Multicomponent Intervention in Caregivers on Quality of Life of People With Dementia: a Clinical Trial

NCT ID: NCT04280861

Last Updated: 2020-02-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 94 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-02-02
• Study Completion Date: 2021-12-21

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.

Conditions

Alzheimer Disease; Caregivers; Quality of Life

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Intervention Group

The 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).

Group Type: EXPERIMENTAL

Multicomponent Intervention

Intervention Type: OTHER

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

Usual clinical care,

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Multicomponent Intervention

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).

Intervention Type: OTHER

Other Intervention Names

Psychological intervention

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Consorci Hospitalari de Vic

OTHER

Sponsor Role: lead

Responsible Party

Dr. Pere Roura-Poch

Head of Epidemiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Consorci Hospitalari de Vic

Vic, Barcelona, Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

Jordina Muñoz Padrós, PhD Student

Role: CONTACT

jmunoz@chv.cat

34-938520000

Jordina Muñoz Padrós, PhD Student

Role: CONTACT

jmunoz@chv.cat

34-398520000

Facility Contacts

Jordina Muñoz Padrós, PhD Student

Role: primary

jmunoz@chv.cat

34-938520000

Other Identifiers

AC278

Identifier Type: -

Identifier Source: org_study_id