PIAF-QVA: Impact of Formal Home Help on Quality of Life for Caregivers of Elderly Patients With Neurocognitive Impairment

Sponsor

Groupe Hospitalier de la Region de Mulhouse et Sud Alsace (Other)

Overall Status

Terminated

CT.gov ID

NCT04732312

Collaborator

(none)

Enrollment

Location

6.9

Actual Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this prospective monocenter observational study is to assess the impact of the first introduction of formal home help (personalized autonomy allowance for seniors) on the quality of life of home caregivers of elderly patients with neurocognitive impairment.

Condition or Disease	Intervention/Treatment	Phase
Age-related Cognitive Decline	Other: Home help

Detailed Description

An aging population is leading to an increase in neurodegenerative disorders that are responsible for loss of autonomy. In order to keep patients with neurocognitive impairment at home, the availability of home caregivers is essential. The neurocognitive deterioration of elderly patients is a significant burden for home caregivers and can affect their quality of life. The implementation of formal home help (personalized autonomy allowance for seniors) can relieve home caregivers and improve their quality of life.

Conduct of research:

Elderly patients followed in the geriatric department of the Mulhouse French hospital, and for whom a formal home help (personalized autonomy allowance for seniors) is initiated will be recruited. The evolution of home caregiver's quality of life, burden and vulnerability, will be assessed during three months.

Study Design

Study Type:

Observational

Actual Enrollment :

12 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Impact of Formal Home Help on Quality of Life for Caregivers of Elderly Patients With Neurocognitive Impairment: a Prospective Monocenter Study

Actual Study Start Date :

Mar 19, 2019

Actual Primary Completion Date :

Oct 16, 2019

Actual Study Completion Date :

Oct 16, 2019

Outcome Measures

Primary Outcome Measures

Caregiver quality of life [90 days]
Variation of caregiver quality of life between inclusion and 90 days. Quality of life is assessed with the PIXEL study evaluation scale. This is a 20-item scale, subdivided in four domains: behavioral capacities to face difﬁculties generated by the patient, relation with the environment, psychological perception of the situation, perception of a possible distress. Score ranges from 0 to 100 points (5 points for each item).

Secondary Outcome Measures

Caregiver vulnerability [90 days]
Variation of caregiver vulnerability between inclusion and 90 days. Vulnerability is assessed through another PIXEL study 20-item evaluation scale. Score ranges from 0 to 100 points.
Caregiver burden [90 days]
Variation of caregiver burden between inclusion and 90 days. Burden is assessed with the 7-item mini-Zarit scale. Score ranges from 0 to 7.
Caregiver quality of life according to the type of formal home care [90 days]
Variation of caregiver quality of life between inclusion and 90 days. Quality of life is assessed with the PIXEL study evaluation scale.
Caregiver vulnerability according to the type of formal home care [90 days]
Vulnerability is assessed through another PIXEL study 20-item evaluation scale.
Caregiver burden according to the type of formal home care [90 days]
Variation of caregiver burden between inclusion and 90 days. Burden is assessed with the 7-item mini-Zarit scale. Score ranges from 0 to 7.
Variation of quality of life score according to each domain [90 days]
Evolution of quality of life according to each domain of the PIXEL study evaluation scale.
Description of the aids set up within the framework of the personalized autonomy allowance for seniors program. [90 days]
Formal home help can include several home services: meal delivery, domestic help, home care nurse, etc.

Eligibility Criteria

Criteria

Ages Eligible for Study:

60 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion criteria:

Patient 60 years of age or older
Diagnosis of neurocognitive disorders
MMSE score less than or equal to 26
GIR score inferior or equal to 4
Introduction of formal home help (personalized autonomy allowance for seniors program)
Patient living in Haut-Rhin department (France)
Patient receiving regular informal help at home (at least once a week)
Availability of the current home helper to participate in the sudy
Non-opposition to participation in the study

Exclusion criteria:

Introduction of formal home care not related to the personalized autonomy allowance program
Patient under legal protection

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	GHRMSA	Mulhouse	Haut-Rhin	France	68100

Sponsors and Collaborators

Groupe Hospitalier de la Region de Mulhouse et Sud Alsace

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Groupe Hospitalier de la Region de Mulhouse et Sud Alsace

ClinicalTrials.gov Identifier:

NCT04732312

Other Study ID Numbers:

GHR 952
ID-RCB 2018-A02307-48

First Posted:

Feb 1, 2021

Last Update Posted:

Feb 1, 2021

Last Verified:

Nov 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Groupe Hospitalier de la Region de Mulhouse et Sud Alsace

cognitive impairment

caregiver quality of life

caregiver burden

caregiver vulnerability

Additional relevant MeSH terms:

Cognitive Dysfunction

Study Results

No Results Posted as of Feb 1, 2021