Emergencies, Chronic DiseaseNCT04883684
A Study to Evaluate Satisfaction of the Personal Health Record Platform for Chronic Patients in Emergency Department
A study testing Personal health wallet service for Chronic Patients in Emergency Department in people with Emergencies, Chronic Disease, 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, Chronic Disease
- What is being tested?
- Personal health wallet service for Chronic Patients in Emergency Department
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteSouth Korea
- Study dates
- 6 Sep 2021to 28 Feb 2022
- 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
<Inclusion Criteria>
- A chronic patient (or his or her care giver) who visits the emergency department and has a plan to visit outpatient or other hospitals in one month of the visiting emergency department.
- Adults over 19 years old.
- Those who voluntarily agreed to participate in the research
<Exclusion Criteria>
- 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. )
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multi-institutional Study to Evaluate Patient Satisfaction of the Personal Health Record Management Platform for Chronic Patients in Emergency Department Based on Actual Demand
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 two 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> Emergency situations for chronic patients are increasing due to aging, eating habits and lifestyle changes. For chronic patients, comprehensive health records and utilization are important for health care and emergency situations. In particular, in the event of an emergency, information on the patient's personal health records, such as recent surgery records, disease history, prescription and dosage history is needed immediately, but it is difficult to check separately for each hospital. In addition, in emergencies, it may take more time for proper treatment to take place if patients themselves cannot directly talk about their medication or past surgical history, or if they are unable to communicate with patients. Recently, conditions have been prepared for the collection and utilization of personal health record information due to changes in policy and technology environment, making it possible to provide services for emergency patients with chronic diseases.
<Objective> To establish a service for collection and utilization of medical records (care, examination, surgery, prescription records) and PGHD for chronic patients and to evaluate its effectiveness.
<Design> Mixed methods study (questionnaires and interview)
<Setting> At the Samsung Medical Center and the Dong-A Medical Center.
<Enrollment> 400 patients(care givers)
<Intervention>
- 400 patients(care givers) are enrolled and use the personal health wallet service. (Personal Health Record service)
- The participants fill out questionnaire to evaluate the service
- Some of them are invited for an in-depth interview.
- Conditions
- Emergencies, Chronic Disease
- Being tested
- Personal health wallet service for Chronic Patients in Emergency Department
- Medical subject headings
- Emergencies, Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personal health wallet service for Chronic Patients in Emergency DepartmentOther
Patients(caregivers) 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. 400 patients(caregivers) are enrolled and use the personal health wallet service (Personal Health Records 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 Chronic Patients in Emergency Department |
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 wallet service.
SUS(System Usability Scale)-based assessment of patients or care givers satisfaction using personal health wallet service. 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: The day of the enrollment of the study
SUS(System Usability Scale)-based assessment of patients or care givers satisfaction using personal health wallet service.
SUS(System Usability Scale)-based assessment of patients or care givers satisfaction using personal health wallet service. 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 weeks after the enrollment
SUS(System Usability Scale)-based assessment of patients or care givers satisfaction using personal health wallet service.
SUS(System Usability Scale)-based assessment of patients or care givers satisfaction using personal health wallet service. 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: 4 weeks after the enrollment
SUS(System Usability Scale)-based assessment of patients or care givers satisfaction using personal health wallet service.
SUS(System Usability Scale)-based assessment of patients or care givers satisfaction using personal health wallet service. 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: 8 weeks after the enrollment
Secondary outcomes (2)
A qualitative study on the satisfaction of patients or care givers through interviews
A qualitative study on the satisfaction of patients or caregivers through interviews
Measured: through study completion, an average of 3 months"
A quantitative or qualitative study on the log data of the application
A quantitative or qualitative study on the log data of the application
Measured: through study completion, an average of 3 months"
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2021
- Study start6 Sep 2021
- Primary completion28 Feb 2022
- Study completion28 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Emergencies, Chronic DiseaseStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Taerim Kim, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04883684
- Sponsor's protocol ID
- 2021-03-019-006
- Status last verified
- May 2023
- First submitted
- 7 May 2021
- Last updated
- 24 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-institutional Study to Evaluate Patient Satisfaction of the Personal Health Record Management Platform for Chronic Patients in Emergency Department Based on Actual Demand
- ClinicalTrials.gov ID
- NCT04883684
- Acronym / sponsor ID
- 2021-03-019-006
- Conditions
- Emergencies, Chronic Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 6 Sep 2021 (actual)
- Primary completion
- 28 Feb 2022 (actual)
- Study completion
- 28 Feb 2022 (actual)
- First posted
- 12 May 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.
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 two 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> Emergency situations for chronic patients are increasing due to aging, eating habits and lifestyle changes. For chronic patients, comprehensive health records and utilization are important for health care and emergency situations. In particular, in the event of an emergency, information on the patient's personal health records, such as recent surgery records, disease history, prescription and dosage history is needed immediately, but it is difficult to check separately for each hospital. In addition, in emergencies, it may take more time for proper treatment to take place if patients themselves cannot directly talk about their medication or past surgical history, or if they are unable to communicate with patients. Recently, conditions have been prepared for the collection and utilization of personal health record information due to changes in policy and technology environment, making it possible to provide services for emergency patients with chronic diseases.
<Objective> To establish a service for collection and utilization of medical records (care, examination, surgery, prescription records) and PGHD for chronic patients and to evaluate its effectiveness.
<Design> Mixed methods study (questionnaires and interview)
<Setting> At the Samsung Medical Center and the Dong-A Medical Center.
<Enrollment> 400 patients(care givers)
<Intervention>
- 400 patients(care givers) are enrolled and use the personal health wallet service. (Personal Health Record service)
- The participants fill out questionnaire to evaluate the service
- Some of them are invited for an in-depth interview.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients(Care givers) | Experimental | Other: Personal health wallet service for Chronic Patients in Emergency Department1. 400 patients(caregivers) are enrolled and use the personal health wallet service (Personal Health Records service). 2. They fill out questionnaire to evaluate the service 3. Some of them 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
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 Chronic Patients in Emergency DepartmentPatients(caregivers) will be provided the personal health wallet service and evaluate the effectiveness and satisfaction for the service. | Other | Patients(Care givers) |
Primary outcome
SUS(System Usability Scale)-based assessment of patients or care givers satisfaction using personal health wallet service.
Time frame: The day of the enrollment of the study
SUS(System Usability Scale)-based assessment of patients or care givers satisfaction using personal health wallet service. 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.
SUS(System Usability Scale)-based assessment of patients or care givers satisfaction using personal health wallet service.
Time frame: 2 weeks after the enrollment
SUS(System Usability Scale)-based assessment of patients or care givers satisfaction using personal health wallet service. 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.
SUS(System Usability Scale)-based assessment of patients or care givers satisfaction using personal health wallet service.
Time frame: 4 weeks after the enrollment
SUS(System Usability Scale)-based assessment of patients or care givers satisfaction using personal health wallet service. 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.
SUS(System Usability Scale)-based assessment of patients or care givers satisfaction using personal health wallet service.
Time frame: 8 weeks after the enrollment
SUS(System Usability Scale)-based assessment of patients or care givers satisfaction using personal health wallet service. 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 secondary outcomes
A qualitative study on the satisfaction of patients or care givers through interviews
Time frame: through study completion, an average of 3 months"
A quantitative or qualitative study on the log data of the application
Time frame: through study completion, an average of 3 months"
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 24 May 2023.
Related trials for Emergencies, Chronic Disease
Recruiting
WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
RecruitingObservational study
Pulmonary Embolism Registry From Short-Term Emergency to Long-Term Follow-Up and Surveillance
Venous Thromboembolism (VTE), Chronic Thromboembolic Pulmonary Hypertension
RecruitingObservational study
Study of the Care Pathway of Patients Admitted to the Palliative Care Unit of Strasbourg University Hospital From Their Home in 2025
Advanced Chronic Disease
Enrolling by invitationPhase 3
Eptinezumab as an Adjunct to Standard of Care for Migraine in an Acute Emergency Context
Migraine, Chronic Migraine
RecruitingObservational study
COPD Exacerbation Follow Up
COPD (Chronic Obstructive Pulmonary Disease)
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.
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 Chronic Patients in Emergency Department in people with Emergencies, Chronic Disease, 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?
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 24 May 2023. 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 wallet service. (time frame: The day of the enrollment of the study). The study lists 4 primary outcomes in all. 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 24 May 2023.