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A Study to Evaluate Satisfaction of the Personal Health Record Platform for Chronic Patients in Emergency Department

Primary Purpose

Emergencies, Chronic Disease

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Personal health wallet service for Chronic Patients in Emergency Department
Sponsored by
Samsung Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Emergencies, Chronic Disease

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

<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. )

Sites / Locations

  • Samsung Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patients(Care givers)

Arm Description

400 patients(caregivers) are enrolled and use the personal health wallet service (Personal Health Records service). They fill out questionnaire to evaluate the service Some of them are invited for an in-depth interview.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.

Secondary Outcome Measures

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
A quantitative or qualitative study on the log data of the application
A quantitative or qualitative study on the log data of the application

Full Information

First Posted
May 7, 2021
Last Updated
May 22, 2023
Sponsor
Samsung Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT04883684
Brief Title
A Study to Evaluate Satisfaction of the Personal Health Record Platform for Chronic Patients in Emergency Department
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
September 6, 2021 (Actual)
Primary Completion Date
February 28, 2022 (Actual)
Study Completion Date
February 28, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Samsung Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Emergencies, Chronic Disease

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
57 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patients(Care givers)
Arm Type
Experimental
Arm Description
400 patients(caregivers) are enrolled and use the personal health wallet service (Personal Health Records service). They fill out questionnaire to evaluate the service Some of them are invited for an in-depth interview.
Intervention Type
Other
Intervention Name(s)
Personal health wallet service for Chronic Patients in Emergency Department
Intervention Description
Patients(caregivers) will be provided the personal health wallet service and evaluate the effectiveness and satisfaction for the service.
Primary Outcome Measure Information:
Title
SUS(System Usability Scale)-based assessment of patients or care givers satisfaction using personal health wallet service.
Description
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.
Time Frame
The day of the enrollment of the study
Title
SUS(System Usability Scale)-based assessment of patients or care givers satisfaction using personal health wallet service.
Description
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.
Time Frame
2 weeks after the enrollment
Title
SUS(System Usability Scale)-based assessment of patients or care givers satisfaction using personal health wallet service.
Description
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.
Time Frame
4 weeks after the enrollment
Title
SUS(System Usability Scale)-based assessment of patients or care givers satisfaction using personal health wallet service.
Description
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.
Time Frame
8 weeks after the enrollment
Secondary Outcome Measure Information:
Title
A qualitative study on the satisfaction of patients or care givers through interviews
Description
A qualitative study on the satisfaction of patients or caregivers through interviews
Time Frame
through study completion, an average of 3 months"
Title
A quantitative or qualitative study on the log data of the application
Description
A quantitative or qualitative study on the log data of the application
Time Frame
through study completion, an average of 3 months"

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
<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. )
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
04742
Country
Korea, Republic of

12. IPD Sharing Statement

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A Study to Evaluate Satisfaction of the Personal Health Record Platform for Chronic Patients in Emergency Department

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