title: A randomized controlled trial of telemonitoring in older adults with multiple chronic conditions: the Tele-ERA study.
abstract: BACKGROUND
  Older adults with multiple chronic illnesses are at risk for worsening functional and medical status and hospitalization. Home telemonitoring may help slow this decline. This protocol of a randomized controlled trial was designed to help determine the impact of home telemonitoring on hospitalization. The specific aim of the study reads as follows: to determine the effectiveness of home telemonitoring compared with usual care in reducing the combined outcomes of hospitalization and emergency department visits in an at-risk population 60 years of age or older.
  
  
  METHODS
  Two-hundred patients with the highest 10% Mayo Clinic Elder Risk Assessment scores will be randomly assigned to one of two interventions. Home telemonitoring involves the use of a computer device, the Intel Health Guide, which records biometric and symptom data from patients in their homes. This information is monitored by midlevel providers associated with a primary care medical practice. Under the usual care scenario, patients make appointments with their providers as problems arise and use ongoing support such as a 24-hour nurse line.Patients will have initial evaluations of gait and quality of life using instruments such as the SF-12 Health Survey, the Kokmen Short Test of Mental Status, and the PHQ-9 health questionnaire. Patients will be followed for 1 year for primary outcomes of hospitalizations and emergency department visits. Secondary analysis will include quality of life, compliance with the device, and attitudes about telemonitoring. Sample size is based on an 80% power to detect a 36% difference between the two groups. The primary analysis will involve Cox proportional time-to-event analysis. Secondary analysis will use t-test comparisons for continuous variables and the chi square test for proportional analysis.
  
  
  CONCLUSIONS
  Patients randomized to home telemonitoring will have daily assessments of their health status using the device. Registered nurse monitoring will assess any change in status followed by videoconferencing by a mid-level provider. We obtained trial registration and Institutional Review Board approval.
  
  
  BACKGROUND
  Trial registration number through http://www.clinicaltrials.gov: NCT01056640.
authors.affiliation: Department of Internal Medicine Mayo Clinic 200 First Street SW Rochester, Minnesota 55905, USA. takahashi.paul@mayo.edu
authors.forename: Paul Y
authors.initials: PY
authors.lastname: Takahashi
authors.forename: Gregory J
authors.initials: GJ
authors.lastname: Hanson
authors.forename: Jennifer L
authors.initials: JL
authors.lastname: Pecina
authors.forename: Robert J
authors.initials: RJ
authors.lastname: Stroebel
authors.forename: Rajeev
authors.initials: R
authors.lastname: Chaudhry
authors.forename: Nilay D
authors.initials: ND
authors.lastname: Shah
authors.forename: James M
authors.initials: JM
authors.lastname: Naessens
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D002908:Chronic Disease / Q000628:therapy*; D015897:Comorbidity; D019468:Disease Management; D005260:Female; D015577:Geriatric Assessment; D006699:Home Care Services / Q000458:organization & administration; D006801:Humans; D008297:Male; D008991:Monitoring, Physiologic; D005791:Patient Care / Q000379:methods; D016016:Proportional Hazards Models; D011787:Quality of Health Care; D012016:Reference Values; D012720:Severity of Illness Index; D017216:Telemedicine / Q000379:methods*; D013686:Telemetry / Q000379:methods*; D014481:United States; D035862:Vulnerable Populations
references.citation: Med Care. 1996 Mar;34(3):220-33
references.pmid: 8628042
references.citation: Aging Clin Exp Res. 2008 Jun;20(3):181-8
references.pmid: 18594183
references.citation: Int J Cardiol. 2009 Jan 9;131(2):192-9
references.pmid: 18222552
references.citation: Age Ageing. 1997 Jan;26(1):15-9
references.pmid: 9143432
references.citation: Health Aff (Millwood). 2001 Mar-Apr;20(2):9-18
references.pmid: 11260963
references.citation: Telemed J E Health. 2004 Summer;10(2):170-83
references.pmid: 15319047
references.citation: Ann Intern Med. 2004 Oct 19;141(8):606-13
references.pmid: 15492340
references.citation: Am J Manag Care. 2006 Aug;12(8):467-74
references.pmid: 16886889
references.citation: J Gen Intern Med. 2001 Sep;16(9):606-13
references.pmid: 11556941
references.citation: Conf Proc IEEE Eng Med Biol Soc. 2004;2004:3264-5
references.pmid: 17270977
references.citation: J Am Med Inform Assoc. 2007 May-Jun;14(3):269-77
references.pmid: 17329725
references.citation: J Am Geriatr Soc. 1991 Feb;39(2):142-8
references.pmid: 1991946
references.citation: Eval Health Prof. 2005 Dec;28(4):464-78
references.pmid: 16272426
references.citation: Age Ageing. 2009 Mar;38(2):219-25
references.pmid: 19171951
references.citation: Ann Intern Med. 2007 Aug 7;147(3):156-64
references.pmid: 17679703
references.citation: Telemed J E Health. 2006 Apr;12(2):128-36
references.pmid: 16620167
references.citation: J Am Geriatr Soc. 1996 Nov;44(11):1332-41
references.pmid: 8909349
references.citation: Telemed J E Health. 2008 Nov;14(9):1003-7
references.pmid: 19035817
references.citation: Int Disabil Stud. 1988;10(2):64-7
references.pmid: 3042746
references.citation: Mayo Clin Proc. 1987 Apr;62(4):281-8
references.pmid: 3561043