Understanding the Lived Experience and Bereavement of Caregivers of People With Alzheimer's Disease (ALCARE)

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 Overview

• Status: Not yet recruiting
• Conditions: Occupational Therapy; Family Caregivers; Alzheimer Disease (AD)
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Estimated): 66

Contacts and Locations

• Study Contact: Name: Sara García-Bravo; Phone Number: +34650664793; Email: sara.garcia.bravo@urjc.es

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

relatives of individuals diagnosed with AD by a neurologist or geriatrician

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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	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).; 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	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).; 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	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).; 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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	baseline

Collaborators and Investigators

• Sponsor: Universidad Rey Juan Carlos

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2025
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): July 31, 2026

Study Registration Dates

• First Submitted: November 18, 2025
• First Submitted That Met QC Criteria: November 18, 2025
• First Posted (Actual): November 26, 2025

Study Record Updates

• Last Update Posted (Actual): November 26, 2025
• Last Update Submitted That Met QC Criteria: November 18, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Alzheimer's disease; Occupational Therapy; occupational balance
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Neurocognitive Disorders; Dementia; Tauopathies; Neurodegenerative Diseases; Alzheimer Disease; Amino Acids, Peptides, and Proteins; Proteins; Membrane Proteins; Protein Precursors; Amyloidogenic Proteins; Amyloid; Protease Nexins; Proteinase Inhibitory Proteins, Secretory; Amyloid beta-Protein Precursor
• Other Study ID Numbers: 041220246522024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No