Prospective Randomized Study of the Impact on the Autonomy of the Elderly of 75 Years of Age and Older by the UPSAV (GEROPASS)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Limoges
ClinicalTrials.gov Identifier:
NCT01369797
First received: May 16, 2011
Last updated: July 10, 2014
Last verified: May 2011
  Purpose

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 ".


Condition Intervention
the Elderly of 75 Years and Older Living at Home
Other: specific intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
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).

Further study details as provided by University Hospital, Limoges:

Primary Outcome Measures:
  • Increase of 5 points of the score(function status) SMAF in 2 years [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Evaluation of the mortality in 2 years [ Time Frame: 2 years ] [ Designated as safety issue: No ]

    At 2 years:

    To evaluate the impact on the mortality of the intervention of UPSAV on the studied population.



Enrollment: 440
Study Start Date: May 2011
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: reference
"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.
Experimental: 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.
Other: specific intervention
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.

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).

  Eligibility

Ages Eligible for Study:   75 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Nursing-home resident
  • Mild to moderate dementia (MMSE > 10) without caregiver
  • Severe dementia (MMSE < 10)
  • Diseases with vital short-term endpoint
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01369797

Locations
France
Pôle Personnes âgées et soins à domicile - Limoges UH
Limoges, France, 87042
Sponsors and Collaborators
University Hospital, Limoges
Investigators
Principal Investigator: Thierry DANTOINE Limoges UH
  More Information

No publications provided

Responsible Party: University Hospital, Limoges
ClinicalTrials.gov Identifier: NCT01369797     History of Changes
Other Study ID Numbers: I10010
Study First Received: May 16, 2011
Last Updated: July 10, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Limoges:
UPSAV
autonomy
the elderly of 75 years and older

ClinicalTrials.gov processed this record on July 22, 2014