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NCT04797754: EISA
Systematic Development and Test-Retest Reliability of EISA
trial in Disabilities Physical in 84 participants. Completed in 1 November 2018.
22 May 2018
Quick facts
| Lead sponsor | University of Pittsburgh |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 84 |
| Start date | 3 November 2017 |
| Primary completion | 22 May 2018 |
| Estimated completion | 1 November 2018 |
| Sites | 1 location across United States |
Conditions studied
- Disabilities Physical — all drugs for Disabilities Physical →
- Sensory Disorder — all drugs for Sensory Disorder →
Sponsor
University of Pittsburgh
Who can join
18 and older, any sex, with Disabilities Physical or Sensory Disorder. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT04797754
- Europe PMC full search
- ASCO Meeting Library
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04797754 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Pittsburgh
- Last refreshed: 15 March 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04797754.
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