An interventional study of Psycho-educational program EHPAD caregivers / Pact & Pad for caregivers with a parent in an institution in Caregivers, sponsored by Assistance Publique - Hôpitaux de Paris. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-12.
Sponsored by Assistance Publique - Hôpitaux de Paris · Not applicable, Interventional, and Prevention
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.
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.
Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,505 studies on the registry; 1,006 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Behavioral: 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
Psycho-educational program EHPAD caregivers / Pact \& Pad for caregivers with a parent in an institution
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.
Time frame: 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.
Time frame: 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.
Time frame: Week 24 for the group C (T3)
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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"
Time frame: 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"
Time frame: 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"
Time frame: 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"
Time frame: 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"
Time frame: 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"
Time frame: 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"
Time frame: 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"
Time frame: 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"
Time frame: 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"
Time frame: 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"
Time frame: 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"
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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).
Time frame: Inclusion
Visual scale
Visual scale for the quality of communication caregiver / carers - From 1 (bad quality) to 10 (very good quality).
Time frame: Week 8
Visual scale
Visual scale for the quality of communication caregiver / carers - From 1 (bad quality) to 10 (very good quality).
Time frame: Week 16
Visual scale
Visual scale for the quality of communication caregiver / carers - From 1 (bad quality) to 10 (very good quality).
Time frame: 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).
Time frame: Inclusion
Visual scale
Visual scale for the quality of communication caregiver / helped - From 1 (bad quality) to 10 (very good quality).
Time frame: Week 8
Visual scale
Visual scale for the quality of communication caregiver / helped - From 1 (bad quality) to 10 (very good quality).
Time frame: Week 16
Visual scale
Visual scale for the quality of communication caregiver / helped - From 1 (bad quality) to 10 (very good quality).
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: Week 24 for the group C (T3)
Plan to share: No
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