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

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.

Study Overview

• Status: Completed
• Conditions: Caregivers
• Intervention / Treatment: Behavioral: Psycho-educational program EHPAD caregivers / Pact & Pad for caregivers with a parent in an institution

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.

• Study Type: Interventional
• Enrollment (Actual): 73
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Île-de-France Region
    • Paris, Île-de-France Region, France, 75013
      • Assistance Publique - Hôpitaux de Paris (AP-HP) - Broca Hospital - Geriatric unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control group	Behavioral: Psycho-educational program EHPAD caregivers / Pact & Pad for caregivers with a parent in an institution; Psycho-educational program EHPAD caregivers / Pact & Pad for caregivers with a parent in an institution
Experimental: N arm	Behavioral: Psycho-educational program EHPAD caregivers / Pact & Pad for caregivers with a parent in an institution; Psycho-educational program EHPAD caregivers / Pact & Pad for caregivers with a parent in an institution

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 8 (T1) for both groups
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 16 for the group C (T2)
Zarit Caregiver Burden Scale	Between 0 and 20 points, the caregiver's burden is considered to be very low or even zero,; Between 21 and 40 points, the burden is light,; Between 41 and 60 points, the burden is moderate,; Between 60 and 88 points, the burden is severe.	Inclusion
Zarit Caregiver Burden Scale	Between 0 and 20 points, the caregiver's workload is considered to be very low or even zero,; Between 21 and 40 points, the burden is light,; Between 41 and 60 points, the burden is reduced,; Between 60 and 88 points, the burden is severe.	Week 8
Zarit Caregiver Burden Scale	Between 0 and 20 points, the caregiver's workload is considered to be very low or even zero,; Between 21 and 40 points, the burden is light,; Between 41 and 60 points, the burden is reduced,; Between 60 and 88 points, the burden is severe.	Week 16
Zarit Caregiver Burden Scale	Between 0 and 20 points, the caregiver's workload is considered to be very low or even zero,; Between 21 and 40 points, the burden is light,; Between 41 and 60 points, the burden is reduced,; Between 60 and 88 points, the burden is severe.	Week 24 for the group C (T3)
CADI (Carers Assessment of Difficulties Index)	30 items - Rating is done using a three-point scale, ranging from 0: "the proposal does not apply to my situation", to 3: "it is a very stressful difficulty / a very useful strategy/a very great satisfaction"	Inclusion
CADI (Carers Assessment of Difficulties Index)	30 items - Rating is done using a three-point scale, ranging from 0: "the proposal does not apply to my situation", to 3: "it is a very stressful difficulty / a very useful strategy/a very great satisfaction"	Week 8
CADI (Carers Assessment of Difficulties Index)	30 items - Rating is done using a three-point scale, ranging from 0: "the proposal does not apply to my situation", to 3: "it is a very stressful difficulty / a very useful strategy/a very great satisfaction"	Week 16
CADI (Carers Assessment of Difficulties Index)	30 items - Rating is done using a three-point scale, ranging from 0: "the proposal does not apply to my situation", to 3: "it is a very stressful difficulty / a very useful strategy/a very great satisfaction"	Week 24 for the group C (T3)
CAMI (Carers Assessment of Managing Index)	38 items - Rating is done using a three-point scale, ranging from 0: "the proposal does not apply to my situation", to 3: "it is a very stressful difficulty / a very useful strategy/a very great satisfaction"	Inclusion
CAMI (Carers Assessment of Managing Index)	38 items - Rating is done using a three-point scale, ranging from 0: "the proposal does not apply to my situation", to 3: "it is a very stressful difficulty / a very useful strategy/a very great satisfaction"	Week 8
CAMI (Carers Assessment of Managing Index)	38 items - Rating is done using a three-point scale, ranging from 0: "the proposal does not apply to my situation", to 3: "it is a very stressful difficulty / a very useful strategy/a very great satisfaction"	Week 16
CAMI (Carers Assessment of Managing Index)	38 items - Rating is done using a three-point scale, ranging from 0: "the proposal does not apply to my situation", to 3: "it is a very stressful difficulty / a very useful strategy/a very great satisfaction"	Week 24 for the group C (T3)
CASI (Carers Assessment of Satisfaction Index)	30 items - Rating is done using a three-point scale, ranging from 0: "the proposal does not apply to my situation", to 3: "it is a very stressful difficulty / a very useful strategy/a very great satisfaction"	Inclusion
CASI (Carers Assessment of Satisfaction Index)	30 items - Rating is done using a three-point scale, ranging from 0: "the proposal does not apply to my situation", to 3: "it is a very stressful difficulty / a very useful strategy/a very great satisfaction"	Week 8
CASI (Carers Assessment of Satisfaction Index)	30 items - Rating is done using a three-point scale, ranging from 0: "the proposal does not apply to my situation", to 3: "it is a very stressful difficulty / a very useful strategy/a very great satisfaction"	Week 16
CASI (Carers Assessment of Satisfaction Index)	30 items - Rating is done using a three-point scale, ranging from 0: "the proposal does not apply to my situation", to 3: "it is a very stressful difficulty / a very useful strategy/a very great satisfaction"	Week 24 for the group C (T3)
Quality of life (QOL AD)	Scoring instructions for QOL-AD: Points are assigned to each item as follows: poor = 1, fair = 2, good = 3, excellent = 4. The total score is the sum of all 13 items	Inclusion
Quality of life (QOL AD)	Scoring instructions for QOL-AD: Points are assigned to each item as follows: poor = 1, fair = 2, good = 3, excellent = 4. The total score is the sum of all 13 items	Week 8
Quality of life (QOL AD)	Scoring instructions for QOL-AD: Points are assigned to each item as follows: poor = 1, fair = 2, good = 3, excellent = 4. The total score is the sum of all 13 items	Week 16
Quality of life (QOL AD)	Scoring instructions for QOL-AD: Points are assigned to each item as follows: poor = 1, fair = 2, good = 3, excellent = 4. The total score is the sum of all 13 items	Week 24 for the group C (T3)
Visual scale	Visual scale for the quality of communication caregiver / carers - From 1 (bad quality) to 10 (very good quality).	Inclusion
Visual scale	Visual scale for the quality of communication caregiver / carers - From 1 (bad quality) to 10 (very good quality).	Week 8
Visual scale	Visual scale for the quality of communication caregiver / carers - From 1 (bad quality) to 10 (very good quality).	Week 16
Visual scale	Visual scale for the quality of communication caregiver / carers - From 1 (bad quality) to 10 (very good quality).	Week 24 for the group C (T3)
Visual scale	Visual scale for the quality of communication caregiver / helped - From 1 (bad quality) to 10 (very good quality).	Inclusion
Visual scale	Visual scale for the quality of communication caregiver / helped - From 1 (bad quality) to 10 (very good quality).	Week 8
Visual scale	Visual scale for the quality of communication caregiver / helped - From 1 (bad quality) to 10 (very good quality).	Week 16
Visual scale	Visual scale for the quality of communication caregiver / helped - From 1 (bad quality) to 10 (very good quality).	Week 24 for the group C (T3)
Scale of Intolerance to Uncertainty	27 items. Items are rated on a Likert scale from 1 ("Not at all relevant") to 5 ("Completely relevant"). The total score is obtained by adding the items. it will be between 27 and 135 (27*5=135)	Inclusion
Scale of Intolerance to Uncertainty	27 items. Items are rated on a Likert scale from 1 ("Not at all relevant") to 5 ("Completely relevant"). The total score is obtained by adding the items. it will be between 27 and 135 (27*5=135)	Week 8
Scale of Intolerance to Uncertainty	27 items. Items are rated on a Likert scale from 1 ("Not at all relevant") to 5 ("Completely relevant"). The total score is obtained by adding the items. it will be between 27 and 135 (27*5=135)	Week 16
Scale of Intolerance to Uncertainty	27 items. Items are rated on a Likert scale from 1 ("Not at all relevant") to 5 ("Completely relevant"). The total score is obtained by adding the items. it will be between 27 and 135 (27*5=135)	Week 24 for the group C (T3)
Visual scale	Measure of guilt - From 1 to 10 It assesses the quality of the relationship with the parent in the eyes of the carer (0 = worse outcome / 10 = better outcome).	Inclusion
Visual scale	Measure of guilt - From 1 to 10 It assesses the quality of the relationship with the parent in the eyes of the carer (0 = worse outcome / 10 = better outcome).	Week 8
Visual scale	Measure of guilt - From 1 to 10 It assesses the quality of the relationship with the parent in the eyes of the carer (0 = worse outcome / 10 = better outcome).	Week 16
Visual scale	Measure of guilt - From 1 to 10 It assesses the quality of the relationship with the parent in the eyes of the carer (0 = worse outcome / 10 = better outcome).	Week 24 for the group C (T3)

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborators: URC Necker Cochin, France
• Investigators: Principal Investigator: Anne-Sophie RIGAUD, MD, PhD, PU-PH, Broca Hospital, Assistance Publique des Hôpitaux de Paris (AP-HP)

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 28, 2023
• Primary Completion (Actual): October 23, 2024
• Study Completion (Actual): June 11, 2025

Study Registration Dates

• First Submitted: December 7, 2022
• First Submitted That Met QC Criteria: December 7, 2022
• First Posted (Actual): December 15, 2022

Study Record Updates

• Last Update Posted (Estimated): September 12, 2025
• Last Update Submitted That Met QC Criteria: September 5, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Caregiving; Psychosocial intervention; Nursing home placement; Nursing home admission; Informal long-term care
• Additional Relevant MeSH Terms: Hydrolases; Enzymes; Enzymes and Coenzymes; Health Care Facilities Workforce and Services; Health Personnel; Caregivers; Protein-Arginine Deiminases
• Other Study ID Numbers: APHP220084; 2021-A00553-38 (Other Identifier: France : ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No