Dissemination and Implementation of Function Focused Care for Assisted Living

NCT ID: NCT03459118

Last Updated: 2021-04-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

853 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-01

Study Completion Date

2021-03-30

Brief Summary

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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

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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.

Conditions

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Dementia Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

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.
Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Function Focused Care

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.

Group Type EXPERIMENTAL

Function Focused Care

Intervention Type BEHAVIORAL

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.

Education Only

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

Group Type PLACEBO_COMPARATOR

Function Focused Care

Intervention Type BEHAVIORAL

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.

Interventions

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Function Focused Care

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Exclusion Criteria

\-
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Aging (NIA)

NIH

Sponsor Role collaborator

National Institute of Nursing Research (NINR)

NIH

Sponsor Role collaborator

University of Maryland, Baltimore

OTHER

Sponsor Role lead

Responsible Party

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Barbara Resnick

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Maryland

Baltimore, Maryland, United States

Site Status

Penn State University

State College, Pennsylvania, United States

Site Status

Countries

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United States

References

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McPherson R, Resnick B, Galik E, Gruber-Baldini AL, Holmes S, Kusmaul N. Considerations for Use of the Cornell Scale for Depression in Dementia Among Assisted Living Residents: Factor Analysis Results. J Appl Gerontol. 2025 Feb 26:7334648251318783. doi: 10.1177/07334648251318783. Online ahead of print.

Reference Type DERIVED
PMID: 40009165 (View on PubMed)

Other Identifiers

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1R01NR015982-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

122345

Identifier Type: -

Identifier Source: org_study_id

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