Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Measuring the Impact of Taking Care in the Context of an Innovative System for Keeping Dependent Elderly People in Their Homes (DIAPASON)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03976661
Recruitment Status : Recruiting
First Posted : June 6, 2019
Last Update Posted : June 19, 2019
Sponsor:
Information provided by (Responsible Party):
Gérond'if

Brief Summary:
The purpose of this study is to compare life quality of patients taking care by DIAPASON 92 with patients or residents from control group EHPAD (retirement home)

Condition or disease
Patient With no Severe Behavioural Disorders and Whose Situation Would Require Entry Into Classique EHPAD (Retirement Home)

Detailed Description:

This study has two components: a quantitative component(for users and caregivers) and a qualitative component (for users, caregivers and professionals)

About population :

For quantitative component: the investigators have two arms:

  • Diapason 92 arm: will be constitued by older patients with loss of autonomy, living at home and benefiting from Diapason 92 device
  • Control arm: will be constituted by people residing at the EHPAD (retirement home)

For qualitative component: Study will cover 5 different populations since it concerns both:- - Diapason 92 professionals who work directly with users

  • Daipason 92 Supervisory staff
  • Diapason 92 professional partners, including referring physicians.
  • The users
  • Non-professional helpers of users

Conduct of study:

- About quantitative component:

After verification of eligibility criteria adapted to each centre and once the non-opposition has been collected and subjects have been included, the following data will be collected at M0, M3, M6 and M12:

  • For patients : Start date of care by Diapason 92 or EHPAD, Quality of Life score, benefit evaluation, Socio-educational level, evaluation of disruptive behaviour disorders, economic indicators, somatic comorbidities, collection of psychiatric follow-up if available, independence, nutritional status, factors(s) that motivated care, cognitive assessment, balance assessment, depression screening, ergonomic assessment (only for Diapason 92
  • Family caregiver: 3 measures will be collected: Measuring the burden by Zarit scale, self-assessment of his quality of life and psychological condition
  • About quality component:

A socio-demographic heel will be collected for each participant interviewed who has given no objection to participating in the study. His agreement on the recording of his voice will also collected.

For all participants, following data will be collected: Age, sex, occupation, date and duration of the interview, relationship with the Diapason 92 user (for family caregivers) and the recovery of socio-demographic data of the case report form (for users)


Layout table for study information
Study Type : Observational [Patient Registry]
Estimated Enrollment : 86 participants
Observational Model: Case-Control
Time Perspective: Other
Target Follow-Up Duration: 12 Months
Official Title: Measuring the Impact of Taking Care in the Context of an Innovative System for Keeping Dependent Elderly People in Their Homes
Actual Study Start Date : April 26, 2019
Estimated Primary Completion Date : December 26, 2021
Estimated Study Completion Date : April 26, 2022

Group/Cohort
DIAPASON 92 arm
Arm will be constitued by older patients with loss of autonomy, living at home benefiting from the device DIAPASON 92 (Innovative support system for elderly people in their homes)
Control arm
Arm will be constituted by people residing at the EHPAD (retirement home)



Primary Outcome Measures :
  1. Assessment of life quality according Nottingham Health Profile (NHP) scale [ Time Frame: 12 months ]
    Difference in 12-month quality of life scores (Nottingham Health Profile) between the 2 groups (Diapason 92 and EHPAD).


Secondary Outcome Measures :
  1. Assessment of the level of loss of autonomy of an elderly people according Autonomy, gerontology Iso Resources Group (AGGIR) scale [ Time Frame: 12 months ]
  2. Assessment of functional status according Lawton Instrumental Activities of Daily Living (IADL) Scale [ Time Frame: 12 months ]
  3. Assessment of activities of daily living, self-care, and independence according Activities of Daily Living (ADL) Scale [ Time Frame: 12 months ]
  4. Assessment of comorbidity according Charlson scale [ Time Frame: 12 months ]
  5. Assessment of cognitive function according Mini-Mental State Examination (MMSE) scale [ Time Frame: 12 months ]
  6. Assessment of disorders of disruptive behaviour according (NPI-ES) scale [ Time Frame: 12 months ]
  7. Assessment of geriatric depression according Geriatric Depression Scale (GDS) scale [ Time Frame: 12 months ]
  8. Measuring of burden of the close caregivers according Popular Caregiver Self-report measure Burden (ZARIT) [ Time Frame: 12 months ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

For quantitative component: we have two arms:

  • Diapason 92 arm: will be constitued by older patients with loss of autonomy, living at home and benefiting from Diapason 92 device
  • Control arm: will be constituted by people residing at the EHPAD (retirement home)

For qualitative component: Study will cover 5 different populations since it concerns both:

  • Diapason 92 professionals who work directly with users
  • Daipason 92 Supervisory staff
  • Diapason 92 professional partners, including referring physicians.
  • The users
  • Non-professional helpers of users
Criteria

Patient/Resident Inclusion Criteria

  • Age 60 years old.
  • (Group iso-resources) GIR ≤ 4
  • Beneficiary of treatment by Diapason 92 or resident at EHPAD Aulagnier for more than 6 months.
  • Not exhibiting severe disruptive behaviour disorders (on NPI-ES all FXG 12 and resonance 4 scores).
  • Affiliate or entitled to a sickness insurance scheme
  • Patient or legal representative expressed no objection

Patient/Resident Exclusion Criteria:

  • Age ≥ 60 years old
  • GIR ˃ 4
  • Not affiliated or entitled to a sickness insurance scheme
  • Patient or legal representative did not express no objection

Professionals and caregivers Inclusion Criteria:

  • Exercise within Diapason 92 device or be identified as assisting a Diapason 92 user or be a professional partner of Diapason 92 device
  • Have expressed no objection to participating in the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03976661


Contacts
Layout table for location contacts
Contact: Isabelle Dufour +33 (0) 185781010 isabelle.dufour@gerondif.org
Contact: Jean-Manuel Morvillers +33 (0) 185781015 jean-manuel.morvillers@gerondif.org

Locations
Layout table for location information
France
Geriatric department , Broca Hospital Recruiting
Paris, Ile-de-France, France, 75013
Contact: Agathe Raynaud-Simon    140257369    agathe.raynaud-simon@aphp.fr   
Sponsors and Collaborators
Gérond'if
Investigators
Layout table for investigator information
Principal Investigator: Olivier Phd Hanon Geriatric department, Broca hospital (Paris)

Layout table for additonal information
Responsible Party: Gérond'if
ClinicalTrials.gov Identifier: NCT03976661     History of Changes
Other Study ID Numbers: A03183-52
First Posted: June 6, 2019    Key Record Dates
Last Update Posted: June 19, 2019
Last Verified: June 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Gérond'if:
No severe behavioural disorders, EHPAD (retirement home), Older patients, loss of autonomy, Groupe-Iso-Ressources (GIR)

Additional relevant MeSH terms:
Layout table for MeSH terms
Mental Disorders