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An In-home Respite Care Program to Support Informal Caregivers of People With Dementia

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ClinicalTrials.gov Identifier: NCT02630446
Recruitment Status : Completed
First Posted : December 15, 2015
Last Update Posted : April 24, 2019
Sponsor:
Collaborators:
InBev-Baillet Latour Fund
Baluchon Alzheimer Belgium vzw
Information provided by (Responsible Party):
University Ghent

Brief Summary:

The general objective of this quasi-experimental study is to assess the effectiveness of an in-home respite care program compared to a control group not receiving the same type of in-home respite on the well-being of the caregiver, the care-recipient and on the healthcare system. The latter in terms of resource use, intention to institutionalize the care-recipient and time to nursing home placement.

A quasi-experimental study will be designed. The intervention group will consist of caregiver/care-recipient dyads receiving an in-home respite program called "Baluchonnage" and will be compared to a control group that doesn't receive "Baluchonnage". Comparison between the groups will be done by collecting health related and economic data. The trial will evaluate outcomes as well in the caregiver as in the care recipient (measured via the caregiver). The primary research outcome is caregiver burden. Secondary outcomes for caregivers are: health related quality of life and reactions to behavioral problems of the care-recipient. A secondary outcome related to the care-recipient is: frequency of behavioral problems. Secondary outcomes for the healthcare system are: intention to institutionalize the recipient into a nursing home and resource use of the recipient. Finally, in a follow up phase of the trial possible differences in time to nursing home placement will be measured (as well as burden and intention to institutionalize. Additionally, willingness to pay for "Baluchonnage" per day will be asked to the informal caregivers. Eventually, if the intervention is effective, modeled and trial based cost-effectiveness analyses will be undertaken in a separate economic evaluation plan.


Condition or disease Intervention/treatment Phase
Dementia Other: in-home respite care program Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 355 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Primary Purpose: Supportive Care
Official Title: Effectiveness and Cost-effectiveness of an In-home Respite Care Program to Support Informal Caregivers of People With Dementia: a Comparative Study
Study Start Date : January 2016
Actual Primary Completion Date : June 2018
Actual Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caregivers Dementia

Arm Intervention/treatment
Experimental: in-home respite care program
During the respite care period, lasting at least five days, a trained or experienced care worker for persons with dementia takes over all caregiving tasks while the informal caregiver is absent. The care worker thus temporary moves into the house of the person with dementia. The care worker also writes down his/her observations in a diary as well as daily experiences and strategies on how to manage the difficult behaviors the caregivers listed before. So additionally to the provision of respite, this program also includes caregiver support and psycho-education. This support enables the caregiver to validate theirs perceptions, to learn how to deal with difficult behaviors and to feel understood by somebody.
Other: in-home respite care program
During the respite care period, lasting at least five days, a trained or experienced care worker for persons with dementia takes over all caregiving tasks while the informal caregiver is absent. The care worker thus temporary moves into the house of the person with dementia. The care worker also writes down his/her observations in a diary as well as daily experiences and strategies on how to manage the difficult behaviors the caregivers listed before. So additionally to the provision of respite, this program also includes caregiver support and psycho-education. This support enables the caregiver to validate theirs perceptions, to learn how to deal with difficult behaviors and to feel understood by somebody.
Other Name: intervention group

No Intervention: standard dementia care
Control group receiving all types of standard dementia care except in-home respite care of the Baluchon type.



Primary Outcome Measures :
  1. Change in burden of caregivers measured using the Zarit Burden Interview-short version [ Time Frame: Assessments over 12 months: T0 = baseline (inclusion), T1 = 14 days after intervention (only intervention group), T3 = T0 + 6 months and T4 = T0 + 12 months. ]
    Burden will be measured using the Zarit Burden Interview-short version (ZBI) which is a 22-item validated self-report questionnaire developed to examine subjective burden of caregivers of people with dementia.


Secondary Outcome Measures :
  1. Health related quality of life measured using the EQ-5D-5L [ Time Frame: T0 = baseline (inclusion) and T2 = T0 + 6 months. ]
    Health related quality of life will be measured using the EQ-5D-5L. The EQ-5D-5L is a valid extension of the 3-level questionnaire. It can be defined as a standardized non-disease specific value-based instrument to describe and value health related quality of life.

  2. Frequency of problematic behaviors in care-recipient (RMBPC) [ Time Frame: T0 = baseline (inclusion), T1 = 14 days after intervention (only intervention group), T2 = T0 + 6 months ]
    To measure the frequency of problematic behaviors in the care-recipient and the reaction of caregivers to these behavioral problems, the Revised Memory and Behavior Problems Checklist (RMBPC) will be used. This validated caregiver self-report measure contains 24 items including three domains (depression, memory-related problems and disruption) and two scales to be answered. One scale measures the frequency of problems behaviors of the recipient and the other measures the reactions of the caregiver to this behavior.

  3. Reaction of caregiver to behavioral problems (RMBPC) [ Time Frame: T0 = baseline (inclusion), T1 = 14 days after intervention (only intervention group), T2 = T0 + 6 months ]
    To measure the reaction of caregivers to behavioral problems of the care-recipient the Revised Memory and Behavior Problems Checklist (RMBPC) will be used.

  4. Intention to institutionalize assessed using Desire To Institutionalize scale [ Time Frame: T0 = baseline (inclusion), T1 = 14 days after intervention (only intervention group), T3 = T0 + 6 months and T4 = T0 + 12 months. ]
    The intention to institutionalize the care-recipient will be assessed using Desire To Institutionalize scale (DTI). This questionnaire contains six yes or no questions each measuring the caregiver's desire to institutionalize the recipient into a nursing home, boarding home or assisted living.

  5. Time to nursing home placement [ Time Frame: T3 = T0 + 12 months ]
    Time to nursing home placement will be obtained by measuring the interval from the date of study enrollment to the date of permanent nursing home placement.

  6. Resource use of the care-recipient measured using the Utilization in Dementia instrument [ Time Frame: T0 = baseline (inclusion) and T2 = T0 + 6 months. ]
    Resource use of the care-recipient will be measured using the Utilization in Dementia instrument (RUD). This valid, standardized and widely used instrument can be used for collecting data on resource use of dementia.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The study participants are caregiver/care-recipient dyads.
  • The caregivers must be informal, meaning that they must not be professional healthcare workers in this caregiving role.
  • The caregivers have to identify themselves as the main person responsible for the informal care (primary caregiver).
  • Also, the caregivers must speak Dutch or French with some fluency and be able to read and write.
  • The care-recipient needs to be diagnosed with dementia based on the criteria of DSM fourth edition (Diagnostic and Statistical Manual of Mental Disorders) and must live in the community.
  • Dyads in the control group must never had respite care of the Baluchon type in the past, but be eligible and willing to have it. (On the other hand, dyads from the intervention group who have already received in-home respite from the Baluchon type in the past are still allowed for inclusion.)

Exclusion Criteria:

  • Caregivers will be excluded if they have cognitive impairments or severe psychiatric comorbidities.
  • Control group dyads who already utilized in-home respite care of the Baluchon type will be excluded.
  • Another reason for exclusion in the control group is not willing to consider in-home respite via Baluchon.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02630446


Locations
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Belgium
Ghent University-Public Health Department
Ghent, East-Flanders, Belgium, 9000
Sponsors and Collaborators
University Ghent
InBev-Baillet Latour Fund
Baluchon Alzheimer Belgium vzw
Investigators
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Study Director: Lieven Annemans, PhD University Ghent
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University Ghent
ClinicalTrials.gov Identifier: NCT02630446    
Other Study ID Numbers: E/01447/15
First Posted: December 15, 2015    Key Record Dates
Last Update Posted: April 24, 2019
Last Verified: April 2019
Keywords provided by University Ghent:
respite care
effectiveness
cost-effectiveness
support
caregiver
dementia
community-based
Additional relevant MeSH terms:
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Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders