Multicomponent Intervention in Caregivers on Quality of Life of People With Dementia: a Clinical Trial
1 other identifier
interventional
94
1 country
1
Brief Summary
The main objective is to determine the effectiveness of a multicomponent intervention for caregivers, conducted by an expert psychologist to improve the quality of life of the people with Alzheimer's disease. Secondarily, will be analyzed the effectiveness of this program on improving anxiety and depressive symptoms, burden, happiness, social support and cognitive performance of the caregivers and alleviate the behavioural and psychological symptoms of dementia (BPSD). The investigators analyze the caregiver's and patient's personality as a possible moderator between dependent and independent variables, and the resources utilization before and after intervention. Methods: randomized study with parallel assignment in two groups: control and intervention group, six-month follow-up. The eligible participants will be 94 adult (≥18 years) caregivers of patients with Alzheimer's disease who follow-up by Osona Integrated Geriatric Unite (Catalonia, Spain). The intervention group will receive a multicomponent intervention that includes dementia psychoeducation and management, emotional and communication skills, mindfulness and healthy lifestyle. The control group will follow the standard management according to the primary and specialized care professionals' team. Main measurements: quality of life of the patients at baseline, after intervention and at six-month follow-up through QoL-AD. Secondary measures: they will be determined, at baseline, after the intervention and at six-month follow-up: depression (HDRS) and anxiety (HARS), burden (CBI), happiness (OHQ), quality of life (QoL-AD), social support (UCLA and DUKE-ANC), cognitive performance (neuropsychological assessment) of the caregivers, resources utilization (RUD), BPSD (NPI), cognitive status (MMSE), functional status (IADL) of the patients. Caregiver's personality at baseline and six-month follow-up and dementia characteristics at baseline will be measured. Other measures: sociodemographic and health characteristics of the caregivers and patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable alzheimer-disease
Started Feb 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 2, 2020
CompletedFirst Submitted
Initial submission to the registry
February 17, 2020
CompletedFirst Posted
Study publicly available on registry
February 21, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 21, 2021
CompletedFebruary 21, 2020
February 1, 2020
1.5 years
February 17, 2020
February 20, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Changes in quality of life of the patients after intervention and 6 months follow-up in control and intervention group: Quality of Life-Alzheimer's Disease (QoL-AD)
Quality of life assessed using Quality of Life-Alzheimer's Disease (QoL-AD). The total score ranges from 13 to 52, with a higher number indicating better quality of life
Baseline, immediately after the intervention and 6 month follow-up
Secondary Outcomes (15)
Changes in quality of life of the caregivers: Quality of Life-Alzheimer's Disease (QoL-AD)
Baseline, immediately after the intervention and 6 month follow-up
Changes in loneliness
Baseline, immediately after the intervention and 6 month follow-up
Changes in depression of the caregivers
Baseline, immediately after the intervention and 6 month follow-up
Characteristics and changes in caregivers personality
Baseline, immediately after the intervention and 6 month follow-up
Changes in cognitive performance of the caregivers
Baseline, immediately after the intervention and 6 month follow-up
- +10 more secondary outcomes
Study Arms (2)
Intervention Group
EXPERIMENTALThe intervention group will participate in multicomponent intervention conducted by and expert psychologist that target different aspects of the caregiving experience (affective responses, communication skills, burden experience, social support and loneliness, cognitive performance, the practice of mindfulness and health-related behaviours). The number of sessions will be 8, 1 session of 90 minutes a week, and the number of participants will be 12-14 per group. In some sessions other collaborators will be invited to participate (social workers, physiotherapist).
Control Group
NO INTERVENTIONUsual clinical care,
Interventions
Multicomponent intervention conducted by and expert psychologist that target different aspects of the caregiving experience (affective responses, communication skills, burden experience, social support and loneliness, cognitive performance, the practice of mindfulness and health-related behaviours). The number of sessions will be 8, 1 session of 90 minutes a week, and the number of participants will be 12-14 per group. In some sessions other collaborators will be invited to participate (social workers, physiotherapist).
Eligibility Criteria
You may qualify if:
- adults (≥18 years of age)
- main caregivers of people with early or mild Alzheimer's disease
- follow-up by Osona Integrated Geriatric Unite (Catalonia)
- signed informed consent.
You may not qualify if:
- non stable medical condition the last six months (or any acute or chronic condition that would limit the ability of the patient to participate in the study)
- cognitive impairment (MMSE\<24)
- substance abuse
- active psychotherapy
- refusal to give informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Consorci Hospitalari de Vic
Vic, Barcelona, 08500, Spain
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head of Epidemiology
Study Record Dates
First Submitted
February 17, 2020
First Posted
February 21, 2020
Study Start
February 2, 2020
Primary Completion
July 31, 2021
Study Completion
December 21, 2021
Last Updated
February 21, 2020
Record last verified: 2020-02