AgeingPROMISINGNCT05822154
Comprehensive Geriatric Assessment in the Elderly Subjects (PROMISING)
An observational study of Ageing and Frailty, run by Istituto Nazionale di Ricovero e Cura per Anziani at 1 site in Italy.
Trial summary
The primary objective of this observational study is to verify, through a comprehensive geriatric assessment, the health status of a sample of elderly subjects. Read more about this study
- Who is it for?
- Ages 65 years and older
- What is being tested?
- comprehensive geriatric assessment
- How many people
- 400 participants
- Where
- 1 siteItaly
- Study dates
- 3 Oct 2022to 31 Dec 2023
- 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
- Older adult
Study population: Elderly patients from different settings (inpatients and outpatients) who attend the hospitals of the participating centres.
Who may be able to join
- subjects with 65 years or older
Who cannot join
- no informed consent
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
IRCCS INRCA Hospital
Cosenza
Andrea Corsonello, MD, a.corsonello@inrca.it
About this study
The primary objective of this observational study is to verify, through a comprehensive geriatric assessment, the health status of a sample of elderly subjects.
Read the detailed description
The primary objective of this observational study is to verify, through a comprehensive geriatric assessment, the health status of a sample of elderly subjects. Short- to medium-term outcomes will also be evaluated through follow-up.
- Being tested
- comprehensive geriatric assessment
- Keywords
- ageing, comprehensive geriatric assessment, polypharmacy
- Medical subject headings
- Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
comprehensive geriatric assessmentOther
The clinical, biological and functional characteristics will be collected in elderly subjects attending the hospitals of participating centers.
| Study group | Role | What they receive |
|---|---|---|
| elderly subjects | subjects aged 65 years and over Receives: Other: comprehensive geriatric assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in health conditions
The prevalence of comorbidities and their risk factors at time of enrolment
Measured: Baseline, 3, 6 and 12 months later
Change in prevalence of polypharmacy
Number of participants with polypharmacy. Polypharmacy will be defined as being on five or more medications at one time
Measured: Baseline, 3, 6 and 12 months later
Secondary outcomes (5)
Change in frailty condition
Clinical Frailty Scale (CFS). The CFS divides patients into 9 classes from very fit (CFS=1) to terminally ill (CFS=9)
Measured: Baseline, 3, 6 and 12 months later
Change in functional capacity
Activity of Daily Living (ADL). A summary score ranges from 0 (low function, dependent) to 6 (high function, independent)
Measured: Baseline, 3, 6 and 12 months later
Change in functional capacity
Activity of Instrumental of Daily Living (IADL). A summary score ranges from 0 (low function, dependent) to 8 (high function, independent)
Measured: Baseline, 3, 6 and 12 months later
Change in physical performance
Physical performance will be ascertained using the Short Physical Performance Battery (SPPB). Summary scores range from 0-12 and higher scores denote higher physical performance
Measured: Baseline, 3, 6 and 12 months later
Change of cognitive function score
Mini-mental State Examination (0-30 points), the higher the score, the better the cognitive function
Measured: Baseline, 3, 6 and 12 months late
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2023
- Study start3 Oct 2022
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgeingStudies of the same condition, open and under way.
- 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
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Nazionale di Ricovero e Cura per Anziani
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Italy
- Responsible party
- Sponsor
- Investigators
- Andrea Corsonello, MD, Principal investigator, IRCCS INRCA, Cosenza, ItalySimona Ciccone, MD, Principal investigator, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milano, ItalyAntonio Greco, MD, Principal investigator, Casa Sollievo della Sofferenza, San Giovanni Rotondo, ItalyRodolfo Sardone, MD, Principal investigator, IRCCS "Saverio de Bellis", Castellana Grotte (BA), ItalyFabrizio Giunco, MD, Principal investigator, Fondazione Don Carlo Gnocchi, Milano, ItalyMariacristina Parravano, MD, Principal investigator, Fondazione G.B. Bietti per lo Studio e la Ricerca in Oftalmologia, Roma, ItalyMarco Lenti, MD, Principal investigator, Fondazione Policlinico San Matteo, Pavia, ItalyRosa Liperoti, MD, Principal investigator, Fondazione Policlinico Universitario A. Gemelli, Roma, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05822154
- Sponsor's protocol ID
- INRCA_001_2023
- Acronym
- PROMISING
- Status last verified
- Mar 2023
- First submitted
- 27 Mar 2023
- Last updated
- 23 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comprehensive Geriatric Assessment in the Elderly Subjects (PROMISING)
- ClinicalTrials.gov ID
- NCT05822154
- Acronym / sponsor ID
- PROMISING / INRCA_001_2023
- Keywords
- ageing, comprehensive geriatric assessment, polypharmacy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Istituto Nazionale di Ricovero e Cura per AnzianiUniversity, hospital or other
- Collaborators
- Ministry of Health, Italy
- Study start
- 3 Oct 2022 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 20 Apr 2023 (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.
The primary objective of this observational study is to verify, through a comprehensive geriatric assessment, the health status of a sample of elderly subjects.
Detailed description
The primary objective of this observational study is to verify, through a comprehensive geriatric assessment, the health status of a sample of elderly subjects. Short- to medium-term outcomes will also be evaluated through follow-up.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| elderly subjects | – | Other: comprehensive geriatric assessmentsubjects aged 65 years and over |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Age groups
- Older adult
- Study population
- Elderly patients from different settings (inpatients and outpatients) who attend the hospitals of the participating centres.
Key inclusion criteria (1 listed)
- subjects with 65 years or older
Key exclusion criteria (1 listed)
- no 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 |
|---|---|---|
| comprehensive geriatric assessmentThe clinical, biological and functional characteristics will be collected in elderly subjects attending the hospitals of participating centers. | Other | elderly subjects |
Primary outcome
Change in health conditions
Time frame: Baseline, 3, 6 and 12 months later
The prevalence of comorbidities and their risk factors at time of enrolment
Change in prevalence of polypharmacy
Time frame: Baseline, 3, 6 and 12 months later
Number of participants with polypharmacy. Polypharmacy will be defined as being on five or more medications at one time
5 secondary outcomes
Change in frailty condition
Time frame: Baseline, 3, 6 and 12 months later
Change in functional capacity
Time frame: Baseline, 3, 6 and 12 months later
Change in functional capacity
Time frame: Baseline, 3, 6 and 12 months later
Change in physical performance
Time frame: Baseline, 3, 6 and 12 months later
Change of cognitive function score
Time frame: Baseline, 3, 6 and 12 months late
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2023.
- Individual participant dataSharing planned: No
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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.
Andrea Corsonello, MD principal investigator
IRCCS INRCA, Cosenza, Italy
Simona Ciccone, MD principal investigator
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milano, Italy
Antonio Greco, MD principal investigator
Casa Sollievo della Sofferenza, San Giovanni Rotondo, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ageing and Frailty, run by Istituto Nazionale di Ricovero e Cura per Anziani at 1 site 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 1 inclusion and 1 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 23 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Anna Rita Bonfigli, PhD (00390718003719, a.bonfigli@inrca.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in health conditions (time frame: Baseline, 3, 6 and 12 months later). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Jun 2023.