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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-A00553-38 | Other Identifier | France : ANSM |
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| Name | Class |
|---|---|
| URC-CIC Paris Descartes Necker Cochin | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| N arm | Experimental |
| |
| Control group | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| 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. |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anne-Sophie RIGAUD, MD, PhD, PU-PH | Broca Hospital, Assistance Publique des Hôpitaux de Paris (AP-HP) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Assistance Publique - Hôpitaux de Paris (AP-HP) - Broca Hospital - Geriatric unit | Paris | Île-de-France Region | 75013 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37328202 | Background | 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. | |
| 41942929 | Derived | Meziane-Damnee S, Rigaud AS, Bayle C, Piccoli M, Blavette L, Dacunha S, Lenoir H, Pino M. Co-designing a psychoeducational intervention for FCs of institutionalized older adults : a participatory double diamond approach. BMC Geriatr. 2026 Apr 6;26(1):691. doi: 10.1186/s12877-026-07398-7. |
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| Week 24 for the group C (T3) |
| 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,
| Inclusion |
| Zarit Caregiver Burden Scale |
| Week 8 |
| Zarit Caregiver Burden Scale |
| Week 16 |
| Zarit Caregiver Burden Scale |
| 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) |
| 41919866 | Derived | Damnee S, Vidal JS, Mercier J, Pino M, Dacunha S, Bayle C, Cantegreil I, Rigaud AS, Lenoir H. Early Nursing-Home Psychoeducation for Family Caregivers: Feasibility and Preliminary Changes in Anxiety, Depression, and Coping. Clin Gerontol. 2026 Jul-Sep;49(4):969-983. doi: 10.1080/07317115.2026.2653581. Epub 2026 Apr 1. |
| ID | Term |
|---|---|
| D000076342 | Protein-Arginine Deiminases |
| D017028 | Caregivers |
| ID | Term |
|---|---|
| D006867 | Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D006282 | Health Personnel |
| D005159 | Health Care Facilities Workforce and Services |
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