CaregiversEAPPNCT05651555
Evaluation of the EHPAD Caregiver/Pact & Pad Psycho-educational Program for Caregivers With an Institutionalized Parent
A study testing Psycho-educational program EHPAD caregivers / Pact & Pad for caregivers with a parent in an institution in people with Caregivers, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Caregivers
- What is being tested?
- Psycho-educational program EHPAD caregivers / Pact & Pad for caregivers with a parent in an institution
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 1 siteFrance
- Study dates
- 28 Mar 2023to 11 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Show all 10Show fewer
- Presence of depression or anxiety according to HAD
- Be motivated to follow the program
- Signature of consent.
- Be affiliated with a social security scheme
Who cannot join
- 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
Show all 9Show fewer
- Already benefit from another caregiver assistance program.
- Patient under AME
- Vulnerable people
Trial locations and contacts
1 site in 1 country.
France1 site
Assistance Publique - Hôpitaux de Paris (AP-HP) - Broca Hospital - Geriatric unit
Paris, Île-de-France Region, 75013
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Caregivers
- Being tested
- Psycho-educational program EHPAD caregivers / Pact & Pad for caregivers with a parent in an institution
- Keywords
- Caregiving, Psychosocial intervention, Nursing home placement, Nursing home admission, Informal long-term care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psycho-educational program EHPAD caregivers / Pact & Pad for caregivers with a parent in an institutionBehavioural
Psycho-educational program EHPAD caregivers / Pact \& Pad for caregivers with a parent in an institution
| Study group | Role | What they receive |
|---|---|---|
| N arm | Experimental | Not described Receives: Behavioral: Psycho-educational program EHPAD caregivers / Pact & Pad for caregivers with a parent in an institution |
| Control group | Active comparator | Not described Receives: Behavioral: Psycho-educational program EHPAD caregivers / Pact & Pad for caregivers with a parent in an institution |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Week 24 for the group C (T3)
Secondary outcomes (38)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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"
Measured: 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"
Measured: 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"
Measured: 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"
Measured: 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"
Measured: 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"
Measured: 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"
Measured: 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"
Measured: 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"
Measured: 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"
Measured: 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"
Measured: 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"
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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).
Measured: Inclusion
Visual scale
Visual scale for the quality of communication caregiver / carers - From 1 (bad quality) to 10 (very good quality).
Measured: Week 8
Visual scale
Visual scale for the quality of communication caregiver / carers - From 1 (bad quality) to 10 (very good quality).
Measured: Week 16
Visual scale
Visual scale for the quality of communication caregiver / carers - From 1 (bad quality) to 10 (very good quality).
Measured: 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).
Measured: Inclusion
Visual scale
Visual scale for the quality of communication caregiver / helped - From 1 (bad quality) to 10 (very good quality).
Measured: Week 8
Visual scale
Visual scale for the quality of communication caregiver / helped - From 1 (bad quality) to 10 (very good quality).
Measured: Week 16
Visual scale
Visual scale for the quality of communication caregiver / helped - From 1 (bad quality) to 10 (very good quality).
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: Week 24 for the group C (T3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2022
- Study start28 Mar 2023
- Primary completion23 Oct 2024
- Study completion11 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for CaregiversStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Anne-Sophie RIGAUD, MD, PhD, PU-PH, Principal investigator, Broca Hospital, Assistance Publique des Hôpitaux de Paris (AP-HP)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05651555
- Sponsor's protocol ID
- APHP220084
- Other IDs
- 2021-A00553-38
- Acronym
- EAPP
- Status last verified
- Sep 2025
- First submitted
- 7 Dec 2022
- Last updated
- 12 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 37328202Meziane-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.
PubMed 41942929Damnee 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.
PubMed 41919866
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the EHPAD Caregiver/Pact & Pad Psycho-educational Program for Caregivers With an Institutionalized Parent
- ClinicalTrials.gov ID
- NCT05651555
- Acronym / sponsor ID
- EAPP / APHP220084
- Conditions
- Caregivers
- Keywords
- Caregiving, Psychosocial intervention, Nursing home placement, Nursing home admission, Informal long-term care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- 28 Mar 2023 (actual)
- Primary completion
- 23 Oct 2024 (actual)
- Study completion
- 11 Jun 2025 (actual)
- First posted
- 15 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psycho-educational program EHPAD caregivers / Pact & Pad for caregivers with a parent in an institutionPsycho-educational program EHPAD caregivers / Pact \& Pad for caregivers with a parent in an institution | Behavioural | Control group, N arm |
Primary outcome
HADS (Hospital Anxiety and Depression scale)
Time frame: Inclusion
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.
HADS (Hospital Anxiety and Depression scale)
Time frame: Week 16 for the group N (T2)
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.
HADS (Hospital Anxiety and Depression scale)
Time frame: Week 24 for the group C (T3)
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.
38 secondary outcomes
HADS (Hospital Anxiety and Depression scale)
Time frame: Week 8 (T1) for both groups
HADS (Hospital Anxiety and Depression scale)
Time frame: Week 16 for the group C (T2)
Zarit Caregiver Burden Scale
Time frame: Inclusion
Zarit Caregiver Burden Scale
Time frame: Week 8
Zarit Caregiver Burden Scale
Time frame: Week 16
Zarit Caregiver Burden Scale
Time frame: Week 24 for the group C (T3)
CADI (Carers Assessment of Difficulties Index)
Time frame: Inclusion
CADI (Carers Assessment of Difficulties Index)
Time frame: Week 8
CADI (Carers Assessment of Difficulties Index)
Time frame: Week 16
CADI (Carers Assessment of Difficulties Index)
Time frame: Week 24 for the group C (T3)
CAMI (Carers Assessment of Managing Index)
Time frame: Inclusion
CAMI (Carers Assessment of Managing Index)
Time frame: Week 8
CAMI (Carers Assessment of Managing Index)
Time frame: Week 16
CAMI (Carers Assessment of Managing Index)
Time frame: Week 24 for the group C (T3)
CASI (Carers Assessment of Satisfaction Index)
Time frame: Inclusion
CASI (Carers Assessment of Satisfaction Index)
Time frame: Week 8
CASI (Carers Assessment of Satisfaction Index)
Time frame: Week 16
CASI (Carers Assessment of Satisfaction Index)
Time frame: Week 24 for the group C (T3)
Quality of life (QOL AD)
Time frame: Inclusion
Quality of life (QOL AD)
Time frame: Week 8
Quality of life (QOL AD)
Time frame: Week 16
Quality of life (QOL AD)
Time frame: Week 24 for the group C (T3)
Visual scale
Time frame: Inclusion
Visual scale
Time frame: Week 8
Visual scale
Time frame: Week 16
Visual scale
Time frame: Week 24 for the group C (T3)
Visual scale
Time frame: Inclusion
Visual scale
Time frame: Week 8
Visual scale
Time frame: Week 16
Visual scale
Time frame: Week 24 for the group C (T3)
Scale of Intolerance to Uncertainty
Time frame: Inclusion
Scale of Intolerance to Uncertainty
Time frame: Week 8
Scale of Intolerance to Uncertainty
Time frame: Week 16
Scale of Intolerance to Uncertainty
Time frame: Week 24 for the group C (T3)
Visual scale
Time frame: Inclusion
Visual scale
Time frame: Week 8
Visual scale
Time frame: Week 16
Visual scale
Time frame: Week 24 for the group C (T3)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2025.
- Background: PubMed 37328202Meziane-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.
- Derived from this study: PubMed 41942929Meziane-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.
- Derived from this study: PubMed 41919866Damnee 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne-Sophie RIGAUD, MD, PhD, PU-PH principal investigator
Broca Hospital, Assistance Publique des Hôpitaux de Paris (AP-HP)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psycho-educational program EHPAD caregivers / Pact & Pad for caregivers with a parent in an institution in people with Caregivers, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HADS (Hospital Anxiety and Depression scale) (time frame: Inclusion). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05651555, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2025.