CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 84 enrolled
Drug / intervention
Not specified
Likely dose
Not stated in record
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Search/NCT04797754
NCT04797754N/ACompleted

Systematic Development and Test-Retest Reliability of Electronic Instrumental Activities of Daily Living Satisfaction Assessment (EISA)

University of Pittsburgh·observational·Posted Mar 15, 2021·Updated Mar 15, 2021

In Brief

An observational study for Disabilities Physical and Sensory Disorder. Completed, enrolled 84 participants across 1 site.

Detailed Summary

The purpose of this proposed study, is the development and validation of EISA, a Self-report outcome measurement tool, for assessing the satisfaction of everyday functional needs, for consumers using Electronic Assistive Devices (EADs) as the primary means to complete Instrumental Activities of Daily Living (IADLs). The EISA outcome measure is proposed to be designed as a questionnaire that can be self or interview-administered to users of EADs. The development of EISA shall be modeled along the lines of development of the self-report outcome measure, Functional Mobility Assessment (FMA) (Kumar et al., 2013). The proposed tool EISA, would serve as a dynamic gage, for assessing perceived user function, related to using EADs for completing IADLs. The instrument is proposed to undergo systematic development in three phases. In phase 1, an initial pool of potential EISA items shall be generated, based on literature review data. In phase 2, content experts (clinician and EADs user) review panels, shall assess the initial pool of potential EISA items for further content validity. The objective of phase 3, would be a validation of the first iteration of EISA, by establishing reliability for test-retest administration and internal consistency, at acceptable levels, by 25-100 EADs users. Statistical analysis for test-retest reliability and internal consistency estimation shall be carried out in phase 3 of the study, using Statistical Package for the Social Sciences (SPSS) version 24 software.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedMar 15, 2021
Enrollment StartNov 3, 2017
Primary CompletionMay 22, 2018
Study CompletionNov 1, 2018
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 5.3 years ago