Hypertension Clinical Trial
— CHAR2Official title:
Home Blood Pressure Monitoring Intervention for Self-Management of High Blood Pressure Among Alaska Native People
The investigators have designed a group randomized, multi-level, sustainable stroke and cardiovascular disease (CVD) prevention trial - "Blood Pressure: Improving Control among Alaska Native People" (BP-ICAN) - that targets blood pressure control among Alaska Native and American Indian people diagnosed with hypertension. Washington State University will assist with design, provides general scientific and clinical consulting, will help guide implementation and conduct statistical analyses. The purpose of the study is to see if monitoring blood pressure at home improves the management of hypertension. Participants will include adults who have a diagnosis of hypertension and have not achieved blood pressure control. During the pandemic, blood pressure control will be assessed during a week long study of home blood pressure readings. This study will include both a control arm (treatment as usual) and an intervention arm. Primary Care Center (PCC) provider teams and associated panels of Alaska Native or American Indian (ANAI) adults will be randomized into the control or intervention arm. The investigators will recruit up to 10 ANAI adults per PCC provider for a total of 324 participants. Intervention participants will receive a home blood pressure monitor (HBPM), upload personal home blood pressure values into a data mall, and be encouraged to communicate with providers and pharmacists about HBPM results using an online electronic health record application, telephone, or other existing clinical processes. HBPM measurements for each intervention arm participant will be provided to provider teams and integrated pharmacists. Control participants will receive care as usual. The investigators will collect data from study participants in both the intervention and control arms over a 12 month period. Participants will meet with investigators at time of consent (baseline), and 3, 6, and 12 months after baseline. At each visit, participants will have blood pressure measured using 3 methods (aneroid sphygmomanometer, automated Omron upper arm cuff device, and automated Omron wrist cuff device), complete surveys, and have height, weight, and arm circumference measured. In-person measures are omitted during the pandemic and only one method of blood pressure measurement is used (upper arm cuff device). Clinical and service utilization information will be electronically queried with participant consent. The investigators will examine whether participants in the intervention arm have better blood pressure control at the end of the 12 month period than participants in the control arm.
Status | Recruiting |
Enrollment | 324 |
Est. completion date | June 30, 2023 |
Est. primary completion date | January 31, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. At least one visit to SCF providers or Community Health Aides within the previous year 2. Alaska Native or American Indian 3. At least 18 years old 4. Meet one of the following two conditions: I. Hypertension diagnosis and 1 SBP >= 140 mmHg in past 24 months in EHR, AND 1. SBP >= 140 mmHg at research visit or from the mean of BP measures during the home screening period, OR 2. SBP 130-139 mmHg at research visit or from the mean of BP measures during the home screening period plus at least one comorbid condition as stated in AHA guidelines (cardiovascular disease, heart failure, stroke, atrial fibrillation, chronic kidney disease, kidney transplant, or diabetes) II. No hypertension diagnosis but 1 SBP >= 140 mmHg in past 18 months in EHR, AND 1. SBP >=140mmHg at research visit or from the mean of BP measures during the home screening period, OR 2. SBP 130-139 mmHg at research visit or from the mean of BP measures during the home screening period plus at least one comorbid condition as stated in AHA guidelines (cardiovascular disease, heart failure, stroke, atrial fibrillation, chronic kidney disease, kidney transplant, or diabetes) 5. Ability to provide informed consent 6. Willingness and ability to use a HBPM 7. Willingness to complete the necessary data collection procedures, including transmission of BP measurements and permission for study staff to access EHR and/or PHR data. |
Country | Name | City | State |
---|---|---|---|
United States | Anchorage Native Primary Care Center | Anchorage | Alaska |
United States | Benteh Nuutah Valley Native Primary Care Center | Wasilla | Alaska |
Lead Sponsor | Collaborator |
---|---|
Southcentral Foundation | Washington State University |
United States,
Artinian NT, Flack JM, Nordstrom CK, Hockman EM, Washington OG, Jen KL, Fathy M. Effects of nurse-managed telemonitoring on blood pressure at 12-month follow-up among urban African Americans. Nurs Res. 2007 Sep-Oct;56(5):312-22. — View Citation
Asayama K, Ohkubo T, Kikuya M, Metoki H, Hoshi H, Hashimoto J, Totsune K, Satoh H, Imai Y. Prediction of stroke by self-measurement of blood pressure at home versus casual screening blood pressure measurement in relation to the Joint National Committee 7 classification: the Ohasama study. Stroke. 2004 Oct;35(10):2356-61. Epub 2004 Aug 26. — View Citation
Barnes PM, Adams PF, Powell-Griner E. Health characteristics of the American Indian or Alaska Native adult population: United States, 2004-2008. Natl Health Stat Report. 2010 Mar 9;(20):1-22. — View Citation
Bobrie G, Chatellier G, Genes N, Clerson P, Vaur L, Vaisse B, Menard J, Mallion JM. Cardiovascular prognosis of "masked hypertension" detected by blood pressure self-measurement in elderly treated hypertensive patients. JAMA. 2004 Mar 17;291(11):1342-9. — View Citation
Bosworth HB, Powers BJ, Olsen MK, McCant F, Grubber J, Smith V, Gentry PW, Rose C, Van Houtven C, Wang V, Goldstein MK, Oddone EZ. Home blood pressure management and improved blood pressure control: results from a randomized controlled trial. Arch Intern Med. 2011 Jul 11;171(13):1173-80. doi: 10.1001/archinternmed.2011.276. — View Citation
Brennan T, Spettell C, Villagra V, Ofili E, McMahill-Walraven C, Lowy EJ, Daniels P, Quarshie A, Mayberry R. Disease management to promote blood pressure control among African Americans. Popul Health Manag. 2010 Apr;13(2):65-72. doi: 10.1089/pop.2009.0019. — View Citation
Carter BL, Ardery G, Dawson JD, James PA, Bergus GR, Doucette WR, Chrischilles EA, Franciscus CL, Xu Y. Physician and pharmacist collaboration to improve blood pressure control. Arch Intern Med. 2009 Nov 23;169(21):1996-2002. doi: 10.1001/archinternmed.2009.358. — View Citation
Carter BL, Rogers M, Daly J, Zheng S, James PA. The potency of team-based care interventions for hypertension: a meta-analysis. Arch Intern Med. 2009 Oct 26;169(19):1748-55. doi: 10.1001/archinternmed.2009.316. Review. — View Citation
Diez Roux AV. Complex systems thinking and current impasses in health disparities research. Am J Public Health. 2011 Sep;101(9):1627-34. doi: 10.2105/AJPH.2011.300149. Epub 2011 Jul 21. — View Citation
Eby D. Integrated primary care. Int J Circumpolar Health. 1998;57 Suppl 1:665-7. — View Citation
Foulds HJ, Warburton DE. The blood pressure and hypertension experience among North American Indigenous populations. J Hypertens. 2014 Apr;32(4):724-34. doi: 10.1097/HJH.0000000000000084. Review. — View Citation
Green BB, Cook AJ, Ralston JD, Fishman PA, Catz SL, Carlson J, Carrell D, Tyll L, Larson EB, Thompson RS. Effectiveness of home blood pressure monitoring, Web communication, and pharmacist care on hypertension control: a randomized controlled trial. JAMA. 2008 Jun 25;299(24):2857-67. doi: 10.1001/jama.299.24.2857. Erratum in: JAMA. 2009 Nov 11;302(18):1972. — View Citation
Harris R, Nelson LA, Muller C, Buchwald D. Stroke in American Indians and Alaska Natives: A Systematic Review. Am J Public Health. 2015 Aug;105(8):e16-26. doi: 10.2105/AJPH.2015.302698. Epub 2015 Jun 11. Review. — View Citation
Horner RD, Day GM, Lanier AP, Provost EM, Hamel RD, Trimble BA. Stroke mortality among Alaska Native people. Am J Public Health. 2009 Nov;99(11):1996-2000. doi: 10.2105/AJPH.2008.148221. Epub 2009 Sep 17. Erratum in: Am J Public Health. 2010 Feb;100(2):199. — View Citation
Howard BV, Devereux RB, Cole SA, Davidson M, Dyke B, Ebbesson SO, Epstein SE, Robinson DR, Jarvis B, Kaufman DJ, Laston S, MacCluer JW, Okin PM, Roman MJ, Romenesko T, Ruotolo G, Swenson M, Wenger CR, Williams-Blangero S, Zhu J, Saccheus C, Fabsitz RR, Robbins DC. A genetic and epidemiologic study of cardiovascular disease in Alaska natives (GOCADAN): design and methods. Int J Circumpolar Health. 2005 Jun;64(3):206-21. — View Citation
Howard BV, Lee ET, Cowan LD, Devereux RB, Galloway JM, Go OT, Howard WJ, Rhoades ER, Robbins DC, Sievers ML, Welty TK. Rising tide of cardiovascular disease in American Indians. The Strong Heart Study. Circulation. 1999 May 11;99(18):2389-95. — View Citation
Hunt JS, Siemienczuk J, Pape G, Rozenfeld Y, MacKay J, LeBlanc BH, Touchette D. A randomized controlled trial of team-based care: impact of physician-pharmacist collaboration on uncontrolled hypertension. J Gen Intern Med. 2008 Dec;23(12):1966-72. doi: 10.1007/s11606-008-0791-x. Epub 2008 Sep 25. — View Citation
Hutchinson RN, Shin S. Systematic review of health disparities for cardiovascular diseases and associated factors among American Indian and Alaska Native populations. PLoS One. 2014 Jan 15;9(1):e80973. doi: 10.1371/journal.pone.0080973. eCollection 2014. Review. — View Citation
Jolly SE, Howard BV, Umans JG. Cardiovascular Disease Among Alaska Native Peoples. Curr Cardiovasc Risk Rep. 2013 Dec 1;7(6). doi: 10.1007/s12170-013-0362-5. — View Citation
Kim MT, Han HR, Hedlin H, Kim J, Song HJ, Kim KB, Hill MN. Teletransmitted monitoring of blood pressure and bilingual nurse counseling-sustained improvements in blood pressure control during 12 months in hypertensive Korean Americans. J Clin Hypertens (Greenwich). 2011 Aug;13(8):605-12. doi: 10.1111/j.1751-7176.2011.00479.x. Epub 2011 Jun 27. — View Citation
Lebeau JP, Cadwallader JS, Aubin-Auger I, Mercier A, Pasquet T, Rusch E, Hendrickx K, Vermeire E. The concept and definition of therapeutic inertia in hypertension in primary care: a qualitative systematic review. BMC Fam Pract. 2014 Jul 2;15:130. doi: 10.1186/1471-2296-15-130. Review. — View Citation
Mala TA, Gottlieb KL. Designing a home health care system for Alaska Natives in Anchorage. Int J Circumpolar Health. 1998;57 Suppl 1:675-8. — View Citation
McManus RJ, Mant J, Bray EP, Holder R, Jones MI, Greenfield S, Kaambwa B, Banting M, Bryan S, Little P, Williams B, Hobbs FD. Telemonitoring and self-management in the control of hypertension (TASMINH2): a randomised controlled trial. Lancet. 2010 Jul 17;376(9736):163-72. doi: 10.1016/S0140-6736(10)60964-6. Epub 2010 Jul 8. — View Citation
Nasothimiou EG, Karpettas N, Dafni MG, Stergiou GS. Patients' preference for ambulatory versus home blood pressure monitoring. J Hum Hypertens. 2014 Apr;28(4):224-9. doi: 10.1038/jhh.2013.104. Epub 2013 Oct 24. — View Citation
Niiranen TJ, Hänninen MR, Johansson J, Reunanen A, Jula AM. Home-measured blood pressure is a stronger predictor of cardiovascular risk than office blood pressure: the Finn-Home study. Hypertension. 2010 Jun;55(6):1346-51. doi: 10.1161/HYPERTENSIONAHA.109.149336. Epub 2010 Apr 12. — View Citation
Oakes JM. The (mis)estimation of neighborhood effects: causal inference for a practicable social epidemiology. Soc Sci Med. 2004 May;58(10):1929-52. Review. — View Citation
Odedosu T, Schoenthaler A, Vieira DL, Agyemang C, Ogedegbe G. Overcoming barriers to hypertension control in African Americans. Cleve Clin J Med. 2012 Jan;79(1):46-56. doi: 10.3949/ccjm.79a.11068. Review. — View Citation
Ohkubo T, Asayama K, Kikuya M, Metoki H, Obara T, Saito S, Hoshi H, Hashimoto J, Totsune K, Satoh H, Imai Y. Prediction of ischaemic and haemorrhagic stroke by self-measured blood pressure at home: the Ohasama study. Blood Press Monit. 2004 Dec;9(6):315-20. Review. — View Citation
Omboni S, Guarda A. Impact of home blood pressure telemonitoring and blood pressure control: a meta-analysis of randomized controlled studies. Am J Hypertens. 2011 Sep;24(9):989-98. doi: 10.1038/ajh.2011.100. Epub 2011 Jun 9. — View Citation
Parati G, Omboni S, Albini F, Piantoni L, Giuliano A, Revera M, Illyes M, Mancia G; TeleBPCare Study Group. Home blood pressure telemonitoring improves hypertension control in general practice. The TeleBPCare study. J Hypertens. 2009 Jan;27(1):198-203. — View Citation
Rhoades DA, Buchwald D. Hypertension in older urban Native-American primary care patients. J Am Geriatr Soc. 2003 Jun;51(6):774-81. — View Citation
Rose AJ, Shimada SL, Rothendler JA, Reisman JI, Glassman PA, Berlowitz DR, Kressin NR. The accuracy of clinician perceptions of "usual" blood pressure control. J Gen Intern Med. 2008 Feb;23(2):180-3. Epub 2007 Nov 28. — View Citation
Roumie CL, Elasy TA, Greevy R, Griffin MR, Liu X, Stone WJ, Wallston KA, Dittus RS, Alvarez V, Cobb J, Speroff T. Improving blood pressure control through provider education, provider alerts, and patient education: a cluster randomized trial. Ann Intern Med. 2006 Aug 1;145(3):165-75. — View Citation
Stergiou GS, Christodoulakis GR, Nasothimiou EG, Giovas PP, Kalogeropoulos PG. Can validated wrist devices with position sensors replace arm devices for self-home blood pressure monitoring? A randomized crossover trial using ambulatory monitoring as reference. Am J Hypertens. 2008 Jul;21(7):753-8. doi: 10.1038/ajh.2008.176. Epub 2008 Apr 24. — View Citation
Svetkey LP, Pollak KI, Yancy WS Jr, Dolor RJ, Batch BC, Samsa G, Matchar DB, Lin PH. Hypertension improvement project: randomized trial of quality improvement for physicians and lifestyle modification for patients. Hypertension. 2009 Dec;54(6):1226-33. doi: 10.1161/HYPERTENSIONAHA.109.134874. — View Citation
Trimble B, Morgenstern LB. Stroke in minorities. Neurol Clin. 2008 Nov;26(4):1177-90, xi. doi: 10.1016/j.ncl.2008.05.010. Review. — View Citation
Viera AJ, Lin FC, Tuttle LA, Olsson E, Stankevitz K, Girdler SS, Klein JL, Hinderliter AL. Reproducibility of masked hypertension among adults 30 years or older. Blood Press Monit. 2014 Aug;19(4):208-15. doi: 10.1097/MBP.0000000000000054. — View Citation
Zhao G, Ford ES, Mokdad AH. Racial/ethnic variation in hypertension-related lifestyle behaviours among US women with self-reported hypertension. J Hum Hypertens. 2008 Sep;22(9):608-16. doi: 10.1038/jhh.2008.52. Epub 2008 May 22. — View Citation
* Note: There are 38 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Individual-level: within-person change in systolic blood pressure | Examine change in systolic blood pressure (mmHg) between participants in the intervention group compared to the control group. | 12 months | |
Primary | Provider-level: frequency of antihypertensive medication adjustments | Examine number of medication adjustments (new prescription or change in dose of antihypertensive medications) between participants in the intervention group compared to the control group. | 3 months, 6 months, and 12 months | |
Primary | System-level: change in systolic blood pressure for all patients with hypertension | Examine change in systolic blood pressure (mmHg) between all patients whose providers are in the intervention group (receiving automated alerts about high blood pressure and pharmacist support), compared to patients whose providers are in the control group (do not receive alerts and pharmacist support). | 12 months |
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