Age-related Cognitive DeclinePIAF-QVANCT04732312
Impact of Formal Home Help on Quality of Life for Caregivers of Elderly Patients With Neurocognitive Impairment
An observational study of Age-related Cognitive Decline, run by Groupe Hospitalier de la Region de Mulhouse et Sud Alsace at 1 site in France.
Trial 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 more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Age-related Cognitive Decline
- What is being tested?
- Home help
- How many people
- 12 participants
- Where
- 1 siteFrance
- Study dates
- 19 Mar 2019to 16 Oct 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Elderly people with neurocognitive disorders benefiting from a home support program (personalized autonomy allowance for seniors program).
Who may be able to join
- 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)
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- 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
Who cannot join
- Introduction of formal home care not related to the personalized autonomy allowance program
- Patient under legal protection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
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.
- Conditions
- Age-related Cognitive Decline
- Being tested
- Home help
- Keywords
- cognitive impairment, caregiver quality of life, caregiver burden, caregiver vulnerability
- Medical subject headings
- Cognitive Dysfunction, Caregiver Burden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home helpOther
Setting up of a formal home help
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 90 days
Secondary outcomes (7)
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.
Measured: 90 days
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.
Measured: 90 days
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.
Measured: 90 days
Caregiver vulnerability according to the type of formal home care
Vulnerability is assessed through another PIXEL study 20-item evaluation scale.
Measured: 90 days
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.
Measured: 90 days
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.
Measured: 90 days
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.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2021
- Study start19 Mar 2019
- Primary completion16 Oct 2019
- Study completion16 Oct 2019
Why it stopped: recruitment issues
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Age-related Cognitive DeclineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Groupe Hospitalier de la Region de Mulhouse et Sud Alsace
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04732312
- Sponsor's protocol ID
- GHRMSA 952
- Other IDs
- ID-RCB 2018-A02307-48
- Acronym
- PIAF-QVA
- Status last verified
- Nov 2018
- First submitted
- 14 Jan 2021
- Last updated
- 20 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Formal Home Help on Quality of Life for Caregivers of Elderly Patients With Neurocognitive Impairment: a Prospective Monocenter Study
- ClinicalTrials.gov ID
- NCT04732312
- Acronym / sponsor ID
- PIAF-QVA / GHRMSA 952
- Conditions
- Age-related Cognitive Decline
- Keywords
- cognitive impairment, caregiver quality of life, caregiver burden, caregiver vulnerability
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: recruitment issues
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Groupe Hospitalier de la Region de Mulhouse et Sud AlsaceUniversity, hospital or other
- Study start
- 19 Mar 2019 (actual)
- Primary completion
- 16 Oct 2019 (actual)
- Study completion
- 16 Oct 2019 (actual)
- First posted
- 1 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Elderly people with neurocognitive disorders benefiting from a home support program (personalized autonomy allowance for seniors program).
Key inclusion criteria (9 listed)
- 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)
Key exclusion criteria (2 listed)
- Introduction of formal home care not related to the personalized autonomy allowance program
- Patient under legal protection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Home helpSetting up of a formal home help | Other | – |
Primary outcome
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).
7 secondary outcomes
Caregiver vulnerability
Time frame: 90 days
Caregiver burden
Time frame: 90 days
Caregiver quality of life according to the type of formal home care
Time frame: 90 days
Caregiver vulnerability according to the type of formal home care
Time frame: 90 days
Caregiver burden according to the type of formal home care
Time frame: 90 days
Variation of quality of life score according to each domain
Time frame: 90 days
Description of the aids set up within the framework of the personalized autonomy allowance for seniors program.
Time frame: 90 days
Results and safety
The study was stopped early (reason given: recruitment issues). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Age-related Cognitive Decline, run by Groupe Hospitalier de la Region de Mulhouse et Sud Alsace at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 20 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: recruitment issues). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Caregiver quality of life (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2025.