Dissemination and Implementation of Function Focused Care for Assisted Living

NCT03459118 | Completed DMC

• 2 other identifiers: 1223451R01NR015982-01A1
• Study Type: interventional
• Target: 853
• Locations: 1 country
• Sites: 2

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.

Conditions

Dementia; Pain

Outcome Measures

Primary Outcomes (9)

• Pain Verbal Descriptor Scale

  Pain scale that allows respondent to state pain intensity and location

  baseline

• PAINAD

  an observation measure of pain for individuals with cognitive impairment

  baseline

• Cornell Scale for Depression in Dementia

  a 19 item survey that assesses depressive symptoms

  baseline

• Resistiveness to Care

  13 item Likert observation scale of resistiveness to care

  baseline

• Quality of Interaction Scale

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

  baseline

• 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

  baseline

• The Barthel Index

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

  baseline

• Motionwatch 8

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

  baseline

• Function Focused Care Behavioral Checklist for Residents

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

  baseline

Other Outcomes (1)

• The Saint Louis University Mental Status Examination (SLUMS)

  baseline

Study Arms (2)

Function Focused Care

EXPERIMENTAL

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.

Behavioral: Function Focused Care

Education Only

PLACEBO COMPARATOR

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

Behavioral: Function Focused Care

Interventions

Function Focused Care 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; Function Focused Care

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• University of Maryland, Baltimore: lead
• National Institute on Aging (NIA): collaborator
• National Institute of Nursing Research (NINR): collaborator

Study Sites (2)

University of Maryland

Baltimore, Maryland, 21201, United States

Location

Penn State University

State College, Pennsylvania, 16801, United States

Location

Related Publications (1)

• 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 Dec;44(12):1972-1980. doi: 10.1177/07334648251318783. Epub 2025 Feb 26.

  PMID: 40009165 DERIVED

MeSH Terms

Conditions

Dementia; Pain

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: February 24, 2018
• First Posted: March 8, 2018
• Study Start: September 1, 2017
• Primary Completion: March 30, 2021
• Study Completion: March 30, 2021
• Last Updated: April 13, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: At the end of the 5 year study period for the full parent study
• Access Criteria: Identification of the purpose for wanting the data

Locations

US (2)