Systematic Development and Test-Retest Reliability of EISA

NCT04797754 | Completed

• 1 other identifier: PRO17030604
• Study Type: observational
• Target: 84
• Locations: 1 country
• Sites: 1

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.

Conditions

Disabilities Physical; Sensory Disorder

Keywords

Assistive Technology; Activities of Daily Living; Information & Communication Technology; Outcome Assessment

Outcome Measures

Primary Outcomes (1)

• Electronic Instrumental activities of daily living Satisfaction Assessment (EISA)

  The EISA is a self-report outcome measurement tool, for assessing satisfaction of everyday functional needs, for consumers using Electronic Assistive Devices (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.

  6 months

Other Outcomes (1)

• Demographic Questionnaires

  Six Months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• Unable to read English
• Unable to independently answer or have assistance from someone to answer the survey questions

Sponsors & Collaborators

• University of Pittsburgh: lead

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15206, United States

Location

Related Publications (6)

• Donnelly C, Carswell A. Individualized outcome measures: a review of the literature. Can J Occup Ther. 2002 Apr;69(2):84-94. doi: 10.1177/000841740206900204.

  PMID: 11977872 BACKGROUND

• Kumar A, Schmeler MR, Karmarkar AM, Collins DM, Cooper R, Cooper RA, Shin H, Holm MB. Test-retest reliability of the functional mobility assessment (FMA): a pilot study. Disabil Rehabil Assist Technol. 2013 May;8(3):213-9. doi: 10.3109/17483107.2012.688240. Epub 2012 May 22.

  PMID: 22612721 BACKGROUND

• Scherer M, Jutai J, Fuhrer M, Demers L, Deruyter F. A framework for modelling the selection of assistive technology devices (ATDs). Disabil Rehabil Assist Technol. 2007 Jan;2(1):1-8. doi: 10.1080/17483100600845414.

  PMID: 19263548 BACKGROUND

• 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.

  PMID: 25344901 BACKGROUND

• Demers L, Monette M, Descent M, Jutai J, Wolfson C. The Psychosocial Impact of Assistive Devices Scale (PIADS): translation and preliminary psychometric evaluation of a Canadian-French version. Qual Life Res. 2002 Sep;11(6):583-92. doi: 10.1023/a:1016397412708.

  PMID: 12206579 BACKGROUND

• 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.

  PMID: 11827152 BACKGROUND

MeSH Terms

Conditions

Sensation Disorders

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Mark R Schmeler, PhD

  University of Pittsburgh, School of Health and Rehabilitation Professionals

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Graduate Student Researcher

Study Record Dates

• First Submitted: March 10, 2021
• First Posted: March 15, 2021
• Study Start: November 3, 2017
• Primary Completion: May 22, 2018
• Study Completion: November 1, 2018
• Last Updated: March 15, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)