Clinical trial NCT04280861: Multicomponent Intervention in Caregivers on Quality of Life of People With Dementia: a Clinical Trial
Official title: Multicomponent Intervention in Caregivers on Quality of Life of People With Dementia: a Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Alzheimer Disease
Caregivers
Quality of Life
Lead sponsor: Consorci Hospitalari de Vic
Sponsor class: OTHER
First posted: 2020-02-21
Enrollment: 94
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: 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)
timeFrame: Baseline, immediately after the intervention and 6 month follow-up
Secondary outcomes:
measure: Changes in quality of life of the caregivers: Quality of Life-Alzheimer's Disease (QoL-AD)
timeFrame: Baseline, immediately after the intervention and 6 month follow-up
measure: Changes in loneliness
timeFrame: Baseline, immediately after the intervention and 6 month follow-up
measure: Changes in depression of the caregivers
timeFrame: Baseline, immediately after the intervention and 6 month follow-up
measure: Characteristics and changes in caregivers personality
timeFrame: Baseline, immediately after the intervention and 6 month follow-up
measure: Changes in cognitive performance of the caregivers
timeFrame: Baseline, immediately after the intervention and 6 month follow-up
measure: Changes in sleep patterns of the caregivers
timeFrame: Baseline, immediately after the intervention and 6 month follow-up
measure: Changes of the resource utilization
timeFrame: Baseline, immediately after the intervention and 6 month follow-up
measure: Changes in cognitive status of the patients
timeFrame: Baseline, immediately after the intervention and 6 month follow-up
measure: Changes in Behavioural and Psychological Symptoms of Dementia
timeFrame: Baseline, immediately after the intervention and 6 month follow-up
measure: Satisfaction with the intervention: Interview
timeFrame: Immediately after the intervention
measure: Changes in perceived social support of the caregivers
timeFrame: Baseline, immediately after the intervention and 6 month follow-up
measure: Anxiety
timeFrame: Baseline, immediately after the intervention and 6 month follow-up
measure: Happiness
timeFrame: Baseline, immediately after the intervention and 6 month follow-up
measure: Burden in caregivers
timeFrame: Baseline, immediately after the intervention and 6 month follow-up
measure: Functional status of the patients
timeFrame: Baseline, immediately after the intervention and 6 month follow-up
Other outcomes:
Locations:
city: Vic
country: Spain
facility: Consorci Hospitalari de Vic
state: Barcelona
Study officials:
References: