title: Telemonitoring and Protocolized Case Management for Hypertensive Community-Dwelling Seniors With Diabetes: Protocol of the TECHNOMED Randomized Controlled Trial.
abstract: BACKGROUND
  Diabetes and hypertension are devastating, deadly, and costly conditions that are very common in seniors. Controlling hypertension in seniors with diabetes dramatically reduces hypertension-related complications. However, blood pressure (BP) must be lowered carefully because seniors are also susceptible to low BP and attendant harms. Achieving "optimal BP control" (ie, avoiding both undertreatment and overtreatment) is the ultimate therapeutic goal in such patients. Regular BP monitoring is required to achieve this goal. BP monitoring at home is cheap, convenient, widely used, and guideline endorsed. However, major barriers prevent proper use. These may be overcome through use of BP telemonitoring-the secure teletransmission of BP readings to a health portal, where BP data are summarized for provider and patient use, with or without protocolized case management.
  
  
  OBJECTIVE
  To examine the incremental effectiveness, safety, cost-effectiveness, usability, and acceptability of home BP telemonitoring, used with or without protocolized case management, compared with "enhanced usual care" in community-dwelling seniors with diabetes and hypertension.
  
  
  METHODS
  A 300-patient, 3-arm, pragmatic randomized controlled trial with blinded outcome ascertainment will be performed in seniors with diabetes and hypertension living independently in seniors' residences in greater Edmonton. Consenting patients will be randomized to usual care, home BP telemonitoring alone, or home BP telemonitoring plus protocolized pharmacist case management. Usual care subjects will receive a home BP monitor but neither they nor their providers will have access to teletransmitted data. In both telemonitored arms, providers will receive telemonitored BP data summaries. In the case management arm, pharmacist case managers will be responsible for reviewing teletransmitted data and initiating guideline-concordant and protocolized changes in BP management.
  
  
  RESULTS
  Outcomes will be ascertained at 6 and 12 months. Within-study-arm change scores will be calculated and compared between study arms. These include: (1) clinical outcomes: proportion of subjects with a mean 24-hour ambulatory systolic BP in the optimal range (110-129 mmHg in patients 65-79 years and 110-139 mmHg in those ≥80 years: primary outcome); additional ambulatory and home BP outcomes; A1c and lipid profile; medications, cognition, health care use, cardiovascular events, and mortality. (2) Safety outcomes: number of serious episodes of hypotension, syncope, falls, and electrolyte disturbances (requiring third party assistance or medical attention). (3) Humanistic outcomes: quality of life, satisfaction, and medication adherence. (4) Economic outcomes: incremental costs, incremental cost-utility, and cost per mmHg change in BP of telemonitoring ± case management compared with usual care (health payor and societal perspectives). (5) Intervention usability and acceptability to patients and providers.
  
  
  CONCLUSIONS
  The potential benefits of telemonitoring remain largely unstudied and unproven in seniors. This trial will comprehensively assess the impact of home BP telemonitoring across a range of outcomes. Results will inform the value of implementing home-based telemonitoring within supportive living residences in Canada.
  
  
  BACKGROUND
  Clinicaltrials.gov NCT02721667; https://clinicaltrials.gov/ct2/show/NCT02721667 (Archived by Webcite at http://www.webcitation.org/6i8tB20Mc).
authors.affiliation: Department of Medicine, University of Alberta, Edmonton, AB, Canada. rpadwal@ualberta.ca.
authors.forename: Raj
authors.identifier: http://orcid.org/0000-0003-3541-2817
authors.initials: R
authors.lastname: Padwal
authors.forename: Finlay Aleck
authors.identifier: http://orcid.org/0000-0001-7435-3341
authors.initials: FA
authors.lastname: McAlister
authors.forename: Peter William
authors.identifier: http://orcid.org/0000-0002-2363-0289
authors.initials: PW
authors.lastname: Wood
authors.forename: Pierre
authors.identifier: http://orcid.org/0000-0002-4219-1699
authors.initials: P
authors.lastname: Boulanger
authors.forename: Miriam
authors.identifier: http://orcid.org/0000-0003-3690-0441
authors.initials: M
authors.lastname: Fradette
authors.forename: Scott
authors.identifier: http://orcid.org/0000-0002-8611-1056
authors.initials: S
authors.lastname: Klarenbach
authors.forename: Alun L
authors.identifier: http://orcid.org/0000-0001-9286-4006
authors.initials: AL
authors.lastname: Edwards
authors.forename: Jayna M
authors.identifier: http://orcid.org/0000-0002-4120-0792
authors.initials: JM
authors.lastname: Holroyd-Leduc
authors.forename: Kannayiram
authors.identifier: http://orcid.org/0000-0003-1444-2451
authors.initials: K
authors.lastname: Alagiakrishnan
authors.forename: Doreen
authors.identifier: http://orcid.org/0000-0001-5317-3843
authors.initials: D
authors.lastname: Rabi
authors.forename: Sumit Ranjan
authors.identifier: http://orcid.org/0000-0003-0686-9914
authors.initials: SR
authors.lastname: Majumdar
keywords: blood pressure; case management; hypertension; randomized controlled trial; seniors; telemonitoring