Frail Elderly SyndromeSUNFRAIL+NCT05646472
ICT-supported Multidimensional Approach for Frailty Screening in Community-dwelling Individuals Aged ≥ 65 Years
An observational study of Frail Elderly Syndrome, run by Federico II University at 8 sites in Italy.
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… Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Frail Elderly Syndrome
- What is being tested?
- Frailty multidimensional assessment
- How many people
- 700 participants
- Where
- 8 sitesItaly
- Study dates
- 1 Jan 2023to 31 Dec 2024
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: primary care clinic, community sample
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Italy8 sites, 8 recruiting
- Recruiting
Azienda Socio Sanitaria Territoriale della Valle Olona
Busto Arsizio
Marino Dell'Acqua
- Recruiting
Azienda Sanitaria Locale Cuneo 1
Cuneo
Paola Obbia
- Recruiting
Azienda Sociosanitaria Ligure n. 4
Genova
Walter Aronni
- Recruiting
Azienda Unità Sanitaria Locale Nord-Ovest
Lucca
Moira Borgioli
- Recruiting
Azeidna Ospedaliera Universitaria Federico II
Naples
Maddalena Illario
- Recruiting
Cooperativa Sociale "Res Omnia"
Reggio Calabria
Fortunata Denisi
- Recruiting
Dipartimento di Biomedicina e Prevenzione dell'Università degli Studi di Roma Tor Vergata
Roma
Giuseppe Liotta
- Recruiting
Azienda Provinciale Socio-Sanitaria Trento
Trento
Stefano Toccoli
About this study
Official title: 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.
- Conditions
- Frail Elderly Syndrome
- Being tested
- Frailty multidimensional assessment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Frailty multidimensional assessmentDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| ≥ 65 Community-dwelling older adults | Not described Receives: Diagnostic Test: Frailty multidimensional assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Month 14
Appropriateness of care
Level of appropriateness of care by the healthcare system
Measured: Month 14
Level of satisfaction of the health professionals
Impact of the IT solution on the organization of services and the workload of professionals
Measured: Month 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2022
- Study start1 Jan 2023
- Primary completion28 Feb 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Frail Elderly SyndromeStudies of the same condition, open and under way.
- More trials run by Federico II UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 700 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Federico II University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maddalena Illario, Federico II University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05646472
- Sponsor's protocol ID
- 284/22
- Acronym
- SUNFRAIL+
- Status last verified
- Sep 2023
- First submitted
- 1 Dec 2022
- Last updated
- 13 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study protocol will be published on an open access scientific journal
Publications
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.
PubMed 36900872
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Approccio Multidimensionale Supportato Dalle ICT Per lo Screening Della fragilità Nei Soggetti di età ≥ 65 Anni Che Vivono in comunità - SUNFRAIL+
- ClinicalTrials.gov ID
- NCT05646472
- Acronym / sponsor ID
- SUNFRAIL+ / 284/22
- Conditions
- Frail Elderly Syndrome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- Federico II UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 28 Feb 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 12 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ≥ 65 Community-dwelling older adults | – | Diagnostic Test: Frailty multidimensional assessment |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- primary care clinic, community sample
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Frailty multidimensional assessmentEach 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. | Diagnostic test | ≥ 65 Community-dwelling older adults |
Primary outcome
Improved quality of life
Time frame: Month 14
Impact of early, integrated and simultaneous "taking care" by health system on the quality of life of community-dwelling older adults
Appropriateness of care
Time frame: Month 14
Level of appropriateness of care by the healthcare system
Level of satisfaction of the health professionals
Time frame: Month 14
Impact of the IT solution on the organization of services and the workload of professionals
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2023.
- Derived from this study: PubMed 36900872De 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.
- Individual participant dataSharing planned: Yes. Study protocol will be published on an open access scientific journal
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Frail Elderly Syndrome, run by Federico II University at 8 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maddalena Illario, PhD (+390817464211, illario@unina.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improved quality of life (time frame: Month 14). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05646472, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2023.