Accidents, TrafficNCT04167930
The Analysis for Termination of Treatment and Satisfaction in Traffic Accident Patient
An observational study of Accidents, Traffic and Whiplash Injuries, run by Jaseng Medical Foundation at 2 sites in South Korea.
Trial summary
Data of one hospital will be used to find out the patient's satisfaction with the treatment, analyze the factors effecting on the treatment termination. Also, plan to see if there is a correlation between prognosis according to the seriousness of the accident. Read more about this study
- Who is it for?
- Ages 19 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Accidents, Traffic, Whiplash Injuries
- What is being tested?
- electronic medical record(EMR) Data and patient survey
- How many people
- 682 participants
- Where
- 2 sitesSouth Korea
- Study dates
- 1 Oct 2019to 31 Jan 2020
- Phase
- Observational
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients who ended up the hospitalization and treatment through car insurance in Haeundae Jaseng Korean Medicine Hospital
Who may be able to join
- Age 19 to 65
- A traffic accident injury patient who had been hospitalized at Haeundae Jaseng Korean Medicine Hospital from Jan. 01, 2016 to Dec. 31, 2018.
Who cannot join
- People whose traffic accidents are not yet agreed to
- Those who have not exceeded 90 days (3 months) since the conclusion of the agreement
- Persons unable to communicate
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites
Haeundae Jaseng Hospital of Korean Medicine
Busan, 48102
Haeundae Jaseng Hospital of Korean Medicine
Busan
About this study
Official title: The Analysis for Factors Affecting Termination of Treatment and Treatment Satisfaction of Korean Medicine in Traffic Accident Injury Patients: A Retrospective Study With Survey
Data of one hospital will be used to find out the patient's satisfaction with the treatment, analyze the factors effecting on the treatment termination.
Also, plan to see if there is a correlation between prognosis according to the seriousness of the accident. In addition, investigators want to find out the participants' perception of car insurance and their satisfaction with traditional Korean medicine treatment.
Read the detailed description
Retrospective data will be extracted using electronic medical records and computerized data of hospitalized patients. Based on this, investigators will conduct research in the form of prospective survey and analyze the causal relationship and factors using the two data.
The hospital's medical records will be used to analyze the patient's condition during the hospitalization period and to determine the situation after the end of treatment through questionnaire. The questionnaire will be developed after consultation with experts from musculoskeletal system and related societies, and will be used for the questionnaire.
- Conditions
- Accidents, Traffic, Whiplash Injuries
- Being tested
- electronic medical record(EMR) Data and patient survey
- Keywords
- traffic accident, traditional Korean medicine, car insurance, whiplash injury
- Medical subject headings
- Whiplash Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
electronic medical record(EMR) Data and patient surveyOther
- Retrospective Data Collection (1) Neck Disability Index (NDI), Oswestry Low Back Disability Index(ODI), euroqol-5 dimension(EQ-5D) scores during hospitalization (2) symptom onset date, symptom onset motive, past history, accident occurrence date, accident treatmen termination agreement date, etc.
- Question items (consistent with the case record) according to the purpose of the investigation (1) General: Demographic sociological characteristics (gender, age, occupation, income, etc.) (2) Matters concerning the correlation between traffic accident agreements and symptoms
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain duration after treatment termination
duration will be checked in week
Measured: Finish all survey by Nov 2019
Spent treatment fee after agreement with car insurance
fee will be measured in tens of thousands
Measured: Finish all data collection by Nov 2019
Secondary outcomes (9)
Change in Neck Disability Index (NDI)
Neck Disability Index (NDI) scores during hospitalization
Measured: Finish all data collection by Nov 2019
Change in Oswestry Disability Index (ODI)
Oswestry Disability Index (ODI) scores during hospitalization
Measured: Finish all data collection by Nov 2019
Change in EuroQol 5-dimensions 5-levels
EuroQol 5-dimensions 5-levels scores during hospitalization
Measured: Finish all data collection by Nov 2019
situation of of traffic accident
Whether in car traffic accident or out car traffic accident
Measured: Finish all survey by Nov 2019
Numeric rating scale (NRS) score
pain score at the accident time
Measured: Finish all survey by Nov 2019
Whiplash-associated disorder (WAD) grade.
seriousness of accidents
Measured: Finish all survey by Nov 2019
overall condition of patient after treatment termination
After the termination of the treatment, confirm that additional treatment was carried out using private expenses and reconfirm the pain after the termination of the treatment.
Measured: Finish all survey by Nov 2019
satisfaction of car insurance
Patients' satisfaction questionnaire (0~10 score) 10 is better
Measured: Finish all survey by Nov 2019
Satisfaction with Korean medicine treatment for traffic accident injury
Patients' satisfaction questionnaire (0~10 score), 10 is better
Measured: Finish all survey by Nov 2019
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2019
- Study start1 Oct 2019
- Primary completion30 Nov 2019
- Study completion31 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Accidents, TrafficStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 682 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jaseng Medical Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- Korea Health Industry Development Institute
- Responsible party
- Principal investigator, In-Hyuk Ha, KMD, Jaseng Medical Foundation
- Investigators
- In-Hyuk Ha, Study chair, Jaseng Medical Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04167930
- Sponsor's protocol ID
- JS-CT-2019-07
- Status last verified
- Aug 2022
- First submitted
- 11 Nov 2019
- Last updated
- 10 Aug 2022
- 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 10 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Analysis for Factors Affecting Termination of Treatment and Treatment Satisfaction of Korean Medicine in Traffic Accident Injury Patients: A Retrospective Study With Survey
- ClinicalTrials.gov ID
- NCT04167930
- Acronym / sponsor ID
- JS-CT-2019-07
- Conditions
- Accidents, Traffic, Whiplash Injuries
- Keywords
- traffic accident, traditional Korean medicine, car insurance, whiplash injury
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 682 participants (actual)
- Lead sponsor
- Jaseng Medical FoundationUniversity, hospital or other
- Collaborators
- Korea Health Industry Development Institute
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 30 Nov 2019 (actual)
- Study completion
- 31 Jan 2020 (actual)
- First posted
- 19 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.
Data of one hospital will be used to find out the patient's satisfaction with the treatment, analyze the factors effecting on the treatment termination.
Also, plan to see if there is a correlation between prognosis according to the seriousness of the accident. In addition, investigators want to find out the participants' perception of car insurance and their satisfaction with traditional Korean medicine treatment.
Detailed description
Retrospective data will be extracted using electronic medical records and computerized data of hospitalized patients. Based on this, investigators will conduct research in the form of prospective survey and analyze the causal relationship and factors using the two data.
The hospital's medical records will be used to analyze the patient's condition during the hospitalization period and to determine the situation after the end of treatment through questionnaire. The questionnaire will be developed after consultation with experts from musculoskeletal system and related societies, and will be used for the questionnaire.
Study design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who ended up the hospitalization and treatment through car insurance in Haeundae Jaseng Korean Medicine Hospital
Key inclusion criteria (2 listed)
- Age 19 to 65
- A traffic accident injury patient who had been hospitalized at Haeundae Jaseng Korean Medicine Hospital from Jan. 01, 2016 to Dec. 31, 2018.
Key exclusion criteria (3 listed)
- People whose traffic accidents are not yet agreed to
- Those who have not exceeded 90 days (3 months) since the conclusion of the agreement
- Persons unable to communicate
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 |
|---|---|---|
| electronic medical record(EMR) Data and patient survey1. Retrospective Data Collection (1) Neck Disability Index (NDI), Oswestry Low Back Disability Index(ODI), euroqol-5 dimension(EQ-5D) scores during hospitalization (2) symptom onset date, symptom onset motive, past history, accident occurrence date, accident treatmen termination agreement date, etc. 2. Question items (consistent with the case record) according to the purpose of the investigation (1) General: Demographic sociological characteristics (gender, age, occupation, income, etc.) (2) Matters concerning the correlation between traffic accident agreements and symptoms | Other | – |
Primary outcome
Pain duration after treatment termination
Time frame: Finish all survey by Nov 2019
duration will be checked in week
Spent treatment fee after agreement with car insurance
Time frame: Finish all data collection by Nov 2019
fee will be measured in tens of thousands
9 secondary outcomes
Change in Neck Disability Index (NDI)
Time frame: Finish all data collection by Nov 2019
Change in Oswestry Disability Index (ODI)
Time frame: Finish all data collection by Nov 2019
Change in EuroQol 5-dimensions 5-levels
Time frame: Finish all data collection by Nov 2019
situation of of traffic accident
Time frame: Finish all survey by Nov 2019
Numeric rating scale (NRS) score
Time frame: Finish all survey by Nov 2019
Whiplash-associated disorder (WAD) grade.
Time frame: Finish all survey by Nov 2019
overall condition of patient after treatment termination
Time frame: Finish all survey by Nov 2019
satisfaction of car insurance
Time frame: Finish all survey by Nov 2019
Satisfaction with Korean medicine treatment for traffic accident injury
Time frame: Finish all survey by Nov 2019
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 10 Aug 2022.
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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.
In-Hyuk Ha study chair
Jaseng Medical Foundation
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Accidents, Traffic and Whiplash Injuries, run by Jaseng Medical Foundation at 2 sites 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 2 inclusion and 3 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 10 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Pain duration after treatment termination (time frame: Finish all survey by Nov 2019). The study lists 2 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 10 Aug 2022.