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Dissemination and Implementation of Function Focused Care for Assisted Living

Primary Purpose

Dementia, Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Function Focused Care
Sponsored by
University of Maryland, Baltimore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Dementia

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

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Sites / Locations

  • University of Maryland
  • Penn State University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Function Focused Care

Education Only

Arm Description

FFC-AL-EIT is implemented by a Research Nurse Facilitator working with the champion and stakeholders using our four step approach: (I) Environment and Policy Assessments; (II) Education; (III) Establishing Resident Function Focused Care Service Plans; and (IV) Mentoring and Motivating.

Education only sites are exposed to Step II of the Four step approach described under the treatment arm. They receive baseline education of staff.

Outcomes

Primary Outcome Measures

Pain Verbal Descriptor Scale
Pain scale that allows respondent to state pain intensity and location
PAINAD
an observation measure of pain for individuals with cognitive impairment
Cornell Scale for Depression in Dementia
a 19 item survey that assesses depressive symptoms
Resistiveness to Care
13 item Likert observation scale of resistiveness to care
Quality of Interaction Scale
Observation scale of the positive and negative interactions between staff and residents
Checklist for Evidence of Use of Function Focused Care in the Service Plan
Addresses four areas focused on function in the resident's care plan
The Barthel Index
A 10-item observation measure of basic activities of daily living
Motionwatch 8
Actigraphy collected for a 5 day period with three full days of data used
Function Focused Care Behavioral Checklist for Residents
a 19-item measure that addresses performance by the resident of function focused care

Secondary Outcome Measures

Full Information

First Posted
February 24, 2018
Last Updated
April 9, 2021
Sponsor
University of Maryland, Baltimore
Collaborators
National Institute on Aging (NIA), National Institute of Nursing Research (NINR)
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1. Study Identification

Unique Protocol Identification Number
NCT03459118
Brief Title
Dissemination and Implementation of Function Focused Care for Assisted Living
Official Title
The Impact of Dementia on Care and Outcomes Associated With a Function Focused Care Intervention Among Residents in Assisted Living Settings.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
September 1, 2017 (Actual)
Primary Completion Date
March 30, 2021 (Actual)
Study Completion Date
March 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Maryland, Baltimore
Collaborators
National Institute on Aging (NIA), National Institute of Nursing Research (NINR)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia, Pain

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
This is an intervention study testing Function Focused Care. The supplement, however, addresses a subsample of the population with dementia and explore the impact of pain on function and behavior and explores if this is a differential impact of the intervention between those with and without dementia. It is a descriptive study.
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
853 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Function Focused Care
Arm Type
Experimental
Arm Description
FFC-AL-EIT is implemented by a Research Nurse Facilitator working with the champion and stakeholders using our four step approach: (I) Environment and Policy Assessments; (II) Education; (III) Establishing Resident Function Focused Care Service Plans; and (IV) Mentoring and Motivating.
Arm Title
Education Only
Arm Type
Placebo Comparator
Arm Description
Education only sites are exposed to Step II of the Four step approach described under the treatment arm. They receive baseline education of staff.
Intervention Type
Behavioral
Intervention Name(s)
Function Focused Care
Intervention Description
The intervention in the parent study involves the use of a participatory implementation approach as delineated in the Evidence Integration Triangle. Prior to implementation, we meet with the administrator, service coordinator, delegating or oversight nurse or setting contact designee to identify the setting champion and stakeholder team members. In addition to the champion, we recommend the following individuals be included in the stakeholder team: an administrator in a leadership position (e.g. assisted living manager, delegating/overseeing nurse); a direct care worker; a family member; an activity staff member if available; and a resident. FFC-AL-EIT is implemented by a Research Nurse Facilitator working with the stakeholders using our four step approach: (I) Environment and Policy Assessments; (II) Education; (III) Establishing Resident Function Focused Care Service Plans; and (IV) Mentoring and Motivating.
Primary Outcome Measure Information:
Title
Pain Verbal Descriptor Scale
Description
Pain scale that allows respondent to state pain intensity and location
Time Frame
baseline
Title
PAINAD
Description
an observation measure of pain for individuals with cognitive impairment
Time Frame
baseline
Title
Cornell Scale for Depression in Dementia
Description
a 19 item survey that assesses depressive symptoms
Time Frame
baseline
Title
Resistiveness to Care
Description
13 item Likert observation scale of resistiveness to care
Time Frame
baseline
Title
Quality of Interaction Scale
Description
Observation scale of the positive and negative interactions between staff and residents
Time Frame
baseline
Title
Checklist for Evidence of Use of Function Focused Care in the Service Plan
Description
Addresses four areas focused on function in the resident's care plan
Time Frame
baseline
Title
The Barthel Index
Description
A 10-item observation measure of basic activities of daily living
Time Frame
baseline
Title
Motionwatch 8
Description
Actigraphy collected for a 5 day period with three full days of data used
Time Frame
baseline
Title
Function Focused Care Behavioral Checklist for Residents
Description
a 19-item measure that addresses performance by the resident of function focused care
Time Frame
baseline
Other Pre-specified Outcome Measures:
Title
The Saint Louis University Mental Status Examination (SLUMS)
Description
a measure of cognitive ability
Time Frame
baseline

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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. -
Facility Information:
Facility Name
University of Maryland
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Penn State University
City
State College
State/Province
Pennsylvania
ZIP/Postal Code
16801
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
will share data based on request and following the development of a IPD sharing plan with the IRB.
IPD Sharing Time Frame
At the end of the 5 year study period for the full parent study
IPD Sharing Access Criteria
Identification of the purpose for wanting the data

Learn more about this trial

Dissemination and Implementation of Function Focused Care for Assisted Living

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