The Residential Care Transition Module (RCTM)

• ClinicalTrials.gov Identifier: NCT02915939
• Recruitment Status: Active, not recruiting
• First Posted: September 27, 2016
• Last Update Posted: April 24, 2020
• Sponsor: University of Minnesota
• Collaborators: Johns Hopkins University; NYU Langone Health; Benjamin Rose Institute; Emory University
• Information provided by (Responsible Party): University of Minnesota

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Alzheimer Disease; Dementia	Behavioral: The Residential Care Transition Module	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 240 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Supportive Care
• Official Title: The Residential Care Transition Module
• Actual Study Start Date: December 2016
• Estimated Primary Completion Date: May 2021
• Estimated Study Completion Date: May 2021

Arms and Interventions

Arm	Intervention/treatment
Experimental: 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.	Behavioral: 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.
No Intervention: 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.

Outcome Measures

Primary Outcome Measures :

1. Change in care-related strain [ Time Frame: 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
2. Change in burden: Zarit Burden Interview [ Time Frame: 12 months ]
   A 7-item version of the Zarit Burden Interview
3. Change in stress: Perceived Stress Scale [ Time Frame: 12 months ]
   The Perceived Stress Scale

Eligibility Criteria

• Ages Eligible for Study: 21 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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)

Contacts and Locations

Locations

United States, Minnesota

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

Minneapolis, Minnesota, United States, 55455

Sponsors and Collaborators

University of Minnesota

Johns Hopkins University

NYU Langone Health

Benjamin Rose Institute

Emory University

Investigators

• Principal Investigator: Joseph E. Gaugler, PhD; University of Minnesota

More Information

Publications:

Gaugler JE, Reese M, Sauld J. A Pilot Evaluation of Psychosocial Support for Family Caregivers of Relatives with Dementia in Long-Term Care: The Residential Care Transition Module. Res Gerontol Nurs. 2015 Jul-Aug;8(4):161-72. doi: 10.3928/19404921-20150304-01. Epub 2015 Mar 10.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: University of Minnesota
• ClinicalTrials.gov Identifier: NCT02915939
• Other Study ID Numbers: 1511S80406
• First Posted: September 27, 2016
• Last Update Posted: April 24, 2020
• Last Verified: April 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: Public access to the research data generated from this study will be offered via de-identified data files maintained by the Principal Investigator, Dr. Gaugler. All personal identifiers of family caregivers of persons with Alzheimer's disease or a related dementia (ADRD) participating in the study will be removed and replaced with random identification numbers prior to distributing WinZip data files. Dr. Gaugler plans to keep all data from the proposed 5-year project on the secure School of Nursing shared server folder for at least 7 years following study completion. Potential external investigators will be asked to complete a data user agreement. Dr. Gaugler will oversee the distribution of public data during the course of the funding period and for an indefinite time thereafter.

Keywords provided by University of Minnesota:

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

Additional relevant MeSH terms:

Alzheimer Disease; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders