Living Kidney DonationNCT04791670
eHealth Usability in Living Kidney Donation
An observational study of Living Kidney Donation, run by Helsinki University Central Hospital.
Trial summary
Several web portals for patients are available, but an assessment of their performance is scarce. This is of particular interest among candidates for kidney living donation. A crucial aspect of living donation is to provide standardized information about the risks of the procedure. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Living Kidney Donation
- What is being tested?
- survey study
- How many people
- 122 participants
- Where
- No sites listed yet
- Study dates
- Mar 2021to Oct 2021
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: All living donor candidates who contacted the living donor transplant coordinator, and were considered initially suitable for kidney donation.
Who may be able to join
- Living donor candidates from Helsinki area, from 2019 onwards
Who cannot join
- Living donor candidates from other areas of the country
- non-Finnish speakers
Trial locations and contacts
No sites are listed yet.
About this study
Official title: USABILITY OF AN INTERACTIVE HEALTH TECHNOLOGY FOR KIDNEY LIVING DONORS ASSESSMENT: TOWARDS A STANDARDIZED INFORMED PROCESS
Several web portals for patients are available, but an assessment of their performance is scarce. This is of particular interest among candidates for kidney living donation. A crucial aspect of living donation is to provide standardized information about the risks of the procedure. In 2019 it was launched a personalized digital care path for kidney living candidates, which contains information about the donation process and facilitates the communication between clinicians, transplant coordinators, and patients, enabling telemedicine.
We aim to investigate living donor candidates' experience with the Health Village web portal and the digital care path for living donor candidates. The secondary aim is to investigate their attitude of living donor candidates to eHealth services.
Read the detailed description
Background. Several web portals for kidney patients are available, but an assessment of their performance is scarce. This is of particular interest among candidates for kidney living donation. A crucial aspect of living donation is to provide standardized information about the risks of the procedure. In Finland, the web portal Health Village contains general information about kidney diseases. In 2019 it was launched a personalized digital care path for kidney living candidates, which contains information about the donation process and facilitates the communication between clinicians, transplant coordinators, and patients, enabling telemedicine. The performance of this eHealth service has not yet been studied.
Objectives. to investigate living donor candidates' experience with the web portal Health Village and the digital care path for living donor candidates. The secondary aim is to investigate their attitude of living donor candidates to eHealth services.
Methods. A prospective cross sectional survey study. Participants will be all kidney donor candidates who have used the digital care path since its implementation in January 2019 up to 1.3.2021 (N=122). The surveys will include general data, the type of electronic devices in possession and the purpose of use. eHealth literacy will be assessed with the eHeals questionnaire. Platform's ease of use will be assessed with the System Usability Scale, and participants´ opinion about the digital path utility with six questions. These items will be answered with a Likert-scale. Finally, we added an open question for qualitative analysis.
- Conditions
- Living Kidney Donation
- Being tested
- survey study
- Keywords
- eHealth, value-based healthcare
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
survey studyOther
The surveys will include general data, the type of electronic devices in possession and the purpose of use. eHealth literacy will be assessed with the eHeals questionnaire. Platform's ease of use will be assessed with the System Usability Scale, and participants´ opinion about the digital path utility with six questions. These items will be answered with a Likert-scale. Finally, we added an open question for qualitative analysis.
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient´s experience
Measured with Likert scale
Measured: 4 months
Patient´s e-Health literature
Measured with Likert scale
Measured: 4 months
Secondary outcomes (1)
Gender differences
to assess gender differences in the use of eHealth
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2021
- Study startMar 2021 (estimated)
- Primary completionMay 2021 (estimated)
- Study completionOct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Living Kidney DonationStudies of the same condition, open and under way.
- More trials run by Helsinki University Central HospitalThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 122 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Helsinki University Central Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oulu
- Responsible party
- Principal investigator, Fernanda Ortiz, Helsinki University Central Hospital
- Investigators
- Fernanda Ortiz, PhD, MD, Principal investigator, Helsinki University Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04791670
- Sponsor's protocol ID
- eHealth/HUS/501
- Status last verified
- Mar 2021
- First submitted
- 7 Mar 2021
- Last updated
- 10 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: In the near future, we plan to extend the use of the digital care path nationwide. This might allow the participation of other centers in the future.
Publications
Ortiz F, Grasberger J, Ekstrand A, Helantera I, Giunti G. Interactive Health Technology Tool for Kidney Living Donor Assessment to Standardize the Informed Consent Process: Usability and Qualitative Content Analysis. JMIR Form Res. 2024 Jul 9;8:e47785. doi: 10.2196/47785.
PubMed 38981119Ortiz F, Giunti G. Usability assessment of an interactive health technology for kidney living donors: protocol for a prospective cross-sectional survey. BMJ Open. 2022 Jan 3;12(1):e051166. doi: 10.1136/bmjopen-2021-051166.
PubMed 34980611
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- USABILITY OF AN INTERACTIVE HEALTH TECHNOLOGY FOR KIDNEY LIVING DONORS ASSESSMENT: TOWARDS A STANDARDIZED INFORMED PROCESS
- ClinicalTrials.gov ID
- NCT04791670
- Acronym / sponsor ID
- eHealth/HUS/501
- Conditions
- Living Kidney Donation
- Keywords
- eHealth, value-based healthcare
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 122 participants (estimated)
- Lead sponsor
- Helsinki University Central HospitalUniversity, hospital or other
- Collaborators
- University of Oulu
- Study start
- Mar 2021 (estimated)
- Primary completion
- May 2021 (estimated)
- Study completion
- Oct 2021 (estimated)
- First posted
- 10 Mar 2021 (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.
Several web portals for patients are available, but an assessment of their performance is scarce. This is of particular interest among candidates for kidney living donation. A crucial aspect of living donation is to provide standardized information about the risks of the procedure. In 2019 it was launched a personalized digital care path for kidney living candidates, which contains information about the donation process and facilitates the communication between clinicians, transplant coordinators, and patients, enabling telemedicine.
We aim to investigate living donor candidates' experience with the Health Village web portal and the digital care path for living donor candidates. The secondary aim is to investigate their attitude of living donor candidates to eHealth services.
Detailed description
Background. Several web portals for kidney patients are available, but an assessment of their performance is scarce. This is of particular interest among candidates for kidney living donation. A crucial aspect of living donation is to provide standardized information about the risks of the procedure. In Finland, the web portal Health Village contains general information about kidney diseases. In 2019 it was launched a personalized digital care path for kidney living candidates, which contains information about the donation process and facilitates the communication between clinicians, transplant coordinators, and patients, enabling telemedicine. The performance of this eHealth service has not yet been studied.
Objectives. to investigate living donor candidates' experience with the web portal Health Village and the digital care path for living donor candidates. The secondary aim is to investigate their attitude of living donor candidates to eHealth services.
Methods. A prospective cross sectional survey study. Participants will be all kidney donor candidates who have used the digital care path since its implementation in January 2019 up to 1.3.2021 (N=122). The surveys will include general data, the type of electronic devices in possession and the purpose of use. eHealth literacy will be assessed with the eHeals questionnaire. Platform's ease of use will be assessed with the System Usability Scale, and participants´ opinion about the digital path utility with six questions. These items will be answered with a Likert-scale. Finally, we added an open question for qualitative analysis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All living donor candidates who contacted the living donor transplant coordinator, and were considered initially suitable for kidney donation.
Key inclusion criteria (1 listed)
- Living donor candidates from Helsinki area, from 2019 onwards
Key exclusion criteria (2 listed)
- Living donor candidates from other areas of the country
- non-Finnish speakers
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 |
|---|---|---|
| survey studyThe surveys will include general data, the type of electronic devices in possession and the purpose of use. eHealth literacy will be assessed with the eHeals questionnaire. Platform's ease of use will be assessed with the System Usability Scale, and participants´ opinion about the digital path utility with six questions. These items will be answered with a Likert-scale. Finally, we added an open question for qualitative analysis. | Other | – |
Primary outcome
Patient´s experience
Time frame: 4 months
Measured with Likert scale
Patient´s e-Health literature
Time frame: 4 months
Measured with Likert scale
1 secondary outcome
Gender differences
Time frame: 4 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2021.
- Derived from this study: PubMed 38981119Ortiz F, Grasberger J, Ekstrand A, Helantera I, Giunti G. Interactive Health Technology Tool for Kidney Living Donor Assessment to Standardize the Informed Consent Process: Usability and Qualitative Content Analysis. JMIR Form Res. 2024 Jul 9;8:e47785. doi: 10.2196/47785.
- Derived from this study: PubMed 34980611Ortiz F, Giunti G. Usability assessment of an interactive health technology for kidney living donors: protocol for a prospective cross-sectional survey. BMJ Open. 2022 Jan 3;12(1):e051166. doi: 10.1136/bmjopen-2021-051166.
- Individual participant dataSharing planned: Undecided. In the near future, we plan to extend the use of the digital care path nationwide. This might allow the participation of other centers in the future.
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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.
Fernanda Ortiz, PhD, MD principal investigator
Helsinki University Central Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Living Kidney Donation, run by Helsinki University Central Hospital.
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 1 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 10 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fernanda Ortiz, PhD, MD (+358504270795, fernanda.ortiz@hus.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient´s experience (time frame: 4 months). The study lists 2 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 NCT04791670, which also lists 2 linked publications.
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 10 Mar 2021.