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

NCT ID: NCT05646472

Last Updated: 2023-09-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

700 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-01-01

Study Completion Date

2024-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Frail Elderly Syndrome

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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≥ 65 Community-dwelling older adults

Frailty multidimensional assessment

Intervention Type DIAGNOSTIC_TEST

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.

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Federico II University

OTHER

Sponsor Role lead

Responsible Party

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Maddalena Illario

Prof

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Azienda Socio Sanitaria Territoriale della Valle Olona

Busto Arsizio, , Italy

Site Status RECRUITING

Azienda Sanitaria Locale Cuneo 1

Cuneo, , Italy

Site Status RECRUITING

Azienda Sociosanitaria Ligure n. 4

Genova, , Italy

Site Status RECRUITING

Azienda Unità Sanitaria Locale Nord-Ovest

Lucca, , Italy

Site Status RECRUITING

Azeidna Ospedaliera Universitaria Federico II

Napoli, , Italy

Site Status RECRUITING

Cooperativa Sociale "Res Omnia"

Reggio Calabria, , Italy

Site Status RECRUITING

Dipartimento di Biomedicina e Prevenzione dell'Università degli Studi di Roma Tor Vergata

Roma, , Italy

Site Status RECRUITING

Azienda Provinciale Socio-Sanitaria Trento

Trento, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Maddalena Illario, PhD

Role: CONTACT

+390817464211

Vincenzo De Luca

Role: CONTACT

+393920535990

Facility Contacts

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Marino Dell'Acqua

Role: primary

Paola Obbia

Role: primary

Walter Aronni

Role: primary

Moira Borgioli

Role: primary

Maddalena Illario

Role: primary

Fortunata Denisi

Role: primary

Giuseppe Liotta

Role: primary

Stefano Toccoli

Role: primary

References

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De Luca V, Femminella GD, Leonardini L, Patumi L, Palummeri E, Roba I, Aronni W, Toccoli S, Sforzin S, Denisi F, Basso AM, Ruatta M, Obbia P, Rizzo A, Borgioli M, Eccher C, Farina R, Conforti D, Mercurio L, Salvatore E, Gentile M, Bocchino M, Sanduzzi Zamparelli A, Viceconte G, Gentile I, Ruosi C, Ferrara N, Fabbrocini G, Colao A, Triassi M, Iaccarino G, Liotta G, Illario M. Digital Health Service for Identification of Frailty Risk Factors in Community-Dwelling Older Adults: The SUNFRAIL+ Study Protocol. Int J Environ Res Public Health. 2023 Feb 21;20(5):3861. doi: 10.3390/ijerph20053861.

Reference Type DERIVED
PMID: 36900872 (View on PubMed)

Other Identifiers

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284/22

Identifier Type: -

Identifier Source: org_study_id

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