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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Frail Elderly Syndrome
• Intervention / Treatment: Diagnostic test: Frailty multidimensional assessment

• Study Type: Observational
• Enrollment (Estimated): 700

Contacts and Locations

• Study Contact: Name: Maddalena Illario, PhD; Phone Number: +390817464211; Email: illario@unina.it
• Study Contact Backup: Name: Vincenzo De Luca; Phone Number: +393920535990; Email: vinc.deluca@gmail.com

Study Locations

• Italy
  • Busto Arsizio, Italy
    • Recruiting
    • Azienda Socio Sanitaria Territoriale della Valle Olona
    • Contact: Marino Dell'Acqua
  • Cuneo, Italy
    • Recruiting
    • Azienda Sanitaria Locale Cuneo 1
    • Contact: Paola Obbia
  • Genova, Italy
    • Recruiting
    • Azienda Sociosanitaria Ligure n. 4
    • Contact: Walter Aronni
  • Lucca, Italy
    • Recruiting
    • Azienda Unità Sanitaria Locale Nord-Ovest
    • Contact: Moira Borgioli
  • Napoli, Italy
    • Recruiting
    • Azeidna Ospedaliera Universitaria Federico II
    • Contact: Maddalena Illario
  • Reggio Calabria, Italy
    • Recruiting
    • Cooperativa Sociale "Res Omnia"
    • Contact: Fortunata Denisi
  • Roma, Italy
    • Recruiting
    • Dipartimento di Biomedicina e Prevenzione dell'Università degli Studi di Roma Tor Vergata
    • Contact: Giuseppe Liotta
  • Trento, Italy
    • Recruiting
    • Azienda Provinciale Socio-Sanitaria Trento
    • Contact: Stefano Toccoli

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

primary care clinic, community sample

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

≥ 65 Community-dwelling older adults

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Appropriateness of care	Level of appropriateness of care by the healthcare system	Month 14
Level of satisfaction of the health professionals	Impact of the IT solution on the organization of services and the workload of professionals	Month 14

Collaborators and Investigators

• Sponsor: Federico II University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2023
• Primary Completion (Estimated): February 28, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: December 1, 2022
• First Submitted That Met QC Criteria: December 9, 2022
• First Posted (Actual): December 12, 2022

Study Record Updates

• Last Update Posted (Actual): September 13, 2023
• Last Update Submitted That Met QC Criteria: September 11, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 284/22

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Study protocol will be published on an open access scientific journal
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No