Comprehensive Geriatric Assessment in the Elderly Subjects (PROMISING)

Recruiting

• Conditions: Ageing; Frailty
• Interventions: Other: comprehensive geriatric assessment

• Registration Number: NCT05822154
• Lead Sponsor: Istituto Nazionale di Ricovero e Cura per Anziani

Brief 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.

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 Timeline

• Study Start: 2022-10-03
• Status Verified: 2023-03
• Study First Submitted: 2023-03-27
• Study First Submitted QC: 2023-04-07
• Study First Posted: 2023-04-20
• Last Update Submitted: 2023-06-22
• Last Update Posted: 2023-06-23
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

• subjects with 65 years or older

Exclusion Criteria

• no informed consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
elderly subjects	comprehensive geriatric assessment	subjects aged 65 years and over

Primary Outcome Measures

Name	Time	Method
Change in prevalence of polypharmacy	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
Change in health conditions	Baseline, 3, 6 and 12 months later	The prevalence of comorbidities and their risk factors at time of enrolment

Secondary Outcome Measures

Name	Time	Method
Change in functional capacity	Baseline, 3, 6 and 12 months later	Activity of Instrumental of Daily Living (IADL). A summary score ranges from 0 (low function, dependent) to 8 (high function, independent)
Change of cognitive function score	Baseline, 3, 6 and 12 months late	Mini-mental State Examination (0-30 points), the higher the score, the better the cognitive function
Change in physical performance	Baseline, 3, 6 and 12 months later	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
Change in frailty condition	Baseline, 3, 6 and 12 months later	Clinical Frailty Scale (CFS). The CFS divides patients into 9 classes from very fit (CFS=1) to terminally ill (CFS=9)

Trial Locations

Locations (1)

IRCCS INRCA Hospital; 🇮🇹 Cosenza, Italy