Clinical trial NCT04797754: Systematic Development and Test-Retest Reliability of EISA
Official title: Systematic Development and Test-Retest Reliability of Electronic Instrumental Activities of Daily Living Satisfaction Assessment (EISA)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Disabilities Physical
Sensory Disorder
Keywords: Assistive Technology
Activities of Daily Living
Information & Communication Technology
Outcome Assessment
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2021-03-15
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The target population for the proposed EISA outcome measure would be Persons with Disabilities (PWD) who use EADs as their primary means for completing IADLs. Recruitment of EADs users shall be carried out in a targeted manner, through an invitation to participate in the study, by clinicians at (1) University of Pittsburgh Medical Center (UPMC) Center for Assistive Technology (CAT); (2) Hiram G. Andrews Center (HGAC) Center for Assistive and Rehabilitative Technology (CART); (3) The Ohio State University (OSU) Assistive Technology Clinic; and (4) the Veterans Administration Assistive Technology Labs.

Brief 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.

Detailed description: Objective: The purpose of this proposed study, is the development and validation of EISA, a Self-report outcome measurement tool, for assessing satisfaction of everyday functional needs, for consumers using EADs as the primary means to complete IADLs. The EISA outcome measure is proposed to be designed as a questionnaire that can be self or interview administered to users of EADs. Development of EISA shall be modeled along the lines of development of the self-report outcome measure, FMA (Kumar et al., 2013). The proposed tool EISA would serve as a dynamic gauge, for assessing perceived user function, related to using EADs for completing IADLs.

Specific Aims:

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 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 using Statistical Package for the Social Sciences (SPSS) version 24 software, in Phase 3 of the study.

Background: Briefly describe previous findings or observations that provide the background leading to this proposal. It cannot be stressed enough, that for both able-bodied individuals and PWD, having access to ICT, is no longer a luxury, but rather, a basic necessity, to cope with the current technology based lifestyle. Furthermore, having equal and timely access to IT for PWD is imperative to enable them to live independently and have a high Quality of Life. Moreover, this equal and timely access not only provides increased life options for PWD but also, wider economic benefits for the society at large. However, currently, several factors are impeding this equal and timely access to ICT for PWD. These factors include (1) lack of an outcome measure specifically designed and validated to assess the satisfaction of everyday functional needs related to EAD; (2) inappropriateness, impracticality, apart from lack of clinical utility and psychometric validation of existing outcome measures to assess the satisfaction of everyday functional needs of PWD, related to EADs; (3) continual and fast-paced, disruptive innovations very often rendering essential services inaccessible for PWD. Therefore, to fill this unmet need, as well as, to enable PWD to have equal opportunity with able-bodied individuals to tap their optimal potential, this study proposes the development and validation of a self-report outcome measure, EISA, specifically designed to assess satisfaction of everyday functional needs of PWD, related to EADs.

Significance: In this day and age of IT, it is crucial for PWD to have access to EAD that matches their individualized needs and enables them to achieve their optimal potential. Nevertheless, as can be gleaned from the aforementioned analysis, currently there is no good outcome tool for the assessment of user-satisfaction in performing functional needs with EADs.

Eligibility criteria: Inclusion Criteria:

1. Should be an existing user of EADs for at least 3 months
2. Must be 18 years of age or older
3. Should be capable of cognitively reading instructions and answering questions within the Qualtrics online research platform

Exclusion Criteria:

1. Unable to read English
2. Unable to independently answer or have assistance from someone to answer the survey questions

Primary outcomes:
measure: Electronic Instrumental activities of daily living Satisfaction Assessment (EISA)
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
measure: Demographic Questionnaires
timeFrame: Six Months
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh, School of Health and Rehabilitation Professionals
name: Mark R Schmeler, PhD
role: STUDY_DIRECTOR
References:
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citation: Schmitter-Edgecombe M, Parsey C, Lamb R. Development and psychometric properties of the instrumental activities of daily living: compensation scale. Arch Clin Neuropsychol. 2014 Dec;29(8):776-92. doi: 10.1093/arclin/acu053. Epub 2014 Oct 25.
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citation: Day H, Jutai J, Campbell KA. Development of a scale to measure the psychosocial impact of assistive devices: lessons learned and the road ahead. Disabil Rehabil. 2002 Jan 10-Feb 15;24(1-3):31-7. doi: 10.1080/09638280110066343.