DementiaNCT03459118
Dissemination and Implementation of Function Focused Care for Assisted Living
A study testing Function Focused Care in people with Dementia and Pain, run by University of Maryland, Baltimore at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Any age
- What is being tested?
- Function Focused Care
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 853 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Sep 2017to 30 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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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Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Maryland
Baltimore, Maryland, 21201
Penn State University
State College, Pennsylvania, 16801
About this study
Official title: 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.
Read the 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.
- Being tested
- Function Focused Care
- Medical subject headings
- Dementia, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Function Focused CareBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Function Focused Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Verbal Descriptor Scale
Pain scale that allows respondent to state pain intensity and location
Measured: baseline
PAINAD
an observation measure of pain for individuals with cognitive impairment
Measured: baseline
Cornell Scale for Depression in Dementia
a 19 item survey that assesses depressive symptoms
Measured: baseline
Resistiveness to Care
13 item Likert observation scale of resistiveness to care
Measured: baseline
Quality of Interaction Scale
Observation scale of the positive and negative interactions between staff and residents
Measured: 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
Measured: baseline
The Barthel Index
A 10-item observation measure of basic activities of daily living
Measured: baseline
Motionwatch 8
Actigraphy collected for a 5 day period with three full days of data used
Measured: baseline
Function Focused Care Behavioral Checklist for Residents
a 19-item measure that addresses performance by the resident of function focused care
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2018
- Study start1 Sep 2017
- Primary completion30 Mar 2021
- Study completion30 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DementiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 853 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA), National Institute of Nursing Research (NINR)
- Responsible party
- Principal investigator, Barbara Resnick, University of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03459118
- Sponsor's protocol ID
- 122345
- Other IDs
- 1R01NR015982-01A1
- Status last verified
- Apr 2021
- First submitted
- 24 Feb 2018
- Last updated
- 13 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: will share data based on request and following the development of a IPD sharing plan with the IRB.
Publications
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.
PubMed 40009165
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Dementia on Care and Outcomes Associated With a Function Focused Care Intervention Among Residents in Assisted Living Settings.
- ClinicalTrials.gov ID
- NCT03459118
- Acronym / sponsor ID
- 122345
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 853 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA), National Institute of Nursing Research (NINR)
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 30 Mar 2021 (actual)
- Study completion
- 30 Mar 2021 (actual)
- First posted
- 8 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Function Focused Care | Experimental | Behavioral: Function Focused CareFFC-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 | Placebo comparator | Behavioral: Function Focused CareEducation only sites are exposed to Step II of the Four step approach described under the treatment arm. They receive baseline education of staff. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Function Focused CareThe 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. | Behavioural | Education Only, Function Focused Care |
Primary outcome
Pain Verbal Descriptor Scale
Time frame: baseline
Pain scale that allows respondent to state pain intensity and location
PAINAD
Time frame: baseline
an observation measure of pain for individuals with cognitive impairment
Cornell Scale for Depression in Dementia
Time frame: baseline
a 19 item survey that assesses depressive symptoms
Resistiveness to Care
Time frame: baseline
13 item Likert observation scale of resistiveness to care
Quality of Interaction Scale
Time frame: baseline
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
Time frame: baseline
Addresses four areas focused on function in the resident's care plan
The Barthel Index
Time frame: baseline
A 10-item observation measure of basic activities of daily living
Motionwatch 8
Time frame: baseline
Actigraphy collected for a 5 day period with three full days of data used
Function Focused Care Behavioral Checklist for Residents
Time frame: baseline
a 19-item measure that addresses performance by the resident of function focused care
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2021.
- Derived from this study: PubMed 40009165McPherson 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.
- Individual participant dataSharing planned: Yes. will share data based on request and following the development of a IPD sharing plan with the IRB.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Function Focused Care in people with Dementia and Pain, run by University of Maryland, Baltimore at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Verbal Descriptor Scale (time frame: baseline). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03459118, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2021; AzTrials last refreshed its copy on 1 Nov 2026.