The Residential Care Transition Module

Not Applicable

Completed

• Conditions: Alzheimer Disease; Dementia
• Interventions: Behavioral: The Residential Care Transition Module

• Registration Number: NCT02915939
• Lead Sponsor: University of Minnesota

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.

Study Timeline

• Study First Submitted: 2016-09-19
• Study First Submitted QC: 2016-09-26
• Study First Posted: 2016-09-27
• Study Start: 2016-12
• Primary Completion: 2021-05-14
• Study Completion: 2021-08-30
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-29
• Last Update Posted: 2022-08-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 240

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment Group	The Residential Care Transition Module	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.

Primary Outcome Measures

Name	Time	Method
Change in care-related strain	12 months	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
Change in burden: Zarit Burden Interview	12 months	A 7-item version of the Zarit Burden Interview
Change in stress: Perceived Stress Scale	12 months	The Perceived Stress Scale

Secondary Outcome Measures

Name	Time	Method
Quantitative measure of resilience to negative psychosocial effects of COVID-19	0, 1 and 4 months post-pandemic onset	Compare trajectories of caregiver stress and well-being across the treatment and control groups using quantitative (survey) data to determine whether the RCTM provides benefits in the context of COVID-19.
Qualitative measure of resilience to negative psychosocial effects of COVID-19	0, 1 and 4 months post-pandemic onset	Compare trajectories of caregiver stress and well-being across the treatment and control groups using qualitative (experiences) data to determine whether the RCTM provides benefits in the context of COVID-19.

Trial Locations

Locations (1)

University of Minnesota, School of Nursing, 6-153 Weaver-Densford Hall; 🇺🇸 Minneapolis, Minnesota, United States