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DementiaNCT07378800

Fostering Positive Care Interactions in Assisted Living

A study testing FPCI-AL and Education Only (EO) in people with Dementia, run by University of Maryland, Baltimore at 3 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The purpose of this study is to improve the quality of staff-resident care interactions particularly among residents living with Alzheimer's disease or related dementias (ADRD ) by testing the Fostering Positive Care Interactions in Assisted Living (FPCI-AL) intervention. Read more about this study

Who is it for?
Ages 55 years and older
Conditions the study is for
Dementia
What is being tested?
FPCI-AL and Education Only (EO)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
3 sitesUnited States
Study dates
5 Feb 2026to 31 Aug 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

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 55 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 55 years of age or older
  • currently residing in a participating community
  • Evidence of ADRD based on a score ≤20 on the Saint Louis University Mental Status Examination

Who cannot join

  • Admitted to the assisted living for short term care

Trial locations and contacts

3 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Rachel McPherson, PhD, MA contact

410-706-3689

rachelmcpherson@umaryland.edu

United States3 sites, 1 recruiting
  • Lorien Harmony Hall

    Columbia, Maryland, 21044

    Active, not recruiting
  • Caraway Assisted Living

    Elkton, Maryland, 21921

    Heather Zeiss, 410-392-4455, hzeiss@carawayassistedliving.com

    Recruiting
  • Lorien Taneytown

    Taneytown, Maryland, 21787

    Active, not recruiting

Other trials in United States

About this study

The purpose of this study is to improve the quality of staff-resident care interactions particularly among residents living with Alzheimer's disease or related dementias (ADRD ) by testing the Fostering Positive Care Interactions in Assisted Living (FPCI-AL) intervention. This study will be a critical first step in determining the sample size needed to test the efficacy of a practical approach to improving the quality of care interactions for assisted living residents living with ADRD, ultimately enhancing behavioral outcomes such as decreasing behavioral symptoms of distress, reducing resistiveness to care, and optimizing engagement in care tasks.

Read the detailed description

Staff-resident care interactions are integral to effective care provision in assisted living communities, and especially critical for residents living Alzheimer's disease or related dementias (ADRD). The purpose of this study is to improve the quality of staff-resident care interactions particularly among residents living with ADRD by testing the Fostering Positive Care Interactions in Assisted Living (FPCI-AL) intervention. This 6 month intervention uses a four-step, theoretically based approach implemented by a research facilitator to change how staff provide care to residents living with ADRD. The research facilitator will work with a community-based stakeholder team and identified champion to implement the following four-step approach: 1) assessments of the environment and policy to facilitate positive interactions; (2) educating staff on fostering positive interactions; (3) establishing individualized positive care interaction approaches for residents and incorporating them into resident service plans; and (4) providing ongoing mentoring, motivating, and role modeling for staff to reinforce positive care interactions. Therefore, the aims of this study are to: Aim 1: Establish the feasibility of the FPCI-AL based on delivery, receipt and enactment of study activities; and establish acceptability of the FPCI-AL; Aim 2: Evaluate the preliminary efficacy of the FPCI-AL on the quality of care interactions received by residents living with ADRD; and Aim 3: Evaluate the preliminary efficacy of the FPCI-AL on behavioral symptoms of distress, resistiveness to care, and resident engagement with staff during care interactions. The investigators will use a cluster randomized controlled trial with a repeated measures design to test the feasibility and preliminary efficacy of the FPCI-AL. This study will include four assisted living communities, and a convenience sample of 25 residents per community (N = 100) will be recruited. Residents will be eligible to participate if they: (a) are 55 years of age or older; (b) are currently residing in a participating community; and (c) have evidence of ADRD based on a score ≤20 on the Saint Louis University Mental Status Examination. Residents will be excluded if they are admitted to the assisted living for short term care. The research facilitator will implement the four intervention steps over 6 months. Communities randomized to Education Only will receive education consistent with step two of the FPCI-AL. All community and resident data will be obtained by a trained research evaluator and will be measured at baseline, 4 months, and 6 months post-intervention. This study will be a critical first step in determining the sample size needed to test the efficacy of a practical approach to improving the quality of care interactions for assisted living residents living with ADRD, ultimately enhancing behavioral outcomes such as decreasing behavioral symptoms of distress, reducing resistiveness to care, and optimizing engagement in care tasks.

Conditions
Dementia
Being tested
FPCI-AL, Education Only (EO)
Keywords
positive care interactions
Medical subject headings
Dementia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FPCI-ALBehavioural

    Following randomization, champions and stakeholder team members from the communities will be identified. The investigators will recommend the following individuals to be members of the stakeholder team: assisted living administrator, nurse manager, nursing assistant, and activity and rehabilitation staff as available.

    Following the initial team meeting, the research facilitator will work with each treatment assisted living community for eight hours weekly during months one and two, and then for four hours weekly for the remaining four months using a face-to-face approach to implement the four components of the FPCI-AL.

  • Education Only (EO)Behavioural

    Communities randomized to education only will receive the same education as provided in FPCI-AL step two via an established PowerPoint. Delivery format will match community preferences (e.g., online or in-person) for pragmatic reasons and to facilitate the education process.

Study groups in NCT07378800
Study groupRoleWhat they receive
FPCI-ALExperimentalThe FPCI-AL is implemented using a research facilitator working with a community-based champion and stakeholder group to provide the following four-steps: (1) assessments of the environment and policy to facilitate positive interactions; (2) educating staff on fostering positive interactions; (3) establishing individualized positive care interaction approaches for residents and incorporating them into resident service plans; and (4) providing ongoing mentoring, motivating, and role modeling for staff to reinforce positive care interactions.
Receives: Behavioral: FPCI-AL
Education Only (EO)Active comparatorCommunities randomized to education only will receive the same education as provided in FPCI-AL step two via an established PowerPoint. Delivery format will match community preferences (e.g., online or in-person) for pragmatic reasons and to facilitate the education process.
Receives: Behavioral: Education Only (EO)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Modified Quality of Interactions Scale

    Quality of care interactions will be measured using the Modified Quality of Interactions Scale, an observational tool that measures interaction characteristics and quality using a quantified scoring system. It records the care interaction location, type of care activity, and type of care provider in care (e.g., nurse). The total score ranges from 0 to 7, with higher scores indicating better, more positive interactions.

    Measured: Baseline, 4 months, 6 months

Secondary outcomes (3)
  1. Neuropsychiatric Inventory Questionnaire

    The Neuropsychiatric Inventory Questionnaire (NPI-Q) assesses the presence, severity, and impact on caregivers of 12 behavioral symptoms of distress (e.g., delusions, hallucinations, anxiety). For the purposes of this study only the presence of behavior will be considered. The total score ranges from 0 to 12, with higher numbers indicating more behavioral symptoms of distress.

    Measured: Baseline, 4 months, 6 months

  2. Resistiveness to Care Scale

    Resistiveness to care will be assessed during care interactions using the Resistiveness to Care Scale, which measures the frequency of 16 resistive behaviors (e.g., kicking, hitting). The total score ranges from 0 to 16, with higher scores indicating more resistiveness to care behaviors.

    Measured: Baseline, 4 months, 6 months

  3. Resident Engagement with Staff During Care Interactions

    The Modified Quality of Interaction Scale item, "What is the level of resident engagement?", will be used during assessments of staff-resident care interactions to record resident engagement as active, passive, or restrictive.

    Measured: Baseline, 4 months, 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jan 2026
  2. Study start5 Feb 2026
  3. Primary completion31 Mar 2028 (estimated)
  4. Study completion31 Aug 2028 (estimated)

Resources

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
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07378800
Sponsor's protocol ID
AARG-25-1481519
Status last verified
Oct 2026
First submitted
22 Jan 2026
Last updated
9 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing FPCI-AL and Education Only (EO) in people with Dementia, run by University of Maryland, Baltimore at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 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. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Rachel McPherson, PhD, MA (410-706-3689, rachelmcpherson@umaryland.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Modified Quality of Interactions Scale (time frame: Baseline, 4 months, 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 9 Oct 2026.

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