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TerminatedNCT04732312PIAF-QVAUpdated Nov 20, 2025

Impact of Formal Home Help on Quality of Life for Caregivers of Elderly Patients With Neurocognitive Impairment

An observational study in Age-related Cognitive Decline, sponsored by Groupe Hospitalier de la Region de Mulhouse et Sud Alsace. Terminated at 1 site in France. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2025-11-20.

Sponsored by Groupe Hospitalier de la Region de Mulhouse et Sud Alsace · Observational

Why this study was terminated
recruitment issues
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
12
Ages
60 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Age-related Cognitive Decline

Keywords

  • cognitive impairment
  • caregiver quality of life
  • caregiver burden
  • caregiver vulnerability
03

In context

Cognitive Dysfunction

3,843 studies on the registry are indexed under Cognitive Dysfunction; 1,099 are open to participants now.

This study's enrollment of 12 is below the median of 150 across 950 observational studies indexed under Cognitive Dysfunction.

Browse Cognitive Dysfunction studies →

Lead sponsor

Groupe Hospitalier de la Region de Mulhouse et Sud Alsace is the lead sponsor of 27 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
60 Years and older
Sexes eligible
All
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).

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

Exclusion criteria:

  • Introduction of formal home care not related to the personalized autonomy allowance program
  • Patient under legal protection
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
12 participants (actual)
Patient registry
No

Interventions

  • OtherHome help

    Setting up of a formal home help

06

What researchers measure

Primary outcomes

  1. Caregiver quality of life

    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).

    Time frame: 90 days

Secondary outcomes

  1. Caregiver vulnerability

    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.

    Time frame: 90 days

  2. Caregiver burden

    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.

    Time frame: 90 days

  3. Caregiver quality of life according to the type of formal home care

    Variation of caregiver quality of life between inclusion and 90 days. Quality of life is assessed with the PIXEL study evaluation scale.

    Time frame: 90 days

  4. Caregiver vulnerability according to the type of formal home care

    Vulnerability is assessed through another PIXEL study 20-item evaluation scale.

    Time frame: 90 days

  5. Caregiver burden according to the type of formal home care

    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.

    Time frame: 90 days

  6. Variation of quality of life score according to each domain

    Evolution of quality of life according to each domain of the PIXEL study evaluation scale.

    Time frame: 90 days

  7. Description of the aids set up within the framework of the personalized autonomy allowance for seniors program.

    Formal home help can include several home services: meal delivery, domestic help, home care nurse, etc.

    Time frame: 90 days

07

Study locations

1 site
  • GHRMSA
    Mulhouse, Haut-Rhin 68100, France
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 20, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04732312
Lead sponsor
Groupe Hospitalier de la Region de Mulhouse et Sud Alsace
Responsible party
Sponsor
First posted
Feb 1, 2021
Start date
Mar 19, 2019
Primary completion
Oct 16, 2019
Completion
Oct 16, 2019
Last update
Nov 20, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Nov 2018. You cannot join it, but the record below documents what was studied.

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