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

Age-related Cognitive Decline Clinical Trial

— PIAF-QVA  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04732312
• Other study ID #: GHR 952
• Secondary ID: ID-RCB 2018-A023
• Status: Terminated
• Start date: March 19, 2019
• Est. completion date: October 16, 2019

Study information

• Verified date: November 2018
• Source: Groupe Hospitalier de la Region de Mulhouse et Sud Alsace
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 12
• Est. completion date: October 16, 2019
• Est. primary completion date: October 16, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Age-related Cognitive Decline
• Cognitive Dysfunction

Intervention

Other:
• Home help
Setting up of a formal home help

Locations

Country	Name	City	State
France	GHRMSA	Mulhouse	Haut-Rhin

Sponsors (1)

Lead Sponsor	Collaborator
Groupe Hospitalier de la Region de Mulhouse et Sud Alsace

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 dif?culties 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	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.	90 days
Secondary	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.	90 days
Secondary	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.	90 days
Secondary	Caregiver vulnerability according to the type of formal home care	Vulnerability is assessed through another PIXEL study 20-item evaluation scale.	90 days
Secondary	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.	90 days
Secondary	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.	90 days
Secondary	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.	90 days