The Residential Care Transition Module

NCT02915939 | Completed

• 1 other identifier: 1511S80406
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (3)

• Change in care-related strain

  A 7-item measure of care-related strain that assesses the stress family caregivers perceive as a result of having a relative in residential care

  12 months

• Change in burden: Zarit Burden Interview

  A 7-item version of the Zarit Burden Interview

  12 months

• Change in stress: Perceived Stress Scale

  The Perceived Stress Scale

  12 months

Secondary Outcomes (2)

• Quantitative measure of resilience to negative psychosocial effects of COVID-19

  0, 1 and 4 months post-pandemic onset

• Qualitative measure of resilience to negative psychosocial effects of COVID-19

  0, 1 and 4 months post-pandemic onset

Study Arms (2)

Treatment Group

EXPERIMENTAL

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.

Behavioral: The Residential Care Transition Module

Usual Care Group

NO INTERVENTION

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.

Interventions

The Residential Care Transition Module BEHAVIORAL

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.

Treatment Group

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Minnesota: lead
• Johns Hopkins University: collaborator
• NYU Langone Health: collaborator
• Benjamin Rose Institute: collaborator
• Emory University: collaborator

Study Sites (1)

University of Minnesota, School of Nursing, 6-153 Weaver-Densford Hall

Minneapolis, Minnesota, 55455, United States

Location

Related Publications (5)

• 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.

  PMID: 32990494 BACKGROUND

• 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.

  PMID: 32293314 BACKGROUND

• 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.

  PMID: 34929196 BACKGROUND

• 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.

  PMID: 34973167 BACKGROUND

• 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.

  PMID: 41146257 DERIVED

MeSH Terms

Conditions

Alzheimer Disease; Dementia; COVID-19

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Joseph E. Gaugler, PhD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: September 19, 2016
• First Posted: September 27, 2016
• Study Start: December 1, 2016
• Primary Completion: May 14, 2021
• Study Completion: August 30, 2021
• Last Updated: August 3, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP

Locations

US (1)