HemodialysisPhase 3NCT03605875
A Web Application for Improving Communication on Hemodialysis Rounds
A Phase 3 study testing Web-App and Paper in people with Hemodialysis, run by University of Alberta at 4 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemodialysis
- What is being tested?
- Web-App and Paper
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- 4 sitesCanada
- Study dates
- 28 Nov 2018to 13 Dec 2019
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Planning to change modality within the next year
Trial locations and contacts
4 sites in 1 country.
Canada4 sites
Edmonton General Hospital
Edmonton, Alberta
Royal Alexandra Hospital
Edmonton, Alberta
University of Alberta Hospital
Edmonton, Alberta
Seven Oaks General Hospital
Winnipeg, Manitoba
About this study
Official title: Voicing Individual Concerns for Engagement in Hemodialysis (VOICE-HD): a Web Application for Rounds
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))
Read the detailed description
Usability is defined as Effectiveness (>70%)
- Number of people submitting a concern/ number of people with opportunity to submit a concern
- Number of concerns entered/number of times concern was satisfactorily addressed
Efficiency
- Proportion of non-completed tasks (<70%)
- The amount of time to complete one concern
Satisfaction
- Semistructured interviews
- Usability survey
- Conditions
- Hemodialysis
- Being tested
- Web-App, Paper
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Web-AppBehavioural
Cambian IT Health solutions from Surrey BC developed the infrastructure
PaperBehavioural
Contains similar questions to the Web-App tool
| Study group | Role | What they receive |
|---|---|---|
| Web-App | Experimental | A customized web-app tool to be used by patients to communicate concerns to their nephrologist Receives: Behavioral: Web-App |
| Paper | Active comparator | A customized paper tool to be used by patients to communicate concerns to their nephrologist Receives: Behavioral: Paper |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 8 weeks
Efficiency - The amount of time to complete one concern
The amount of time to log a concern in the web app
Measured: 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
Measured: 8 weeks
Secondary outcomes (1)
Communication Assessment Tool
Items rated from 1 (poor) to 5 (excellent). Published at Makoul et al. Patient Educ Couns 2007
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2018
- Study start28 Nov 2018
- Primary completion12 Dec 2018
- Study completion13 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HemodialysisStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 1:1 allocation
- Masking
- None (open label)
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stephanie Thompson, University of Alberta
- Investigators
- Stephanie Thompson, MD PhD, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03605875
- Sponsor's protocol ID
- Pro00076483
- Status last verified
- Mar 2020
- First submitted
- 18 Jul 2018
- Last updated
- 25 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34377501
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Voicing Individual Concerns for Engagement in Hemodialysis (VOICE-HD): a Web Application for Rounds
- ClinicalTrials.gov ID
- NCT03605875
- Acronym / sponsor ID
- Pro00076483
- Conditions
- Hemodialysis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Study start
- 28 Nov 2018 (actual)
- Primary completion
- 12 Dec 2018 (actual)
- Study completion
- 13 Dec 2019 (actual)
- First posted
- 30 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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))
Detailed description
Usability is defined as Effectiveness (>70%)
- Number of people submitting a concern/ number of people with opportunity to submit a concern
- Number of concerns entered/number of times concern was satisfactorily addressed
Efficiency
- Proportion of non-completed tasks (<70%)
- The amount of time to complete one concern
Satisfaction
- Semistructured interviews
- Usability survey
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 1:1 allocation
| Arm | Type | Receives |
|---|---|---|
| Web-App | Experimental | Behavioral: Web-AppA customized web-app tool to be used by patients to communicate concerns to their nephrologist |
| Paper | Active comparator | Behavioral: PaperA customized paper tool to be used by patients to communicate concerns to their nephrologist |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- Planning to change modality within the next year
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Web-AppCambian IT Health solutions from Surrey BC developed the infrastructure | Behavioural | Web-App |
| PaperContains similar questions to the Web-App tool | Behavioural | Paper |
Primary outcome
Effectiveness - Number of patients submitting a concern divided by the number of patients
Time frame: 8 weeks
Number of patients submitting a concern divided by the number of patients with an opportunity to submit a concern
Effectiveness - Number of concerns entered divided by the number of concerns that were satisfactorily addressed
Time frame: 8 weeks
Number of concerns entered divided by the number of concerns that were satisfactorily addressed
Efficiency - The amount of time to complete one concern
Time frame: 8 weeks
The amount of time to log a concern in the web app
Satisfaction - Usability survey
Time frame: 8 weeks
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
1 secondary outcome
Communication Assessment Tool
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2020.
- Derived from this study: PubMed 34377501Thompson 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephanie Thompson, MD PhD principal investigator
University of Alberta
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Web-App and Paper in people with Hemodialysis, run by University of Alberta at 4 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness - Number of patients submitting a concern divided by the number of patients (time frame: 8 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03605875, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2020.