Telemonitoring of Hypertensive Patients With Chronic Kidney Disease
A legfontosabb adatok
- Hol
- Edmonton (Kanada)A helyszín megnézése
AI-kivonat: kiket keres a vizsgálat
A vizsgálat saját részvételi feltételeiből. Gép olvasta ki az oldalon álló regiszterszövegből, ezért tévedhet. Hogy ki vehet részt, azt a lenti regiszterszöveg és a vizsgálat csapata dönti el.
A vizsgálat olyan felnőtteket keres, akiknek krónikus vesebetegségük és magas vérnyomásuk van, az albertai (Kanada) Peace River távoli térségében élnek, és van okostelefonjuk.
- Életkor
- 18 éves vagy idősebb
- Nem
- Bármely nem
- A betegség stádiuma
- Igazolt krónikus vesebetegség, dialízis nélkül, eGFR < 60 mL/min/1.73m2 és/vagy fehérje a vizeletben > 1 g/nap. Az 5. stádiumú vesebetegség (eGFR ≤ 15 ml/min/1.73m2) kizárási ok.
- Korábbi kezelés
- Jelenleg vérnyomáscsökkentő gyógyszert kell szednie. Nem kaphat vesepótló kezelést.
A részvétel fő kizáró okai
- 5. stádiumú vesebetegség vagy vesepótló kezelés
- Csökkent pumpafunkcióval járó szívelégtelenség (csökkent ejekciós frakció)
- Végstádiumú betegség (várható élettartam < 1 év)
- Terhesség vagy szoptatás
- Részvétel másik klinikai gyógyszervizsgálatban
Gépi kiolvasás: 2026. november 12.
Helyszínek itt: Kanada
- University of AlbertaEdmonton, KanadaContact: Aminu Bello, MDRésztvevőt keres
Kérdések a vizsgálat csapatának
- Milyen gyakran kell bejárnom, és egy-egy alkalom mennyi ideig tart?
- Megtérítik az utazási költséget?
- Megtarthatom a saját orvosomat?
- Mi történik, ha ki akarok lépni?
Contact the study team: see the registry record → Contacts and Locations
Oldal nyomtatása az orvosomnakA vizsgálat adatai
- Ki végzi
- University of Alberta
- Azonosító
- NCT04098354
- A regiszteradat frissítve
- 2026. szeptember 29.
- Eredeti leírás
Background:A teljes eredeti leírásKevesebb
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
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.
Bevonási feltételek: 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).
Kizáró feltételek: Participation in any ongoing clinical drug trial; 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); Presence of any terminal illness (life expectancy < 1 year); Patients with stage 5 CKD (eGFR ≤ 15 ml/min/1.73m2) or patients receiving kidney replacement therapy; Heart failure with reduced ejection fraction; Pregnancy, lactation / breastfeeding; Planning to relocate out of the Peace River region or residence in an area without mobile phone coverage.