Telemonitoring of Hypertensive Patients With Chronic Kidney Disease

NCT04098354 | Recruiting

• 1 other identifier: Pro00095231
• Study Type: interventional
• Target: 146
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Kidney Diseases

Outcome Measures

Primary Outcomes (1)

• Effectiveness of telemonitoring and protocol-based case management versus usual care:

  The primary outcome will be the mean difference (MD) in home SBP at 12 months, from baseline values.

  Upto 12 months

Secondary Outcomes (1)

• Proportion of patients with systolic blood pressure within guideline target, user acceptability, adverse events, cost-effectiveness and utility.

  upto 12 months

Study Arms (2)

home-based BP telemonitoring

ACTIVE COMPARATOR

Patients will receive a Bluetooth-enabled and validated electronic upper arm oscillometric BP device (A\&D Ltd. UA-651BLE; San Jose, CA) that will be paired to their smartphone. Patients will be required to sit with their back rested for at least 5 minutes with the BP cuff around their arm. They will then be required to push the start button on the HBPT device to initiate BP measurement. HBPT values will be based on a series comprised of the mean of duplicate measures, for morning and evening, for a 7-day period and the first day home BP values will not be considered. The BP data will be auto transmitted via Bluetooth to their smartphone and relayed to a secure web portal for review.

Diagnostic Test: home BP telemonitoring system .

usual care

PLACEBO COMPARATOR

Patients in the control arm will also follow the same BP measurement protocol as the 'active comparator (intervention) group, 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.

Diagnostic Test: home BP telemonitoring system .

Interventions

home BP telemonitoring system . DIAGNOSTIC_TEST

Patients will receive a Bluetooth-enabled and validated electronic upper arm oscillometric BP device (A\&D Ltd. UA-651BLE; San Jose, CA) that will be paired to their smartphone. Patients will be required to sit with their back rested for at least 5 minutes with the BP cuff around their arm. They will then be required to push the start button on the HBPT device to initiate BP measurement. HBPT values will be based on a series comprised of the mean of duplicate measures, for morning and evening, for a 7-day period and the first day home BP values will not be considered. The BP data will be auto transmitted via Bluetooth to their smartphone and relayed to a secure web portal for review.

home-based BP telemonitoring; usual care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Alberta: lead

Study Sites (1)

University of Alberta

Edmonton, Albert, T6G 2C8, Canada

RECRUITING

Related Publications (1)

• Okpechi IG, Zaidi D, Ye F, Fradette M, Schick-Makaroff K, Berendonk C, Abdulrahman A, Braam B, Ghimire A, Hariramani VK, Jindal K, Khan M, Klarenbach S, Muneer S, Ringrose J, Scott-Douglas N, Shojai S, Slabu D, Sultana N, Tinwala MM, Thompson S, Padwal R, Bello AK. 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. Can J Kidney Health Dis. 2022 Feb 13;9:20543581221077500. doi: 10.1177/20543581221077500. eCollection 2022.

  PMID: 35186305 DERIVED

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Aminu Bello

  University of Alberta

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Deenaz Zaidi

CONTACT

17807098964; deenaz@ualberta.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: No masking
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study is designed as a pragmatic randomized controlled trial (RCT) of HBPT plus clinical case management compared to HBPT with usual care. 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.

Study Record Dates

• First Submitted: September 17, 2019
• First Posted: September 23, 2019
• Study Start: April 15, 2022
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: September 18, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)