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Alzheimer DiseaseNCT04280861

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

A study testing Multicomponent Intervention in people with Alzheimer Disease and Caregivers, run by Consorci Hospitalari de Vic at 1 site in Spain.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Alzheimer Disease, Caregivers, Quality of Life
What is being tested?
Multicomponent Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
94 participants
Where
1 siteSpain
Study dates
2 Feb 2020to 21 Dec 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Jordina Muñoz Padrós, PhD Student contact

34-938520000

jmunoz@chv.cat

Jordina Muñoz Padrós, PhD Student contact

34-398520000

jmunoz@chv.cat

Spain1 site, 1 recruiting

  • Consorci Hospitalari de Vic

    Vic, Barcelona, 08500

    Jordina Muñoz Padrós, PhD Student, 34-938520000, jmunoz@chv.cat

    Jordina Muñoz Padrós, PhD Student

    Recruiting

Other trials in Spain

About this study

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).

Read more

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.

Being tested
Multicomponent Intervention
Medical subject headings
Alzheimer Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Multicomponent InterventionOther

    Also called Psychological 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).

Study groups in NCT04280861
Study groupRoleWhat they receive
Intervention GroupExperimentalThe 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).
Receives: Other: Multicomponent Intervention
Control GroupNo interventionUsual clinical care,

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Baseline, immediately after the intervention and 6 month follow-up

Secondary outcomes (15)

  1. Changes in quality of life of the caregivers: 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

    Measured: Baseline, immediately after the intervention and 6 month follow-up

  2. Changes in loneliness

    UCLA - University of California Loneliness Scale. The total score ranges from 10 to 40. Score: 20-30: moderate depression, and ≥ 20: severe loneliness

    Measured: Baseline, immediately after the intervention and 6 month follow-up

  3. Changes in depression of the caregivers

    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

    Measured: Baseline, immediately after the intervention and 6 month follow-up

  4. Characteristics and changes in caregivers personality

    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.

    Measured: Baseline, immediately after the intervention and 6 month follow-up

  5. Changes in cognitive performance of the caregivers

    Neuropsychological assessment

    Measured: Baseline, immediately after the intervention and 6 month follow-up

  6. Changes in sleep patterns of the caregivers

    PSQI: Pittsburgh Sleep Quality Index. The total score ranges from 0 to 21, with a higher number indicating better sleep quality

    Measured: Baseline, immediately after the intervention and 6 month follow-up

  7. Changes of the resource utilization

    RUD: Resource Utilization in Dementia Questionnaire Scale

    Measured: Baseline, immediately after the intervention and 6 month follow-up

  8. Changes in cognitive status of the patients

    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

    Measured: Baseline, immediately after the intervention and 6 month follow-up

  9. Changes in Behavioural and Psychological Symptoms of Dementia

    NeuroPsychiatric Inventory. 12 scales, the domain total score is the product of the frequency score multiplied by the severity score for that behavioral domain

    Measured: Baseline, immediately after the intervention and 6 month follow-up

  10. Satisfaction with the intervention: Interview

    Satisfaction Interview

    Measured: Immediately after the intervention

  11. Changes in perceived social support of the caregivers

    DUKE-ANC. The total score ranges from 11 to 55, with a higher number indicating worse perceibed social support

    Measured: Baseline, immediately after the intervention and 6 month follow-up

  12. Anxiety

    HARS- Hamilton Anxiety Rating Scale. Score: 0-5: No anxiety; 6-14: Mild anxiety; ≥ 15: Moderate to severe anxiety

    Measured: Baseline, immediately after the intervention and 6 month follow-up

  13. Happiness

    OHQ : Oxford Happiness Questionnaire. The total score ranges from 8 to 54, with a higher number indicating better subjective wellness

    Measured: Baseline, immediately after the intervention and 6 month follow-up

  14. Burden in caregivers

    CBI: Caregiver Burden Interview. Total score ranges from 22 to 110. Score: 22-46: No burden; 47-55: burden; 56-110: intense burden

    Measured: Baseline, immediately after the intervention and 6 month follow-up

  15. Functional status of the patients

    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

    Measured: Baseline, immediately after the intervention and 6 month follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Feb 2020
  2. Study start2 Feb 2020
  3. Primary completion31 Jul 2021 (estimated)
  4. Study completion21 Dec 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
94 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04280861
Sponsor's protocol ID
AC278
Status last verified
Feb 2020
First submitted
17 Feb 2020
Last updated
21 Feb 2020
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Munoz-Padros J, Garolera M, Puigoriol-Juvanteny E, Bartes-Plans A, Romero Mas T, Roura-Poch P, Foguet-Boreu Q. Caregiver-Targeted Online Multicomponent Intervention and Quality of Life in Alzheimer's Disease: A Randomized Controlled Trial. Clin Gerontol. 2026 Jul-Sep;49(4):984-998. doi: 10.1080/07317115.2026.2659355. Epub 2026 Apr 14.

    PubMed 41979453

Questions about this trial

What is this clinical trial studying?

A study testing Multicomponent Intervention in people with Alzheimer Disease and Caregivers, run by Consorci Hospitalari de Vic at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 21 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Jordina Muñoz Padrós, PhD Student (34-938520000, jmunoz@chv.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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) (time frame: Baseline, immediately after the intervention and 6 month follow-up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04280861, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2020.

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