Dissemination and Implementation of Function Focused Care for Assisted Living

April 9, 2021 updated by: Barbara Resnick, University of Maryland, Baltimore

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
853

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • University of Maryland
    • Pennsylvania
      • State College, Pennsylvania, United States, 16801
        • Penn State University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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.
Behavioral: 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.
Placebo Comparator: 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.
Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Pain Verbal Descriptor Scale
Time Frame: baseline
Pain scale that allows respondent to state pain intensity and location
baseline
PAINAD
Time Frame: baseline
an observation measure of pain for individuals with cognitive impairment
baseline
Cornell Scale for Depression in Dementia
Time Frame: baseline
a 19 item survey that assesses depressive symptoms
baseline
Resistiveness to Care
Time Frame: baseline
13 item Likert observation scale of resistiveness to care
baseline
Quality of Interaction Scale
Time Frame: baseline
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
Time Frame: baseline
Addresses four areas focused on function in the resident's care plan
baseline
The Barthel Index
Time Frame: baseline
A 10-item observation measure of basic activities of daily living
baseline
Motionwatch 8
Time Frame: baseline
Actigraphy collected for a 5 day period with three full days of data used
baseline
Function Focused Care Behavioral Checklist for Residents
Time Frame: baseline
a 19-item measure that addresses performance by the resident of function focused care
baseline

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The Saint Louis University Mental Status Examination (SLUMS)
Time Frame: baseline
a measure of cognitive ability
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Maryland, Baltimore

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of Nursing Research (NINR)
National Institute on Aging (NIA)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 30, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 30, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 24, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 1, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 8, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 13, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 9, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 122345
  • 1R01NR015982-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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