Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-31 @ 7:19 AM
Study NCT ID:
NCT07397260
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-09
First Post:
2026-02-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Automatically Transmitted Home Blood Pressure and Automated Patient Feedback in Hypertension Care: the AUTO 2 Trial
Sponsor:
Organization:
Raw JSON
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Statistical Analysis of Zero-Inflated Nonnegative Continuous Data: A Review. Stat Sci. 2019;34(2):253-279'}, {'type': 'BACKGROUND', 'citation': 'HealthMeasures. PROMIS Scale v1.2 - Global Health. 2024. Available at https://www.healthmeasures.net/index.php?option=com_instruments&view=measure&id=778&Itemid=992.'}, {'pmid': '29436308', 'type': 'BACKGROUND', 'citation': "Wolf MS, Smith SG, Pandit AU, Condon DM, Curtis LM, Griffith J, O'Conor R, Rush S, Bailey SC, Kaplan G, Haufle V, Martin D. Development and Validation of the Consumer Health Activation Index. Med Decis Making. 2018 Apr;38(3):334-343. doi: 10.1177/0272989X17753392. Epub 2018 Feb 13."}, {'type': 'BACKGROUND', 'citation': 'Voils CI, King HA, Thorpe CT, et al. Content Validity and Reliability of a Self-Report Measure of Medication Nonadherence in Hepatitis C Treatment. Dig Dis Sci. 2019;64(10):2784-2797'}, {'pmid': '22922431', 'type': 'BACKGROUND', 'citation': 'Voils CI, Maciejewski ML, Hoyle RH, Reeve BB, Gallagher P, Bryson CL, Yancy WS Jr. Initial validation of a self-report measure of the extent of and reasons for medication nonadherence. Med Care. 2012 Dec;50(12):1013-9. doi: 10.1097/MLR.0b013e318269e121.'}, {'pmid': '36419584', 'type': 'BACKGROUND', 'citation': 'Voils CI, Gavin KL, Thorpe CT, Pabich SK, Reeve BB, Mian GJ, Faacks A, Kronish IM. Validating a Self-Reported Medication Nonadherence Measure in the Context of Multiple Chronic Diseases and Routes of Medication Administration Among Patients with Type 2 Diabetes. Patient Prefer Adherence. 2022 Nov 17;16:3119-3130. doi: 10.2147/PPA.S382885. eCollection 2022.'}, {'type': 'BACKGROUND', 'citation': 'American Heart Association. Available at https://www.heart.org/en/health-topics/high-blood-pressure/understanding-blood-pressure-readings/monitoring-your-blood-pressure-at-home. 2024.'}, {'pmid': '23621969', 'type': 'BACKGROUND', 'citation': 'Kronish IM, Ye S. Adherence to cardiovascular medications: lessons learned and future directions. Prog Cardiovasc Dis. 2013 May-Jun;55(6):590-600. doi: 10.1016/j.pcad.2013.02.001. Epub 2013 Mar 23.'}, {'pmid': '33660211', 'type': 'BACKGROUND', 'citation': 'Peh KQE, Kwan YH, Goh H, Ramchandani H, Phang JK, Lim ZY, Loh DHF, Ostbye T, Blalock DV, Yoon S, Bosworth HB, Low LL, Thumboo J. An Adaptable Framework for Factors Contributing to Medication Adherence: Results from a Systematic Review of 102 Conceptual Frameworks. J Gen Intern Med. 2021 Sep;36(9):2784-2795. doi: 10.1007/s11606-021-06648-1. Epub 2021 Mar 3.'}, {'pmid': '23205755', 'type': 'BACKGROUND', 'citation': 'AlGhurair SA, Hughes CA, Simpson SH, Guirguis LM. A systematic review of patient self-reported barriers of adherence to antihypertensive medications using the world health organization multidimensional adherence model. J Clin Hypertens (Greenwich). 2012 Dec;14(12):877-86. doi: 10.1111/j.1751-7176.2012.00699.x. Epub 2012 Aug 20.'}, {'type': 'BACKGROUND', 'citation': "Oliveria SA, Lapuerta P, McCarthy BD, L'Italien GJ, Berlowitz DR, Asch SM. Physician-related barriers to the effective management of uncontrolled hypertension. Arch Intern Med. 2002;162(4):413-420"}, {'pmid': '18043980', 'type': 'BACKGROUND', '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. doi: 10.1007/s11606-007-0464-1. Epub 2007 Nov 28.'}, {'pmid': '34615363', 'type': 'BACKGROUND', 'citation': 'Choudhry NK, Kronish IM, Vongpatanasin W, Ferdinand KC, Pavlik VN, Egan BM, Schoenthaler A, Houston Miller N, Hyman DJ; American Heart Association Council on Hypertension; Council on Cardiovascular and Stroke Nursing; and Council on Clinical Cardiology. Medication Adherence and Blood Pressure Control: A Scientific Statement From the American Heart Association. Hypertension. 2022 Jan;79(1):e1-e14. doi: 10.1161/HYP.0000000000000203. Epub 2021 Oct 7.'}, {'type': 'BACKGROUND', 'citation': 'Kerr EA, Zikmund-Fisher BJ, Klamerus ML, Subramanian U, Hogan MM, Hofer TP. The role of clinical uncertainty in treatment decisions for diabetic patients with uncontrolled blood pressure. Ann Intern Med. 2008;148(10):717-727'}, {'pmid': '36116516', 'type': 'BACKGROUND', 'citation': 'Baldridge AS, Huffman MD, Lazar D, Abbas H, Flowers FM, Quintana A, Jackson A, Khan SS, Chopra A, Vu M, Tripathi P, Jacobson T, Sanuade OA, Kandula NR, Persell SD, Paparello JJ, Rosul LL, Mejia J, Lloyd-Jones DM, Chow CK, Ciolino JD. Efficacy and safety of a quadruple ultra-low-dose treatment for hypertension (QUARTET USA): Rationale and design for a randomized controlled trial. Am Heart J. 2022 Dec;254:183-193. doi: 10.1016/j.ahj.2022.09.004. Epub 2022 Sep 15.'}, {'pmid': '38448578', 'type': 'BACKGROUND', 'citation': 'Persell SD, Anthony L, Peprah YA, Lee JY, Li J, Sato H, Petito LC. Blood pressure outcomes at 18 months in primary care patients prescribed remote physiological monitoring for hypertension: a prospective cohort study. J Hum Hypertens. 2024 Mar;38(3):286-288. doi: 10.1038/s41371-024-00904-7. Epub 2024 Mar 6.'}, {'pmid': '37479812', 'type': 'BACKGROUND', 'citation': 'Petito LC, Anthony L, Peprah Y, Lee JY, Li J, Sato H, Persell SD. Blood pressure outcomes at 12 months in primary care patients prescribed remote physiological monitoring for hypertension: a prospective cohort study. J Hum Hypertens. 2023 Dec;37(12):1091-1097. doi: 10.1038/s41371-023-00850-w. Epub 2023 Jul 21.'}, {'pmid': '36743315', 'type': 'BACKGROUND', 'citation': 'Petito LC, Anthony L, Peprah YA, Lee JY, Li J, Sato H, Persell SD. Remote physiologic monitoring for hypertension in primary care: a prospective pragmatic pilot study in electronic health records using propensity score matching. JAMIA Open. 2023 Jan 31;6(1):ooac111. doi: 10.1093/jamiaopen/ooac111. eCollection 2023 Apr.'}, {'pmid': '38315997', 'type': 'BACKGROUND', 'citation': 'Persell SD, Petito LC, Lee JY, Meeker D, Doctor JN, Goldstein NJ, Fox CR, Rowe TA, Linder JA, Chmiel R, Peprah YA, Brown T. Reducing Care Overuse in Older Patients Using Professional Norms and Accountability : A Cluster Randomized Controlled Trial. Ann Intern Med. 2024 Mar;177(3):324-334. doi: 10.7326/M23-2183. Epub 2024 Feb 6. Erratum In: Ann Intern Med. 2024 May;177(5):692. doi: 10.7326/L24-0117.'}, {'pmid': '34993860', 'type': 'BACKGROUND', 'citation': 'Persell SD, Brown T, Doctor JN, Fox CR, Goldstein NJ, Handler SM, Hanlon JT, Lee JY, Linder JA, Meeker D, Rowe TA, Sullivan MD, Friedberg MW. Development of High-Risk Geriatric Polypharmacy Electronic Clinical Quality Measures and a Pilot Test of EHR Nudges Based on These Measures. J Gen Intern Med. 2022 Aug;37(11):2777-2785. doi: 10.1007/s11606-021-07296-1. Epub 2022 Jan 6.'}, {'type': 'BACKGROUND', 'citation': 'Persell SD. Reducing High-Risk Geriatric Polypharmacy Via EHR Nudges R01 Trial (HRPP), available at https://clinicaltrials.gov/study/NCT05656560?a=4.'}, {'pmid': '33636344', 'type': 'BACKGROUND', 'citation': 'Kelley MA, Persell SD, Linder JA, Friedberg MW, Meeker D, Fox CR, Goldstein NJ, Knight TK, Zein D, Rowe TA, Sullivan MD, Doctor JN. The protocol of the Application of Economics & Social psychology to improve Opioid Prescribing Safety Trial 1 (AESOPS-1): Electronic health record nudges. Contemp Clin Trials. 2021 Apr;103:106329. doi: 10.1016/j.cct.2021.106329. Epub 2021 Feb 24.'}, {'pmid': '38626940', 'type': 'BACKGROUND', 'citation': 'Priyanath Gupta A, Patel D, Lee JY, Volpentesta M, Schachter M, Persell SD. Health information technology tools to accelerate gastrointestinal evaluation in patients with iron deficiency anaemia: a cluster randomised controlled trial. BMJ Open Qual. 2024 Apr 15;13(2):e002565. doi: 10.1136/bmjoq-2023-002565.'}, {'type': 'BACKGROUND', 'citation': 'Persell SD, Brown T, Lee JY, et al. Individualized Risk Communication and Outreach for Primary Cardiovascular Disease Prevention in Community Health Centers: Randomized Trial. Circ Cardiovasc Qual Outcomes. 2015;8(6):560-566'}, {'pmid': '23143672', 'type': 'BACKGROUND', 'citation': 'Persell SD, Lloyd-Jones DM, Friesema EM, Cooper AJ, Baker DW. Electronic health record-based patient identification and individualized mailed outreach for primary cardiovascular disease prevention: a cluster randomized trial. J Gen Intern Med. 2013 Apr;28(4):554-60. doi: 10.1007/s11606-012-2268-1. Epub 2012 Nov 11.'}, {'pmid': '26864410', 'type': 'BACKGROUND', 'citation': 'Meeker D, Linder JA, Fox CR, Friedberg MW, Persell SD, Goldstein NJ, Knight TK, Hay JW, Doctor JN. Effect of Behavioral Interventions on Inappropriate Antibiotic Prescribing Among Primary Care Practices: A Randomized Clinical Trial. JAMA. 2016 Feb 9;315(6):562-70. doi: 10.1001/jama.2016.0275.'}, {'pmid': '29987324', 'type': 'BACKGROUND', 'citation': 'Persell SD, Karmali KN, Lazar D, Friesema EM, Lee JY, Rademaker A, Kaiser D, Eder M, French DD, Brown T, Wolf MS. Effect of Electronic Health Record-Based Medication Support and Nurse-Led Medication Therapy Management on Hypertension and Medication Self-management: A Randomized Clinical Trial. JAMA Intern Med. 2018 Aug 1;178(8):1069-1077. doi: 10.1001/jamainternmed.2018.2372.'}, {'pmid': '38584159', 'type': 'BACKGROUND', 'citation': 'Huffman MD, Baldridge AS, Lazar D, Abbas H, Mejia J, Flowers FM, Quintana A, Jackson A, Kandula NR, Lloyd-Jones DM, Persell SD, Khan SS, Paparello JJ, Chopra A, Tripathi P, Vu MH, Chow CK, Ciolino JD. Efficacy and safety of a four-drug, quarter-dose treatment for hypertension: the QUARTET USA randomized trial. Hypertens Res. 2024 Jun;47(6):1668-1677. doi: 10.1038/s41440-024-01658-y. Epub 2024 Apr 8.'}, {'type': 'BACKGROUND', 'citation': 'Persell SD, Liss DT, Walunas TL, et al. Effects of 2 Forms of Practice Facilitation on Cardiovascular Prevention in Primary Care: A Practice-randomized, Comparative Effectiveness Trial. Med Care. 2020;58(4):344-351'}, {'type': 'BACKGROUND', 'citation': 'Azizi M, Sharp ASP, Fisher NDL, et al. Patient-Level Pooled Analysis of Endovascular Ultrasound Renal Denervation or a Sham Procedure 6 Months After Medication Escalation: The RADIANCE Clinical Trial Program. Circulation. 2024;149(10):747-759'}, {'type': 'BACKGROUND', 'citation': "Bhatt DL, Kandzari DE, O'Neill WW, et al. A controlled trial of renal denervation for resistant hypertension. N Engl J Med. 2014;370(15):1393-1401"}, {'pmid': '38051324', 'type': 'BACKGROUND', 'citation': 'Kahan BC, Hall SS, Beller EM, Birchenall M, Chan AW, Elbourne D, Little P, Fletcher J, Golub RM, Goulao B, Hopewell S, Islam N, Zwarenstein M, Juszczak E, Montgomery AA. Reporting of Factorial Randomized Trials: Extension of the CONSORT 2010 Statement. JAMA. 2023 Dec 5;330(21):2106-2114. doi: 10.1001/jama.2023.19793.'}, {'type': 'BACKGROUND', 'citation': 'Schulz KF, Altman DG, Moher D, Group C. CONSORT 2010 statement: updated guidelines for reporting parallel group randomized trials. Ann Intern Med. 2010;152(11):726-732'}, {'pmid': '25956159', 'type': 'BACKGROUND', 'citation': 'Loudon K, Treweek S, Sullivan F, Donnan P, Thorpe KE, Zwarenstein M. The PRECIS-2 tool: designing trials that are fit for purpose. BMJ. 2015 May 8;350:h2147. doi: 10.1136/bmj.h2147. No abstract available.'}, {'pmid': '38353950', 'type': 'BACKGROUND', 'citation': 'Katz ME, Mszar R, Grimshaw AA, Gunderson CG, Onuma OK, Lu Y, Spatz ES. Digital Health Interventions for Hypertension Management in US Populations Experiencing Health Disparities: A Systematic Review and Meta-Analysis. JAMA Netw Open. 2024 Feb 5;7(2):e2356070. doi: 10.1001/jamanetworkopen.2023.56070.'}, {'pmid': '32311957', 'type': 'BACKGROUND', 'citation': 'Gong K, Yan YL, Li Y, Du J, Wang J, Han Y, Zou Y, Zou XY, Huang H, She Q; APP Study Group. Mobile health applications for the management of primary hypertension: A multicenter, randomized, controlled trial. Medicine (Baltimore). 2020 Apr;99(16):e19715. doi: 10.1097/MD.0000000000019715.'}, {'pmid': '33468518', 'type': 'BACKGROUND', 'citation': 'McManus RJ, Little P, Stuart B, Morton K, Raftery J, Kelly J, Bradbury K, Zhang J, Zhu S, Murray E, May CR, Mair FS, Michie S, Smith P, Band R, Ogburn E, Allen J, Rice C, Nuttall J, Williams B, Yardley L; HOME BP investigators. Home and Online Management and Evaluation of Blood Pressure (HOME BP) using a digital intervention in poorly controlled hypertension: randomised controlled trial. BMJ. 2021 Jan 19;372:m4858. doi: 10.1136/bmj.m4858.'}, {'pmid': '29710289', 'type': 'BACKGROUND', 'citation': 'Morawski K, Ghazinouri R, Krumme A, Lauffenburger JC, Lu Z, Durfee E, Oley L, Lee J, Mohta N, Haff N, Juusola JL, Choudhry NK. Association of a Smartphone Application With Medication Adherence and Blood Pressure Control: The MedISAFE-BP Randomized Clinical Trial. JAMA Intern Med. 2018 Jun 1;178(6):802-809. doi: 10.1001/jamainternmed.2018.0447.'}, {'pmid': '35969408', 'type': 'BACKGROUND', 'citation': "Pletcher MJ, Fontil V, Modrow MF, Carton T, Chamberlain AM, Todd J, O'Brien EC, Sheer A, Vittinghoff E, Park S, Orozco J, Lin F, Maeztu C, Wozniak G, Rakotz M, Shay CM, Cooper-DeHoff RM. Effectiveness of Standard vs Enhanced Self-measurement of Blood Pressure Paired With a Connected Smartphone Application: A Randomized Clinical Trial. JAMA Intern Med. 2022 Oct 1;182(10):1025-1034. doi: 10.1001/jamainternmed.2022.3355."}, {'pmid': '32119093', 'type': 'BACKGROUND', 'citation': 'Persell SD, Peprah YA, Lipiszko D, Lee JY, Li JJ, Ciolino JD, Karmali KN, Sato H. Effect of Home Blood Pressure Monitoring via a Smartphone Hypertension Coaching Application or Tracking Application on Adults With Uncontrolled Hypertension: A Randomized Clinical Trial. JAMA Netw Open. 2020 Mar 2;3(3):e200255. doi: 10.1001/jamanetworkopen.2020.0255.'}, {'pmid': '35819830', 'type': 'BACKGROUND', 'citation': 'Kassavou A, Wang M, Mirzaei V, Shpendi S, Hasan R. The Association Between Smartphone App-Based Self-monitoring of Hypertension-Related Behaviors and Reductions in High Blood Pressure: Systematic Review and Meta-analysis. JMIR Mhealth Uhealth. 2022 Jul 12;10(7):e34767. doi: 10.2196/34767.'}, {'pmid': '32696695', 'type': 'BACKGROUND', 'citation': 'Bryant KB, Sheppard JP, Ruiz-Negron N, Kronish IM, Fontil V, King JB, Pletcher MJ, Bibbins-Domingo K, Moran AE, McManus RJ, Bellows BK. Impact of Self-Monitoring of Blood Pressure on Processes of Hypertension Care and Long-Term Blood Pressure Control. J Am Heart Assoc. 2020 Aug 4;9(15):e016174. doi: 10.1161/JAHA.120.016174. Epub 2020 Jul 22.'}, {'pmid': '36933552', 'type': 'BACKGROUND', 'citation': 'Persell SD, Petito LC, Anthony L, Peprah Y, Lee JY, Campanella T, Campbell J, Pigott K, Kadric J, Duax CJ, Li J, Sato H. Prospective Cohort Study of Remote Patient Monitoring with and without Care Coordination for Hypertension in Primary Care. Appl Clin Inform. 2023 May;14(3):428-438. doi: 10.1055/a-2057-7277. Epub 2023 Mar 18.'}, {'type': 'BACKGROUND', 'citation': 'Centers for Medicare and Medicaid Services Federal Register/Vol. 84, No. 221/Friday, November 15, 2019/Rules and Regulations. 42 CFR Parts 403, 409, 410, 411, 414, 415, 416, 418, 424, 425, 489, and 498 [CMS-1715-F and IFC].'}, {'pmid': '38523586', 'type': 'BACKGROUND', 'citation': 'Carey NP, Curtis F, Eisenbeisz ML, Akbari S, Sambharia M, Jalal DI, Wilkinson TJ. Does home blood pressure monitoring improve blood pressure-related outcomes in people living with chronic kidney disease? A systematic review. J Clin Hypertens (Greenwich). 2024 Apr;26(4):314-329. doi: 10.1111/jch.14795. Epub 2024 Mar 25.'}, {'pmid': '36281763', 'type': 'BACKGROUND', 'citation': "Margolis KL, Bergdall AR, Crain AL, JaKa MM, Anderson JP, Solberg LI, Sperl-Hillen J, Beran M, Green BB, Haugen P, Norton CK, Kodet AJ, Sharma R, Appana D, Trower NK, Pawloski PA, Rehrauer DJ, Simmons ML, McKinney ZJ, Kottke TE, Ziegenfuss JY, Williams RA, O'Connor PJ. Comparing Pharmacist-Led Telehealth Care and Clinic-Based Care for Uncontrolled High Blood Pressure: The Hyperlink 3 Pragmatic Cluster-Randomized Trial. Hypertension. 2022 Dec;79(12):2708-2720. doi: 10.1161/HYPERTENSIONAHA.122.19816. Epub 2022 Oct 25."}, {'pmid': '36883454', 'type': 'BACKGROUND', 'citation': 'Bryant KB, Rao AS, Cohen LP, Dandan N, Kronish IM, Barai N, Fontil V, Zhang Y, Moran AE, Bellows BK. Effectiveness and Cost-Effectiveness of Team-Based Care for Hypertension: A Meta-Analysis and Simulation Study. Hypertension. 2023 Jun;80(6):1199-1208. doi: 10.1161/HYPERTENSIONAHA.122.20292. Epub 2023 Mar 8.'}, {'pmid': '23821088', 'type': 'BACKGROUND', 'citation': "Margolis KL, Asche SE, Bergdall AR, Dehmer SP, Groen SE, Kadrmas HM, Kerby TJ, Klotzle KJ, Maciosek MV, Michels RD, O'Connor PJ, Pritchard RA, Sekenski JL, Sperl-Hillen JM, Trower NK. Effect of home blood pressure telemonitoring and pharmacist management on blood pressure control: a cluster randomized clinical trial. JAMA. 2013 Jul 3;310(1):46-56. doi: 10.1001/jama.2013.6549."}, {'pmid': '30646139', 'type': 'BACKGROUND', 'citation': "Margolis KL, Asche SE, Dehmer SP, Bergdall AR, Green BB, Sperl-Hillen JM, Nyboer RA, Pawloski PA, Maciosek MV, Trower NK, O'Connor PJ. Long-term Outcomes of the Effects of Home Blood Pressure Telemonitoring and Pharmacist Management on Blood Pressure Among Adults With Uncontrolled Hypertension: Follow-up of a Cluster Randomized Clinical Trial. JAMA Netw Open. 2018 Sep 7;1(5):e181617. doi: 10.1001/jamanetworkopen.2018.1617."}, {'pmid': '23689927', 'type': 'BACKGROUND', 'citation': 'Green BB, Anderson ML, Ralston JD, Catz SL, Cook AJ. Blood pressure 1 year after completion of web-based pharmacist care. JAMA Intern Med. 2013 Jul 8;173(13):1250-2. doi: 10.1001/jamainternmed.2013.1037. No abstract available.'}, {'type': 'BACKGROUND', 'citation': 'Magid DJ, Olson KL, Billups SJ, Wagner NM, Lyons EE, Kroner BA. A pharmacist-led, American Heart Association Heart360 Web-enabled home blood pressure monitoring program. Circ Cardiovasc Qual Outcomes. 2013;6(2):157-163'}, {'pmid': '24657991', 'type': 'BACKGROUND', 'citation': 'Ogedegbe G, Tobin JN, Fernandez S, Cassells A, Diaz-Gloster M, Khalida C, Pickering T, Schwartz JE. Counseling African Americans to Control Hypertension: cluster-randomized clinical trial main effects. Circulation. 2014 May 20;129(20):2044-51. doi: 10.1161/CIRCULATIONAHA.113.006650. Epub 2014 Mar 21.'}, {'type': 'BACKGROUND', 'citation': 'Bosworth HB, Powers BJ, Olsen MK, et al. Home blood pressure management and improved blood pressure control: results from a randomized controlled trial. Arch Intern Med. 2011;171(13):1173-1180'}, {'pmid': '25525344', 'type': 'BACKGROUND', 'citation': 'Leiva A, Aguilo A, Fajo-Pascual M, Moreno L, Martin MC, Garcia EM, Duro RE, Serra F, Dagosto P, Iglesias-Iglesias AA, Company RM, Yanez A, Llobera J. Efficacy of a brief multifactorial adherence-based intervention in reducing blood pressure: a randomized clinical trial. Patient Prefer Adherence. 2014 Dec 5;8:1683-90. doi: 10.2147/PPA.S66927. eCollection 2014.'}, {'pmid': '34455443', 'type': 'BACKGROUND', 'citation': 'Kario K, Nomura A, Harada N, Okura A, Nakagawa K, Tanigawa T, Hida E. Efficacy of a digital therapeutics system in the management of essential hypertension: the HERB-DH1 pivotal trial. Eur Heart J. 2021 Oct 21;42(40):4111-4122. doi: 10.1093/eurheartj/ehab559.'}, {'type': 'BACKGROUND', 'citation': 'McManus RJ, Mant J, Haque MS, et al. Effect of self-monitoring and medication self-titration on systolic blood pressure in hypertensive patients at high risk of cardiovascular disease: the TASMIN-SR randomized clinical trial. JAMA. 2014;312(8):799-808'}, {'type': 'BACKGROUND', 'citation': 'McManus RJ, Mant J, Bray EP, et al. Telemonitoring and self-management in the control of hypertension (TASMINH2): a randomised controlled trial. Lancet. 2010;376(9736):163-172'}, {'pmid': '18577730', 'type': 'BACKGROUND', '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.'}, {'type': 'BACKGROUND', 'citation': 'Wakefield BJ, Holman JE, Ray A, et al. Effectiveness of home telehealth in comorbid diabetes and hypertension: a randomized, controlled trial. Telemed J E Health. 2011;17(4):254-261'}, {'pmid': '29277852', 'type': 'BACKGROUND', 'citation': 'Mills KT, Obst KM, Shen W, Molina S, Zhang HJ, He H, Cooper LA, He J. Comparative Effectiveness of Implementation Strategies for Blood Pressure Control in Hypertensive Patients: A Systematic Review and Meta-analysis. Ann Intern Med. 2018 Jan 16;168(2):110-120. doi: 10.7326/M17-1805. Epub 2017 Dec 26.'}, {'pmid': '28926573', 'type': 'BACKGROUND', 'citation': 'Tucker KL, Sheppard JP, Stevens R, Bosworth HB, Bove A, Bray EP, Earle K, George J, Godwin M, Green BB, Hebert P, Hobbs FDR, Kantola I, Kerry SM, Leiva A, Magid DJ, Mant J, Margolis KL, McKinstry B, McLaughlin MA, Omboni S, Ogedegbe O, Parati G, Qamar N, Tabaei BP, Varis J, Verberk WJ, Wakefield BJ, McManus RJ. Self-monitoring of blood pressure in hypertension: A systematic review and individual patient data meta-analysis. PLoS Med. 2017 Sep 19;14(9):e1002389. doi: 10.1371/journal.pmed.1002389. eCollection 2017 Sep.'}, {'pmid': '31730171', 'type': 'BACKGROUND', 'citation': 'Sheppard JP, Tucker KL, Davison WJ, Stevens R, Aekplakorn W, Bosworth HB, Bove A, Earle K, Godwin M, Green BB, Hebert P, Heneghan C, Hill N, Hobbs FDR, Kantola I, Kerry SM, Leiva A, Magid DJ, Mant J, Margolis KL, McKinstry B, McLaughlin MA, McNamara K, Omboni S, Ogedegbe O, Parati G, Varis J, Verberk WJ, Wakefield BJ, McManus RJ. Self-monitoring of Blood Pressure in Patients With Hypertension-Related Multi-morbidity: Systematic Review and Individual Patient Data Meta-analysis. Am J Hypertens. 2020 Mar 13;33(3):243-251. doi: 10.1093/ajh/hpz182.'}, {'pmid': '34852639', 'type': 'BACKGROUND', 'citation': 'Bryant KB, Green MB, Shimbo D, Schwartz JE, Kronish IM, Zhang Y, Sheppard JP, McManus RJ, Moran AE, Bellows BK. Home Blood Pressure Monitoring for Hypertension Diagnosis by Current Recommendations: A Long Way to Go. Hypertension. 2022 Feb;79(2):e15-e17. doi: 10.1161/HYPERTENSIONAHA.121.18463. Epub 2021 Dec 2. No abstract available.'}, {'type': 'BACKGROUND', 'citation': 'Stergiou GS, Kollias A, Zeniodi M, Karpettas N, Ntineri A. Home blood pressure monitoring: primary role in hypertension management. Curr Hypertens Rep. 2014;16(8):462'}, {'type': 'BACKGROUND', 'citation': 'Lu Y, Linderman GC, Mahajan S, et al. Quantifying Blood Pressure Visit-to-Visit Variability in the Real-World Setting: A Retrospective Cohort Study. Circ Cardiovasc Qual Outcomes. 2023;16(4):e009258'}, {'type': 'BACKGROUND', 'citation': 'Campbell NR, Culleton BW, McKay DW. Misclassification of blood pressure by usual measurement in ambulatory physician practices. Am J Hypertens. 2005;18(12 Pt 1):1522-1527'}, {'type': 'BACKGROUND', 'citation': 'Stergiou GS. How to cope with unreliable office blood pressure measurement? Am J Hypertens. 2005;18(12 Pt 1):1519-1521'}, {'pmid': '30827125', 'type': 'BACKGROUND', 'citation': 'Muntner P, Shimbo D, Carey RM, Charleston JB, Gaillard T, Misra S, Myers MG, Ogedegbe G, Schwartz JE, Townsend RR, Urbina EM, Viera AJ, White WB, Wright JT Jr. Measurement of Blood Pressure in Humans: A Scientific Statement From the American Heart Association. Hypertension. 2019 May;73(5):e35-e66. doi: 10.1161/HYP.0000000000000087.'}, {'pmid': '27977471', 'type': 'BACKGROUND', 'citation': "Kallioinen N, Hill A, Horswill MS, Ward HE, Watson MO. Sources of inaccuracy in the measurement of adult patients' resting blood pressure in clinical settings: a systematic review. J Hypertens. 2017 Mar;35(3):421-441. doi: 10.1097/HJH.0000000000001197."}, {'type': 'BACKGROUND', 'citation': 'Whelton PK, Carey RM, Aronow WS, et al. 2017 ACC/AHA/AAPA/ABC/ACPM/AGS/APhA/ASH/ASPC/NMA/PCNA Guideline for the Prevention, Detection, Evaluation, and Management of High Blood Pressure in Adults: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. J Am Coll Cardiol. 2018;71(19):e127-e248'}, {'type': 'BACKGROUND', 'citation': 'Panagiotakos D, Antza C, Kotsis V. Ambulatory and home blood pressure monitoring for cardiovascular disease risk evaluation: a systematic review and meta-analysis of prospective cohort studies. J Hypertens. 2024;42(1):1-9'}, {'type': 'BACKGROUND', 'citation': 'Kollias A, Kyriakoulis KG, Komnianou A, Stathopoulou P, Stergiou GS. Prognostic value of home versus ambulatory blood pressure monitoring: a systematic review and meta-analysis of outcome studies. J Hypertens. 2024;42(3):385-392'}, {'type': 'BACKGROUND', 'citation': 'Krist AH, Davidson KW, et al. Screening for Hypertension in Adults: US Preventive Services Task Force Reaffirmation Recommendation Statement. JAMA. 2021;325(16):1650-1656'}, {'pmid': '32902588', 'type': 'BACKGROUND', 'citation': 'Muntner P, Hardy ST, Fine LJ, Jaeger BC, Wozniak G, Levitan EB, Colantonio LD. Trends in Blood Pressure Control Among US Adults With Hypertension, 1999-2000 to 2017-2018. JAMA. 2020 Sep 22;324(12):1190-1200. doi: 10.1001/jama.2020.14545.'}, {'pmid': '38264914', 'type': 'BACKGROUND', 'citation': 'Martin SS, Aday AW, Almarzooq ZI, Anderson CAM, Arora P, Avery CL, Baker-Smith CM, Barone Gibbs B, Beaton AZ, Boehme AK, Commodore-Mensah Y, Currie ME, Elkind MSV, Evenson KR, Generoso G, Heard DG, Hiremath S, Johansen MC, Kalani R, Kazi DS, Ko D, Liu J, Magnani JW, Michos ED, Mussolino ME, Navaneethan SD, Parikh NI, Perman SM, Poudel R, Rezk-Hanna M, Roth GA, Shah NS, St-Onge MP, Thacker EL, Tsao CW, Urbut SM, Van Spall HGC, Voeks JH, Wang NY, Wong ND, Wong SS, Yaffe K, Palaniappan LP; American Heart Association Council on Epidemiology and Prevention Statistics Committee and Stroke Statistics Subcommittee. 2024 Heart Disease and Stroke Statistics: A Report of US and Global Data From the American Heart Association. Circulation. 2024 Feb 20;149(8):e347-e913. doi: 10.1161/CIR.0000000000001209. Epub 2024 Jan 24.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the effectiveness of automatically-generated medical advice to patients about to their home blood pressure monitoring results sent through patient portal messages compared to no automated advice and the effectiveness of automated transmission of remotely-obtained blood pressure values compared to self-reported values on systolic blood pressure at 1-year follow up in patients with uncontrolled hypertension whose physicians or advance practice providers provide primary care at Northwestern Medicine. Persistence of effects through 18 months will also be assessed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '84 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age 18-84 years at enrollment date\n* Receives hypertension care primarily from a participating clinician\n* Blood pressure on the two most recent days when ambulatory clinic blood pressure was obtained prior to patient identification to was ≥140 mm Hg systolic and/or ≥90 diastolic or last ambulatory clinic blood pressure was ≥150 mm Hg systolic and/or ≥95 diastolic\n* Currently has or is willing to obtain a patient portal account from NM.\n\nExclusion Criteria:\n\n* Dementia,\n* Nursing home resident,\n* Stage 5 chronic kidney disease or renal replacement therapy,\n* Pregnancy,\n* Receiving hospice,\n* Not planning to continue to receive hypertension care from NM clinician for the next year,\n* Planning to move from the region in the next year,\n* Planning to change clinician treating their hypertension in the next year,\n* Medical or psychological reason they cannot perform home blood pressure monitoring.\n* Known to have average home blood pressure or most recent home blood pressure value of \\<130/80 mm Hg.\n\nCLINICIAN PARTICIPANT INCLUSION Physician, advanced practice nurse or physician assistant working at a Northwestern Medicine ambulatory primary care site that cares for adults with hypertension (family medicine, internal medicine, medicine/pediatrics, and ambulatory geriatrics sites).\n\nCLINICIAN PARTICIPANT EXCLUSION\n\n* Primary care physicians and clinicians not willing for their patients to participate in study\n* Planning to depart NM within the next year\n* Not willing to receive patients' out-of-office blood pressure data"}, 'identificationModule': {'nctId': 'NCT07397260', 'acronym': 'AUTO 2', 'briefTitle': 'Automatically Transmitted Home Blood Pressure and Automated Patient Feedback in Hypertension Care: the AUTO 2 Trial', 'organization': {'class': 'OTHER', 'fullName': 'Northwestern University'}, 'officialTitle': 'Effects of Manually Recorded or Automatically Transmitted Home Blood Pressures With or Without Automated Patient Feedback on Hypertension Care', 'orgStudyIdInfo': {'id': 'STU00224615'}, 'secondaryIdInfos': [{'id': 'R01HL179919', 'link': 'https://reporter.nih.gov/quickSearch/R01HL179919', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Enhanced Usual Care', 'description': 'Participants receive a blood pressure monitor and are encouraged to enter blood pressure results into their EHR patient portal.', 'interventionNames': ['Other: Self report of home measured blood pressure via patient EHR portal']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Automated Transmission of Remotely Monitored Blood Pressure', 'description': 'Participants receive a blood pressure monitor and an application to directly transmit measurements to their EHR record.', 'interventionNames': ['Other: Automated Transmission of Remotely Measured Blood Pressure']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Automated Patient Feedback on Self Blood Pressure Monitoring', 'description': 'Participants receive a blood pressure monitor and are encouraged to enter blood pressure results into their EHR patient portal. Participants receive messages through the EHR patient portal about their home blood pressure results.', 'interventionNames': ['Other: Self report of home measured blood pressure via patient EHR portal', 'Other: Automated feedback about home blood pressure results']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Automated Transmission of Remotely Monitored Blood Pressure and Automated Feedback', 'description': 'Participants receive a blood pressure monitor and an application to directly transmit measurements to their EHR record. Participants receive messages through the EHR patient portal about their home blood pressure results.', 'interventionNames': ['Other: Automated feedback about home blood pressure results', 'Other: Automated Transmission of Remotely Measured Blood Pressure']}], 'interventions': [{'name': 'Self report of home measured blood pressure via patient EHR portal', 'type': 'OTHER', 'description': 'Participants will be provided with a home blood pressure monitor and method to use the EHR portal to enter home collected blood pressures into the EHR.', 'armGroupLabels': ['Automated Patient Feedback on Self Blood Pressure Monitoring', 'Enhanced Usual Care']}, {'name': 'Automated feedback about home blood pressure results', 'type': 'OTHER', 'description': 'Patients will received periodic messages about the results of their home blood pressure monitoring with suggestions to consult with clinical care team when indicated.', 'armGroupLabels': ['Automated Patient Feedback on Self Blood Pressure Monitoring', 'Automated Transmission of Remotely Monitored Blood Pressure and Automated Feedback']}, {'name': 'Automated Transmission of Remotely Measured Blood Pressure', 'type': 'OTHER', 'description': 'Participants will be provided with a blood pressure monitor and application to automatically transmit home blood pressures to their EHR record.', 'armGroupLabels': ['Automated Transmission of Remotely Monitored Blood Pressure', 'Automated Transmission of Remotely Monitored Blood Pressure and Automated Feedback']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Yaw Amofa Peprah, MPH', 'role': 'CONTACT', 'email': 'yaw.peprah@northwestern.edu', 'phone': '3125032753'}], 'overallOfficials': [{'name': 'Stephen D Persell, MD,MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Northwestern University'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Northwestern University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Heart, Lung, and Blood Institute (NHLBI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Medicine', 'investigatorFullName': 'Stephen Persell, MD, MPH', 'investigatorAffiliation': 'Northwestern University'}}}}