Geriatric DisorderUMGNCT01449968
Provision of a Mobile Geriatric Team Extra-Community Hospital
An observational study of Geriatric Disorder and Mobil Unit, run by University Hospital, Grenoble at 3 sites in France.
Trial summary
The purpose of this study is to demonstrate the effectiveness of the mobile unit to reduce the geriatric hospital inappropriate (especially for emergencies) to 1 month. The primary endpoint: survival without hospitalization through the emergency inappropriate to 1 month. Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Geriatric Disorder, Mobil Unit
- What is being tested?
- home visit and telephone management
- How many people
- 334 participants
- Where
- 3 sitesFrance
- Study dates
- Jun 2011to Nov 2013
- 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 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: The study population includes patients over 75 years in medical condition or psycho-social complex, followed by a general practitioner to population centers include: Grenoble, Annecy and Roanne.
Who may be able to join
- Patient aged 75 and over living in complex medical or psycho-social complex or at risk of hospitalization
- Patient affiliated to social security or beneficiary of such a regime
- Patient available for follow-up to 6 months with a caregiver or accompanying social duly appointed.
Who cannot join
- Patient residing outside intervention sector
- Life-threatening emergency (ambulance)
- Lack of complexity of the situation, supported by routine care
Trial locations and contacts
3 sites in 1 country.
France3 sites
CH Annecy
Annecy, 74000
University Hospital of Grenoble
Grenoble, 38000
CH Roanne
Roanne, 42300
About this study
Official title: Provision of a Mobile Geriatric Team Extra-Community Hospital in Assessing and Regulating the Hospitalization of Frail Elderly Patients With Complex Medical and Social Situation
The purpose of this study is to demonstrate the effectiveness of the mobile unit to reduce the geriatric hospital inappropriate (especially for emergencies) to 1 month.
The primary endpoint: survival without hospitalization through the emergency inappropriate to 1 month.
Read the detailed description
The purpose of this study is to assess the effectiveness of the Mobile Geriatrics on the management of complex situations in retirement homes and in ambulatory care of frail elderly patients, reported by the generalist doctor, in terms of improving the conditions of use technical support hospital follow-up recommendations given by the mobile team and their impact on outcomes of care.
- Conditions
- Geriatric Disorder, Mobil Unit
- Being tested
- home visit, telephone management
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
home visitOther
home visit of UMG
telephone managementOther
Also called telephone management of the mobile unit of Geriatrics
telephone management of the situation reported by the patient's GP
| Study group | Role | What they receive |
|---|---|---|
| home visit of UMG | home visit with evaluation and management of the situation (control over in-home telephone) Receives: Other: home visit | |
| telephone management | geriatric mobile unit provides a telephone advice only to the general practitioner with guidance and recommendations (call control) Receives: Other: telephone management |
What is being measured
The primary outcome is the main question the study is designed to answer.
effectiveness of the visit of the mobile unit to reduce the geriatric hospital inappropriate (especially for emergencies) to 1 month
inappropriate survival without hospitalization through the emergency room at 1 month
Measured: 1 month
Secondary outcomes (5)
follow-up rate of the proposals of UMG ext (adherence to recommendations and feasibility) and analyze the reasons for not monitoring these proposals one month
follow-up of recommendations made by the mobile unit of Geriatrics
Measured: 1 month
survival without hospitalization inappropriate, mortality, changes in functional status and cognitive health care consumption up to 6 months of surgery
Unplanned hospitalization rates obtained by telephone follow-up at 3 and 6 months
Measured: 6 months
effectiveness of the visit of the mobile geriatric home versus telephone follow-up of mobile geriatric unit
Analysis of sub-groups
Measured: 6 months
needs and difficulties of attending physicians in the care of frail elderly patients with complex medical and social situation before and after the establishment of mobile units for geriatrics.
Questionnaire to GPs in the health sector concerned
Measured: 1 year
cost effectiveness of two types of visit of the mobile unit of Geriatrics (telephone regulation and control over travel home phone)
Cost of hospitalization.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2011 (estimated)
- Study startJun 2011
- Primary completionMay 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Geriatric DisorderStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 334 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, AdministrateurCIC, University Hospital, Grenoble
- Investigators
- Pascal COUTURIER, PUPH, Principal investigator, Geriatric unit - University Hospital of Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01449968
- Sponsor's protocol ID
- DCIC 10 16
- Acronym
- UMG
- Status last verified
- Apr 2014
- First submitted
- 7 Jul 2011
- Last updated
- 28 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Bernabei R, Landi F, Gambassi G, Sgadari A, Zuccala G, Mor V, Rubenstein LZ, Carbonin P. Randomised trial of impact of model of integrated care and case management for older people living in the community. BMJ. 1998 May 2;316(7141):1348-51. doi: 10.1136/bmj.316.7141.1348.
PubMed 9563983Stuck AE, Siu AL, Wieland GD, Adams J, Rubenstein LZ. Comprehensive geriatric assessment: a meta-analysis of controlled trials. Lancet. 1993 Oct 23;342(8878):1032-6. doi: 10.1016/0140-6736(93)92884-v.
PubMed 8105269Elkan R, Kendrick D, Dewey M, Hewitt M, Robinson J, Blair M, Williams D, Brummell K. Effectiveness of home based support for older people: systematic review and meta-analysis. BMJ. 2001 Sep 29;323(7315):719-25. doi: 10.1136/bmj.323.7315.719.
PubMed 11576978
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Provision of a Mobile Geriatric Team Extra-Community Hospital in Assessing and Regulating the Hospitalization of Frail Elderly Patients With Complex Medical and Social Situation
- ClinicalTrials.gov ID
- NCT01449968
- Acronym / sponsor ID
- UMG / DCIC 10 16
- Conditions
- Geriatric Disorder, Mobil Unit
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 334 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- May 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 10 Oct 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.
The purpose of this study is to demonstrate the effectiveness of the mobile unit to reduce the geriatric hospital inappropriate (especially for emergencies) to 1 month.
The primary endpoint: survival without hospitalization through the emergency inappropriate to 1 month.
Detailed description
The purpose of this study is to assess the effectiveness of the Mobile Geriatrics on the management of complex situations in retirement homes and in ambulatory care of frail elderly patients, reported by the generalist doctor, in terms of improving the conditions of use technical support hospital follow-up recommendations given by the mobile team and their impact on outcomes of care.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| home visit of UMG | – | Other: home visithome visit with evaluation and management of the situation (control over in-home telephone) |
| telephone management | – | Other: telephone managementgeriatric mobile unit provides a telephone advice only to the general practitioner with guidance and recommendations (call control) |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- The study population includes patients over 75 years in medical condition or psycho-social complex, followed by a general practitioner to population centers include: Grenoble, Annecy and Roanne.
Key inclusion criteria (3 listed)
- Patient aged 75 and over living in complex medical or psycho-social complex or at risk of hospitalization
- Patient affiliated to social security or beneficiary of such a regime
- Patient available for follow-up to 6 months with a caregiver or accompanying social duly appointed.
Key exclusion criteria (3 listed)
- Patient residing outside intervention sector
- Life-threatening emergency (ambulance)
- Lack of complexity of the situation, supported by routine care
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 |
|---|---|---|
| home visithome visit of UMG | Other | home visit of UMG |
| telephone managementAlso: telephone management of the mobile unit of Geriatricstelephone management of the situation reported by the patient's GP | Other | telephone management |
Primary outcome
effectiveness of the visit of the mobile unit to reduce the geriatric hospital inappropriate (especially for emergencies) to 1 month
Time frame: 1 month
inappropriate survival without hospitalization through the emergency room at 1 month
5 secondary outcomes
follow-up rate of the proposals of UMG ext (adherence to recommendations and feasibility) and analyze the reasons for not monitoring these proposals one month
Time frame: 1 month
survival without hospitalization inappropriate, mortality, changes in functional status and cognitive health care consumption up to 6 months of surgery
Time frame: 6 months
effectiveness of the visit of the mobile geriatric home versus telephone follow-up of mobile geriatric unit
Time frame: 6 months
needs and difficulties of attending physicians in the care of frail elderly patients with complex medical and social situation before and after the establishment of mobile units for geriatrics.
Time frame: 1 year
cost effectiveness of two types of visit of the mobile unit of Geriatrics (telephone regulation and control over travel home phone)
Time frame: 6 months
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 28 Apr 2014.
- Background: PubMed 9563983Bernabei R, Landi F, Gambassi G, Sgadari A, Zuccala G, Mor V, Rubenstein LZ, Carbonin P. Randomised trial of impact of model of integrated care and case management for older people living in the community. BMJ. 1998 May 2;316(7141):1348-51. doi: 10.1136/bmj.316.7141.1348.
- Background: PubMed 8105269Stuck AE, Siu AL, Wieland GD, Adams J, Rubenstein LZ. Comprehensive geriatric assessment: a meta-analysis of controlled trials. Lancet. 1993 Oct 23;342(8878):1032-6. doi: 10.1016/0140-6736(93)92884-v.
- Background: PubMed 11576978Elkan R, Kendrick D, Dewey M, Hewitt M, Robinson J, Blair M, Williams D, Brummell K. Effectiveness of home based support for older people: systematic review and meta-analysis. BMJ. 2001 Sep 29;323(7315):719-25. doi: 10.1136/bmj.323.7315.719.
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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.
Pascal COUTURIER, PUPH principal investigator
Geriatric unit - University Hospital of Grenoble
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Geriatric Disorder and Mobil Unit, run by University Hospital, Grenoble at 3 sites 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: finished, as of the sponsor's last update on 28 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
effectiveness of the visit of the mobile unit to reduce the geriatric hospital inappropriate (especially for emergencies) to 1 month (time frame: 1 month). 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 NCT01449968, which also lists 3 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 28 Apr 2014.