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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04167930
Other study ID # JS-CT-2019-07
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 1, 2019
Est. completion date January 31, 2020

Study information

Verified date August 2022
Source Jaseng Medical Foundation
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. In addition, investigators want to find out the participants' perception of car insurance and their satisfaction with traditional Korean medicine treatment.


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.


Recruitment information / eligibility

Status Completed
Enrollment 682
Est. completion date January 31, 2020
Est. primary completion date November 30, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 19 Years to 65 Years
Eligibility Inclusion Criteria: - 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. Exclusion Criteria: - 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
electronic medical record(EMR) Data and patient survey
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

Locations

Country Name City State
Korea, Republic of Haeundae Jaseng Hospital of Korean Medicine Busan
Korea, Republic of Haeundae Jaseng Hospital of Korean Medicine Busan

Sponsors (2)

Lead Sponsor Collaborator
Jaseng Medical Foundation Korea Health Industry Development Institute

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pain duration after treatment termination duration will be checked in week Finish all survey by Nov 2019
Primary Spent treatment fee after agreement with car insurance fee will be measured in tens of thousands Finish all data collection by Nov 2019
Secondary Change in Neck Disability Index (NDI) Neck Disability Index (NDI) scores during hospitalization Finish all data collection by Nov 2019
Secondary Change in Oswestry Disability Index (ODI) Oswestry Disability Index (ODI) scores during hospitalization Finish all data collection by Nov 2019
Secondary Change in EuroQol 5-dimensions 5-levels EuroQol 5-dimensions 5-levels scores during hospitalization Finish all data collection by Nov 2019
Secondary situation of of traffic accident Whether in car traffic accident or out car traffic accident Finish all survey by Nov 2019
Secondary Numeric rating scale (NRS) score pain score at the accident time Finish all survey by Nov 2019
Secondary Whiplash-associated disorder (WAD) grade. seriousness of accidents Finish all survey by Nov 2019
Secondary 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. Finish all survey by Nov 2019
Secondary satisfaction of car insurance Patients' satisfaction questionnaire (0~10 score) 10 is better Finish all survey by Nov 2019
Secondary Satisfaction with Korean medicine treatment for traffic accident injury Patients' satisfaction questionnaire (0~10 score), 10 is better Finish all survey by Nov 2019
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