Community-based Pro-Active Monitoring Program (CAMP) and Older Adults (CAMP-80)

University of Rome Tor Vergata

Status: Unknown

Conditions: Frailty; Social Isolation

Treatments: Other: Community-based pro-Active Monitoring Program

Study type: Interventional

Funder types: Other

Identifiers

NCT04785664

LLE001

Details and patient eligibility

About

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.

Enrollment: 1,185 patients

Sex: All

Ages: 80+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• People enrolled into the study must be older than 80 years old
• People enrolled into the study had to answer to the FGE questionnaire.
• Advanced mental impairment was not an exclusion criteria, but in such cases the consent have been signed by the closest relative who also answered to the questionnaire on behalf of the selected participant.

Exclusion criteria

• People living in an institution (nursing homes or similar) have been excluded.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,185 participants in 2 patient groups

LLE- Long Live the Elderly!

Experimental group

Description:

The group has been randomized among the "Long Live the Elderly!" (LLE) clients in two cities: Rome and Naples. The LLE central database includes all the participants to the program in Naples and Rome who have been administered the Functional Geriatric Evaluation (FGE) questionnaire.

Treatment:

Other: Community-based pro-Active Monitoring Program

SoC- Standard of Care

No Intervention group

Description:

No intervention will be carried out. The control group is selected by randomization from a pool of over-80s followed up by General Practitioners in the same cities who have been available to be involved in the study. Each GP provided a list of patients which 10 names have been selected from by randomization. The total pool consisted of approximately 8500 individuals. The sample was made up of 690 selected patients of which 83 (12.02%) refused to participate in the study.