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

NCT02630446 | Completed

• 1 other identifier: E/01447/15
• Study Type: interventional
• Target: 355
• Locations: 1 country
• Sites: 1

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.

Conditions

Dementia

Keywords

respite care; effectiveness; cost-effectiveness; support; caregiver; dementia; community-based

Outcome Measures

Primary Outcomes (1)

• Change in burden of caregivers measured using the Zarit Burden Interview-short version

  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.

  Assessments over 12 months: T0 = baseline (inclusion), T1 = 14 days after intervention (only intervention group), T3 = T0 + 6 months and T4 = T0 + 12 months.

Secondary Outcomes (6)

• Health related quality of life measured using the EQ-5D-5L

  T0 = baseline (inclusion) and T2 = T0 + 6 months.

• Frequency of problematic behaviors in care-recipient (RMBPC)

  T0 = baseline (inclusion), T1 = 14 days after intervention (only intervention group), T2 = T0 + 6 months

• Reaction of caregiver to behavioral problems (RMBPC)

  T0 = baseline (inclusion), T1 = 14 days after intervention (only intervention group), T2 = T0 + 6 months

• Intention to institutionalize assessed using Desire To Institutionalize scale

  T0 = baseline (inclusion), T1 = 14 days after intervention (only intervention group), T3 = T0 + 6 months and T4 = T0 + 12 months.

• Time to nursing home placement

  T3 = T0 + 12 months

Study Arms (2)

in-home respite care program

EXPERIMENTAL

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

standard dementia care

NO INTERVENTION

Control group receiving all types of standard dementia care except in-home respite care of the Baluchon type.

Interventions

in-home respite care program OTHER

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.

Also known as: intervention group

in-home respite care program

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Ghent: lead
• InBev-Baillet Latour Fund: collaborator
• Baluchon Alzheimer Belgium vzw: collaborator

Study Sites (1)

Ghent University-Public Health Department

Ghent, East-Flanders, 9000, Belgium

Location

Related Publications (3)

• Vandepitte S, Van Wilder L, Putman K, Van Den Noortgate N, Verhaeghe S, Trybou J, Annemans L. Factors associated with costs of care in community-dwelling persons with dementia from a third party payer and societal perspective: a cross-sectional study. BMC Geriatr. 2020 Jan 16;20(1):18. doi: 10.1186/s12877-020-1414-6.

  PMID: 31948386 DERIVED

• Vandepitte S, Putman K, Van Den Noortgate N, Verhaeghe S, Annemans L. Effectiveness of an in-home respite care program to support informal dementia caregivers: A comparative study. Int J Geriatr Psychiatry. 2019 Oct;34(10):1534-1544. doi: 10.1002/gps.5164. Epub 2019 Jul 11.

  PMID: 31243801 DERIVED

• Vandepitte S, Van Den Noortgate N, Putman K, Verhaeghe S, Annemans L. Effectiveness and cost-effectiveness of an in-home respite care program in supporting informal caregivers of people with dementia: design of a comparative study. BMC Geriatr. 2016 Dec 2;16(1):207. doi: 10.1186/s12877-016-0373-4.

  PMID: 27912740 DERIVED

MeSH Terms

Conditions

Dementia

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Lieven Annemans, PhD

  University Ghent

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2015
• First Posted: December 15, 2015
• Study Start: January 1, 2016
• Primary Completion: June 1, 2018
• Study Completion: December 1, 2018
• Last Updated: April 24, 2019

Record last verified: 2019-04

Locations

BE (1)