Alzheimer Disease (AD)ALCARENCT07251738
Understanding the Lived Experience and Bereavement of Caregivers of People With Alzheimer's Disease
An observational study of Alzheimer Disease (AD) and Occupational Therapy, run by Universidad Rey Juan Carlos.
Trial summary
The main objective of this study is to explore the lived experience of caregivers and family members of people with Alzheimer's disease (AD), from the beginning of caregiving through the bereavement process following the patient's death. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease (AD), Occupational Therapy, Family Caregivers
- What is being tested?
- Assessment of occupational balance, role performance, caregiving burden, and quality of life among carers or family members of individuals with Alzheimer's disease (AD).
- How many people
- 66 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2025to 31 Jul 2026
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: relatives of individuals diagnosed with AD by a neurologist or geriatrician
Who may be able to join
- Inclusion criteria for Group 1: relatives of people diagnosed with AD by a neurologist or geriatrician, who have suffered the loss of a relative with AD; who have lived with and/or cared for the person with AD until the end of their life; who agree to participate voluntarily in the project and who have signed the informed consent form.
- Inclusion criteria for Group 2: relatives of people diagnosed with AD by a neurologist or geriatrician; who live with and/or care for the person with AD; who attend the Day Centre and who agree to participate voluntarily in the project and have signed the informed consent form.
- Inclusion criteria for Group 3: relatives of people diagnosed with AD by a neurologist or geriatrician; who have their relative institutionalised in a nursing home and who agree to participate voluntarily in the project and have signed the informed consent form.
Who cannot join
- Those who have not lived with or cared for relatives with AD and who do not agree to participate in the study will be excluded from the project.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
The main objective of this study is to explore the lived experience of caregivers and family members of people with Alzheimer's disease (AD), from the beginning of caregiving through the bereavement process following the patient's death. Using a mixed-methods design, qualitative data will be collected through in-depth interviews and combined with quantitative data obtained from standardized scales. The results will aim to determine whether prolonged caregiving significantly affects the caregiver's or family member's personal, emotional, and occupational well-being, as well as whether it leads to a reorganization of activities of daily living (ADL), an increased perception of burden, and/or a decreased quality of life. The study will also examine the presence of positive adaptation experiences.
- Being tested
- Assessment of occupational balance, role performance, caregiving burden, and quality of life among carers or family members of individuals with Alzheimer's disease (AD).
- Keywords
- Alzheimer's disease, Occupational Therapy, occupational balance
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assessment of occupational balance, role performance, caregiving burden, and quality of life among carers or family members of individuals with Alzheimer's disease (AD).Other
Assessment of occupational balance, role performance, caregiving burden, and quality of life among carers or family members of individuals with Alzheimer's disease (AD).
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | relatives of people diagnosed with AD by a neurologist or geriatrician, who have suffered the loss of a relative with AD; who have lived with and/or cared for the person with AD until the end of their life Receives: Other: Assessment of occupational balance, role performance, caregiving burden, and quality of life among carers or family members of individuals with Alzheimer's disease (AD). | |
| Group 2 | relatives of people diagnosed with AD by a neurologist or geriatrician; who lived with and/or cared for the person with AD; who attended the Day Centre Receives: Other: Assessment of occupational balance, role performance, caregiving burden, and quality of life among carers or family members of individuals with Alzheimer's disease (AD). | |
| Group 3 | relatives of people diagnosed with AD by a neurologist or geriatrician; who had their relative institutionalised in the Residence Receives: Other: Assessment of occupational balance, role performance, caregiving burden, and quality of life among carers or family members of individuals with Alzheimer's disease (AD). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Zarit Burden Interview, ZBI
is a tool designed to assess the level of perceived burden experienced by informal carers of dependent persons. It consists of 22 items that explore emotional, social and physical aspects related to caregiving, allowing the impact of the carer role on their quality of life to be identified. Each item is scored on a Likert scale, with higher scores indicating greater burden.
Measured: baseline
Role Checklist
It is an instrument based on the Human Occupation Model (HOM) designed to assess the occupational roles that a person performs throughout their life. It allows for the identification of current, past, and future roles, as well as the subjective value assigned to each one. This instrument is useful for understanding how occupational roles contribute to a sense of identity, the organisation of daily life and overall well-being, facilitating the planning of client-centred interventions.
Measured: baseline
Short Form-36 Health Survey
It is a widely used tool for measuring health-related quality of life. It assesses eight dimensions: physical functioning, physical role, bodily pain, general health, vitality, social functioning, emotional role, and mental health. It is a generic instrument, applicable to diverse populations and useful in both research and practice, providing a broad profile of people's health status.
Measured: baseline
Occupational Balance Questionnaire
It is an assessment tool designed to measure occupational balance, understood as people's perception of the appropriate distribution of their time and energy in meaningful activities. This questionnaire explores aspects related to satisfaction and management of daily occupations, considering both the quantity and quality of the activities performed. It has proven useful in clinical and research contexts to identify occupational imbalances that can affect health and well-being. The original version was developed in Sweden and has been adapted to various languages and cultures, maintaining its validity and reliability.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2025
- Study start1 Dec 2025 (estimated)
- Primary completion31 May 2026 (estimated)
- Study completion31 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alzheimer Disease (AD)Studies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 66 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Universidad Rey Juan Carlos
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara Garcia Bravo, Universidad Rey Juan Carlos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07251738
- Sponsor's protocol ID
- 041220246522024
- Acronym
- ALCARE
- Status last verified
- Nov 2025
- First submitted
- 18 Nov 2025
- Last updated
- 26 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Risquez-Salgado N, Garcia-Bravo S, Huertas-Hoyas E, Perez-Corrales J, Salcedo-Perez-Juana M, Donovan M, Palacios-Cena D, Bullon-Benito E, Garcia-Bravo C. Understanding the Lived Experience and Bereavement of Caregivers of People with Alzheimer's Disease: A Mixed-Methods Study Protocol. Healthcare (Basel). 2026 Mar 31;14(7):899. doi: 10.3390/healthcare14070899.
PubMed 41975901
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding the Lived Experience and Bereavement of Caregivers of People With Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT07251738
- Acronym / sponsor ID
- ALCARE / 041220246522024
- Keywords
- Alzheimer's disease, Occupational Therapy, occupational balance
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Universidad Rey Juan CarlosUniversity, hospital or other
- Study start
- 1 Dec 2025 (estimated)
- Primary completion
- 31 May 2026 (estimated)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 26 Nov 2025 (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.
The main objective of this study is to explore the lived experience of caregivers and family members of people with Alzheimer's disease (AD), from the beginning of caregiving through the bereavement process following the patient's death. Using a mixed-methods design, qualitative data will be collected through in-depth interviews and combined with quantitative data obtained from standardized scales. The results will aim to determine whether prolonged caregiving significantly affects the caregiver's or family member's personal, emotional, and occupational well-being, as well as whether it leads to a reorganization of activities of daily living (ADL), an increased perception of burden, and/or a decreased quality of life. The study will also examine the presence of positive adaptation experiences.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Other: Assessment of occupational balance, role performance, caregiving burden, and quality of life among carers or family members of individuals with Alzheimer's disease (AD).relatives of people diagnosed with AD by a neurologist or geriatrician, who have suffered the loss of a relative with AD; who have lived with and/or cared for the person with AD until the end of their life |
| Group 2 | – | Other: Assessment of occupational balance, role performance, caregiving burden, and quality of life among carers or family members of individuals with Alzheimer's disease (AD).relatives of people diagnosed with AD by a neurologist or geriatrician; who lived with and/or cared for the person with AD; who attended the Day Centre |
| Group 3 | – | Other: Assessment of occupational balance, role performance, caregiving burden, and quality of life among carers or family members of individuals with Alzheimer's disease (AD).relatives of people diagnosed with AD by a neurologist or geriatrician; who had their relative institutionalised in the Residence |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- relatives of individuals diagnosed with AD by a neurologist or geriatrician
Key inclusion criteria (3 listed)
- Inclusion criteria for Group 1: relatives of people diagnosed with AD by a neurologist or geriatrician, who have suffered the loss of a relative with AD; who have lived with and/or cared for the person with AD until the end of their life; who agree to participate voluntarily in the project and who have signed the informed consent form.
- Inclusion criteria for Group 2: relatives of people diagnosed with AD by a neurologist or geriatrician; who live with and/or care for the person with AD; who attend the Day Centre and who agree to participate voluntarily in the project and have signed the informed consent form.
- Inclusion criteria for Group 3: relatives of people diagnosed with AD by a neurologist or geriatrician; who have their relative institutionalised in a nursing home and who agree to participate voluntarily in the project and have signed the informed consent form.
Key exclusion criteria (1 listed)
- Those who have not lived with or cared for relatives with AD and who do not agree to participate in the study will be excluded from the project.
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 |
|---|---|---|
| Assessment of occupational balance, role performance, caregiving burden, and quality of life among carers or family members of individuals with Alzheimer's disease (AD).Assessment of occupational balance, role performance, caregiving burden, and quality of life among carers or family members of individuals with Alzheimer's disease (AD). | Other | Group 1, Group 2, Group 3 |
Primary outcome
Zarit Burden Interview, ZBI
Time frame: baseline
is a tool designed to assess the level of perceived burden experienced by informal carers of dependent persons. It consists of 22 items that explore emotional, social and physical aspects related to caregiving, allowing the impact of the carer role on their quality of life to be identified. Each item is scored on a Likert scale, with higher scores indicating greater burden.
Role Checklist
Time frame: baseline
It is an instrument based on the Human Occupation Model (HOM) designed to assess the occupational roles that a person performs throughout their life. It allows for the identification of current, past, and future roles, as well as the subjective value assigned to each one. This instrument is useful for understanding how occupational roles contribute to a sense of identity, the organisation of daily life and overall well-being, facilitating the planning of client-centred interventions.
Short Form-36 Health Survey
Time frame: baseline
It is a widely used tool for measuring health-related quality of life. It assesses eight dimensions: physical functioning, physical role, bodily pain, general health, vitality, social functioning, emotional role, and mental health. It is a generic instrument, applicable to diverse populations and useful in both research and practice, providing a broad profile of people's health status.
Occupational Balance Questionnaire
Time frame: baseline
It is an assessment tool designed to measure occupational balance, understood as people's perception of the appropriate distribution of their time and energy in meaningful activities. This questionnaire explores aspects related to satisfaction and management of daily occupations, considering both the quantity and quality of the activities performed. It has proven useful in clinical and research contexts to identify occupational imbalances that can affect health and well-being. The original version was developed in Sweden and has been adapted to various languages and cultures, maintaining its validity and reliability.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2025.
- Derived from this study: PubMed 41975901Risquez-Salgado N, Garcia-Bravo S, Huertas-Hoyas E, Perez-Corrales J, Salcedo-Perez-Juana M, Donovan M, Palacios-Cena D, Bullon-Benito E, Garcia-Bravo C. Understanding the Lived Experience and Bereavement of Caregivers of People with Alzheimer's Disease: A Mixed-Methods Study Protocol. Healthcare (Basel). 2026 Mar 31;14(7):899. doi: 10.3390/healthcare14070899.
- Individual participant dataSharing planned: No
Related trials for Alzheimer Disease (AD)
RecruitingObservational study
Effectiveness and Safety of Disease-Modifying Therapy for Alzheimer's Disease: A Multicenter Retrospective Study
Alzheimer's Disease (AD)
Active, not recruitingPhase 2
A Study to Evaluate the Safety and Biomarker Effects of RO7269162 in Participants at Risk for or at the Prodromal Stage of Alzheimer's Disease (AD)
Alzheimer's Disease
RecruitingPhase 1
PET Imaging of Phosphodiesterase-4 (PDE4) in Volunteers With Alzheimer Disease (AD) or Mild Cognitive Impairment (MCI)
Alzheimer s Disease, Mild Cognitive Impairment
RecruitingObservational study
Community-based Screening for Alzheimer's Disease
Alzheimer's Disease(AD), Mild Cognitive Impairment (MCI)
RecruitingObservational study
InRAD Observational Study
Alzheimer's Disease(AD), Mild Cognitive Impairment (MCI)
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Alzheimer Disease (AD) and Occupational Therapy, run by Universidad Rey Juan Carlos.
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 3 inclusion and 1 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: opening soon, as of the sponsor's last update on 26 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sara García-Bravo (+34650664793, sara.garcia.bravo@urjc.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Zarit Burden Interview, ZBI (time frame: baseline). The study lists 4 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 NCT07251738, which also lists 1 linked publication.
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 26 Nov 2025.