HypertensionTECHNOMEDNCT02721667
Telemonitoring and Protocolized Case Management for Hypertensive Community Dwelling Seniors With Complex Care Needs
A study testing Telemonitoring and Case Management in people with Hypertension, run by University of Alberta at 1 site in Canada.
Trial summary
Hypertension affects over 70% of Canadians over the age of 65y. Seniors with hypertension are at high risk for cardiovascular disease and death. Most of this risk is mediated through high blood pressure (BP). However, seniors are also at risk for side effects from BP lowering medication. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- Telemonitoring and Case Management
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2016to 15 May 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Documented diagnosis of hypertension.
- Adequate English fluency (both verbal and written).
Who cannot join
- Systolic BP level >220 mmHg or diastolic BP level >110 mmHg on screening BP measurement (WatchBP [Microlife Corp., Widnau, Switzerland]).
- Heart failure
- Severe cognitive impairment, defined as a score of ≥ 5 on the Short Portable Mental Status Questionnaire.
- Severe depression (Patient Health Questionnaire [PHQ-8] ≥15).
- Foreshortened life expectancy (<1y).
- Participation in a concurrent cardiovascular trial.
- Currently receiving case management services for cardiovascular risk factor control.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Seniors independent living or supportive living residences in greater Edmonton.
Edmonton, Alberta
About this study
Hypertension affects over 70% of Canadians over the age of 65y. Seniors with hypertension are at high risk for cardiovascular disease and death. Most of this risk is mediated through high blood pressure (BP). However, seniors are also at risk for side effects from BP lowering medication. These can be life threatening and costly. Therefore, BP monitoring is required to ensure BP levels are in the recommended range (neither too high nor low).
Home BP monitoring can be used to ensure that BP is in the right range and is recommended for all patients with high BP. Studies in other health care systems show that, to optimally perform home monitoring, the readings should be teletransmitted (electronically sent to the care provider). Additional studies indicate that BP control improves when health care providers (usually pharmacists or nurses) are specifically assigned to review teletransmitted BP readings and, using protocols, make therapeutic adjustments. However, a study needs to be conducted within the Canadian healthcare system to prove that telemonitoring±case management is cost-effective. In addition, proof that seniors consider telemonitoring to be usable and acceptable is required.
The investigators will conduct a 200 patient randomized trial in community-dwelling seniors that will compare home BP monitoring alone to telemonitoring plus case management, to comprehensively assess cost-effectiveness, usability, and acceptability. Our partners include TeleMED, a medium sized Canadian technology company with a wealth of experience in medical data management and transmission; Pharmacare, which will provide case-management services. The study will take place in seniors' supportive living residences; by virtue of residing in these institutions, these seniors have complex care needs. This intervention, if effective, cost-effective and safe, can be widely implemented.
Read the detailed description
Objective:
Assess the 'real world' effectiveness, safety and cost-effectiveness of home BP telemonitoring in combination with protocolized pharmacist case management in community-dwelling seniors with diabetes and hypertension.
Background:
Hypertension, present in over 70% of seniors, causes devastating cardiovascular complications and premature death. Despite its critical importance to health, high BP is uncontrolled in about 35% of seniors with diabetes (i.e., undertreatment). Conversely, antihypertensive drug therapy can excessively lower BP, causing serious adverse effects that warrant drug discontinuation or dose reduction (i.e., overtreatment). Both undertreatment and overtreatment lead to potentially preventable harms and thus need to be minimized.
Office BP measurements are currently used to monitor the vast majority of Canadians with hypertension; however, they are inaccurate and Canadian guidelines (May 2015) instead strongly endorse use of home BP because home readings are more accurate and more convenient to measure. Home readings can be taken in 3 ways: 1. by the patient alone (who bears responsibility for giving the readings to their provider); 2. via telemonitoring, in which readings are automatically summarized and sent to the care provider; 3. through telemonitoring plus protocolized case management, in which the summarized readings are reviewed by a case manager (usually a nurse or pharmacist) authorized to adjust treatments. Telemonitoring and case management is not being used in Canada because validation data in this country are lacking and the pre-requisite tech infrastructure does not exist. The patient alone method is being used exclusively but has many barriers and pitfalls (including failure to take the proper number of readings, report all readings, calculate mean BP, or use this information to optimally manage both inappropriately high and low BP).
Design:
In this 1-year pragmatic, prospective, randomized open label trial with blinded ascertainment of endpoints, 200 patients will be randomly assigned (1:1) to one of 2 study arms: enhanced usual care (home BP monitoring alone) or home BP telemonitoring plus protocolized case management. Randomization will be performed independent of the study team (by EPICORE Centre) through a centralized computerized concealed process, stratified by baseline BP (above versus below 140 mmHg systolic BP). Outcomes assessors and analysts will be masked to allocation status. Blinded assessment of the primary endpoint (24-hour ambulatory BP) will be performed.
Methods:
All participants will receive a validated electronic upper arm oscillometric BP device (A\&D Ltd. UA-651BLE; San Jose, CA) and a set top box (a hub for wireless data transmission to a secure server). Participants without internet access will also receive a cellphone with a data plan. Pushing a single button activates the device and initiates a BP measurement, which is auto-transmitted to the set top box via a bluetooth connection. The academic research team in collaboration with TeleMED, a Canadian based telemedicine company, will build data transmission protocols (using Secure Sockets Layer [SSL] encrypted data transmission) and TeleMED will build and maintain the health portal platform.
Four BP measurements will be taken daily for 1 week (home BP series). If BP is high or low, the home BP series will be done each month until BP is in the therapeutic range. Once controlled, the protocol will be repeated every 3 months, as recommended by guidelines.
Teletransmitted BP readings will be summarized within a secure health portal using TeleMED software, which will be used to calculate an overall weekly mean. Temporal trends will be plotted. BP teletransmission will occur in all study arms but will be used differently in each.
Consecutive, consenting seniors (≥65 years) with hypertension, will be recruited from seniors supportive living residences including (but not necessarily limited to) 43 Greater Edmonton Foundation (GEF) Seniors Housing (www.gef.org) and Rosedale Seniors' Living (rosedaledevelopments.com) residences; none of these residents currently receive telemonitoring or case management. They will be followed by the study team for a period of 1 year; outcome assessments will occur at 6 and 12-months post randomization.
- Conditions
- Hypertension
- Being tested
- Telemonitoring, Case Management
- Keywords
- Blood pressure, Telemonitoring, Case management, Seniors
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TelemonitoringDevice
Secure, wireless transmission of home blood pressure measurements that are summarized in a secure health portal for healthcare providers use for clinical management decisions, including calculation of mean BP and graphing of temporal trends.
Case ManagementOther
Case managers work collaboratively with patients and physicians to optimize health behaviours, monitor risk factors, implement therapeutic adjustments, encourage adherence, and coordinate follow-up care.
| Study group | Role | What they receive |
|---|---|---|
| Enhanced Usual Care | No intervention | Participants receive a home BP monitor, are taught how to measure home BP and are encouraged to take BP readings to appointments with their providers. In addition, they will be reminded to perform a home BP series each quarter for study outcome purposes, which will encourage self-monitoring. Home BP readings will be teletransmitted for data collection purposes but neither participants nor providers will have access to the these readings. High BP levels that trigger safety alerts to research personnel are the only exception - participants and their primary care providers will be made aware of these. |
| Telemonitoring and Case Management | Active comparator | Home BP series mean, trends and individual readings will be generated for use by the case manager. Participants in this arm will each be assigned a pharmacist case manager who holds full prescribing privileges and who will:
1. Administer health behaviour modification counselling, teach BP self-monitoring, and monitor medication adherence;
2. Review telemonitored health portal BP summaries and make medication regimen adjustments according to guideline-concordant study protocol;
3. Fax a summary of these adjustments to the participant's primary care provider (to make them aware of treatment changes); and
4. Facilitate communication between participants and providers. Receives: Device: Telemonitoring; Other: Case Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Pressure (24-hour Ambulatory Blood Pressure Monitoring, ABPM))
Proportion of patients with overall 24-hour ABPM in the optimal range (110-129 mmHg in patients 65-79y and 110-139 mmHg in patients 80 y or older)
Measured: one year
Secondary outcomes (6)
Blood Pressure
Change in mean 24-hour systolic and diastolic BP (overall, daytime, and nighttime), home BP and the automated BP measurements (taken at each study visit) will be examined
Measured: one year
Postural Blood pressure changes
Change in automated BP measurements examining postural changes (sitting, supine, standing)
Measured: one year
Antihypertensive Medications
Initiation, dosage modification and/or discontinuation of medications to control blood pressure
Measured: one year
Incidence of Treatment-Emergent Adverse Events
Frequency of serious non-mechanical falls, syncope, hypotension, and electrolyte disturbances.
Measured: one year
Cognition
Change in Montreal Cognitive Assessment Scale score
Measured: one year
Cost-Effectiveness of Telemonitoring
Economic models from the health care payor perspective will be constructed and standard cost-effectiveness metrics analyzed.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2016 (estimated)
- Study startSep 2016
- Primary completion15 May 2020
- Study completion15 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Alberta Innovates Health Solutions
- Responsible party
- Principal investigator, Raj Padwal, University of Alberta
- Investigators
- Raj Padwal, MD, Msc, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02721667
- Sponsor's protocol ID
- CIHR EH2-143571
- Acronym
- TECHNOMED
- Status last verified
- Nov 2020
- First submitted
- 17 Mar 2016
- Last updated
- 4 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Padwal R, McAlister FA, Wood PW, Boulanger P, Fradette M, Klarenbach S, Edwards AL, Holroyd-Leduc JM, Alagiakrishnan K, Rabi D, Majumdar SR. Telemonitoring and Protocolized Case Management for Hypertensive Community-Dwelling Seniors With Diabetes: Protocol of the TECHNOMED Randomized Controlled Trial. JMIR Res Protoc. 2016 Jun 24;5(2):e107. doi: 10.2196/resprot.5775.
PubMed 27343147
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telemonitoring and Protocolized Case Management for Hypertensive Community Dwelling Seniors With Complex Care Needs
- ClinicalTrials.gov ID
- NCT02721667
- Acronym / sponsor ID
- TECHNOMED / CIHR EH2-143571
- Conditions
- Hypertension
- Keywords
- Blood pressure, Telemonitoring, Case management, Seniors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Alberta Innovates Health Solutions
- Study start
- Sep 2016 (actual)
- Primary completion
- 15 May 2020 (actual)
- Study completion
- 15 May 2020 (actual)
- First posted
- 29 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Hypertension affects over 70% of Canadians over the age of 65y. Seniors with hypertension are at high risk for cardiovascular disease and death. Most of this risk is mediated through high blood pressure (BP). However, seniors are also at risk for side effects from BP lowering medication. These can be life threatening and costly. Therefore, BP monitoring is required to ensure BP levels are in the recommended range (neither too high nor low).
Home BP monitoring can be used to ensure that BP is in the right range and is recommended for all patients with high BP. Studies in other health care systems show that, to optimally perform home monitoring, the readings should be teletransmitted (electronically sent to the care provider). Additional studies indicate that BP control improves when health care providers (usually pharmacists or nurses) are specifically assigned to review teletransmitted BP readings and, using protocols, make therapeutic adjustments. However, a study needs to be conducted within the Canadian healthcare system to prove that telemonitoring±case management is cost-effective. In addition, proof that seniors consider telemonitoring to be usable and acceptable is required.
The investigators will conduct a 200 patient randomized trial in community-dwelling seniors that will compare home BP monitoring alone to telemonitoring plus case management, to comprehensively assess cost-effectiveness, usability, and acceptability. Our partners include TeleMED, a medium sized Canadian technology company with a wealth of experience in medical data management and transmission; Pharmacare, which will provide case-management services. The study will take place in seniors' supportive living residences; by virtue of residing in these institutions, these seniors have complex care needs. This intervention, if effective, cost-effective and safe, can be widely implemented.
Detailed description
Objective:
Assess the 'real world' effectiveness, safety and cost-effectiveness of home BP telemonitoring in combination with protocolized pharmacist case management in community-dwelling seniors with diabetes and hypertension.
Background:
Hypertension, present in over 70% of seniors, causes devastating cardiovascular complications and premature death. Despite its critical importance to health, high BP is uncontrolled in about 35% of seniors with diabetes (i.e., undertreatment). Conversely, antihypertensive drug therapy can excessively lower BP, causing serious adverse effects that warrant drug discontinuation or dose reduction (i.e., overtreatment). Both undertreatment and overtreatment lead to potentially preventable harms and thus need to be minimized.
Office BP measurements are currently used to monitor the vast majority of Canadians with hypertension; however, they are inaccurate and Canadian guidelines (May 2015) instead strongly endorse use of home BP because home readings are more accurate and more convenient to measure. Home readings can be taken in 3 ways: 1. by the patient alone (who bears responsibility for giving the readings to their provider); 2. via telemonitoring, in which readings are automatically summarized and sent to the care provider; 3. through telemonitoring plus protocolized case management, in which the summarized readings are reviewed by a case manager (usually a nurse or pharmacist) authorized to adjust treatments. Telemonitoring and case management is not being used in Canada because validation data in this country are lacking and the pre-requisite tech infrastructure does not exist. The patient alone method is being used exclusively but has many barriers and pitfalls (including failure to take the proper number of readings, report all readings, calculate mean BP, or use this information to optimally manage both inappropriately high and low BP).
Design:
In this 1-year pragmatic, prospective, randomized open label trial with blinded ascertainment of endpoints, 200 patients will be randomly assigned (1:1) to one of 2 study arms: enhanced usual care (home BP monitoring alone) or home BP telemonitoring plus protocolized case management. Randomization will be performed independent of the study team (by EPICORE Centre) through a centralized computerized concealed process, stratified by baseline BP (above versus below 140 mmHg systolic BP). Outcomes assessors and analysts will be masked to allocation status. Blinded assessment of the primary endpoint (24-hour ambulatory BP) will be performed.
Methods:
All participants will receive a validated electronic upper arm oscillometric BP device (A\&D Ltd. UA-651BLE; San Jose, CA) and a set top box (a hub for wireless data transmission to a secure server). Participants without internet access will also receive a cellphone with a data plan. Pushing a single button activates the device and initiates a BP measurement, which is auto-transmitted to the set top box via a bluetooth connection. The academic research team in collaboration with TeleMED, a Canadian based telemedicine company, will build data transmission protocols (using Secure Sockets Layer [SSL] encrypted data transmission) and TeleMED will build and maintain the health portal platform.
Four BP measurements will be taken daily for 1 week (home BP series). If BP is high or low, the home BP series will be done each month until BP is in the therapeutic range. Once controlled, the protocol will be repeated every 3 months, as recommended by guidelines.
Teletransmitted BP readings will be summarized within a secure health portal using TeleMED software, which will be used to calculate an overall weekly mean. Temporal trends will be plotted. BP teletransmission will occur in all study arms but will be used differently in each.
Consecutive, consenting seniors (≥65 years) with hypertension, will be recruited from seniors supportive living residences including (but not necessarily limited to) 43 Greater Edmonton Foundation (GEF) Seniors Housing (www.gef.org) and Rosedale Seniors' Living (rosedaledevelopments.com) residences; none of these residents currently receive telemonitoring or case management. They will be followed by the study team for a period of 1 year; outcome assessments will occur at 6 and 12-months post randomization.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Enhanced Usual Care | No intervention | –Participants receive a home BP monitor, are taught how to measure home BP and are encouraged to take BP readings to appointments with their providers. In addition, they will be reminded to perform a home BP series each quarter for study outcome purposes, which will encourage self-monitoring. Home BP readings will be teletransmitted for data collection purposes but neither participants nor providers will have access to the these readings. High BP levels that trigger safety alerts to research personnel are the only exception - participants and their primary care providers will be made aware of these. |
| Telemonitoring and Case Management | Active comparator | Device: Telemonitoring, Other: Case ManagementHome BP series mean, trends and individual readings will be generated for use by the case manager. Participants in this arm will each be assigned a pharmacist case manager who holds full prescribing privileges and who will: 1. Administer health behaviour modification counselling, teach BP self-monitoring, and monitor medication adherence; 2. Review telemonitored health portal BP summaries and make medication regimen adjustments according to guideline-concordant study protocol; 3. Fax a summary of these adjustments to the participant's primary care provider (to make them aware of treatment changes); and 4. Facilitate communication between participants and providers. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Documented diagnosis of hypertension.
- Adequate English fluency (both verbal and written).
Key exclusion criteria (7 listed)
- Systolic BP level >220 mmHg or diastolic BP level >110 mmHg on screening BP measurement (WatchBP [Microlife Corp., Widnau, Switzerland]).
- Heart failure
- Severe cognitive impairment, defined as a score of ≥ 5 on the Short Portable Mental Status Questionnaire.
- Severe depression (Patient Health Questionnaire [PHQ-8] ≥15).
- Foreshortened life expectancy (<1y).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TelemonitoringSecure, wireless transmission of home blood pressure measurements that are summarized in a secure health portal for healthcare providers use for clinical management decisions, including calculation of mean BP and graphing of temporal trends. | Device | Telemonitoring and Case Management |
| Case ManagementCase managers work collaboratively with patients and physicians to optimize health behaviours, monitor risk factors, implement therapeutic adjustments, encourage adherence, and coordinate follow-up care. | Other | Telemonitoring and Case Management |
Primary outcome
Blood Pressure (24-hour Ambulatory Blood Pressure Monitoring, ABPM))
Time frame: one year
Proportion of patients with overall 24-hour ABPM in the optimal range (110-129 mmHg in patients 65-79y and 110-139 mmHg in patients 80 y or older)
6 secondary outcomes
Blood Pressure
Time frame: one year
Postural Blood pressure changes
Time frame: one year
Antihypertensive Medications
Time frame: one year
Incidence of Treatment-Emergent Adverse Events
Time frame: one year
Cognition
Time frame: one year
Cost-Effectiveness of Telemonitoring
Time frame: one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2020.
- Background: PubMed 27343147Padwal R, McAlister FA, Wood PW, Boulanger P, Fradette M, Klarenbach S, Edwards AL, Holroyd-Leduc JM, Alagiakrishnan K, Rabi D, Majumdar SR. Telemonitoring and Protocolized Case Management for Hypertensive Community-Dwelling Seniors With Diabetes: Protocol of the TECHNOMED Randomized Controlled Trial. JMIR Res Protoc. 2016 Jun 24;5(2):e107. doi: 10.2196/resprot.5775.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Raj Padwal, MD, Msc principal investigator
University of Alberta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telemonitoring and Case Management in people with Hypertension, run by University of Alberta at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood Pressure (24-hour Ambulatory Blood Pressure Monitoring, ABPM)) (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02721667, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2020.