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

March 4, 2021 updated by: Giuseppe Liotta, University of Rome Tor Vergata

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1185

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Rome, Italy, 00153
        • University of Rome Tor Vergata

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

80 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: LLE- Long Live the Elderly!
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.
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.
No Intervention: SoC- Standard of Care
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of death
Time Frame: 3 years
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
Incidence of hospitalization
Time Frame: 3 years
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
Incidence of ER admission
Time Frame: 3 years
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
Incidence of admission to LTC facilities
Time Frame: 3 years
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Rome Tor Vergata

Collaborators

Comunità di S.Egidio ACAP Onlus

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2018

Primary Completion (Actual)

December 31, 2020

Study Completion (Anticipated)

December 31, 2021

Study Registration Dates

First Submitted

February 1, 2021

First Submitted That Met QC Criteria

March 4, 2021

First Posted (Actual)

March 8, 2021

Study Record Updates

Last Update Posted (Actual)

March 8, 2021

Last Update Submitted That Met QC Criteria

March 4, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LLE001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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