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

February 20, 2020 updated by: Dr. Pere Roura-Poch, Consorci Hospitalari de Vic

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.

Study Overview

Status

Unknown

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

94

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Jordina Muñoz Padrós, PhD Student
  • Phone Number: 34-938520000
  • Email: jmunoz@chv.cat

Study Contact Backup

  • Name: Jordina Muñoz Padrós, PhD Student
  • Phone Number: 34-398520000
  • Email: jmunoz@chv.cat

Study Locations

    • Barcelona
      • Vic, Barcelona, Spain, 08500
        • Recruiting
        • Consorci Hospitalari de Vic
        • Contact:
          • Jordina Muñoz Padrós, PhD Student
          • Phone Number: 34-938520000
          • Email: jmunoz@chv.cat
        • Principal Investigator:
          • Jordina Muñoz Padrós, PhD Student
        • Sub-Investigator:
          • Quintí Foguet Boreu, PhD
        • Sub-Investigator:
          • Maite Garolera Freixa, PhD
        • Sub-Investigator:
          • Anna Bartés Plans, Bachelor
        • Sub-Investigator:
          • Yemila Plana, Master
        • Sub-Investigator:
          • Èlia Pagespetit Feliu, Master

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 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).
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).
Other Names:
  • Psychological intervention
NO_INTERVENTION: Control Group
Usual clinical care,

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Time Frame: Baseline, immediately after the intervention and 6 month follow-up
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in quality of life of the caregivers: Quality of Life-Alzheimer's Disease (QoL-AD)
Time Frame: Baseline, immediately after the intervention and 6 month follow-up
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
Changes in loneliness
Time Frame: Baseline, immediately after the intervention and 6 month follow-up
UCLA - University of California Loneliness Scale. The total score ranges from 10 to 40. Score: 20-30: moderate depression, and ≥ 20: severe loneliness
Baseline, immediately after the intervention and 6 month follow-up
Changes in depression of the caregivers
Time Frame: Baseline, immediately after the intervention and 6 month follow-up
HDRS: Hamilton Depression Rating Scale. Score: 0-7: No depression; 8-13: Mild depression; 14-18: Moderate depression; 19-22: Severe depression and ≥ 23: Very severe depression
Baseline, immediately after the intervention and 6 month follow-up
Characteristics and changes in caregivers personality
Time Frame: Baseline, immediately after the intervention and 6 month follow-up
NEO-Personality Inventory-R. For each scale, the interval 20-35 indicates very low scores. The interval 35-45 indicates low scores. The interval 45-55 indicates average scores. The interval 55-65 indicates high scores. The interval 65-80 indicates very high scores.
Baseline, immediately after the intervention and 6 month follow-up
Changes in cognitive performance of the caregivers
Time Frame: Baseline, immediately after the intervention and 6 month follow-up
Neuropsychological assessment
Baseline, immediately after the intervention and 6 month follow-up
Changes in sleep patterns of the caregivers
Time Frame: Baseline, immediately after the intervention and 6 month follow-up
PSQI: Pittsburgh Sleep Quality Index. The total score ranges from 0 to 21, with a higher number indicating better sleep quality
Baseline, immediately after the intervention and 6 month follow-up
Changes of the resource utilization
Time Frame: Baseline, immediately after the intervention and 6 month follow-up
RUD: Resource Utilization in Dementia Questionnaire Scale
Baseline, immediately after the intervention and 6 month follow-up
Changes in cognitive status of the patients
Time Frame: Baseline, immediately after the intervention and 6 month follow-up
MMSE (Mini Mental State Examination). Range scores 0 to 30. Score: 24-30: no cognitive impairment; 19-23: mild cognitive impairment; 10-18: moderate cognitive impairment; ≤9: severe cognitive impairment
Baseline, immediately after the intervention and 6 month follow-up
Changes in Behavioural and Psychological Symptoms of Dementia
Time Frame: Baseline, immediately after the intervention and 6 month follow-up
NeuroPsychiatric Inventory. 12 scales, the domain total score is the product of the frequency score multiplied by the severity score for that behavioral domain
Baseline, immediately after the intervention and 6 month follow-up
Satisfaction with the intervention: Interview
Time Frame: Immediately after the intervention
Satisfaction Interview
Immediately after the intervention
Changes in perceived social support of the caregivers
Time Frame: Baseline, immediately after the intervention and 6 month follow-up
DUKE-ANC. The total score ranges from 11 to 55, with a higher number indicating worse perceibed social support
Baseline, immediately after the intervention and 6 month follow-up
Anxiety
Time Frame: Baseline, immediately after the intervention and 6 month follow-up
HARS- Hamilton Anxiety Rating Scale. Score: 0-5: No anxiety; 6-14: Mild anxiety; ≥ 15: Moderate to severe anxiety
Baseline, immediately after the intervention and 6 month follow-up
Happiness
Time Frame: Baseline, immediately after the intervention and 6 month follow-up
OHQ : Oxford Happiness Questionnaire. The total score ranges from 8 to 54, with a higher number indicating better subjective wellness
Baseline, immediately after the intervention and 6 month follow-up
Burden in caregivers
Time Frame: Baseline, immediately after the intervention and 6 month follow-up
CBI: Caregiver Burden Interview. Total score ranges from 22 to 110. Score: 22-46: No burden; 47-55: burden; 56-110: intense burden
Baseline, immediately after the intervention and 6 month follow-up
Functional status of the patients
Time Frame: Baseline, immediately after the intervention and 6 month follow-up
IADL: Instrumental. Activities of Daily Living. Sum the binary responses of each activity, sum the eight responses The higher the score, the greater the person's abilities
Baseline, immediately after the intervention and 6 month follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 2, 2020

Primary Completion (ANTICIPATED)

July 31, 2021

Study Completion (ANTICIPATED)

December 21, 2021

Study Registration Dates

First Submitted

February 17, 2020

First Submitted That Met QC Criteria

February 20, 2020

First Posted (ACTUAL)

February 21, 2020

Study Record Updates

Last Update Posted (ACTUAL)

February 21, 2020

Last Update Submitted That Met QC Criteria

February 20, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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