Telemonitoring blood pressure in 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
This study is testing if using home blood pressure monitoring along with extra support can help people with high blood pressure and chronic kidney disease manage their condition better than standard care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 146 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Alberta Academic / other |
| Locations | 1 site (Edmonton, Albert) |
| Trial ID | NCT04098354 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of home blood pressure telemonitoring (HBPT) combined with clinical case management compared to HBPT with usual care in patients with hypertension and chronic kidney disease (CKD) living in Northern Alberta. The primary focus is to assess the mean difference in systolic blood pressure over 12 months. Additionally, the study will explore the cost-effectiveness and acceptability of HBPT, as well as monitor any adverse events. The study is designed as a pragmatic randomized controlled trial to provide insights into managing hypertension in remote populations.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with chronic kidney disease, hypertension, and access to a smartphone and internet.
Not a fit: Patients with severe chronic kidney disease (stage 5) or those experiencing hypertensive emergencies may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to better blood pressure control and improved health outcomes for patients with chronic kidney disease.
How similar studies have performed: Previous studies have shown positive outcomes with home blood pressure telemonitoring in similar populations, indicating a promising approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Edmonton, Albert
- University of Alberta — Edmonton, Albert, Canada (Recruiting)
Study contacts
- Principal investigator: Aminu Bello — University of Alberta
- Study coordinator: Deenaz Zaidi
- Email: deenaz@ualberta.ca
- Phone: 17807098964
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.