NCT02244060

Brief Summary

Objective measures of health are relatively expensive; meanwhile, self-reports are critiqued to be subjective and not comparable. A middle ground approach is to apply the frontier work of vignette methods. The aim of the survey experiment is to explore the validity of survey instruments to identify students who need glasses, using objectively measured visual acuity as a gold standard. It is hypothesized that direct comparison against vignette (DCV) is significantly different from indirect comparison against vignette (ICV); meanwhile, self-assessment of vision (SAV) is significantly different from primed self-assessment of vision (PSAV). It is also hypothesized that DCV is a more valid survey instrument than ICV to classify students who need glasses, using objective visual acuity as a gold standard. Lastly, it is hypothesized that priming effect from vignettes improves the validity of self-assessment. It is planned to enroll 3,755 subjects in the survey experiment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
4,320

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2014

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

September 14, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 18, 2014

Completed
13 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
Last Updated

April 7, 2015

Status Verified

April 1, 2015

Enrollment Period

1 month

First QC Date

September 14, 2014

Last Update Submit

April 5, 2015

Conditions

Keywords

VignettePriming effect

Outcome Measures

Primary Outcomes (4)

  • Self-assessed vision

    One and half months

  • Direct comparison against vignette (DCV)

    One and half months

  • Indirect comparison against vignette (ICV)

    One and half months

  • Primed self-assessed vision

    One and half months

Secondary Outcomes (1)

  • Objectively measured vision

    One and half months

Study Arms (2)

Direct comparison

EXPERIMENTAL

The Direct comparison against vignette (DCV) questionnaire asks subjects to estimate their own vision against vignette situations.Priming effect from vignette is designed in the arm of DCV.

Other: Priming effect from vignette

Indirect comparison

NO INTERVENTION

The Indirect comparison against vignette (ICV) questionnaire asks self-assessed vision and single evaluation of vignettes.

Interventions

In the arm of DCV, the self-assessed vision (PSAV) is listed after the vignette questions; however, in the arm of ICV, the self-assessment of vision (SAV) is listed before the vignette questions. Priming effect from vignette will be estimated by comparing those two randomized variables (i.e., SAV and PSAV).

Also known as: primed self-assessed vision, primed self-assessment of vision
Direct comparison

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Middle school students (i.e., Grade 7 to Grade12) in Jingning County.

You may not qualify if:

  • Primary school students (i.e., Grade 1 to Grade 6) in Jingning County.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jingning County

Lishui, Zhejiang, 323500, China

Location

Study Officials

  • Linyu Su

    Jingning Health Center

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctoral Candidate

Study Record Dates

First Submitted

September 14, 2014

First Posted

September 18, 2014

Study Start

September 1, 2014

Primary Completion

October 1, 2014

Study Completion

October 1, 2014

Last Updated

April 7, 2015

Record last verified: 2015-04

Locations