Clinical trial NCT04787068: Support for Caregivers of Older Adults With Cognitive Decline
Official title: Providing Support to Caregivers of Frail Older Adults With Cognitive Impairments
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Caregiver Burden
Depression
Confidence, Self
Cognition
Fatigue
Function
Keywords: Informal caregivers
Intervention
Lead sponsor: State University of New York at Buffalo
Sponsor class: OTHER
Collaborators: name: Ralph C. Wilson Jr. Foundation (Funding source)
First posted: 2021-03-08
Enrollment: 35
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Experimental study
Primary purpose: SUPPORTIVE_CARE

Brief summary: This randomized control study is to test effectiveness of occupational therapy support for informal caregivers of older adults with cognitive decline. Care recipients are community-living older adults who are eligible for a nursing home level of care. At baseline challenges that caregivers are facing will be expressed and individualized solutions will be identified and delivered for the treatment and educational material will be given to the control group. Two and four months later, follow up interview will be made to identify changes in burden, depression, fatigue, self-efficacy, and positive aspect of care giving. It is expected to show when the effectiveness becomes clear.

Detailed description: Family caregivers of frail older adults with cognitive impairments face special challenges in caring for their care recipients (CR) due to their fast declining health. Examples of difficulties include managing CR's behaviors and daily activities, as well as maintaining their own psychological and physical health, which result in high caregiver burden. The aim is to support these caregivers of older adults who are enrollees of the Program for All-inclusive Care for the Elderly (PACE) through occupational therapy (OT) interventions to reduce caregiver burden and depression, and increase positive aspects of caregiving and self-efficacy. Since PACE organizations offer limited support for caregivers due to understanding, supervised OT graduate students (OTGS) will provide caregivers with customized supports. By doing so, the students will gain precious experience before they enter the workforce. This proposal will develop and test the effectiveness of this collaborative model. This study will use a randomized controlled design with about a 4- month intervention period. The assessments will take place at baseline, 2 months and 4 months. The study period will be two years. Participants will be 60 convenience family caregivers of the PACE enrollees in Western New York; therefore, CRs are 55 years old or older, need a nursing home level of care, but remain living in the community. Caregivers are adults who visit the CR at least once a week. OTGS will contact the caregivers, using a phone, and conduct an in depth interview to understand their difficulties. Then solutions will be brainstormed amongst OTs and geriatric specialists, and interventions will be formed. At the first visit to the CRs' homes, interviews will be conducted using the Zarit Burden Interview, the Center for Epidemiology Study for Depression, the Buffalo Fatigue Scale, the Positive Aspect of Caregiving, and the Visual Analogue Scale for self-efficacy. The possible solutions will be discussed with caregivers and more detailed difficulties will be videotaped. The solutions that caregivers are comfortable with will be reviewed by the PACE Rehabilitation Department and need to be approved before their implementation. The solutions may include: education of disease process, training for caregivers in supporting CR's activities of daily living (ADL) and instrumental ADL, coordination of family caregivers, problematic behaviors, functional exercise, fall prevention, and increased number of CR's visits to a PACE daycare facility. Statistical analysis will use Generalized Estimating Equations to compare the two groups' linear trends. We expect CRs' condition will deteriorate but the treatment group will reduce caregiver burden and increase self-efficacy.

Eligibility criteria: Inclusion Criteria:

* • Caregivers of community-dwelling older adults (55 and over) who are member of the PACE

  * Adult 21 years or older
  * Living with the care recipient or within a distance so that they can visit him/her minimum once a week
  * Cognitively intact (can recall three words immediately and 3 minutes later)
  * Competent in English

Exclusion Criteria:

* One instrument (Positive aspect of caregiving) is only available in English. To fully understand caregivers' challenges and convey solutions, our current study OT graduate students are not competent enough in other languages to provide interventions. We do not have budget to hire interpreters.

Primary outcomes:
measure: Change in caregiver burden measured by the Zarit Burden Interview
timeFrame: 4 months
measure: Change in depression change measured by the Center for Epidemiology Studies-Depression
timeFrame: 4 months
measure: Change in confidence to continue caring for the care recipient in the future (6 months)
timeFrame: 4 months
Secondary outcomes:
measure: Change in a cognitive level of care recipients measured by the Global Deterioration Scale
timeFrame: 4 months
measure: Change in instrumental activities of daily living (IADL) of care recipients measured by IADL from the Older Americans Resources and Services
timeFrame: 4 months
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: State University of New York
state: New York
Study officials:
affiliation: State University of New York at Buffalo
name: Machiko R Tomita, Ph.D.
role: PRINCIPAL_INVESTIGATOR
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