Comprehensive Geriatric Assessment in the Elderly Subjects (PROMISING)

Frailty Clinical Trial

— PROMISING  

Official title:

Comprehensive Geriatric Assessment in the Elderly Subjects (PROMISING)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05822154
• Other study ID #: INRCA_001_2023
• Status: Recruiting
• Start date: October 3, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: March 2023
• Source: Istituto Nazionale di Ricovero e Cura per Anziani
• Contact: Anna Rita Bonfigli, PhD
• Phone: 00390718003719
• Email: a.bonfigli[@]inrca.it
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• subjects with 65 years or older

Exclusion Criteria:

• no informed consent

Related Conditions & MeSH terms

• Ageing
• Frailty

Intervention

Other:
• comprehensive geriatric assessment
The clinical, biological and functional characteristics will be collected in elderly subjects attending the hospitals of participating centers.

Locations

Country	Name	City	State
Italy	IRCCS INRCA Hospital	Cosenza

Sponsors (2)

Lead Sponsor	Collaborator
Istituto Nazionale di Ricovero e Cura per Anziani	Ministry of Health, Italy

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in health conditions	The prevalence of comorbidities and their risk factors at time of enrolment	Baseline, 3, 6 and 12 months later
Primary	Change in prevalence of polypharmacy	Number of participants with polypharmacy. Polypharmacy will be defined as being on five or more medications at one time	Baseline, 3, 6 and 12 months later
Secondary	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)	Baseline, 3, 6 and 12 months later
Secondary	Change in functional capacity	Activity of Daily Living (ADL). A summary score ranges from 0 (low function, dependent) to 6 (high function, independent)	Baseline, 3, 6 and 12 months later
Secondary	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)	Baseline, 3, 6 and 12 months later
Secondary	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	Baseline, 3, 6 and 12 months later
Secondary	Change of cognitive function score	Mini-mental State Examination (0-30 points), the higher the score, the better the cognitive function	Baseline, 3, 6 and 12 months late