Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT03459118 |
Other study ID # |
122345 |
Secondary ID |
1R01NR015982-01A |
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
September 1, 2017 |
Est. completion date |
March 30, 2021 |
Study information
Verified date |
April 2021 |
Source |
University of Maryland, Baltimore |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
This study will evaluate pain, management of pain, behavioral symptoms, and the quality of
staff-resident interactions between residents with and without dementia, test the
relationship of these variables to participation in function focused care at baseline, and
consider if there is a differential impact of FFC-AL-EIT between those with and without
dementia with regard to participation in function focused care, functional outcomes and
physical activity over the 12 month study period. Findings from this study will provide new
information on how to optimize function and physical activity among older adults with
dementia in assisted living.
Description:
Estimates derived from National data indicate that seven out of ten residents in assisted
living have some form of dementia, with 29% having mild impairment, 23% with moderate
impairment, and 19% with severe impairment. More than one-third of these residents display
behavioral symptoms commonly associated with dementia, approximately 30-50% experience pain,
the majority require assistance with activities of daily living (ADLs) and instrumental
activities of daily living (IADLs), are sedentary and have limited opportunities to engage in
physical activity. Innovative approaches are needed to help residents with dementia remain in
assisted living settings. Typically, however, the care of older adults with dementia living
in assisted living settings has followed a "just get it done" approach. The focus of care is
on task completion and minimization of behavioral symptoms. This results in care that ignores
what the resident is able to do for him or herself and is custodial. Residents are not
encouraged to perform activities such as combing their own hair, brushing their teeth, or
ambulating. Providing custodial care facilitates a decline in physical capability and
function, causes medical complications, exacerbates depressive symptoms, increases the
likelihood of sustaining a fall and ultimately may result in a need to be transferred to
acute or skilled nursing care. To overcome custodial care we use an approach referred to as
Function Focused Care. Function Focused Care is a philosophy of care in which staff members
engage residents in physical activity at their highest level of ability during all care
interactions. Prior research has repeatedly supported the effectiveness of Function Focused
Care in terms of maintaining function and increasing time spent in physical activity among
older adults in assisted living settings. We do not know, however, if: (1) there is a
difference between those with and without dementia in pain, pain management, behavioral and
affective symptoms, or the quality of staff-resident interactions; (2) these factors are
associated with participation in function focused care activities at baseline; or (3) there
is a differential impact of the Function Focused Care for Assisted Living using the Evidence
Integration Triangle Intervention (FFC-AL-EIT) between those with and without dementia in
terms of participation in function focused care activities, function and physical activity
over the 12 month study period. To answer these questions we propose adding measures for
pain, behavioral and affective symptoms and quality of staff-resident interactions to Cohort
2 of the parent study, Testing the Dissemination and Implementation of Function Focused Care
(1R01AG050516-01A1). The findings from this study will add to what is currently known about
older adults with dementia in assisted living and will be used to revise the FFC-AL-EIT
intervention as needed to optimize participation in function focused care activities and
thereby maintain and improve function and physical activity among older adults with dementia
in assisted living.