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

NCT07251738 | Not Yet Recruiting

• 1 other identifier: 041220246522024
• Study Type: observational
• Target: 66
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Alzheimer Disease (AD); Occupational Therapy; Family Caregivers

Keywords

Alzheimer's disease; Occupational Therapy; occupational balance

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (3)

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).

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).

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).

Interventions

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).

Group 1; Group 2; Group 3

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

relatives of individuals diagnosed with AD by a neurologist or geriatrician

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad Rey Juan Carlos: lead

MeSH Terms

Conditions

Alzheimer Disease

Interventions

Amyloid beta-Protein Precursor

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Amyloidogenic Proteins; Amyloid; Proteins; Amino Acids, Peptides, and Proteins; Membrane Proteins; Protein Precursors; Protease Nexins; Proteinase Inhibitory Proteins, Secretory

Central Study Contacts

Sara García-Bravo

CONTACT

+34650664793; sara.garcia.bravo@urjc.es

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Physiotherapist

Study Record Dates

• First Submitted: November 18, 2025
• First Posted: November 26, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: November 26, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share