Quality of LifeNCT03074396
Usefulness of a Mobile Information Management System for Haemodialysis Patient
A study testing Use of DialysisNet for doctor and Use of Avatar Beans for patient in people with Quality of Life and Drug Habit, run by Inje University.
Trial summary
The investigators developed and used the DialysisNet mobile application for physicians and Avatar Beans mobile application for haemodialysis patients. Patient-centred data integration and exchange were based on the American Society for Testing and Materials Continuity of Care Record standard. Read more about this study
- Who is it for?
- Ages 20 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Quality of Life, Drug Habit
- What is being tested?
- Use of DialysisNet for doctor and Use of Avatar Beans for patient
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2016to 31 Dec 2016
- Phase
- Interventional
- 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 20 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- patients who have maintenance hemodialysis treatment
- accept consent form
Who cannot join
- pregnant
About this study
Official title: Usefulness of a Mobile Information Management System for Haemodialysis Patients and the Prospect of Participatory Medicine
The investigators developed and used the DialysisNet mobile application for physicians and Avatar Beans mobile application for haemodialysis patients. Patient-centred data integration and exchange were based on the American Society for Testing and Materials Continuity of Care Record standard. The investigators enrolled 10 patients and 4 physicians. Questionnaires to evaluate user experience and usefulness were administered before and after use.
- Conditions
- Quality of Life, Drug Habit
- Being tested
- Use of DialysisNet for doctor, Use of Avatar Beans for patient
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use of DialysisNet for doctorDevice
DialysisNet is mobile application for physicians for haemodialysis patients. Patient-centred data integration and exchange were based on the American Society for Testing and Materials Continuity of Care Record standard.
Use of Avatar Beans for patientDevice
Avatar Beans is mobile application for haemodialysis patients. Patient-centred data integration and exchange were based on the American Society for Testing and Materials Continuity of Care Record.
| Study group | Role | What they receive |
|---|---|---|
| before and after use of program | Other | one arm (10 patients and 4 physicians) before and after use of dialysisNet (for doctors) and Avatar Beans (for patients) Receives: Device: Use of DialysisNet for doctor; Device: Use of Avatar Beans for patient |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change of Short Form 36 questionnaire for quality of life
Measured: 3 month after the use of DialysisNet (for doctors) and Avatar Beans (for patients)
Secondary outcomes (1)
The change of morisky medication adherence scale (MMAS) for drug compliance
Measured: 3 month Before and after the use of DialysisNet (for doctors) and Avatar Beans (for patients)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2017
- Study start1 Feb 2016
- Primary completion20 Dec 2016
- Study completion31 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quality of LifeStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Health services research
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inje University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hoseok Koo, Inje University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03074396
- Sponsor's protocol ID
- DialysisNet
- Status last verified
- Aug 2018
- First submitted
- 25 Feb 2017
- Last updated
- 10 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Usefulness of a Mobile Information Management System for Haemodialysis Patients and the Prospect of Participatory Medicine
- ClinicalTrials.gov ID
- NCT03074396
- Acronym / sponsor ID
- DialysisNet
- Conditions
- Quality of Life, Drug Habit
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Inje UniversityUniversity, hospital or other
- Study start
- 1 Feb 2016 (actual)
- Primary completion
- 20 Dec 2016 (actual)
- Study completion
- 31 Dec 2016 (actual)
- First posted
- 8 Mar 2017 (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.
The investigators developed and used the DialysisNet mobile application for physicians and Avatar Beans mobile application for haemodialysis patients. Patient-centred data integration and exchange were based on the American Society for Testing and Materials Continuity of Care Record standard. The investigators enrolled 10 patients and 4 physicians. Questionnaires to evaluate user experience and usefulness were administered before and after use.
Study design
- Primary purpose
- Health services research
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| before and after use of program | Other | Device: Use of DialysisNet for doctor, Device: Use of Avatar Beans for patientone arm (10 patients and 4 physicians) before and after use of dialysisNet (for doctors) and Avatar Beans (for patients) |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patients who have maintenance hemodialysis treatment
- accept consent form
Key exclusion criteria (1 listed)
- pregnant
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 |
|---|---|---|
| Use of DialysisNet for doctorDialysisNet is mobile application for physicians for haemodialysis patients. Patient-centred data integration and exchange were based on the American Society for Testing and Materials Continuity of Care Record standard. | Device | before and after use of program |
| Use of Avatar Beans for patientAvatar Beans is mobile application for haemodialysis patients. Patient-centred data integration and exchange were based on the American Society for Testing and Materials Continuity of Care Record. | Device | before and after use of program |
Primary outcome
The change of Short Form 36 questionnaire for quality of life
Time frame: 3 month after the use of DialysisNet (for doctors) and Avatar Beans (for patients)
1 secondary outcome
The change of morisky medication adherence scale (MMAS) for drug compliance
Time frame: 3 month Before and after the use of DialysisNet (for doctors) and Avatar Beans (for patients)
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 10 Aug 2018.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Use of DialysisNet for doctor and Use of Avatar Beans for patient in people with Quality of Life and Drug Habit, run by Inje University.
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 10 Aug 2018. 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?
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?
The change of Short Form 36 questionnaire for quality of life (time frame: 3 month after the use of DialysisNet (for doctors) and Avatar Beans (for patients)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Aug 2018.