the Elderly of 75 Years and Older Living at HomeGEROPASSNCT01369797
Prospective Randomized Study of the Impact on the Autonomy of the Elderly of 75 Years of Age and Older by the UPSAV
A study testing specific intervention in people with the Elderly of 75 Years and Older Living at Home, run by University Hospital, Limoges at 1 site in France.
Trial summary
Background : The evolving concept of frailty was born in the United States under the term of " frail elderly ". It allows describing geriatrics situations, dominated by the weakness or the functional instability of aged person, illustrating situations at risk. Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- the Elderly of 75 Years and Older Living at Home
- What is being tested?
- specific intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 440 participants
- Where
- 1 siteFrance
- Study dates
- May 2011to Feb 2015
- 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 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 75 years of age and older man or woman
- Patient covered by the health care system
- Patient coverd by a complementary health system or supported by 100% by the health care system
- Patient having the intellectual skills to understand the study, to respect its imperatives and accept the UPSAV's plan or subject with mild to moderate dementia (MMSE > 10) but with a caregiver at home capable of understanding the protocol and of making respect its imperatives written consent signed by the patient
Who cannot join
- Nursing-home resident
- Mild to moderate dementia (MMSE > 10) without caregiver
- Severe dementia (MMSE < 10)
- Diseases with vital short-term endpoint
Trial locations and contacts
1 site in 1 country.
France1 site
Pôle Personnes âgées et soins à domicile - Limoges UH
Limoges, Limoges, 87042
About this study
Official title: Prospective Randomized Study of the Impact on the Autonomy of the Elderly of 75 Years of Age and Older by the Unit for Prevention, Monitoring and Analysis of Aging (UPSAV).
Background :
The evolving concept of frailty was born in the United States under the term of " frail elderly ". It allows describing geriatrics situations, dominated by the weakness or the functional instability of aged person, illustrating situations at risk. It is about an effective concept, especially in the field of the prevention where it determines strategies of specific care. The ageing, changing according to individuals, is characterized by a decrease of the physiological reserves leading to a precarious balance and to a destabilization.
Read more
Epidemiological studies show a very uneven distribution of three categories of old persons according to their health status. Every year, approximately, 12 % of the independent population of 75 years of age and older and living at home, lose their autonomy for one of the activities of the daily life and turn into frailty.
Identifying frailty of old subjects is interesting in order to apply preventive and specific care strategies to reduce the risks of decompensation. The Global Geriatric Assessment (GGA) is the gold standard to detect frailty in this population. The beneficial effects of the GGA during the hospitalization have been recognized in international literature.
The ageing heterogeneousness complexity and the high time-consuming character of GGA led to a difficult approach for the nurses or family practioners in taking care of old persons at home.
To balance these difficulties and to optimize prevention of dependence in the elderly, an experimental unit of prevention was created : Unit for Prevention, Monitoring and Analysis of Aging (UPSAV) on January 4th, 2010 within the geriatric department of the Hospital University of Limoges. It is an innovative organizational structure because, for the first time, the geriatric expertise is proposed freely to the elderly at home. A multidisciplinary gerontological team consisting in a geriatrician, a nurse, a psychomotor therapist and an occupational therapist, can, on requiry, move at old persons' home to make a preventive GGA to detect the risks of loss of autonomy and to propose a coordination of preventive actions.
Purpose :
UPSAV's endpoints are to prevent frail elderly persons from the risk of autonomy loss. This action is led in partnership with all the professionals working around old persons.
The randomized study endpoint is to evaluate elderly from 75 years of age and older at home and to select two homogeneous groups: "reference" and " specific intervention ".
Read the detailed description
Abstract : The recruitment will be made in the Limousin region within a period of one year by cooptation of families, patients, family practitioners and other partners.
After checking the inclusion criteria and obtaining the signatures of consents, patients will be assessed using the functional status (SMAF) and the Global Geriatric Assessment (GGA).
Patients included in the "specific intervention" group will benefit from a personalized action plan presented in a multidisciplinary staff that will be established according to the detected frailties. In follow up visits, a new evaluation will be done and the action plan reviewed.
Every month, patients of this group will receive a Unit for Prevention, Monitoring and Analysis of Aging (UPSAV) phone call in order to complete the secondary assessment criteria of the trial. Therefore, every patient will be re-evaluated according to the intervention plan of the study.
The quality of life of the patient will be estimated by the scale EQ-5D. In every visit, will be collected in a forward-looking way the medical direct costs (ambulatory, hospital care and medicines) and the non medical costs (transport, helpers, arrangements of the place of residence).
- Being tested
- specific intervention
- Keywords
- UPSAV, autonomy, the elderly of 75 years and older
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
specific interventionOther
Patients included in the "specific intervention" group will benefit from a personalized action plan presented in a multidisciplinary staff that will be established according to the detected frailties. In follow up visits, a new evaluation will be done and the action plan reviewed.
| Study group | Role | What they receive |
|---|---|---|
| reference | No intervention | "reference" group, where every patient will benefit: of the same GGA at home as those of the " specific intervention " group. The GGA results will not be supplied to the family practioner. |
| specific intervention | Experimental | "specific intervention" group, where every patient will benefit: of an GGA at home. According to the frailties or the detected morbidity, a specific plan of intervention will be established for the person. all the preventive actions will be coordinated by UPSAV. Receives: Other: specific intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Increase of 5 points of the score(function status) SMAF in 2 years
To evaluate at 2 years the impact of the preventive and coordination action of the UPSAV's gerontological expertise by means of a questionnaire of quality of life.
Measured: 2 years
Secondary outcomes (1)
Evaluation of the mortality in 2 years
At 2 years:
To evaluate the impact on the mortality of the intervention of UPSAV on the studied population.
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 posted9 Jun 2011 (estimated)
- Study startMay 2011
- Primary completionFeb 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for the Elderly of 75 Years and Older Living at HomeStudies of the same condition, open and under way.
- More trials run by University Hospital, LimogesThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 440 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Limoges
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thierry DANTOINE, Principal investigator, Limoges UH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01369797
- Sponsor's protocol ID
- I10010
- Acronym
- GEROPASS
- Status last verified
- Feb 2016
- First submitted
- 16 May 2011
- Last updated
- 24 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Study of the Impact on the Autonomy of the Elderly of 75 Years of Age and Older by the Unit for Prevention, Monitoring and Analysis of Aging (UPSAV).
- ClinicalTrials.gov ID
- NCT01369797
- Acronym / sponsor ID
- GEROPASS / I10010
- Keywords
- UPSAV, autonomy, the elderly of 75 years and older
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 440 participants (actual)
- Lead sponsor
- University Hospital, LimogesUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 9 Jun 2011 (estimated)
- 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 :
The evolving concept of frailty was born in the United States under the term of " frail elderly ". It allows describing geriatrics situations, dominated by the weakness or the functional instability of aged person, illustrating situations at risk. It is about an effective concept, especially in the field of the prevention where it determines strategies of specific care. The ageing, changing according to individuals, is characterized by a decrease of the physiological reserves leading to a precarious balance and to a destabilization.
Epidemiological studies show a very uneven distribution of three categories of old persons according to their health status. Every year, approximately, 12 % of the independent population of 75 years of age and older and living at home, lose their autonomy for one of the activities of the daily life and turn into frailty.
Identifying frailty of old subjects is interesting in order to apply preventive and specific care strategies to reduce the risks of decompensation. The Global Geriatric Assessment (GGA) is the gold standard to detect frailty in this population. The beneficial effects of the GGA during the hospitalization have been recognized in international literature.
The ageing heterogeneousness complexity and the high time-consuming character of GGA led to a difficult approach for the nurses or family practioners in taking care of old persons at home.
To balance these difficulties and to optimize prevention of dependence in the elderly, an experimental unit of prevention was created : Unit for Prevention, Monitoring and Analysis of Aging (UPSAV) on January 4th, 2010 within the geriatric department of the Hospital University of Limoges. It is an innovative organizational structure because, for the first time, the geriatric expertise is proposed freely to the elderly at home. A multidisciplinary gerontological team consisting in a geriatrician, a nurse, a psychomotor therapist and an occupational therapist, can, on requiry, move at old persons' home to make a preventive GGA to detect the risks of loss of autonomy and to propose a coordination of preventive actions.
Purpose :
UPSAV's endpoints are to prevent frail elderly persons from the risk of autonomy loss. This action is led in partnership with all the professionals working around old persons.
The randomized study endpoint is to evaluate elderly from 75 years of age and older at home and to select two homogeneous groups: "reference" and " specific intervention ".
Detailed description
Abstract : The recruitment will be made in the Limousin region within a period of one year by cooptation of families, patients, family practitioners and other partners.
After checking the inclusion criteria and obtaining the signatures of consents, patients will be assessed using the functional status (SMAF) and the Global Geriatric Assessment (GGA).
Patients included in the "specific intervention" group will benefit from a personalized action plan presented in a multidisciplinary staff that will be established according to the detected frailties. In follow up visits, a new evaluation will be done and the action plan reviewed.
Every month, patients of this group will receive a Unit for Prevention, Monitoring and Analysis of Aging (UPSAV) phone call in order to complete the secondary assessment criteria of the trial. Therefore, every patient will be re-evaluated according to the intervention plan of the study.
The quality of life of the patient will be estimated by the scale EQ-5D. In every visit, will be collected in a forward-looking way the medical direct costs (ambulatory, hospital care and medicines) and the non medical costs (transport, helpers, arrangements of the place of residence).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| reference | No intervention | –"reference" group, where every patient will benefit: of the same GGA at home as those of the " specific intervention " group. The GGA results will not be supplied to the family practioner. |
| specific intervention | Experimental | Other: specific intervention"specific intervention" group, where every patient will benefit: of an GGA at home. According to the frailties or the detected morbidity, a specific plan of intervention will be established for the person. all the preventive actions will be coordinated by UPSAV. |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 75 years of age and older man or woman
- Patient covered by the health care system
- Patient coverd by a complementary health system or supported by 100% by the health care system
- Patient having the intellectual skills to understand the study, to respect its imperatives and accept the UPSAV's plan or subject with mild to moderate dementia (MMSE > 10) but with a caregiver at home capable of understanding the protocol and of making respect its imperatives written consent signed by the patient
Key exclusion criteria (4 listed)
- Nursing-home resident
- Mild to moderate dementia (MMSE > 10) without caregiver
- Severe dementia (MMSE < 10)
- Diseases with vital short-term endpoint
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 |
|---|---|---|
| specific interventionPatients included in the "specific intervention" group will benefit from a personalized action plan presented in a multidisciplinary staff that will be established according to the detected frailties. In follow up visits, a new evaluation will be done and the action plan reviewed. | Other | specific intervention |
Primary outcome
Increase of 5 points of the score(function status) SMAF in 2 years
Time frame: 2 years
To evaluate at 2 years the impact of the preventive and coordination action of the UPSAV's gerontological expertise by means of a questionnaire of quality of life.
1 secondary outcome
Evaluation of the mortality in 2 years
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2016.
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.
Thierry DANTOINE principal investigator
Limoges UH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing specific intervention in people with the Elderly of 75 Years and Older Living at Home, run by University Hospital, Limoges 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 4 inclusion and 4 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: finished, as of the sponsor's last update on 24 Feb 2016. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Increase of 5 points of the score(function status) SMAF in 2 years (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 24 Feb 2016.