Clinical trial NCT04785664: Community-based Pro-Active Monitoring Program (CAMP) and Older Adults
Official title: Assessing the Impact of Community-based Pro-Active Monitoring Program (CAMP) on Community-dwelling Citizens Aged More Than 80
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Social Isolation
Frailty
Keywords: Frail Elderly
Aged,80 and over
Social Isolation
Social Support
Mortality
Functional Geriatric Evaluation
Hospital Admission Rate
Lead sponsor: University of Rome Tor Vergata
Sponsor class: OTHER
Collaborators: name: Comunità di S.Egidio ACAP Onlus
First posted: 2021-03-08
Enrollment: 1185
Sex: ALL
Minimum age (years): 80
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study is a pragmatic trial according which, according to the ecological model, provides for a Community-based Pro-Active Monitoring intervention, on people aged\>80, compared with a standard of care in two Italian Regions. The study is articulated in two phases: the baseline assessment provides a multidimensional assessment of the Functional Geriatric Evaluation questionnaire to the Long Live the Elderly (LLE) and Standard of Care (SoC) cohort. The follow up provides to collect information as Hospital Admission, Emergency Room accesses, Mortality rate, Admission to LCT facilities and use of home care services, with the collaboration of GPs and the regional database. The follow up will be gathered every six months over three years.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of death
timeFrame: 3 years
measure: Incidence of hospitalization
timeFrame: 3 years
measure: Incidence of ER admission
timeFrame: 3 years
measure: Incidence of admission to LTC facilities
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Rome
country: Italy
facility: University of Rome Tor Vergata
Study officials:
References:
citation: Liotta G, O'Caoimh R, Gilardi F, Proietti MG, Rocco G, Alvaro R, Scarcella P, Molloy DW, Orlando S, Mancinelli S, Palombi L, Stievano A, Marazzi MC. Assessment of frailty in community-dwelling older adults residents in the Lazio region (Italy): A model to plan regional community-based services. Arch Gerontol Geriatr. 2017 Jan-Feb;68:1-7. doi: 10.1016/j.archger.2016.08.004. Epub 2016 Aug 12.
citation: Liotta G, Madaro O, Scarcella P, Inzerilli MC, Frattini B, Riccardi F, Accarino N, Mancinelli S, Terracciano E, Orlando S, Marazzi MC. Assessing the Impact of A Community-Based Pro-Active Monitoring Program Addressing the need for Care of Community-Dwelling Citizens aged more than 80: Protocol for a Prospective Pragmatic Trial and Results of the Baseline Assessment. Transl Med UniSa. 2020 Oct 31;23:22-27. doi: 10.37825/2239-9747.1004. eCollection 2020 Oct.
citation: Liotta G, Scarcella P, Mancinelli S, Palombi L, Cancelli A, Marazzi MC. [The evaluation of care needs in elderly people: the use of Geriatric Functional Evaluation Questionnaire]. Ann Ig. 2006 May-Jun;18(3):225-35. Italian.
citation: Liotta G, Inzerilli MC, Palombi L, Madaro O, Orlando S, Scarcella P, Betti D, Marazzi MC. Social Interventions to Prevent Heat-Related Mortality in the Older Adult in Rome, Italy: A Quasi-Experimental Study. Int J Environ Res Public Health. 2018 Apr 11;15(4):715. doi: 10.3390/ijerph15040715.