Outcomes of ICT Assistive Technology in RehabiliTAtIoN Pathways
- Conditions
- Communication Aids for DisabledMotor DisordersCommunication DisordersCognitive Disorder
- Interventions
- Other: scales and questionnaire administration
- Registration Number
- NCT06546813
- Lead Sponsor
- Fondazione Don Carlo Gnocchi Onlus
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 50
- patients in need of prosthetic interventions for Augmentative Alternative Communication, computer accessibility, and environmental control
- patients who agree to participate in the study
- none
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Fifty patients in need of ICT prosthetic interventions scales and questionnaire administration Persons with communication, mobility or cognitive disability
- Primary Outcome Measures
Name Time Method EQ-5D-5L (EuroQol - 5 Dimensions - 5 Levels) T0, T1 (3-6 months) The EQ-5D-5L(EuroQol - 5 Dimensions - 5 Levels) measures health-related quality of life across five dimensions: Mobility, Self-care, Usual activities, Pain/discomfort, and Anxiety/depression. Each dimension has five severity levels ranging from "No problems" to "Extreme problems." Respondents choose a level for each dimension, resulting in a health profile of five numbers. Additionally, the scale includes a Visual Analog Scale (VAS) where overall health is rated from 0 (worst imaginable) to 100 (best imaginable). The profile can be converted into a single utility score, ranging from about -0.281 (worse than death) to 1 (perfect health). Higher scores indicate better health outcomes.
QUEST-Quebec User Evaluation of Satisfaction with Assistive Technology Questionnaire T1 (6 months) The "Questionnaire de Satisfaction des Usagers des Services en Travailleur Autonome" (QUEST) evaluates user satisfaction with home care and assistive technology services. It assesses:
1. Overall Satisfaction: How well the service met expectations.
2. Quality of Services: Perception of service quality, including provider competence and professionalism.
3. Effectiveness: Impact on quality of life and independence.
4. Accessibility: Ease of accessing services, considering geography, waiting times, and cost.
5. Adequacy: How well the service met individual needs and preferences.
6. Support and Training: Quality of support and training for using the service or technology.
Users answer specific questions on a rating scale, helping to identify areas for improvement and optimize service quality.IPPA-Individual Prioritised Problems Assessment T0, T1 (3-6 months) Perceived effectiveness of prescribed AT
- Secondary Outcome Measures
Name Time Method ICF (International Classification of Functioning) core-sets T0, T1 (3-6 months) Classification of functioning, disability and health
Barthel Index (BI) 20 T0, T1 (3-6 months) The Barthel Index (BI) - 20-point version assesses basic daily living activities to measure a patient's independence. It scores 10 activities (e.g., feeding, bathing, dressing) from 0 to 2 points each, where 0 is total dependence, 1 is partial assistance needed, and 2 is complete independence. Scores are summed to determine the level of dependence: 0-4 (total dependence), 5-9 (severe), 10-14 (moderate), 15-19 (slight), and 20 (complete independence). The index is used by healthcare professionals or caregivers through a structured questionnaire or checklist to evaluate disability, plan discharge, and monitor rehabilitation progress.
CIRS-Modified Cumulative Illness Rating Scale (CIRS-CIRS) T0, T1 (3-6 months) Health condition:
A low total score indicates good overall health with few or no significant chronic problems.
A high total score indicates numerous severe chronic conditions, suggesting a high degree of comorbidity and a need for intensive medical intervention.
Trial Locations
- Locations (1)
IRCCS Fondazione Don Carlo Gnocchi ONLUS
🇮🇹Milano, MI, Italy