The Residential Care Transition Module (RCTM)
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT02915939 |
|
Recruitment Status :
Recruiting
First Posted : September 27, 2016
Last Update Posted : May 3, 2018
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Alzheimer Disease Dementia | Behavioral: The Residential Care Transition Module | Not Applicable |
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 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 |
| 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.
|
- 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
- Change in burden: Zarit Burden Interview [ Time Frame: 12 months ]A 7-item version of the Zarit Burden Interview
- Change in stress: Perceived Stress Scale [ Time Frame: 12 months ]The Perceived Stress Scale
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 21 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Family caregivers who consider themselves the most involved in visiting and providing assistance to relatives experiencing a long-stay admission to a nursing home or memory care assisted living unit
- 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
- Family caregivers of relatives who have received a physician's diagnosis of Alzheimer's disease or a related dementia (ADRD)
Exclusion Criteria:
- Family caregivers who are participating in any other type of service that provides one-to-one psychosocial consultation (support groups excluded)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02915939
| Contact: Joseph E. Gaugler, PhD | 612-626-2485 | gaug0015@umn.edu |
| United States, Minnesota | |
| University of Minnesota, School of Nursing, 6-153 Weaver-Densford Hall | Recruiting |
| Minneapolis, Minnesota, United States, 55455 | |
| Contact: Joseph E. Gaugler, PhD 612-626-2485 gaug0015@umn.edu | |
| Principal Investigator: | Joseph E. Gaugler, PhD | University of Minnesota - Clinical and Translational Science Institute |
Publications:
| Responsible Party: | University of Minnesota - Clinical and Translational Science Institute |
| ClinicalTrials.gov Identifier: | NCT02915939 History of Changes |
| Other Study ID Numbers: |
R01AG048931 ( U.S. NIH Grant/Contract ) |
| First Posted: | September 27, 2016 Key Record Dates |
| Last Update Posted: | May 3, 2018 |
| Last Verified: | April 2018 |
| 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 - Clinical and Translational Science Institute:
|
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 |