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

Frailty Clinical Trial

— CAMP-80  

Official title:

Assessing the Impact of Community-based Pro-Active Monitoring Program (CAMP) on Community-dwelling Citizens Aged More Than 80

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04785664
• Other study ID #: LLE001
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 1, 2018
• Est. completion date: December 31, 2021

Study information

• Verified date: March 2021
• Source: University of Rome Tor Vergata
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1185
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 80 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Frailty
• Social Isolation

Intervention

Other:
• Community-based pro-Active Monitoring Program
The Intervention provides phone monitoring addressed to all the clients and home visits tailored to the individual needs. Moreover, it activates other formal or informal care resources based on the needs of the patients reported in the Individualized Care Plan (ICP) which derives from the assessment of multidimensional frailty. The main peculiarity of the program is that the operators identify the main problem of the client and try to track down the best solution in agreement with the client. It can be a health or social intervention or a different kind. Interventions may include assistance to make clients' houses safer thereby reducing risk factors for falls or reviewing the therapeutic scheme to improve patient adherence to the treatment in collaboration with the GP.

Locations

Country	Name	City	State
Italy	University of Rome Tor Vergata	Rome

Sponsors (2)

Lead Sponsor	Collaborator
University of Rome Tor Vergata	Comunità di S.Egidio ACAP Onlus

Country where clinical trial is conducted

Italy, 

References & Publications (4)

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 — View 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-Dwelli — View 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 — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of death	Mortality will be measured at 1 and 3 years from the collected data, it will be studied as a standardized rate adjusted for gender, age, and frailty level in LLE and SoC cohort. It will be the number of patient death per unit of time (1 year and 3 years).	3 years
Primary	Incidence of hospitalization	Hospitalization will be measured as a standardized rate (adjusted for gender, age, and frailty) in LLE and SOC groups at 1 year and 3 years (excluding patients transferred to another Region). Hospitalization will be measured on three factors: 1) the number of hospital admission for patients; 2) the number of hospitalization days; 3) the number of hospitalized patients.	3 years
Primary	Incidence of ER admission	Emergency Room admission will be measured in LLE and SoC cohort at 1 and 3 years (excluding patients transferred to another Region). ER, admission will be based on two indicators: 1) the number of ER admissions per patient; 2) the number of patients admitted to the ER.	3 years
Primary	Incidence of admission to LTC facilities	Admission to Long-Term- Care facilities will be measured as a standardized rate (adjusted for gender, age, and frailty) in LLE and SOC groups at 1 and 3 years. It will include the number of patients accessing LTC facilities per observation period.	3 years