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

November 17, 2025 updated by: Groupe Hospitalier de la Region de Mulhouse et Sud Alsace

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

12

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Haut-Rhin
      • Mulhouse, Haut-Rhin, France, 68100
        • GHRMSA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Elderly people with neurocognitive disorders benefiting from a home support program (personalized autonomy allowance for seniors program).

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Caregiver quality of life
Time Frame: 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).
90 days

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Groupe Hospitalier de la Region de Mulhouse et Sud Alsace

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 19, 2019

Primary Completion (Actual)

October 16, 2019

Study Completion (Actual)

October 16, 2019

Study Registration Dates

First Submitted

January 14, 2021

First Submitted That Met QC Criteria

January 26, 2021

First Posted (Actual)

February 1, 2021

Study Record Updates

Last Update Posted (Actual)

November 20, 2025

Last Update Submitted That Met QC Criteria

November 17, 2025

Last Verified

November 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GHRMSA 952
  • ID-RCB 2018-A02307-48 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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