Clinical trial NCT06546813: Outcomes of ICT Assistive Technology in RehabiliTAtIoN Pathways
Official title: Outcomes of ICT Assistive Technology in RehabiliTAtIoN Pathways
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Communication Aids for Disabled
Communication Disorders
Motor Disorders
Cognitive Disorder
Keywords: ICT AT
AAC AT
AAL AT
Assistive Technology
Outcome Assessment
Lead sponsor: Fondazione Don Carlo Gnocchi Onlus
Sponsor class: OTHER
Collaborators: name: Ministry of Health, Italy
First posted: 2024-08-09
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with mobility, communication or cognitive disability

Brief summary: The study aims to improve the quality of prosthetic intervention and verify the adequacy of assistive devices, and measurement outcomes. Fifty patients in need of prosthetic interventions for Augmentative Alternative Communication, computer accessibility, and environmental control will be recruited within the DAT Unit of the Fondazione Don Carlo Gnocchi "IRCCS S.Maria Nascente" in Milan. At baseline (T0) a physician and a psychologist will perform a clinical evaluation and the AT outcome assessment. The participants will be contacted for the follow-up phase (T1) 3 to 6 months after having received the assistive solution. At T1 clinicians will readminister the AT outcome assessment. In order to make the assessment accessible to all participants, these tests and questionnaires will be administered on Windows PCs, using Grid3 software, or on a specifically created accessible web page.

Detailed description: Fifty patients in need of prosthetic interventions for Augmentative Alternative Communication (AAC), computer accessibility, and environmental control (for example, communicators, facilitated keyboards, mouse emulators, eye pointers, accessibility software, and remote controls for home control) will be recruited within the DAT Unit of the Fondazione Don Carlo Gnocchi ONLUS "IRCCS Santa Maria Nascente" in Milan. At baseline (T0) a physician will administer the Barthel Index 20 the Modified Cumulative Illness Rating Scale (CIRS), the ICF Generic Core Set-7, the ICF-core set for profiling communicative competence for AAC AT assessments or the ICF-Vocational Rehabilitation Brief Core Set integrated with some items of the Comprehensive one for ICT AT. A psychologist will assess patients' cognitive status using the Oxford Cognitive Screening (OCS), the CPM-Coloured Progressive Matrices, the Palm and Pyramid Trees Test - short version, the Aachener Aphasie Test (AAT) subtest on written and oral comprehension of words and sentences, the Multiple Features Targets Cancellation (MFTC). In order to make the cognitive assessment accessible to all participants, these tests will be administered on Windows PCs, using The Grid3 software, or on a specifically created accessible web page. According to the clinical and cognitive assessment, the health practitioner will decide whether to administer the assessment protocol to the patient or to the closest relative. The AT assessment protocol includes at baseline: the EQ-5D-5L questionnaire for quality of life and the Individual Prioritised Problems Assessment (IPPA) to assess the importance and severity of the problems the participants expect to improve with the AT use. The DAT multidisciplinary team will conduct the AT assessment and the most appropriate assistive solution will be identified and prescribed or suggested. The assistive devices received will be classified according to the international standard ISO 9999:2016 and the Ministry of Health Prosthetics and Assistive Products List (DPCM 12/01/2017). The participants will be contacted for the follow-up phase (T1) 3 to 6 months after having received the assistive solution. At T1 clinicians will administer the IPPA questionnaire, the ICF Core Sets, the EQ-5D-5L questionnaire, and the Quebec User Evaluation of Satisfaction with Assistive Technology Questionnaire (QUEST). Quantitative data will be summarized by appropriate descriptive statistics (mean, standard deviation, median, and ranges). Qualitative data will be summarized in contingency tables.

Eligibility criteria: consecutive enrollment of subjects falling within

Inclusion Criteria:

* patients in need of prosthetic interventions for Augmentative Alternative Communication, computer accessibility, and environmental control
* patients who agree to participate in the study

Exclusion Criteria:

* none

Primary outcomes:
measure: QUEST-Quebec User Evaluation of Satisfaction with Assistive Technology Questionnaire
timeFrame: T1 (6 months)
measure: IPPA-Individual Prioritised Problems Assessment
timeFrame: T0, T1 (3-6 months)
measure: EQ-5D-5L (EuroQol - 5 Dimensions - 5 Levels)
timeFrame: T0, T1 (3-6 months)
Secondary outcomes:
measure: Barthel Index (BI) 20
timeFrame: T0, T1 (3-6 months)
measure: CIRS-Modified Cumulative Illness Rating Scale (CIRS-CIRS)
timeFrame: T0, T1 (3-6 months)
measure: ICF (International Classification of Functioning) core-sets
timeFrame: T0, T1 (3-6 months)
Other outcomes:
Locations:
city: Milano
country: Italy
facility: IRCCS Fondazione Don Carlo Gnocchi ONLUS
state: MI
Study officials:
affiliation: IRCCS Fondazione Don Carlo Gnocchi ONLUS
name: Claudia Salatino
role: PRINCIPAL_INVESTIGATOR
References:
citation: Borgnis F, Desideri L, Converti RM, Salatino C. Available Assistive Technology Outcome Measures: Systematic Review. JMIR Rehabil Assist Technol. 2023 Nov 15;10:e51124. doi: 10.2196/51124.
citation: Salatino C, Andrich R, Converti RM, Saruggia M. An observational study of powered wheelchair provision in Italy. Assist Technol. 2016 Spring;28(1):41-52. doi: 10.1080/10400435.2015.1074631.
citation: Caronni A, Ramella M, Arcuri P, Salatino C, Pigini L, Saruggia M, Folini C, Scarano S, Converti RM. The Rasch Analysis Shows Poor Construct Validity and Low Reliability of the Quebec User Evaluation of Satisfaction with Assistive Technology 2.0 (QUEST 2.0) Questionnaire. Int J Environ Res Public Health. 2023 Jan 6;20(2):1036. doi: 10.3390/ijerph20021036.