allyn Vital Signs automated blood pressure monitor.
|
Outcome is measured at 6-month follow-up
|
Colon Cancer Screening Behavior
Tidsramme: The outcome will be measured at 6-month follow-up
|
Whether or not the participant was screened for colon cancer between baseline and 6-month follow-up will be assessed using self-report and patient medical records.
|
The outcome will be measured at 6-month follow-up
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Medication Adherence
Tidsramme: 6-month follow-up
|
Medication adherence will be assessed using the 4-item Morisky Medication Adherence scale.
|
6-month follow-up
|
Physical Activity
Tidsramme: 6-month follow-up
|
Physical activity will be measured using the International Physical Activity Questionnaire (IPAQ).
|
6-month follow-up
|
Intrinsic Motivation to Exercise
Tidsramme: 6-month Follow-up
|
Intrinsic motivation will be assessed using a 17-item questionnaire.
|
6-month Follow-up
|
Self-Efficacy (Exercise)
Tidsramme: 6-month follow-up
|
Self-efficacy related to exercise will be measured using a 12-iten questionnaire.
|
6-month follow-up
|
Dietary Intake
Tidsramme: 6-month follow-up
|
Dietary intake will be assessed using the Food Frequency Questionnaire.
|
6-month follow-up
|
Intrinsic Motivation (Diet)
Tidsramme: 6-month follow-up
|
Intrinsic motivation relating to diet will be assessed using a 17-item scale.
|
6-month follow-up
|
Self-efficacy (Diet)
Tidsramme: 6-month follow-up
|
Self-efficacy relating to diet will be assessed using a 10-item scale.
|
6-month follow-up
|
Facilitators and Barriers to obtaining a colonoscopy
Tidsramme: 6-month follow-up
|
Facilitators and barriers to obtaining a colonoscopy will be assessed using a self-reported scale.
|
6-month follow-up
|
Behavioral Intention relating to colon cancer screening
Tidsramme: 6-month follow-up
|
Behavioral intention to screen for colon cancer will be assessed using a self-reported scale.
|
6-month follow-up
|
Social Influence relating to colon cancer screening
Tidsramme: 6-month follow-up
|
Social influence relating to colon cancer screening will be assessed using a self-reported questionnaire.
|
6-month follow-up
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Joseph Ravenell, MD, MS, NYU School of Medicine
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- Ravenell J, Thompson H, Cole H, Plumhoff J, Cobb G, Afolabi L, Boutin-Foster C, Wells M, Scott M, Ogedegbe G. A novel community-based study to address disparities in hypertension and colorectal cancer: a study protocol for a randomized control trial. Trials. 2013 Sep 8;14:287. doi: 10.1186/1745-6215-14-287.
- Cole H, Thompson HS, White M, Browne R, Trinh-Shevrin C, Braithwaite S, Fiscella K, Boutin-Foster C, Ravenell J. Community-Based, Preclinical Patient Navigation for Colorectal Cancer Screening Among Older Black Men Recruited From Barbershops: The MISTER B Trial. Am J Public Health. 2017 Sep;107(9):1433-1440. doi: 10.2105/AJPH.2017.303885. Epub 2017 Jul 20.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. maj 2010
Primær færdiggørelse (Faktiske)
1. maj 2014
Studieafslutning (Faktiske)
1. maj 2014
Datoer for studieregistrering
Først indsendt
18. marts 2010
Først indsendt, der opfyldte QC-kriterier
23. marts 2010
Først opslået (Skøn)
24. marts 2010
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
22. april 2015
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
20. april 2015
Sidst verificeret
1. april 2015
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 09-0151
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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