Ignite Creation Date:
2024-05-06 @ 9:08 AM
Last Modification Date:
2024-10-26 @ 12:10 PM
Study NCT ID:
NCT02915939
Status:
COMPLETED
Last Update Posted:
2022-08-03
First Post:
2016-09-19
Brief Title:
The Residential Care Transition Module
Sponsor:
University of Minnesota
Organization:
University of Minnesota
Study Overview
Official Title:
The Residential Care Transition Module
Status:
COMPLETED
Status Verified Date:
2022-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RCTM
Brief Summary:
Emerging research on family caregiving and institutionalization has emphasized that families do not disengage from care responsibilities following a relatives 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 relatives 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 Alzheimers 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None