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

NCT05646472 | Unknown

• 1 other identifier: 284/22
• Study Type: observational
• Target: 700
• Locations: 1 country
• Sites: 8

Brief 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.

Conditions

Frail Elderly Syndrome

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (1)

≥ 65 Community-dwelling older adults

Diagnostic Test: Frailty multidimensional assessment

Interventions

Frailty multidimensional assessment 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.

≥ 65 Community-dwelling older adults

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

primary care clinic, community sample

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Federico II University: lead

Study Sites (8)

Azienda Socio Sanitaria Territoriale della Valle Olona

Busto Arsizio, Italy

RECRUITING

Azienda Sanitaria Locale Cuneo 1

Cuneo, Italy

RECRUITING

Azienda Sociosanitaria Ligure n. 4

Genova, Italy

RECRUITING

Azienda Unità Sanitaria Locale Nord-Ovest

Lucca, Italy

RECRUITING

Azeidna Ospedaliera Universitaria Federico II

Napoli, Italy

RECRUITING

Cooperativa Sociale "Res Omnia"

Reggio Calabria, Italy

RECRUITING

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

Roma, Italy

RECRUITING

Azienda Provinciale Socio-Sanitaria Trento

Trento, Italy

RECRUITING

Related Publications (1)

• 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.

  PMID: 36900872 DERIVED

Central Study Contacts

Maddalena Illario, PhD

CONTACT

+390817464211; illario@unina.it

Vincenzo De Luca

CONTACT

+393920535990; vinc.deluca@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof

Study Record Dates

• First Submitted: December 1, 2022
• First Posted: December 12, 2022
• Study Start: January 1, 2023
• Primary Completion: February 28, 2024
• Study Completion: December 31, 2024
• Last Updated: September 13, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

IT (8)