Spinal DiseaseNCT02387073
The Efficacy of Electrical Version of Patient Reported Outcome
An observational study of Spinal Disease, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
Recently the importance of electrical PRO system is increased for the accuracy, convenience, and efficiency for both patients and physicians. For the evaluation of quality of life, various self-reported questionnaires is filled-out by the patient, mostly in front of outpatient clinic, and doctor usually take times to… Read more about this study
- Who is it for?
- Ages 15 to 80 years
- Conditions the study is for
- Spinal Disease
- What is being tested?
- Electrical version patient reported outcome questionnaire
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2013to Mar 2014
- How long will I take part?
- 1 Month
- 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 15 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: the patients who have experienced paper questionnaire
Who may be able to join
- We assessed the effectiveness of application of electrical-PRO in outpatients' clinic for patients who had filled-up same questionnaire in paper version
Who cannot join
- Computer illiterate
- Uncooperative patient
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Efficacy of Electrical Version of Patient Reported Outcome: Patient Survey
Recently the importance of electrical PRO system is increased for the accuracy, convenience, and efficiency for both patients and physicians. For the evaluation of quality of life, various self-reported questionnaires is filled-out by the patient, mostly in front of outpatient clinic, and doctor usually take times to calculate the score. If there is electrical PRO which is available with mobile device, the efficacy of clinic would be improved. The investigators developed such a system and applied the system for patients with spinal disease. The investigators assessed the effectiveness of application of electrical-PRO in outpatients' clinic for patients who had filled-up same questionnaire in paper version.
Read the detailed description
Age, sex, education levels, use of smartphone, the number of applications.
- Conditions
- Spinal Disease
- Being tested
- Electrical version patient reported outcome questionnaire
- Keywords
- outcome assessment, self-reported, patient, clinical outcome
- Medical subject headings
- Spinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electrical version patient reported outcome questionnaireOther
Also called Electrical patient reported outcome
Assess satisfaction of patients with "electrical version patient reported outcome questionnaire".
| Study group | Role | What they receive |
|---|---|---|
| Electrical version | Electrical version patient reported outcome questionnaire was used for patients who had filled-up same questionnaire in a paper version Receives: Other: Electrical version patient reported outcome questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
The necessity of electrical PRO system (quantitative analysis)
Do you feel the e-PRO system is necessary?
- Absolutely yes
- Yes
- No
- Absolutely no
Measured: up to 6 months after introduction of e-PRO system
Secondary outcomes (1)
Consultation efficacy with doctor Satisfaction for the enough exchange of information
Do you feel the e-PRO system make the consultation time with doctor to be efficient?
- Absolutely yes
- Yes
- No
- Absolutely no
Do you think your status was expressed better with the use of e-PRO
- Absolutely yes
- Yes
- No
- Absolutely no
Measured: up to 6 months after introduction of e-PRO system
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2015 (estimated)
- Study startSep 2013
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal DiseaseStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (actual)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- SK Telecom Consortium
- Responsible party
- Principal investigator, Chun Kee Chung, Seoul National University Hospital
- Investigators
- Chun Kee Chung, MD, PhD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02387073
- Sponsor's protocol ID
- E-PRO
- Other IDs
- H-1207-088-418
- Status last verified
- Jul 2015
- First submitted
- 29 Nov 2013
- Last updated
- 8 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Electrical Version of Patient Reported Outcome: Patient Survey
- ClinicalTrials.gov ID
- NCT02387073
- Acronym / sponsor ID
- E-PRO
- Conditions
- Spinal Disease
- Keywords
- outcome assessment, self-reported, patient, clinical outcome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- SK Telecom Consortium
- Study start
- Sep 2013
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 12 Mar 2015 (estimated)
- 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.
Recently the importance of electrical PRO system is increased for the accuracy, convenience, and efficiency for both patients and physicians. For the evaluation of quality of life, various self-reported questionnaires is filled-out by the patient, mostly in front of outpatient clinic, and doctor usually take times to calculate the score. If there is electrical PRO which is available with mobile device, the efficacy of clinic would be improved. The investigators developed such a system and applied the system for patients with spinal disease. The investigators assessed the effectiveness of application of electrical-PRO in outpatients' clinic for patients who had filled-up same questionnaire in paper version.
Detailed description
Age, sex, education levels, use of smartphone, the number of applications.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Month
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Electrical version | – | Other: Electrical version patient reported outcome questionnaireElectrical version patient reported outcome questionnaire was used for patients who had filled-up same questionnaire in a paper version |
Who may qualify
- Ages
- 15 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- the patients who have experienced paper questionnaire
Key inclusion criteria (1 listed)
- We assessed the effectiveness of application of electrical-PRO in outpatients' clinic for patients who had filled-up same questionnaire in paper version
Key exclusion criteria (2 listed)
- Computer illiterate
- Uncooperative patient
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 |
|---|---|---|
| Electrical version patient reported outcome questionnaireAlso: Electrical patient reported outcomeAssess satisfaction of patients with "electrical version patient reported outcome questionnaire". | Other | Electrical version |
Primary outcome
The necessity of electrical PRO system (quantitative analysis)
Time frame: up to 6 months after introduction of e-PRO system
Do you feel the e-PRO system is necessary? 1. Absolutely yes 2. Yes 3. No 4. Absolutely no
1 secondary outcome
Consultation efficacy with doctor Satisfaction for the enough exchange of information
Time frame: up to 6 months after introduction of e-PRO system
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 8 Jul 2015.
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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.
Chun Kee Chung, MD, PhD principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spinal Disease, run by Seoul National University Hospital 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?
The sponsor lists 1 inclusion and 2 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 8 Jul 2015. 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?
The necessity of electrical PRO system (quantitative analysis) (time frame: up to 6 months after introduction of e-PRO system). 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 8 Jul 2015.