Telemonitoring of Hypertensive Patients With Chronic Kidney Disease
Telemonitoring and Case Management for Hypertensive and Remote-dwelling Patients With Chronic Kidney Disease - The Telemonitoring for Improved Kidney Outcomes Study (TIKO): A Clinical Research Protocol
- Chronic Kidney Diseases
At a glance
- Phase
- Phase not stated
- Study type
- Interventional
- Sponsor
- University of Alberta
- Enrolment target
- 146
- Started
- 15 April 2022
- Main results due
- 31 December 2026
- Study sites
- 1
- Registry updated
- 29 September 2026
Can you take part?
- Aged 18 years and over.
- Open to any sex.
- You need the condition being studied — healthy volunteers are not accepted.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full eligibility criteria
Inclusion Criteria: * Age equal to and more than 18 years with documented diagnosis of established CKD (not on dialysis with eGFR \< 60 mL/min/1.73m2 and/or proteinuria \> 1 g/day) * Remote dwelling patients in the Peace River region of Alberta, Canada * Patients known with hypertension (physician diagnosed / self reported and currently taking antihypertensive medications) * Owning a smartphone (iOS or Android) with access to wireless internet connection. * Proficiency in English language (both verbal and written); and ability and willingness to provide informed consent for participation. * Ability and willingness to use the HBPT device (≥ 80% recordings sent in the training period) Exclusion Criteria: * Patients with hypertensive urgency or emergency identified during the training period (immediate consultation will be initiated with the patient's PCP or with a hypertension specialist) * Patients with stage 5 CKD (eGFR ≤ 15 ml/min/1.73m2) or patients receiving kidney replacement therapy * Heart failure with reduced ejection fraction * Presence of any terminal illness (life expectancy \< 1 year) * Participation in any ongoing clinical drug trial * Pregnancy, lactation / breastfeeding * Planning to relocate out of the Peace River region or residence in an area without mobile phone coverage.
What this study is about
In the sponsor’s own words, from the registry.
Background:
Hypertension, together with poorly controlled blood pressure (BP) are known risk factors for kidney disease and progression to kidney failure as well as increased cardiovascular (CV) morbidity and mortality. Several studies in patients without kidney disease have demonstrated the efficacy of home BP telemonitoring (HBPT) for BP control.
Objective:
The primary aim of this study is to assess the mean difference in systolic BP (SBP) at 12 months, from baseline in remote dwelling patients with hypertension and chronic kidney disease (CKD) in Northern Alberta, Canada, comparing HBPT + usual care versus HBPT + a case manager. Other secondary objectives, including cost-effectiveness and acceptability of HBPT as well as occurrence of adverse events will also be assessed.
Methods
Design:
This study is designed as a pragmatic randomized controlled trial (RCT) of HBPT plus clinical case management compared to HBPT with usual care.
Setting:
Peace River region in Northern Alberta Region, Canada.
Patients:
Primary care patients with CKD and hypertension.
Measurements:
Eligible patients will be randomized 1:1 to HBPT + BP case management versus HBPT + usual care. In the intervention arm, BP will be measured 4 times daily for 1 week, with medications titrated up or down by the study case manager until guideline targets (systolic BP \[SBP\]: \<130mmHg) are achieved. Once BP is controlled, (i.e., to guideline-concordant targets), this 1-week protocol will be repeated every 3 months for 1 year. Patients in the control arm will also follow the same BP measurement protocol, however, there will be no interactions with the case manager; they will share their BP readings with their primary care physicians or nurse practitioners at scheduled visits.
Limitations:
Potential limitations of this study include the relatively short duration of follow-up, possible technological pitfalls, and need for patients to own a smartphone and have access to the internet to participate.
Conclusions:
As this study will focus on a high-risk population that has been characterized by a large care gap, it will generate important evidence that would allow targeted and effective population-level strategies to be implemented to improve health outcomes for high-risk hypertensive CKD patients in Canada's remote communities.
Study sites(1)
University of Alberta
Edmonton, Albert, Canada
Recruiting
Showing 1 of 1 sites. 1 of the 1 site on this study is recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT04098354. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
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