- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03074396
Usefulness of a Mobile Information Management System for Haemodialysis Patient
August 9, 2018 updated by: Hoseok Koo, Inje University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
14
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- patients who have maintenance hemodialysis treatment
- accept consent form
Exclusion Criteria:
- pregnant
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: before and after use of program
one arm (10 patients and 4 physicians) before and after use of dialysisNet (for doctors) and Avatar Beans (for patients)
|
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.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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)
|
3 month after the use of DialysisNet (for doctors) and Avatar Beans (for patients)
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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)
|
3 month Before and after the use of DialysisNet (for doctors) and Avatar Beans (for patients)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 1, 2016
Primary Completion (Actual)
December 20, 2016
Study Completion (Actual)
December 31, 2016
Study Registration Dates
First Submitted
February 25, 2017
First Submitted That Met QC Criteria
March 7, 2017
First Posted (Actual)
March 8, 2017
Study Record Updates
Last Update Posted (Actual)
August 10, 2018
Last Update Submitted That Met QC Criteria
August 9, 2018
Last Verified
August 1, 2018
More Information
Terms related to this study
Other Study ID Numbers
- DialysisNet
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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