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

Caregivers Clinical Trial

— EAPP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05651555
• Other study ID #: APHP220084
• Secondary ID: 2021-A00553-38
• Status: Recruiting
• Phase: N/A
• Start date: March 28, 2023
• Est. completion date: September 2025

Study information

• Verified date: January 2024
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Souad MEZIANE DAMNEE
• Phone: 0033609315479
• Email: souad.damnee[@]aphp.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: September 2025
• Est. primary completion date: July 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Caregivers

Intervention

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

Locations

Country	Name	City	State
France	Assistance Publique - Hôpitaux de Paris (AP-HP) - Broca Hospital - Geriatric unit	Paris	Ile De France

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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)
Primary	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	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
Secondary	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)
Secondary	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
Secondary	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
Secondary	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
Secondary	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)
Secondary	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
Secondary	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
Secondary	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
Secondary	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)
Secondary	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
Secondary	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
Secondary	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
Secondary	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)
Secondary	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
Secondary	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
Secondary	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
Secondary	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)
Secondary	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
Secondary	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
Secondary	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
Secondary	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)
Secondary	Visual scale	Visual scale for the quality of communication caregiver / carers - From 1 (bad quality) to 10 (very good quality).	Inclusion
Secondary	Visual scale	Visual scale for the quality of communication caregiver / carers - From 1 (bad quality) to 10 (very good quality).	Week 8
Secondary	Visual scale	Visual scale for the quality of communication caregiver / carers - From 1 (bad quality) to 10 (very good quality).	Week 16
Secondary	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)
Secondary	Visual scale	Visual scale for the quality of communication caregiver / helped - From 1 (bad quality) to 10 (very good quality).	Inclusion
Secondary	Visual scale	Visual scale for the quality of communication caregiver / helped - From 1 (bad quality) to 10 (very good quality).	Week 8
Secondary	Visual scale	Visual scale for the quality of communication caregiver / helped - From 1 (bad quality) to 10 (very good quality).	Week 16
Secondary	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)
Secondary	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
Secondary	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
Secondary	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
Secondary	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)
Secondary	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
Secondary	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
Secondary	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
Secondary	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)