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

Quality of Life Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04280861
• Other study ID #: AC278
• Status: Recruiting
• Phase: N/A
• Start date: February 2, 2020
• Est. completion date: December 21, 2021

Study information

• Verified date: February 2020
• Source: Consorci Hospitalari de Vic
• Contact: Jordina Muñoz Padrós, PhD Student
• Phone: 34-938520000
• Email: jmunoz[@]chv.cat
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 94
• Est. completion date: December 21, 2021
• Est. primary completion date: July 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Caregivers
• Dementia
• Quality of Life

Intervention

Other:
• 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).

Locations

Country	Name	City	State
Spain	Consorci Hospitalari de Vic	Vic	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Consorci Hospitalari de Vic

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	Baseline, immediately after the intervention and 6 month follow-up
Secondary	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	Baseline, immediately after the intervention and 6 month follow-up
Secondary	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	Baseline, immediately after the intervention and 6 month follow-up
Secondary	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.	Baseline, immediately after the intervention and 6 month follow-up
Secondary	Changes in cognitive performance of the caregivers	Neuropsychological assessment	Baseline, immediately after the intervention and 6 month follow-up
Secondary	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	Baseline, immediately after the intervention and 6 month follow-up
Secondary	Changes of the resource utilization	RUD: Resource Utilization in Dementia Questionnaire Scale	Baseline, immediately after the intervention and 6 month follow-up
Secondary	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	Baseline, immediately after the intervention and 6 month follow-up
Secondary	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	Baseline, immediately after the intervention and 6 month follow-up
Secondary	Satisfaction with the intervention: Interview	Satisfaction Interview	Immediately after the intervention
Secondary	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	Baseline, immediately after the intervention and 6 month follow-up
Secondary	Anxiety	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
Secondary	Happiness	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
Secondary	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	Baseline, immediately after the intervention and 6 month follow-up
Secondary	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	Baseline, immediately after the intervention and 6 month follow-up