EmergenciesNCT04180618
Study to Evaluate Satisfaction Using Personal Health Wallet Service
A study testing Personal health wallet service for emergency situation in people with Emergencies, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Emergencies
- What is being tested?
- Personal health wallet service for emergency situation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,010 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Oct 2019to 29 Nov 2019
- 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 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Emergencies
- Being tested
- Personal health wallet service for emergency situation
- Medical subject headings
- Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personal health wallet service for emergency situationOther
Patients(caregivers) and medical staffs will be provided the personal health wallet service and evaluate the effectiveness and satisfaction for the service.
| Study group | Role | What they receive |
|---|---|---|
| Patients(Care givers) | Experimental | 1. 1,000 patients(caregivers) are enrolled and use the personal health wallet service.
2. They fill out questionnaire to evaluate the service
3. Some of them are invited for an in-depth interview. Receives: Other: Personal health wallet service for emergency situation |
| Medical staffs | Experimental | 1. 12 medical staffs are enrolled and use the personal health wallet service.
2. After that, they are invited for an in-depth interview. Receives: Other: Personal health wallet service for emergency situation |
What is being measured
The primary outcome is the main question the study is designed to answer.
SUS(System Usability Scale)-based assessment of patients or care givers satisfaction using personal health care for emergency situations
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.
Measured: 2 month for enrollment and study
Secondary outcomes (1)
A qualitative study on the satisfaction of patients(caregivers) and medical staffs through interviews
A qualitative study on the satisfaction of patients(caregivers) and medical staffs through interviews
Measured: 2 month for enrollment and study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2019
- Study start1 Oct 2019
- Primary completion29 Nov 2019
- Study completion29 Nov 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 EmergenciesStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,010 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Taerim KIM, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04180618
- Sponsor's protocol ID
- 2019-07-066-006
- Status last verified
- Nov 2019
- First submitted
- 26 Nov 2019
- Last updated
- 3 Dec 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kim SM, Kim T, Cha WC, Lee JH, Kwon IH, Choi Y, Kim JS. User Experience of Mobile Personal Health Records for the Emergency Department: Mixed Methods Study. JMIR Mhealth Uhealth. 2020 Dec 15;8(12):e24326. doi: 10.2196/24326.
PubMed 33320102
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-centered Study to Evaluate Patient Satisfaction and Work Efficiency of Medical Staff When Using Personal Health Wallet Service for Emergency Situation
- ClinicalTrials.gov ID
- NCT04180618
- Acronym / sponsor ID
- 2019-07-066-006
- Conditions
- Emergencies
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,010 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 29 Nov 2019 (actual)
- Study completion
- 29 Nov 2019 (actual)
- First posted
- 27 Nov 2019 (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 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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients(Care givers) | Experimental | Other: Personal health wallet service for emergency situation1. 1,000 patients(caregivers) are enrolled and use the personal health wallet service. 2. They fill out questionnaire to evaluate the service 3. Some of them are invited for an in-depth interview. |
| Medical staffs | Experimental | Other: Personal health wallet service for emergency situation1. 12 medical staffs are enrolled and use the personal health wallet service. 2. After that, they are invited for an in-depth interview. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- SUS-based usability assessment and survey
- Interview
Key exclusion criteria (6 listed)
- SUS-based usability assessment and survey
- Interview
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 |
|---|---|---|
| Personal health wallet service for emergency situationPatients(caregivers) and medical staffs will be provided the personal health wallet service and evaluate the effectiveness and satisfaction for the service. | Other | Medical staffs, Patients(Care givers) |
Primary outcome
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.
1 secondary outcome
A qualitative study on the satisfaction of patients(caregivers) and medical staffs through interviews
Time frame: 2 month for enrollment and study
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 3 Dec 2019.
- Derived from this study: PubMed 33320102Kim SM, Kim T, Cha WC, Lee JH, Kwon IH, Choi Y, Kim JS. User Experience of Mobile Personal Health Records for the Emergency Department: Mixed Methods Study. JMIR Mhealth Uhealth. 2020 Dec 15;8(12):e24326. doi: 10.2196/24326.
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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.
Taerim KIM principal investigator
Samsung Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Personal health wallet service for emergency situation in people with Emergencies, run by Samsung Medical Center at 1 site in South Korea.
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 10 inclusion and 6 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 3 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. 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.
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?
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). 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 NCT04180618, 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 3 Dec 2019.