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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04180618
Other study ID # 2019-07-066-006
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 1, 2019
Est. completion date November 29, 2019

Study information

Verified date November 2019
Source Samsung Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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

1. Patients or care givers

1. 1,000 patients(care givers) are enrolled and use the personal health wallet service.

2. The participants fill out questionnaire to evaluate the service

3. Some of them are invited for an in-depth interview.

2. Medical staffs

1. About 12 medical staffs are enrolled and use the personal health wallet service.

2. After that, the medical staffs are invited for an in-depth interview.


Recruitment information / eligibility

Status Completed
Enrollment 1010
Est. completion date November 29, 2019
Est. primary completion date November 29, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 19 Years and older
Eligibility Inclusion Criteria:

1. 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

2. 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:

1. 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. )

2. 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Personal health wallet service for emergency situation
Patients(caregivers) and medical staffs will be provided the personal health wallet service and evaluate the effectiveness and satisfaction for the service.

Locations

Country Name City State
Korea, Republic of Samsung Medical Center Seoul

Sponsors (1)

Lead Sponsor Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 2 month for enrollment and study
Secondary 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 2 month for enrollment and study
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