Clinical trial NCT05651555: Evaluation of the EHPAD Caregiver/Pact & Pad Psycho-educational Program for Caregivers With an Institutionalized Parent
Official title: Evaluation of the EHPAD Caregiver/Pact & Pad Psycho-educational Program for Caregivers With an Institutionalized Parent
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Caregivers
Keywords: Caregiving
Psychosocial intervention
Nursing home placement
Nursing home admission
Informal long-term care
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2022-12-15
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Moving into an institution is a new stage in the life of the patient but also of the caregiver. The caregiver is overwhelmed by various feelings such as loss of control, powerlessness, guilt, sadness, the feeling of loneliness at home but also relief. This experience can be characterized by great anxiety and the feeling of being misunderstood by the family and professional environment.

This emotional state is not without consequences for the caregiver/resident and caregiver/care team relationship.

Several factors have been identified that may be at the origin of these states.

A new training, information and support program has been created to present these different factors to caregivers and to allow them to address them with professionals in a group setting.

Detailed description: In 2015, there were 593,005 places for dependent elderly people in institutions in France. The increase in the life expectancy of the population and the decrease in the number of caregivers predicted by the World Health Organization suggests that institutions will be increasingly solicited. Also, due to the increase in neurodegenerative diseases, family caregivers are being forced to resort to institutionalization. According to the study conducted by the number of family caregivers of sick, elderly, or dependent individuals is estimated to be around 11 million in France. 58% of these caregivers are women. 52% work, 86% help a family member, including 41% one of their parents, 34% help several people, compared to 28% in 2017 (multi-caregivers), 57% help a relative in a situation of dependence due to old age (compared to 48% in 2017). Finally, 82% devote at least 20 hours per week on average to their loved one(s), 37% of the caregivers surveyed admit to receiving no outside help even though they are often elderly themselves.

Moving into an institution is a new stage in the life of the patient but also of the caregiver. The caregiver is overwhelmed by various feelings such as loss of control, powerlessness, guilt, sadness, the feeling of loneliness at home but also relief. This experience can be characterized by great anxiety and the feeling of being misunderstood by the family and professional environment.

This emotional state is not without consequences for the caregiver/resident and caregiver/care team relationship.

Several factors have been identified that may be at the origin of these states.

A new training, information and support program has been created to present these different factors to caregivers and to allow them to address them with professionals in a group setting.

Hypothesis 1: The psycho-educational program "EHPAD aidant" containing various information about the financial and medical-psychological care of a resident in an EHPAD, combined with the intervention of various professionals in this sector and a group therapy, allows for a decrease in anxiety symptoms.

Hypothesis 2: The psycho-educational program "EHPAD caregiver" allows for a decrease in depressive symptoms, an improvement in perceived stress, coping strategies, satisfaction, quality of life, the caregiver/caregiver relationship, as well as a decrease in perceived burden and guilt related to the institutionalization of the parent

Hypothesis 3: There is a link between anxiety symptomatology and intolerance of uncertainty.

Eligibility criteria: Inclusion Criteria:

* Family caregivers defined according to the European charter for family caregivers COFACE: "the non-professional person who comes to the aid mainly, in part or totally, to a person dependent on his or her entourage, for activities of daily living. This regular help can be provided on a permanent basis or not and can take several forms, in particular: nursing, care, support for education and social life, administrative procedures, coordination, permanent vigilance, psychological support, communication, domestic activities. . Currently, these caregivers have an elderly relative living in an institution or in the process of institutionalization
* Have been a caregiver for at least six months
* Have a parent in an EHPAD for less than 25 weeks
* The loved one is not at the end of life when the caregiver starts the program
* Participate in at least five workshops out of the seven offered as part of the program.
* Be of legal age (at least 18 years old)
* Presence of depression or anxiety according to HAD
* Be motivated to follow the program
* Signature of consent.
* Be affiliated with a social security scheme

Exclusion Criteria:

* Caregiver with a loved one living at home without institutionalization plans
* Professional caregivers, former caregivers
* Absence of depression and/or anxiety
* Deceased relative
* Have untreated diagnosed psychiatric disorders
* To be suffering from proven cognitive disorders
* Already benefit from another caregiver assistance program.
* Patient under AME
* Vulnerable people

Primary outcomes:
measure: HADS (Hospital Anxiety and Depression scale)
timeFrame: Inclusion
measure: HADS (Hospital Anxiety and Depression scale)
timeFrame: Week 16 for the group N (T2)
measure: HADS (Hospital Anxiety and Depression scale)
timeFrame: Week 24 for the group C (T3)
Secondary outcomes:
measure: HADS (Hospital Anxiety and Depression scale)
timeFrame: Week 8 (T1) for both groups
measure: HADS (Hospital Anxiety and Depression scale)
timeFrame: Week 16 for the group C (T2)
measure: Zarit Caregiver Burden Scale
timeFrame: Inclusion
measure: Zarit Caregiver Burden Scale
timeFrame: Week 8
measure: Zarit Caregiver Burden Scale
timeFrame: Week 16
measure: Zarit Caregiver Burden Scale
timeFrame: Week 24 for the group C (T3)
measure: CADI (Carers Assessment of Difficulties Index)
timeFrame: Inclusion
measure: CADI (Carers Assessment of Difficulties Index)
timeFrame: Week 8
measure: CADI (Carers Assessment of Difficulties Index)
timeFrame: Week 16
measure: CADI (Carers Assessment of Difficulties Index)
timeFrame: Week 24 for the group C (T3)
measure: CAMI (Carers Assessment of Managing Index)
timeFrame: Inclusion
measure: CAMI (Carers Assessment of Managing Index)
timeFrame: Week 8
measure: CAMI (Carers Assessment of Managing Index)
timeFrame: Week 16
measure: CAMI (Carers Assessment of Managing Index)
timeFrame: Week 24 for the group C (T3)
measure: CASI (Carers Assessment of Satisfaction Index)
timeFrame: Inclusion
measure: CASI (Carers Assessment of Satisfaction Index)
timeFrame: Week 8
measure: CASI (Carers Assessment of Satisfaction Index)
timeFrame: Week 16
measure: CASI (Carers Assessment of Satisfaction Index)
timeFrame: Week 24 for the group C (T3)
measure: Quality of life (QOL AD)
timeFrame: Inclusion
measure: Quality of life (QOL AD)
timeFrame: Week 8
measure: Quality of life (QOL AD)
timeFrame: Week 16
measure: Quality of life (QOL AD)
timeFrame: Week 24 for the group C (T3)
measure: Visual scale
timeFrame: Inclusion
measure: Visual scale
timeFrame: Week 8
measure: Visual scale
timeFrame: Week 16
measure: Visual scale
timeFrame: Week 24 for the group C (T3)
measure: Visual scale
timeFrame: Inclusion
measure: Visual scale
timeFrame: Week 8
measure: Visual scale
timeFrame: Week 16
measure: Visual scale
timeFrame: Week 24 for the group C (T3)
measure: Scale of Intolerance to Uncertainty
timeFrame: Inclusion
measure: Scale of Intolerance to Uncertainty
timeFrame: Week 8
measure: Scale of Intolerance to Uncertainty
timeFrame: Week 16
measure: Scale of Intolerance to Uncertainty
timeFrame: Week 24 for the group C (T3)
measure: Visual scale
timeFrame: Inclusion
measure: Visual scale
timeFrame: Week 8
measure: Visual scale
timeFrame: Week 16
measure: Visual scale
timeFrame: Week 24 for the group C (T3)
Other outcomes:
Locations:
city: Paris
country: France
facility: Assistance Publique - Hôpitaux de Paris (AP-HP) - Broca Hospital - Geriatric unit
state: Ile De France
Study officials:
affiliation: Broca Hospital, Assistance Publique des Hôpitaux de Paris (AP-HP)
name: Anne-Sophie RIGAUD, MD, PhD, PU-PH
role: PRINCIPAL_INVESTIGATOR
References: