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Clinical Trials/NCT03459118
NCT03459118
Completed
Not Applicable

The Impact of Dementia on Care and Outcomes Associated With a Function Focused Care Intervention Among Residents in Assisted Living Settings.

University of Maryland, Baltimore2 sites in 1 country853 target enrollmentSeptember 1, 2017
ConditionsDementiaPain

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Dementia
Sponsor
University of Maryland, Baltimore
Enrollment
853
Locations
2
Primary Endpoint
Cornell Scale for Depression in Dementia
Status
Completed
Last Updated
5 years ago

Overview

Brief 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.

Detailed 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.

Registry
clinicaltrials.gov
Start Date
September 1, 2017
End Date
March 30, 2021
Last Updated
5 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Barbara Resnick

Professor

University of Maryland, Baltimore

Eligibility Criteria

Inclusion Criteria

  • Residents are eligible to participate if: (1) they are living in a participating assisted living setting and are 65 years of age or older; (2) score at least a one out of three on the three out of three word recall question within the Minicog; and (3) are not enrolled in Hospice.

Exclusion Criteria

  • Residents will be excluded from the study if they are younger than 65 years of age and do not answer at least one out of three on the three out of three word recall question within the minicog.

Outcomes

Primary Outcomes

Cornell Scale for Depression in Dementia

Time Frame: baseline

a 19 item survey that assesses depressive symptoms

Quality of Interaction Scale

Time Frame: baseline

Observation scale of the positive and negative interactions between staff and residents

PAINAD

Time Frame: baseline

an observation measure of pain for individuals with cognitive impairment

The Barthel Index

Time Frame: baseline

A 10-item observation measure of basic activities of daily living

Function Focused Care Behavioral Checklist for Residents

Time Frame: baseline

a 19-item measure that addresses performance by the resident of function focused care

Resistiveness to Care

Time Frame: baseline

13 item Likert observation scale of resistiveness to care

Checklist for Evidence of Use of Function Focused Care in the Service Plan

Time Frame: baseline

Addresses four areas focused on function in the resident's care plan

Motionwatch 8

Time Frame: baseline

Actigraphy collected for a 5 day period with three full days of data used

Pain Verbal Descriptor Scale

Time Frame: baseline

Pain scale that allows respondent to state pain intensity and location

Study Sites (2)

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