Elopement or Escaping of Nursing Home Resident With or Without DementiaESCAPENCT03662464
ESCAPE Study : Validation of a Specific Tool Scoring Residents at Risk of Escaping/Elopement From Nursing Homes (ESCAPE)
An observational study of Elopement or Escaping of Nursing Home Resident With or Without Dementia, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
Residents' escapes occur even if most of the nursing homes (NH) have set up specific devices to prevent from this risk. Therefore, the need to develop and validate a specific tool to assess the risk of escaping was obvious to the working group, aim at emphasizing patient centered-care by the nurses' staff and help to… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Elopement or Escaping of Nursing Home Resident With or Without Dementia
- How many people
- 4,050 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2018to Apr 2021
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Resident of the nursing homes in Provence Alpes Cotes d'Azur Region ( South East of France)
Who may be able to join
- Every resident of Nursing home participating to the study
- Living in the NH for three months or more
- With a living prognosis longer than 3 Months
Who cannot join
- Prognosis less than three months
- Bedridden (not able to move alone from bed to chair)
- Nursing home short stay scheduled < 3 months
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Direction Recherche clinique et Innovation
Marseille, PACA, 13354
Kahena AMICHI, drci@ap-hm.fr
About this study
Official title: ESCAPE STUDY : A Specific Tool for Detecting Nursing Home Residents (With or Without Dementia) at Risk of Escaping for the Use of Caregivers: Psychometric Properties and Definition of Risk Levels
Residents' escapes occur even if most of the nursing homes (NH) have set up specific devices to prevent from this risk. Therefore, the need to develop and validate a specific tool to assess the risk of escaping was obvious to the working group, aim at emphasizing patient centered-care by the nurses' staff and help to develop personalized devices.
Aim of the study: develop and validate a specific tool to score the risk of escaping in NH residents Study design: Observational prospective multicentered cohort study Nursing homes volunteer to participate Location: Provence Alpes Cotes d'Azur Region ( South East of France) Population: 4050 NH residents. Duration: two years, each resident included is followed up for one year Measures: Nursing homes characteristics, residents characteristics ( social and from medical record); Escape Scale (25 items with a Yes/no answer; filled up during a nurses staff meeting for each resident and every three months; 3 sub scales: resident environmental items, social items, and medical items.
- Being tested
- No intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
develop and validate a specific tool to score the risk of escaping in Nursing Homes residents
What is being measured
The primary outcome is the main question the study is designed to answer.
Escape/elopement occurence
Each Event occurrence is notify by the nurses staff at any time
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2018
- Study startOct 2018 (estimated)
- Primary completionOct 2020 (estimated)
- Study completionApr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Elopement or Escaping of Nursing Home Resident With or Without DementiaStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 4,050 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Olivier ARNAUD, Study director, Assitance Publique des Hopitaux de Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03662464
- Sponsor's protocol ID
- 2016-55
- Other IDs
- IDRCB
- Acronym
- ESCAPE
- Status last verified
- Jan 2018
- First submitted
- 31 Aug 2018
- Last updated
- 4 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ESCAPE STUDY : A Specific Tool for Detecting Nursing Home Residents (With or Without Dementia) at Risk of Escaping for the Use of Caregivers: Psychometric Properties and Definition of Risk Levels
- ClinicalTrials.gov ID
- NCT03662464
- Acronym / sponsor ID
- ESCAPE / 2016-55
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 4,050 participants (estimated)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- Oct 2018 (estimated)
- Primary completion
- Oct 2020 (estimated)
- Study completion
- Apr 2021 (estimated)
- First posted
- 7 Sep 2018 (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.
Residents' escapes occur even if most of the nursing homes (NH) have set up specific devices to prevent from this risk. Therefore, the need to develop and validate a specific tool to assess the risk of escaping was obvious to the working group, aim at emphasizing patient centered-care by the nurses' staff and help to develop personalized devices.
Aim of the study: develop and validate a specific tool to score the risk of escaping in NH residents Study design: Observational prospective multicentered cohort study Nursing homes volunteer to participate Location: Provence Alpes Cotes d'Azur Region ( South East of France) Population: 4050 NH residents. Duration: two years, each resident included is followed up for one year Measures: Nursing homes characteristics, residents characteristics ( social and from medical record); Escape Scale (25 items with a Yes/no answer; filled up during a nurses staff meeting for each resident and every three months; 3 sub scales: resident environmental items, social items, and medical items.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Resident of the nursing homes in Provence Alpes Cotes d'Azur Region ( South East of France)
Key inclusion criteria (3 listed)
- Every resident of Nursing home participating to the study
- Living in the NH for three months or more
- With a living prognosis longer than 3 Months
Key exclusion criteria (3 listed)
- Prognosis less than three months
- Bedridden (not able to move alone from bed to chair)
- Nursing home short stay scheduled < 3 months
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 |
|---|---|---|
| No interventiondevelop and validate a specific tool to score the risk of escaping in Nursing Homes residents | Other | – |
Primary outcome
Escape/elopement occurence
Time frame: 2 years
Each Event occurrence is notify by the nurses staff at any time
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2018.
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.
Jean-Olivier ARNAUD study director
Assitance Publique des Hopitaux de Marseille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Elopement or Escaping of Nursing Home Resident With or Without Dementia, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
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 3 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 4 Oct 2018. 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 France. 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?
Contact Elisabeth POULIN (06 79 72 41 09, elisabeth.poulin@ap-hm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Escape/elopement occurence (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Oct 2018.