Study Results
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Basic Information
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COMPLETED
NA
240 participants
INTERVENTIONAL
2016-12-31
2021-08-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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Treatment Group
The Residential Care Transition Module (RCTM) includes six in-person consultation sessions over a 4-month period conducted by a trained Transition Counselor (TC) with a primary family caregiver (self-identified as the person most responsible for providing on-going assistance to the care recipient in a residential long-term care setting such (RLTC) such as a nursing home or assisted living memory care unit.
The Residential Care Transition Module
Residential Care Transition Module sessions focus on the experiences of the caregiver, the care recipient, and (potentially) other family members immediately following residential long-term care (RLTC) admission. The sessions are designed to establish a therapeutic rapport with the caregiver and the family; provide a safe environment to explore stressors; examine family relational dynamics as they relate to the RLTC placement decision itself as well as the roles different family members play in the life of the caregiver and relative in RLTC; identify new modes of communication to facilitate more effective interactions with other family members and care staff; and identify effective ways to advocate for improved quality of care for and quality of life of their relatives in RLTC.
Usual Care Group
The usual care control group will adjust for the social engagement provided to the Residential Care Transition Module (RCTM )treatment condition. The Transition Counselor (TC) will provide quarterly contact calls and the research coordinator will send a bi-annual project newsletter to all participants. If caregivers in the control group initiate contact with the TC for care needs, the TC will provide information and referral support.
No interventions assigned to this group
Interventions
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The Residential Care Transition Module
Residential Care Transition Module sessions focus on the experiences of the caregiver, the care recipient, and (potentially) other family members immediately following residential long-term care (RLTC) admission. The sessions are designed to establish a therapeutic rapport with the caregiver and the family; provide a safe environment to explore stressors; examine family relational dynamics as they relate to the RLTC placement decision itself as well as the roles different family members play in the life of the caregiver and relative in RLTC; identify new modes of communication to facilitate more effective interactions with other family members and care staff; and identify effective ways to advocate for improved quality of care for and quality of life of their relatives in RLTC.
Eligibility Criteria
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Inclusion Criteria
* 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
21 Years
ALL
Yes
Sponsors
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Johns Hopkins University
OTHER
NYU Langone Health
OTHER
Benjamin Rose Institute
OTHER
Emory University
OTHER
University of Minnesota
OTHER
Responsible Party
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Principal Investigators
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Joseph E. Gaugler, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Minnesota
Locations
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University of Minnesota, School of Nursing, 6-153 Weaver-Densford Hall
Minneapolis, Minnesota, United States
Countries
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References
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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.
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.
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.
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.
Urbanski DP, Birkeland RW, Albers EA, Roth DL, Baker ZG, Gustavson AM, Yam H, Gaugler JE. Process evaluation of the residential care transition module. BMC Health Serv Res. 2025 Oct 27;25(1):1412. doi: 10.1186/s12913-025-13547-2.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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1511S80406
Identifier Type: -
Identifier Source: org_study_id
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