NCT03089385

Brief Summary

The objective of this project is to develop, validate, and implement a tool to help manager hypertension in patients on hemodialysis.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at below P25 for not_applicable hypertension

Timeline
Completed

Started Feb 2016

Longer than P75 for not_applicable hypertension

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 22, 2016

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

March 20, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 24, 2017

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 9, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 9, 2021

Completed
Last Updated

May 6, 2021

Status Verified

April 1, 2021

Enrollment Period

5.1 years

First QC Date

March 20, 2017

Last Update Submit

April 30, 2021

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

  • Blood pressure

    3 months

Study Arms (2)

Implementation group

EXPERIMENTAL

This group will have the hypertension tool implemented on them.

Other: Hypertension tool

Control group

NO INTERVENTION

This group will not have the tool implemented.

Interventions

Hypertension toolOTHER

An algorithm developed by staff at UHN to help manage hypertension in hemodialysis patients.

Implementation group

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • ≥ 18 years of age
  • Receiving in-centre HD for at least 3 months
  • Considered hypertensive based on a median intradialytic blood pressure ≥ 140/90 mmgHG

You may not qualify if:

  • Are unable to provide informed consent
  • Are deemed medically unstable by the primary physician

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Toronto General Hospital

Toronto, Ontario, Canada

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Marisa Battistella

    University Health Network, Toronto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 20, 2017

First Posted

March 24, 2017

Study Start

February 22, 2016

Primary Completion

April 9, 2021

Study Completion

April 9, 2021

Last Updated

May 6, 2021

Record last verified: 2021-04

Locations

CA(1)