Study Stopped
recruitment issues
Impact of Formal Home Help on Quality of Life for Caregivers of Elderly Patients With Neurocognitive Impairment
PIAF-QVA
2 other identifiers
observational
12
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Mar 2019
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 19, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 16, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
October 16, 2019
CompletedFirst Submitted
Initial submission to the registry
January 14, 2021
CompletedFirst Posted
Study publicly available on registry
February 1, 2021
CompletedNovember 20, 2025
November 1, 2018
7 months
January 14, 2021
November 17, 2025
Conditions
Keywords
Outcome Measures
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).
90 days
Secondary Outcomes (7)
Caregiver vulnerability
90 days
Caregiver burden
90 days
Caregiver quality of life according to the type of formal home care
90 days
Caregiver vulnerability according to the type of formal home care
90 days
Caregiver burden according to the type of formal home care
90 days
- +2 more secondary outcomes
Interventions
Setting up of a formal home help
Eligibility Criteria
Elderly people with neurocognitive disorders benefiting from a home support program (personalized autonomy allowance for seniors program).
You may qualify if:
- 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
You may not qualify if:
- Introduction of formal home care not related to the personalized autonomy allowance program
- Patient under legal protection
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
GHRMSA
Mulhouse, Haut-Rhin, 68100, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 14, 2021
First Posted
February 1, 2021
Study Start
March 19, 2019
Primary Completion
October 16, 2019
Study Completion
October 16, 2019
Last Updated
November 20, 2025
Record last verified: 2018-11
Data Sharing
- IPD Sharing
- Will not share