- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04180618
Study to Evaluate Satisfaction Using Personal Health Wallet Service
December 1, 2019 updated by: Samsung Medical Center
Multi-centered Study to Evaluate Patient Satisfaction and Work Efficiency of Medical Staff When Using Personal Health Wallet Service for Emergency Situation
The investigators developed the service showing patient health record altogether which is managed by each hospital separately and recording the patient health information based on mobile application.
This study is a multi-centered study involving three hospitals, providing services to patients, care givers and medical staffs.
After the participants use this service, the investigators evaluate the effectiveness and satisfaction of this service through questionnaires and in-depth interviews.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
- Background: In emergency situations there are difficulties for treatment in that patient health records are not immediately provided because patient information is separately managed by each hospital. Another reason for the difficulty is that if the patients don't know their personal health record, they can't inform medical staffs of it. In addition, the increase of emergency situation of the chronically ill is also problematic. And patients have a growing desire for their health information. In this situation, the investigators developed the service showing patient health record altogether which is managed by each hospital separately and recording the patient health information based on mobile application.
- Objective: This study evaluates the effectiveness and satisfaction of the developed service in the emergency situation
- Design: Mixed method(questionnaires and interview)
- Setting: In the Department of Emergency at the Samsung Medical Center, the Asan Medical Center, the Dong-A Medical Center, and cooperative hospitals
- Enrollment: 1,000 patients(care givers) and about 12 medical staffs
Intervention
Patients or care givers
- 1,000 patients(care givers) are enrolled and use the personal health wallet service.
- The participants fill out questionnaire to evaluate the service
- Some of them are invited for an in-depth interview.
Medical staffs
- About 12 medical staffs are enrolled and use the personal health wallet service.
- After that, the medical staffs are invited for an in-depth interview.
Study Type
Interventional
Enrollment (Actual)
1010
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Seoul, Korea, Republic of
- Samsung Medical Center
-
-
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
19 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
SUS-based usability assessment and survey
- Patient and caregivers of emergency room at Samsung Medical Center
- Adults over 19 years old.
- Those who voluntarily agreed to participate in the research
- Patients who are past the acute period and in stable condition can agree with them
Interview
- Users of the personal health wallet service for emergency situations among patients and caregivers in the emergency room of Samsung Medical Center
- Medical staffs at Samsung Medical Center and associated hospitals
- Adults over 19 years old.
- Those who voluntarily agreed to participate in the research
Exclusion Criteria:
SUS-based usability assessment and survey
- Anyone who disagrees with this study
- Patients who are not conscious when leaving the emergency room, patients who are not aware of or are not aware of their orientation, patients who are not aware of their level of awareness, or people who are in shock or in deep shutdown situations) (Even in the above cases, caregivers can be included in the clinical trial target if they are present. )
Interview
- Patient is the same as SUS based usability assessment and exclusion criteria for survey participants
- In the case of medical staffs, those who do not agree with this study
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: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Patients(Care givers)
|
Patients(caregivers) and medical staffs will be provided the personal health wallet service and evaluate the effectiveness and satisfaction for the service.
|
|
Experimental: Medical staffs
|
Patients(caregivers) and medical staffs will be provided the personal health wallet service and evaluate the effectiveness and satisfaction for the service.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
SUS(System Usability Scale)-based assessment of patients or care givers satisfaction using personal health care for emergency situations
Time Frame: 2 month for enrollment and study
|
SUS(System Usability Scale)-based assessment of patients or care givers satisfaction using personal health care for emergency situations.
SUS consists of a 10 item questionnaire with five response options for respondents; from Strongly agree to Strongly disagree.
Its score range is 0~100 and the higher the score, the higher the satisfaction level.
|
2 month for enrollment and study
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
A qualitative study on the satisfaction of patients(caregivers) and medical staffs through interviews
Time Frame: 2 month for enrollment and study
|
A qualitative study on the satisfaction of patients(caregivers) and medical staffs through interviews
|
2 month for enrollment and study
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Taerim KIM, Samsung Medical Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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)
October 1, 2019
Primary Completion (Actual)
November 29, 2019
Study Completion (Actual)
November 29, 2019
Study Registration Dates
First Submitted
November 26, 2019
First Submitted That Met QC Criteria
November 26, 2019
First Posted (Actual)
November 27, 2019
Study Record Updates
Last Update Posted (Actual)
December 3, 2019
Last Update Submitted That Met QC Criteria
December 1, 2019
Last Verified
November 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2019-07-066-006
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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