Evaluation of the EHPAD Caregiver/Pact & Pad Psycho-educational Program for Caregivers With an Institutionalized Parent

NCT05651555 | Completed

• 2 other identifiers: APHP2200842021-A00553-38
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 1

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.

Conditions

Caregivers

Keywords

Caregiving; Psychosocial intervention; Nursing home placement; Nursing home admission; Informal long-term care

Outcome Measures

Primary Outcomes (3)

• HADS (Hospital Anxiety and Depression scale)

  Reduction in anxiety symptoms of 1 to 3 points according to the HADS Hospital Anxiety and Depression scale) between the start and the end of the program. The depression score assessed by the HADS will be measured. The maximum score that can be obtained for this sub-score is 21. is possible to determine the presence or not, as well as the intensity of the depressive disorder: absence of depressive disorder (score ranging from 0 to 7), suspected depressive disorder (score ranging from 8 to 10) and proven depressive disorder (score ranging from 11 to 21). Thus, the higher the score, the more severe the participant's symptomatology.

  Inclusion

• HADS (Hospital Anxiety and Depression scale)

  Reduction in anxiety symptoms of 1 to 3 points according to the HADS Hospital Anxiety and Depression scale) between the start and the end of the program. The anxiety score assessed by the HADS will be measured. The maximum score that can be obtained for this sub-score is 21. Within the questionnaire, the order of scoring (from 0 to 3 or from 3 to 0) is alternated, in order to limit the bias linked to their repetition. Depending on the participants' scores on the depression subscale, it is possible to determine the presence or not, as well as the intensity of the depressive disorder: absence of depressive disorder (score ranging from 0 to 7), suspected depressive disorder (score ranging from 8 to 10) and proven depressive disorder (score ranging from 11 to 21). Thus, the higher the score, the more severe the participant's symptomatology. The first French validation of this scale was carried out by Lepine et al., 1985.

  Week 16 for the group N (T2)

• HADS (Hospital Anxiety and Depression scale)

  Reduction in anxiety symptoms of 1 to 3 points according to the HADS Hospital Anxiety and Depression scale) between the start and the end of the program. The depression score assessed by the HADS will be measured. The maximum score that can be obtained for this sub-score is 21. Within the questionnaire, the order of scoring (from 0 to 3 or from 3 to 0) is alternated, in order to limit the bias linked to their repetition. Depending on the participants' scores on the depression subscale, it is possible to determine the presence or not, as well as the intensity of the depressive disorder: absence of depressive disorder (score ranging from 0 to 7), suspected depressive disorder (score ranging from 8 to 10) and proven depressive disorder (score ranging from 11 to 21). Thus, the higher the score, the more severe the participant's symptomatology. The first French validation of this scale was carried out by Lepine et al., 1985.

  Week 24 for the group C (T3)

Secondary Outcomes (38)

• HADS (Hospital Anxiety and Depression scale)

  Week 8 (T1) for both groups

• HADS (Hospital Anxiety and Depression scale)

  Week 16 for the group C (T2)

• Zarit Caregiver Burden Scale

  Inclusion

• Zarit Caregiver Burden Scale

  Week 8

• Zarit Caregiver Burden Scale

  Week 16

Study Arms (2)

N arm

EXPERIMENTAL

Behavioral: Psycho-educational program EHPAD caregivers / Pact & Pad for caregivers with a parent in an institution

Control group

ACTIVE COMPARATOR

Behavioral: Psycho-educational program EHPAD caregivers / Pact & Pad for caregivers with a parent in an institution

Interventions

Psycho-educational program EHPAD caregivers / Pact & Pad for caregivers with a parent in an institution BEHAVIORAL

Psycho-educational program EHPAD caregivers / Pact \& Pad for caregivers with a parent in an institution

Control group; N arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• URC-CIC Paris Descartes Necker Cochin: collaborator

Study Sites (1)

Assistance Publique - Hôpitaux de Paris (AP-HP) - Broca Hospital - Geriatric unit

Paris, Île-de-France Region, 75013, France

Location

Related Publications (1)

• Meziane-Damnee S, Bayle C, Pino M, Lenoir H, Cantegreil I, Rigaud AS. [A psycho-educational program for family caregivers of people with Alzheimer's disease entering an institution]. Soins Gerontol. 2023 May-Jun;28(161):20-23. doi: 10.1016/j.sger.2023.04.007. Epub 2023 Jun 1. French.

  PMID: 37328202 BACKGROUND

MeSH Terms

Interventions

Protein-Arginine Deiminases; Caregivers

Intervention Hierarchy (Ancestors)

Hydrolases; Enzymes; Enzymes and Coenzymes; Health Personnel; Health Care Facilities Workforce and Services

Study Officials

• Anne-Sophie RIGAUD, MD, PhD, PU-PH

  Broca Hospital, Assistance Publique des Hôpitaux de Paris (AP-HP)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2022
• First Posted: December 15, 2022
• Study Start: March 28, 2023
• Primary Completion: October 23, 2024
• Study Completion: June 11, 2025
• Last Updated: September 12, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)