Disabilities PhysicalEISANCT04797754
Systematic Development and Test-Retest Reliability of EISA
An observational study of Disabilities Physical and Sensory Disorder, run by University of Pittsburgh at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Disabilities Physical, Sensory Disorder
- How many people
- 84 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Nov 2017to 1 Nov 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Unable to read English
- Unable to independently answer or have assistance from someone to answer the survey questions
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh
Pittsburgh, Pennsylvania, 15206
About this study
Official title: Systematic Development and Test-Retest Reliability of Electronic Instrumental Activities of Daily Living Satisfaction Assessment (EISA)
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.
Read the 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.
- Conditions
- Disabilities Physical, Sensory Disorder
- Keywords
- Assistive Technology, Activities of Daily Living, Information & Communication Technology, Outcome Assessment
- Medical subject headings
- Sensation Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2021
- Study start3 Nov 2017
- Primary completion22 May 2018
- Study completion1 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Disabilities PhysicalStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abbas Quamar, University of Pittsburgh
- Investigators
- Mark R Schmeler, PhD, Study director, University of Pittsburgh, School of Health and Rehabilitation Professionals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04797754
- Sponsor's protocol ID
- PRO17030604
- Acronym
- EISA
- Status last verified
- Mar 2021
- First submitted
- 10 Mar 2021
- Last updated
- 15 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data will be uploaded by study participants to the Qualtrics Research Platform that is secure, encrypted and password protected. Only study personnel will have access to download unidentified data on excel sheets for data analysis.
Publications
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.
PubMed 11977872Kumar 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.
PubMed 22612721Scherer 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.
PubMed 19263548Schmitter-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.
PubMed 25344901Demers 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.
PubMed 12206579Day 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.
PubMed 11827152
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Systematic Development and Test-Retest Reliability of Electronic Instrumental Activities of Daily Living Satisfaction Assessment (EISA)
- ClinicalTrials.gov ID
- NCT04797754
- Acronym / sponsor ID
- EISA / PRO17030604
- Conditions
- Disabilities Physical, Sensory Disorder
- Keywords
- Assistive Technology, Activities of Daily Living, Information & Communication Technology, Outcome Assessment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- 3 Nov 2017 (actual)
- Primary completion
- 22 May 2018 (actual)
- Study completion
- 1 Nov 2018 (actual)
- First posted
- 15 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Unable to read English
- Unable to independently answer or have assistance from someone to answer the survey questions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Electronic Instrumental activities of daily living Satisfaction Assessment (EISA)
Time frame: 6 months
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2021.
- Background: PubMed 11977872Donnelly 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.
- Background: PubMed 22612721Kumar 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.
- Background: PubMed 19263548Scherer 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.
- Background: PubMed 25344901Schmitter-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.
- Background: PubMed 12206579Demers 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.
- Background: PubMed 11827152Day 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.
- Individual participant dataSharing planned: No. The data will be uploaded by study participants to the Qualtrics Research Platform that is secure, encrypted and password protected. Only study personnel will have access to download unidentified data on excel sheets for data analysis.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark R Schmeler, PhD study director
University of Pittsburgh, School of Health and Rehabilitation Professionals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Disabilities Physical and Sensory Disorder, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Electronic Instrumental activities of daily living Satisfaction Assessment (EISA) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04797754, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2021.