NCT04785664: CAMP-80

Community-based Pro-Active Monitoring Program (CAMP) and Older Adults

Status unknown NA Last updated 8 March 2021

What this trial tests

NA trial testing Community-based pro-Active Monitoring Program in Social Isolation in 1,185 participants. Status unknown.

Timeline

1 January 2018

Primary endpoint
31 December 2020

31 December 2021

Quick facts

Lead sponsor	University of Rome Tor Vergata
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	health services research
Enrollment	1,185
Start date	1 January 2018
Primary completion	31 December 2020
Estimated completion	31 December 2021
Sites	1 location across Italy

Drugs / interventions tested

• Community-based pro-Active Monitoring Program

Conditions studied

• Social Isolation — all drugs for Social Isolation →
• Frailty — all drugs for Frailty →

Sponsor

University of Rome Tor Vergata

Who can join

80 and older, any sex, with Social Isolation or Frailty. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Background: According to World Health Organization the world population is rapidly aging, and this impacts Health and Social Services. To improve older adults' quality of life and to reduce negative outcomes is necessary to provide appropriate care at affordable costs. To achieve this goal and to address the most effective intervention, stratification by frailty and negative outcomes is needed. Another crucial point to older adults is social isolation, this is related to the extension and quality of life of the individual's relationship network. Social isolation, as well as the level of frailty, are associated with an increased risk of death, hospitalization, and institutionalization.

Results: Analysis of data collected in the Lazio region during the pre-intervention phase is finished. Total patients enrolled are 1185 (578 cases and 607 control). The intervention is focused on increasing social capital at the individual and community level and aimed at improving survival among the cases as well as reducing the use of hospital and residential Long-Term Care.

Conclusions: The proposed study will address a crucial issue: assess the impact of a bottom-up care service consisting of social and health interventions aimed at reducing social isolation and improving access to health care services. The results of the study will be shared in the country, to reach the larger spread and to direct the policymaker.

Objective: The objective of this study is to evaluate the impact of a community-based proactive monitoring program. This study aims to improve community care by measuring the effect in countering the negative outcomes related to the frailty of older adults (over 80).

Methods: A prospective pragmatic trial will be carried out to describe the impact of an intervention on people aged\>80, adjusted for relevant parameters: demographic variables, comorbidities, disability, and bio-psycho-social frailty. The multidimensional frailty will be evaluated with the Functional Geriatric Evaluation questionnaire that is a validated tool. The questionnaire was administrated at baseline to the two groups. Two clusters of patients have been enrolled and interviewed. The first made up of 578 cases (undergoing the intervention) and the second by 607 controls, among which no intervention will be performed. Case cluster intervention is a Community-based Pro-Active Monitoring Program performed by a multidisciplinary team on individual needs (level of frailty, social isolation, and physical disability). The primary outcome of this study is the evaluation of Mortality, Acute Hospital Admission rates, Emergency Room Visit rates, and Institutionalization rates. Data will be collected over three years in two cities: Rome and Naples.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Case management for integrated care of older people with frailty in community settings.
   Sadler E, Khadjesari Z, Ziemann A, Sheehan KJ, et al · · 2023 · cited 23× · PMID 37218645 · DOI 10.1002/14651858.cd013088.pub2