Social IsolationCAMP-80NCT04785664
Community-based Pro-Active Monitoring Program (CAMP) and Older Adults
A study testing Community-based pro-Active Monitoring Program in people with Social Isolation and Frailty, run by University of Rome Tor Vergata at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 80 years and older
- Conditions the study is for
- Social Isolation, Frailty
- What is being tested?
- Community-based pro-Active Monitoring Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,185 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2018to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 80 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- People living in an institution (nursing homes or similar) have been excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
- Conditions
- Social Isolation, Frailty
- Being tested
- Community-based pro-Active Monitoring Program
- Keywords
- Frail Elderly, Aged,80 and over, Social Isolation, Social Support, Mortality, Functional Geriatric Evaluation, Hospital Admission Rate
- Medical subject headings
- Social Isolation, Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Community-based pro-Active Monitoring ProgramOther
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.
| Study group | Role | What they receive |
|---|---|---|
| LLE- Long Live the Elderly! | Experimental | 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. Receives: Other: Community-based pro-Active Monitoring Program |
| SoC- Standard of Care | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 3 years
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.
Measured: 3 years
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.
Measured: 3 years
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.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2021
- Study start1 Jan 2018
- Primary completion31 Dec 2020
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Social IsolationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 1,185 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rome Tor Vergata
- Sponsor type
- University, hospital or other
- Collaborators
- Comunità di S.Egidio ACAP Onlus
- Responsible party
- Principal investigator, Giuseppe Liotta, University of Rome Tor Vergata
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04785664
- Sponsor's protocol ID
- LLE001
- Acronym
- CAMP-80
- Status last verified
- Mar 2021
- First submitted
- 1 Feb 2021
- Last updated
- 8 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 27567441Liotta 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.
PubMed 33457318Liotta 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.
PubMed 16821500Liotta 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.
PubMed 29641436
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Impact of Community-based Pro-Active Monitoring Program (CAMP) on Community-dwelling Citizens Aged More Than 80
- ClinicalTrials.gov ID
- NCT04785664
- Acronym / sponsor ID
- CAMP-80 / LLE001
- Conditions
- Social Isolation, Frailty
- Keywords
- Frail Elderly, Aged,80 and over, Social Isolation, Social Support, Mortality, Functional Geriatric Evaluation, Hospital Admission Rate
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,185 participants (actual)
- Lead sponsor
- University of Rome Tor VergataUniversity, hospital or other
- Collaborators
- Comunità di S.Egidio ACAP Onlus
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 8 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| LLE- Long Live the Elderly! | Experimental | Other: Community-based pro-Active Monitoring ProgramThe 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. |
| SoC- Standard of Care | No intervention | –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. |
Who may qualify
- Ages
- 80 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- People living in an institution (nursing homes or similar) have been excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Community-based pro-Active Monitoring ProgramThe 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. | Other | LLE- Long Live the Elderly! |
Primary outcome
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).
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.
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2021.
- Results publication: PubMed 27567441Liotta 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.
- Results publication: PubMed 33457318Liotta 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.
- Results publication: PubMed 16821500Liotta 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.
- Results publication: PubMed 29641436Liotta 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.
- Individual participant dataSharing planned: Undecided
Related trials for Social Isolation
Not yet recruiting
A Mobile Informatics Solution to Assist Caregivers in Care Coordination and Monitoring Social Engagement
Memory Disorders, Mild Cognitive Impairment
Recruiting
Does Attachment Anxiety Moderate the Influence of Social Rejection on Alcohol Use Among Young Adults?
Social Rejection, Attachement Style
Active, not recruiting
Multimodal Training With Immersive Virtual Reality to Improve the Cognitive Health and Emotional Well-being of Older Women Living Alone
Social Isolation in Older Adults, Poverty
Recruiting
Social Connection Collective for Older Adults in Subsidized Housing
Social Isolation in Older Adults, Social Isolation or Loneliness
Not yet recruiting
Improving Diet Quality of Community-Dwelling Seniors Using a Community-Based Participatory Approach
Diet Quality, Social Isolation in Older Adults
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Community-based pro-Active Monitoring Program in people with Social Isolation and Frailty, run by University of Rome Tor Vergata at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of death (time frame: 3 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04785664, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2021.