Clinical trial NCT02915939: The Residential Care Transition Module
Official title: The Residential Care Transition Module
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alzheimer Disease
Dementia
Keywords: Family caregiving
Institutionalization
Residential long-term care
Placement
Psychosocial support
Dementia
Caregivers
Nursing homes
Assisted Living Facilities
Long-Term Care
Intervention Study
Psychosocial Support Systems
Social Support
Coping
COVID-19
Lead sponsor: University of Minnesota
Sponsor class: OTHER
Collaborators: name: Johns Hopkins University
name: NYU Langone Health
name: Benjamin Rose Institute
name: Emory University
First posted: 2016-09-27
Enrollment: 240
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Emerging research on family caregiving and institutionalization has emphasized that families do not disengage from care responsibilities following a relative's admission to residential long-term care settings. The Residential Care Transition Module (RCTM) provides 6 formal sessions of consultation (one-to-one and family sessions) over a 4-month period to those family caregivers who have admitted a cognitively impaired relative to a residential long-term care setting (nursing home, assisted living memory care unit). The proposed mixed method, randomized controlled trial will determine whether and how the RCTM decreases family caregivers' emotional and psychological distress, placement-related strain, and increases relative's transitions back to the community. The RCTM will fill an important clinical and research gap by evaluating a psychosocial intervention designed for families following RLTC placement to determine whether and how this approach can help families better navigate the residential care transitions of relatives with Alzheimer's disease or a related dementia.

Detailed description: Emerging research on family caregiving and institutionalization has found that families do not disengage from care responsibilities following relatives' admissions to residential long-term care settings. Families instead remain involved in a spectrum of care activities ranging from instrumental activities of daily living to emotional support. Perhaps for these reasons, a number of studies have noted that caregiving stress, depression, or other key outcomes remain stable or sometimes increase following residential long-term care (RLTC) entry for certain types of caregivers. A few interventions have attempted to increase family involvement after institutionalization, but no rigorous studies have demonstrated that these interventions are effective in helping families navigate transitions to RLTC environments.

The Residential Care Transition Module (RCTM) provides 6 formal sessions of consultation (one-to-one and family sessions) over a 4-month period to those family caregivers who have recently admitted a relative to a RLTC setting. In this randomized controlled trial, family members who have admitted a cognitively impaired relative to a RLTC setting will be randomly assigned to the RCTM \[(n = 120)\] or a usual care control condition \[(n = 120)\]. A mixed methods analysis will be used to pursue the following aims: Specific Aim 1: Assess whether the RCTM yields statistically significant reductions in family members' primary subjective stress and negative mental health outcomes; Specific Aim 2) Determine whether family members who receive the RCTM will indicate statistically significant decreases in secondary role strains over a 12-month period when compared to usual care controls; Specific Aim 3) Determine whether RCTM family members report statistically significant decreases in residential care stress when compared to family members in the usual care control group; and Specific Aim 4) Delineate the mechanism of action of RCTM under conditions of high and low success by "embedding" qualitative components (30 semi-structured interviews) at the conclusion of the 12-month evaluation.

The proposed project will fill an important clinical and research gap by evaluating a psychosocial intervention designed for families following RLTC placement that determines whether and how the RCTM can help families better navigate the residential care transitions of cognitively impaired relatives.

Eligibility criteria: Inclusion Criteria:

* Family caregivers of relatives who have received a physician's diagnosis of Alzheimer's disease or a related dementia (ADRD)
* Family caregivers who consider themselves the most involved in visiting and providing assistance to a relative experiencing a long-stay admission to an assisted living, nursing home, memory care, or other residential long-term care setting. Those who share the primary caregiving role equally are also eligible.
* Family caregivers must be English speaking, 21 years of age or older
* Family caregivers on psychotropic medications, such as anti-depressants or anti-psychotics, will be eligible if they have remained on a stable dosage for the last 3 months

Exclusion Criteria:

* Family caregivers who are participating in any other type of service that provides one-to-one psychosocial consultation specifically for caregiving (support group participation is not a deterrent to enrollment, nor is general counseling not specific to caregiving)

Primary outcomes:
measure: Change in care-related strain
timeFrame: 12 months
measure: Change in burden: Zarit Burden Interview
timeFrame: 12 months
measure: Change in stress: Perceived Stress Scale
timeFrame: 12 months
Secondary outcomes:
measure: Quantitative measure of resilience to negative psychosocial effects of COVID-19
timeFrame: 0, 1 and 4 months post-pandemic onset
measure: Qualitative measure of resilience to negative psychosocial effects of COVID-19
timeFrame: 0, 1 and 4 months post-pandemic onset
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota, School of Nursing, 6-153 Weaver-Densford Hall
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Joseph E. Gaugler, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zmora R, Statz TL, Birkeland RW, McCarron HR, Finlay JM, Rosebush CE, Gaugler JE. Transitioning to Long-Term Care: Family Caregiver Experiences of Dementia, Communities, and Counseling. J Aging Health. 2021 Jan;33(1-2):133-146. doi: 10.1177/0898264320963588. Epub 2020 Sep 29.
citation: Gaugler JE, Statz TL, Birkeland RW, Louwagie KW, Peterson CM, Zmora R, Emery A, McCarron HR, Hepburn K, Whitlatch CJ, Mittelman MS, Roth DL. The ResidentialCare Transition Module: a single-blinded randomized controlled evaluation of a telehealth support intervention for family caregivers of persons with dementia living in residential long-term care. BMC Geriatr. 2020 Apr 15;20(1):133. doi: 10.1186/s12877-020-01542-7.
citation: Mitchell LL, Albers EA, Birkeland RW, Peterson CM, Stabler H, Horn B, Cha J, Drake A, Gaugler JE. Caring for a Relative With Dementia in Long-Term Care During COVID-19. J Am Med Dir Assoc. 2022 Mar;23(3):428-433.e1. doi: 10.1016/j.jamda.2021.11.026. Epub 2021 Dec 17.
citation: Gaugler JE, Mitchell LL. Reimagining Family Involvement in Residential Long-Term Care. J Am Med Dir Assoc. 2022 Feb;23(2):235-240. doi: 10.1016/j.jamda.2021.12.022. Epub 2021 Dec 29.