NCT03605875

Brief Summary

To evaluate a web application tool that hemodialysis patients can use outside of dialysis time to log and prioritize their concerns for the nephrologists. Specifically, the investigators will compare the usability of a web application tool to a structured paper form. The investigators will also use data from semi-structured interviews to better understand the experience and acceptability of the web app among patient participants randomized to the web application and among participating nephrologists. Primary outcome

  • Usability (effectiveness, efficiency, satisfaction) Secondary outcomes
  • Quality of the patient-physician interaction (Communication Assessment Tool (CAT-14))

Trial Health

87
On Track

Trial Health Score

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

Enrollment
77

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Nov 2018

Shorter than P25 for phase_3

Geographic Reach
1 country

4 active sites

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

First Submitted

Initial submission to the registry

July 18, 2018

Completed
12 days until next milestone

First Posted

Study publicly available on registry

July 30, 2018

Completed
4 months until next milestone

Study Start

First participant enrolled

November 28, 2018

Completed
14 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 12, 2018

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 13, 2019

Completed
Last Updated

March 25, 2020

Status Verified

March 1, 2020

Enrollment Period

14 days

First QC Date

July 18, 2018

Last Update Submit

March 23, 2020

Conditions

Hemodialysis

Outcome Measures

Primary Outcomes (4)

  • Effectiveness - Number of patients submitting a concern divided by the number of patients

    Number of patients submitting a concern divided by the number of patients with an opportunity to submit a concern

    8 weeks

  • Effectiveness - Number of concerns entered divided by the number of concerns that were satisfactorily addressed

    Number of concerns entered divided by the number of concerns that were satisfactorily addressed

    8 weeks

  • Efficiency - The amount of time to complete one concern

    The amount of time to log a concern in the web app

    8 weeks

  • Satisfaction - Usability survey

    Usability survey Defined as greater than 70% of users who agree or strongly agree with the statement on the usability survey. Ranked on a 5 -point Likert scale

    8 weeks

Secondary Outcomes (1)

  • Communication Assessment Tool

    8 weeks

Study Arms (2)

Web-App

EXPERIMENTAL

A customized web-app tool to be used by patients to communicate concerns to their nephrologist

Behavioral: Web-App

Paper

ACTIVE COMPARATOR

A customized paper tool to be used by patients to communicate concerns to their nephrologist

Behavioral: Paper

Interventions

Web-AppBEHAVIORAL

Cambian IT Health solutions from Surrey BC developed the infrastructure

Web-App
PaperBEHAVIORAL

Contains similar questions to the Web-App tool

Paper

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Chronic in-center hemodialysis patients in Edmonton, Alberta and Winnipeg, Manitoba
  • Able to provide consent, understand and read English or have a family member that can do this for them

You may not qualify if:

  • Planning to change modality within the next year

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Edmonton General Hospital

Edmonton, Alberta, Canada

Location

Royal Alexandra Hospital

Edmonton, Alberta, Canada

Location

University of Alberta Hospital

Edmonton, Alberta, Canada

Location

Seven Oaks General Hospital

Winnipeg, Manitoba, Canada

Location

Related Publications (1)

  • Thompson S, Schick-Makaroff K, Bello A, Tonelli M, Wiebe N, Buzinski R, Courtney M, Szigety S, Shah N, Bohm C. Voicing Individual Concerns for Engagement in Hemodialysis (VOICE-HD): A Mixed Method, Randomized Pilot Trial of Digital Health in Dialysis Care Delivery. Can J Kidney Health Dis. 2021 Jul 27;8:20543581211032857. doi: 10.1177/20543581211032857. eCollection 2021.

    PMID: 34377501DERIVED

MeSH Terms

Interventions

Paper

Intervention Hierarchy (Ancestors)

Manufactured MaterialsTechnology, Industry, and Agriculture

Study Officials

  • Stephanie Thompson, MD PhD

    University of Alberta

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: 1:1 allocation
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

July 18, 2018

First Posted

July 30, 2018

Study Start

November 28, 2018

Primary Completion

December 12, 2018

Study Completion

December 13, 2019

Last Updated

March 25, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations

CA(4)