A novel community-based study to address disparities in hypertension and colorectal cancer: A study protocol for a randomized control trial

Trials

Volumn 14, Issue 1, 2013, Pages

  Ravenell, Joseph ^a   Thompson, Hayley ^b   Cole, Helen ^a   Plumhoff, Jordan ^a   Cobb, Gia ^a   Afolabi, Lola ^c   Boutin Foster, Carla ^d   Wells, Martin ^e   Scott, Marian ^f   Ogedegbe, Gbenga ^a  

^a NEW YORK UNIVERSITY SCHOOL OF MEDICINE   (United States)

^b KARMANOS CANCER INSTITUTE   (United States)

^c Formerly with the Center for Healthful Behavior Change   (United States)

^d Cornell University ^*  (United States)

^e Department of Obstetrics Gynecology   (United States)

^f ST LUKE S ROOSEVELT HOSPITAL CENTER   (United States)

Author keywords

African Americans; Barbershops; Hypertension; Patient navigation

Indexed keywords

ADULT; ARTICLE; BLOOD PRESSURE REGULATION; CANCER SCREENING; COLORECTAL CANCER; COMMUNITY PROGRAM; COMPARATIVE EFFECTIVENESS; CONTROLLED STUDY; DIASTOLIC BLOOD PRESSURE; HEALTH AUXILIARY; HEALTH CARE DISPARITY; HUMAN; HYPERTENSION; INTERMETHOD COMPARISON; INTERVENTION STUDY; LIFESTYLE MODIFICATION; MAJOR CLINICAL STUDY; MALE; MOTIVATIONAL INTERVIEWING; NEGRO; PATIENT CARE; RANDOMIZED CONTROLLED TRIAL; STUDY DESIGN; SYSTOLIC BLOOD PRESSURE;

AFRICAN AMERICANS; AGE FACTORS; BARBERING; BLOOD PRESSURE; CLINICAL PROTOCOLS; COLORECTAL NEOPLASMS; COMMUNITY HEALTH SERVICES; CULTURAL CHARACTERISTICS; EARLY DETECTION OF CANCER; HEALTH KNOWLEDGE, ATTITUDES, PRACTICE; HEALTH PROMOTION; HEALTH STATUS DISPARITIES; HEALTHCARE DISPARITIES; HUMANS; HYPERTENSION; MALE; MIDDLE AGED; MOTIVATIONAL INTERVIEWING; NEW YORK CITY; PATIENT NAVIGATION; PATIENT SELECTION; PREDICTIVE VALUE OF TESTS; RESEARCH DESIGN; RISK FACTORS; RISK REDUCTION BEHAVIOR; SEX FACTORS; TIME FACTORS; TREATMENT OUTCOME;

EID: 84883540930     PISSN: None     EISSN: 17456215     Source Type: Journal    
DOI: 10.1186/1745-6215-14-287     Document Type: Article

References (66)

1. Mensah GA, Dunbar SB. A framework for addressing disparities in cardiovascular health. J Cardiovasc Nurs 2006, 21:451-456. 10.1097/00005082-200611000-00007, 17293734.
2. Wong MD, Shapiro MF, Boscardin WJ, Ettner SL. Contribution of major diseases to disparities in mortality. N Engl J Med 2002, 347:1585-1592. 10.1056/NEJMsa012979, 12432046.
3. Effects of weight loss and sodium reduction intervention on blood pressure and hypertension incidence in overweight people with high-normal blood pressure. The Trials of Hypertension Prevention, phase II. The Trials of Hypertension Prevention Collaborative Research Group. Arch Intern Med 1997, 157:657-667.
4. Appel LJ, Champagne CM, Harsha DW, Cooper LS, Obarzanek E, Elmer PJ, Stevens VJ, Vollmer WM, Lin PH, Svetkey LP, Stedman SW, Young DR, Writing Group of the PREMIER Collaborative Research Group Effects of comprehensive lifestyle modification on blood pressure control: main results of the PREMIER clinical trial. JAMA 2003, 289:2083-2093. Writing Group of the PREMIER Collaborative Research Group.
5. Appel LJ, Espeland MA, Easter L, Wilson AC, Folmar S, Lacy CR. Effects of reduced sodium intake on hypertension control in older individuals: results from the trial of nonpharmacologic interventions in the elderly (TONE). Arch Intern Med 2001, 161:685-693. 10.1001/archinte.161.5.685, 11231700.
6. Appel LJ, Moore TJ, Obarzanek E, Vollmer WM, Svetkey LP, Sacks FM, Bray GA, Vogt TM, Cutler JA, Windhauser MM, Lin PH, Karanja N. A clinical trial of the effects of dietary patterns on blood pressure. DASH Collaborative Research Group. N Engl J Med 1997, 336:1117-1124. 10.1056/NEJM199704173361601, 9099655.
7. Elmer PJ, Obarzanek E, Vollmer WM, Simons-Morton D, Stevens VJ, Young DR, Lin PH, Champagne C, Harsha DW, Svetkey LP, Ard J, Brantley PJ, Proschan MA, Erlinger TP, Appel LJ, PREMIER Collaborative Research Group Effects of comprehensive lifestyle modification on diet, weight, physical fitness, and blood pressure control: 18-month results of a randomized trial. Ann Intern Med 2006, 144:485-495. 10.7326/0003-4819-144-7-200604040-00007, 16585662, PREMIER Collaborative Research Group.
8. Stamler R, Stamler J, Grimm R, Gosch FC, Elmer P, Dyer A, Berman R, Fishman J, Van Heel N, Civinelli J, et al. Nutritional therapy for high blood pressure. Final report of a four-year randomized controlled trial--the Hypertension Control Program. JAMA 1987, 257:1484-1491. 10.1001/jama.1987.03390110060027, 3546747.
9. Stevens VJ, Obarzanek E, Cook NR, Lee IM, Appel LJ, Smith West D, Milas NC, Mattfeldt-Beman M, Belden L, Bragg C, Millstone M, Raczynski J, Brewer A, Singh B, Cohen J, Trials for the Hypertension Prevention Research Group Long-term weight loss and changes in blood pressure: results of the trials of hypertension prevention, phase II. Ann Intern Med 2001, 134:1-11. 10.7326/0003-4819-134-1-200101020-00007, 11187414, Trials for the Hypertension Prevention Research Group.
10. Svetkey LP, Erlinger TP, Vollmer WM, Feldstein A, Cooper LS, Appel LJ, Ard JD, Elmer PJ, Harsha D, Stevens VJ. Effect of lifestyle modifications on blood pressure by race, sex, hypertension status, and age. J Hum Hypertens 2005, 19:21-31. 10.1038/sj.jhh.1001770, 15385946.
11. Whelton PK, Appel LJ, Espeland MA, Applegate WB, Ettinger WH, Kostis JB, Kumanyika S, Lacy CR, Johnson KC, Folmar S, Cutler JA. Sodium reduction and weight loss in the treatment of hypertension in older persons: a randomized controlled trial of nonpharmacologic interventions in the elderly (TONE). TONE collaborative research group. JAMA 1998, 279:839-846. 10.1001/jama.279.11.839, 9515998.
12. Jehn ML, Patt MR, Appel LJ, Miller ER. One year follow-up of overweight and obese hypertensive adults following intensive lifestyle therapy. J Hum Nutr Diet 2006, 19:349-354. 10.1111/j.1365-277X.2006.00711.x, 16961681.
13. Kumanyika SK, Cook NR, Cutler JA, Belden L, Brewer A, Cohen JD, Hebert PR, Lasser VI, Raines J, Raczynski J, Shepek L, Diller L, Whelton PK, Yamamoto M, Trials of Hypertension Prevention Collaborative Research Group Sodium reduction for hypertension prevention in overweight adults: further results from the trials of hypertension prevention phase II. J Hum Hypertens 2005, 19:33-45. 10.1038/sj.jhh.1001774, 15372064, Trials of Hypertension Prevention Collaborative Research Group.
14. Miller ER, Erlinger TP, Young DR, Jehn M, Charleston J, Rhodes D, Wasan SK, Appel LJ. Results of the diet, exercise, and weight loss intervention trial (DEW-IT). Hypertension 2002, 40:612-618. 10.1161/01.HYP.0000037217.96002.8E, 12411452.
15. Chobanian AV, Bakris GL, Black HR, Cushman WC, Green LA, Izzo JL, Jones DW, Materson BJ, Oparil S, Wright JT, Roccella EJ, National Heart, Lung, and Blood Institute Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure; National High Blood Pressure Education Program Coordinating Committee The Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment Of High Blood Pressure: the JNC 7 report. JAMA 2003, 289:2560-2572. 10.1001/jama.289.19.2560, 12748199, National Heart, Lung, and Blood Institute Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure; National High Blood Pressure Education Program Coordinating Committee.
16. Roger VL, Go AS, Lloyd-Jones DM, Benjamin EJ, Berry JD, Borden WB, Bravata DM, Dai S, Ford ES, Fox CS, Fullerton HJ, Gillespie C, Hailpern SM, Heit JA, Howard VJ, Kissela BM, Kittner SJ, Lackland DT, Lichtman JH, Lisabeth LD, Makuc DM, Marcus GM, Marelli A, Matchar DB, Moy CS, Mozaffarian D, Mussolino ME, Nichol G, Paynter NP, Soliman EZ, et al. Heart disease and stroke statistics-2012 update: a report from the American Heart Association. Circulation 2012, 125:e2-e220. Erratum in: Circulation 2012, 125:e1002.
17. U.S. Cancer Statistics Working Group United States Cancer Statistics: 1999-2009 Incidence and Mortality Web-Based Report 2013, Atlanta, GA: Department of Health and Human Services, Centers for Disease Control and Prevention and National Cancer Institute, U.S. Cancer Statistics Working Group.
18. Society American Cancer Cancer Facts & Figures for African Americans 2011-2012 2011, Atlanta, GA: American Cancer Society, Society American Cancer.
19. Centers for Disease Control and Prevention (CDC) Cancer screening- United States, 2010. MMWR Morb Mortal Wkly Rep 2012, 61(3):41-58. Centers for Disease Control and Prevention (CDC).
20. American Cancer Society Colorectal Cancer Facts & Figures 2011-2012 2011, Atlanta, GA: American Cancer Society, American Cancer Society.
21. Lewis CL, Brenner AT, Griffith JM, Pignone MP. The uptake and effect of a mailed multi-modal colon cancer screening intervention: a pilot controlled trial. Implement Sci 2008, 3:32. 10.1186/1748-5908-3-32, 2427049, 18518990.
22. Denberg TD, Coombes JM, Byers TE, Marcus AC, Feinberg LE, Steiner JF, Ahnen DJ. Effect of a mailed brochure on appointment-keeping for screening colonoscopy: a randomized trial. Ann Intern Med 2006, 145:895-900. 10.7326/0003-4819-145-12-200612190-00006, 17179058.
23. Basch CE, Wolf RL, Brouse CH, Shmukler C, Neugut A, DeCarlo LT, Shea S. Telephone outreach to increase colorectal cancer screening in an urban minority population. Am J Public Health 2006, 96:2246-2253. 10.2105/AJPH.2005.067223, 1698159, 17077394.
24. The National Cancer Institute The NCI Strategic Plan for Leading the Nation to Eliminate the Suffering and Death Due to Cancer 2006, Bethesda, MD: National Cancer Institute, The National Cancer Institute.
25. Nash D, Azeez S, Vlahov D, Schori M. Evaluation of an intervention to increase screening colonoscopy in an urban public hospital setting. J Urban Health 2006, 83:231-243. 10.1007/s11524-006-9029-6, 2527164, 16736372.
26. Chen LA, Santos S, Jandorf L, Christie J, Castillo A, Winkel G, Itzkowitz S. A program to enhance completion of screening colonoscopy among urban minorities. Clin Gastroenterol Hepatol 2008, 6:443-450. 10.1016/j.cgh.2007.12.009, 18304882.
27. Christie J, Itzkowitz S, Lihau-Nkanza I, Castillo A, Redd W, Jandorf L. A randomized controlled trial using patient navigation to increase colonoscopy screening among low-income minorities. J Natl Med Assoc 2008, 100:278-284.
28. Dohan D, Schrag D. Using navigators to improve care of underserved patients: current practices and approaches. Cancer 2005, 104:848-855. 10.1002/cncr.21214, 16010658.
29. Ell K, Vourlekis B, Lee PJ, Xie B. Patient navigation and case management following an abnormal mammogram: a randomized clinical trial. Prev Med 2007, 44:26-33. 10.1016/j.ypmed.2006.08.001, 16962652.
30. Ferrante JM, Chen PH, Kim S. The effect of patient navigation on time to diagnosis, anxiety, and satisfaction in urban minority women with abnormal mammograms: a randomized controlled trial. J Urban Health 2008, 85:114-124. 10.1007/s11524-007-9228-9, 2430139, 17906931.
31. Freeman HP, Muth BJ, Kerner JF. Expanding access to cancer screening and clinical follow-up among the medically underserved. Cancer Pract 1995, 3:19-30.
32. Jandorf L, Gutierrez Y, Lopez J, Christie J, Itzkowitz SH. Use of a patient navigator to increase colorectal cancer screening in an urban neighborhood health clinic. J Urban Health 2005, 82:216-224. 10.1093/jurban/jti046, 3456577, 15888638.
33. Murphy M. Barbershop Talk: the Other Side of Black Men 1998, Merrifield, VA: Murphy Communicatons.
34. Mitka M. Efforts needed to foster participation of blacks in stroke studies. JAMA 2004, 291:1311-1312.
35. Kong BW. Community-based hypertension control programs that work. J Health Care Poor Underserved 1997, 8:409-415. 10.1353/hpu.2010.0031, 9334533.
36. Ferdinand KC. The healthy heart community prevention project: a model for primary cardiovascular risk reduction in the African-American population. J Natl Med Assoc 1995, 87:638-641. 2607934, 7674364.
37. Ferdinand KC. Lessons learned from the healthy heart community prevention project in reaching the African American population. J Health Care Poor Underserved 1997, 8:366-371. discussion 371-362, 10.1353/hpu.2010.0580, 9253228.
38. Victor RG, Ravenell JE, Freeman A, Leonard D, Bhat DG, Shafiq M, Knowles P, Storm JS, Adhikari E, Bibbins-Domingo K, Coxson PG, Pletcher MJ, Hannan P, Haley RW. Effectiveness of a barber-based intervention for improving hypertension control in black men: the BARBER-1 study: a cluster randomized trial. Arch Intern Med 2011, 171:342-350. 10.1001/archinternmed.2010.390, 3365537, 20975012.
39. Hess PL, Reingold JS, Jones J, Fellman MA, Knowles P, Ravenell JE, Kim S, Raju J, Ruger E, Clark S, Okoro C, Ogunji O, Knowles P, Leonard D, Wilson RP, Haley RW, Ferdinand KC, Freeman A, Victor RG. Barbershops as hypertension detection, referral, and follow-up centers for black men. Hypertension 2007, 49:1040-1046. 10.1161/HYPERTENSIONAHA.106.080432, 17404187.
40. Rollnick SM. What is motivational interviewing?. Behav Cogn Psychother 1995, 23:10.
41. Miller WR. Motivational Interviewing: Preparing People for Change 1991, New York: Guilford Press.
42. Resnicow K, Jackson A, Blissett D, Wang T, McCarty F, Rahotep S, Periasamy S. Results of the healthy body healthy spirit trial. Health Psychol 2005, 24:339-348.
43. Resnicow K, Jackson A, Wang T, De AK, McCarty F, Dudley WN, Baranowski T. A motivational interviewing intervention to increase fruit and vegetable intake through black churches: results of the Eat for life trial. Am J Public Health 2001, 91:1686-1693. 10.2105/AJPH.91.10.1686, 1446855, 11574336.
44. Resnicow K, Campbell M, Carr C, McCarty F, Wang T, Periasamy S, Rehotep S, Doyle C, Williams A, Stables G. Body and soul: a dietary intervention conducted through African-American churches. Am J Prev Med 2004, 27:97-105. 10.1016/j.amepre.2004.04.009, 15261895.
45. Campbell MK, Demark-Wahnefried W, Symons M, Kalsbeek WD, Dodds J, Cowan A, Jackson B, Motsinger B, Hoben K, Lashley J, Demissie S, McClelland JW. Fruit and vegetable consumption and prevention of cancer: the Black Churches United for Better Health Project. Am J Public Health 1999, 89:1390-1396. 10.2105/AJPH.89.9.1390, 1508774, 10474558.
46. DeHaven MJ, Hunter IB, Wilder L, Walton JW, Berry J. Health programs in faith-based organizations: are they effective?. Am J Public Health 2004, 94:1030-1036. 10.2105/AJPH.94.6.1030, 1448385, 15249311.
47. Ogedegbe G, Chaplin W, Schoenthaler A, Statman D, Berger D, Richardson T, Phillips E, Spencer J, Allegrante JP. A practice-based trial of motivational interviewing and adherence in hypertensive African Americans. Am J Hypertens 2008, 21:1137-1143. 10.1038/ajh.2008.240, 3747638, 18654123.
48. Bellg AJ, Borrelli B, Resnick B, Hecht J, Minicucci DS, Ory M, Ogedegbe G, Orwig D, Ernst D, Czajkowski S. Enhancing treatment fidelity in health behavior change studies: best practices and recommendations from the NIH behavior change consortium. Health Psychol 2004, 23:443-451.
49. Borrelli B, Sepinwall D, Ernst D, Bellg AJ, Czajkowski S, Breger R, DeFrancesco C, Levesque C, Sharp DL, Ogedegbe G, Resnick B, Orwig D. A new tool to assess treatment fidelity and evaluation of treatment fidelity across 10 years of health behavior research. J Consult Clin Psychol 2005, 73:852-860.
50. Madson MB, Campbell TC, Barrett DE, Brondino MJ, Melchert TP. Development of the Motivational Interviewing Supervision and Training Scale. Psychol Addict Behav 2005, 19:303-310.
51. Moyers TB, Martin T, Manuel JK, Hendrickson SM, Miller WR. Assessing competence in the use of motivational interviewing. J Subst Abuse Treat 2005, 28:19-26. 10.1016/j.jsat.2004.11.001, 15723728.
52. New York City's Department of Health and Mental Hygiene Colonoscopy Patient Navigator Program Orientation Manual New York, NY: New York City's Department of Health and Mental Hygiene, New York City's Department of Health and Mental Hygiene.
53. Kreuter MW, Lukwago SN, Bucholtz RD, Clark EM, Sanders-Thompson V. Achieving cultural appropriateness in health promotion programs: targeted and tailored approaches. Health Educ Behav 2003, 30:133-146. 10.1177/1090198102251021, 12693519.
54. Herek GM, Gillis JR, Glunt EK, Lewis J, Welton D, Capitanio JP. Culturally sensitive AIDS educational videos for African American audiences: effects of source, message, receiver, and context. Am J Commun Psychol 1998, 26:705-743.
55. Matthews AK, Sanchez-Johnsen L, King A. Development of a culturally targeted smoking cessation intervention for African American smokers. J Commun Health 2009, 34:480-492.
56. Shaikh AR, Vinokur AD, Yaroch AL, Williams GC, Resnicow K. Direct and mediated effects of two theoretically based interventions to increase consumption of fruits and vegetables in the Healthy Body Healthy Spirit Trial. Health Educ Behav 2011, 38:492-501. 10.1177/1090198110384468, 21596903.
57. Wang JH, Schwartz MD, Brown RL, Maxwell AE, Lee MM, Adams IF, Mandelblatt JS. Results of a randomized controlled trial testing the efficacy of a culturally targeted and a generic video on mammography screening among Chinese-American immigrants. Cancer Epidemiol Biomarkers Prev 2012, 21:1923-1932. 10.1158/1055-9965.EPI-12-0821, 22971901.
58. Rex DK, Johnson DA, Lieberman DA, Burt RW, Sonnenberg A. Colorectal cancer prevention 2000: screening recommendations of the American College of Gastroenterology. American College of Gastroenterology. Am J Gastroenterol 2000, 95:868-877.
59. Shelton RC, Thompson HS, Jandorf L, Varela A, Oliveri B, Villagra C, Valdimarsdottir HB, Redd WH. Training experiences of lay and professional patient navigators for colorectal cancer screening. J Cancer Educ 2011, 26:277-284. 10.1007/s13187-010-0185-8, 3608460, 21287311.
60. Calhoun EA, Whitley EM, Esparza A, Ness E, Greene A, Garcia R, Valverde PA. A national patient navigator training program. Health Promot Pract 2010, 11:205-215. 10.1177/1524839908323521, 19116415.
61. Waltz J, Addis ME, Koerner K, Jacobson NS. Testing the integrity of a psychotherapy protocol: assessment of adherence and competence. J Consult Clin Psychol 1993, 61:620-630.
62. Perloff D, Grim C, Flack J, Frohlich ED, Hill M, McDonald M, Morgenstern BZ. Human blood pressure determination by sphygmomanometry. Circulation 1993, 88:2460-2470. 10.1161/01.CIR.88.5.2460, 8222141.
63. Elmer PJ, Grimm R, Laing B, Grandits G, Svendsen K, Van Heel N, Betz E, Raines J, Link M, Stamler J, et al. Lifestyle intervention: results of the Treatment of Mild Hypertension Study (TOMHS). Prev Med 1995, 24:378-388. 10.1006/pmed.1995.1062, 7479629.
64. Hsieh FY, Lavori PW, Cohen HJ, Feussner JR. An overview of variance inflation factors for sample-size calculation. Eval Health Prof 2003, 26:239-257. 10.1177/0163278703255230, 12971199.
65. Centers for Disease Control Behavioral Risk Factor Surveillance System Survey Data 2007, Atlanta, GA: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, Centers for Disease Control.
66. The R Development Core Team A Language and Environment for Statistical Computing 2006, Vienna: R Foundation for Statistical Computing, The R Development Core Team.