NCT02387073

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2013

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 29, 2013

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
1 year until next milestone

First Posted

Study publicly available on registry

March 12, 2015

Completed
Last Updated

July 8, 2015

Status Verified

July 1, 2015

Enrollment Period

6 months

First QC Date

November 29, 2013

Last Update Submit

July 6, 2015

Conditions

Keywords

outcome assessmentself-reportedpatientclinical outcome

Outcome Measures

Primary Outcomes (1)

  • The necessity of electrical PRO system (quantitative analysis)

    Do you feel the e-PRO system is necessary? 1. Absolutely yes 2. Yes 3. No 4. Absolutely no

    up to 6 months after introduction of e-PRO system

Secondary Outcomes (1)

  • Consultation efficacy with doctor Satisfaction for the enough exchange of information

    up to 6 months after introduction of e-PRO system

Study Arms (1)

Electrical version

Electrical version patient reported outcome questionnaire was used for patients who had filled-up same questionnaire in a paper version

Other: Electrical version patient reported outcome questionnaire

Interventions

Assess satisfaction of patients with "electrical version patient reported outcome questionnaire".

Also known as: Electrical patient reported outcome
Electrical version

Eligibility Criteria

Age15 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

the patients who have experienced paper questionnaire

You may qualify if:

  • We assessed the effectiveness of application of electrical-PRO in outpatients' clinic for patients who had filled-up same questionnaire in paper version

You may not qualify if:

  • Computer illiterate
  • Uncooperative patient

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, 110-744, South Korea

Location

MeSH Terms

Conditions

Spinal Diseases

Condition Hierarchy (Ancestors)

Bone DiseasesMusculoskeletal Diseases

Study Officials

  • Chun Kee Chung, MD, PhD

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Target Duration
1 Month
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 29, 2013

First Posted

March 12, 2015

Study Start

September 1, 2013

Primary Completion

March 1, 2014

Study Completion

March 1, 2014

Last Updated

July 8, 2015

Record last verified: 2015-07

Locations