ICT-supported Multidimensional Approach for Frailty Screening in Community-dwelling Individuals Aged ≥ 65 Years

Frail Elderly Syndrome Clinical Trial

— SUNFRAIL+  

Official title:

Approccio Multidimensionale Supportato Dalle ICT Per lo Screening Della fragilità Nei Soggetti di età ≥ 65 Anni Che Vivono in comunità - SUNFRAIL+

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05646472
• Other study ID #: 284/22
• Status: Recruiting
• Start date: January 1, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: September 2023
• Source: Federico II University
• Contact: Maddalena Illario, PhD
• Phone: +390817464211
• Email: illario[@]unina.it
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

SUNFRAIL+ is a prospective observational cohort study aimed to carry out a multidimensional assessment of community-dwelling older adults, through an IT platform, which allows to connect the items of the SUNFRAIL frailty assessment tool with a cascading multidimensional in-depth assessment of the bio-psycho-social domains of frailty. It is a multicentric study. Seven centres will administer SUNFRAIL questionnaire to 100 older adults each and, according to the specific "alerts" triggered by the answers provided, older adults will be subjected to one or more validated in-depth tests in order to perform further diagnostic or dimensional evaluations.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 700
• Est. completion date: December 31, 2024
• Est. primary completion date: February 28, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• Age =65 years;
• Living at home;
• accessing participating centres for social and healthcare services other than those covered by this study;
• ability to sign the informed consent

Exclusion Criteria:

• Age <65 years;
• Residents in care facilities (hospital, nursing home);
• have overt frailty or disability; are already enrolled in home care; are unable to understand the study aims and sign the informed consent

Related Conditions & MeSH terms

• Frail Elderly Syndrome

Intervention

Diagnostic Test:
• Frailty multidimensional assessment
Each Centre will administer SUNFRAIL frailty assessment tool to the enrolled older adults and, according to the specific "alerts" triggered by the answers provided, older adults will be subjected (at the same time or subsequently) to one or more validated in-depth tests (already included in the SUNFRAIL+ platform) in order to perform further diagnostic or dimensional evaluations. During the observation phase, subjects will be given different health promotion activities, depending on the assessment. During the follow-up phase, 6 months after enrolment, SUNFRAIL tool and in-depth tests will be administered again. In addition, during the follow up, the extent to which exposure to interventions has influenced the quality of life of older adults will be measured and the number of users enrolled by territorial services, based on user care needs. In addition, the level of satisfaction and usability of the SUNFRAIL+ solution by health and social care professionals will be measured.

Locations

Country	Name	City	State
Italy	Azienda Socio Sanitaria Territoriale della Valle Olona	Busto Arsizio
Italy	Azienda Sanitaria Locale Cuneo 1	Cuneo
Italy	Azienda Sociosanitaria Ligure n. 4	Genova
Italy	Azienda Unità Sanitaria Locale Nord-Ovest	Lucca
Italy	Azeidna Ospedaliera Universitaria Federico II	Napoli
Italy	Cooperativa Sociale "Res Omnia"	Reggio Calabria
Italy	Dipartimento di Biomedicina e Prevenzione dell'Università degli Studi di Roma Tor Vergata	Roma
Italy	Azienda Provinciale Socio-Sanitaria Trento	Trento

Sponsors (1)

Lead Sponsor	Collaborator
Federico II University

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improved quality of life	Impact of early, integrated and simultaneous "taking care" by health system on the quality of life of community-dwelling older adults	Month 14
Primary	Appropriateness of care	Level of appropriateness of care by the healthcare system	Month 14
Primary	Level of satisfaction of the health professionals	Impact of the IT solution on the organization of services and the workload of professionals	Month 14