Recruiting

FPCI-AL

Sponsor:

University of Maryland, Baltimore

Code:

NCT07378800

Conditions

Dementia

Eligibility Criteria

Sex: All

Age: 55+

Healthy Volunteers: Not accepted

Interventions

FPCI-AL

Education Only (EO)

Study Details

Brief 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. 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

Study ID

NCT07378800

Start date

Feb 5, 2026

Status verified date

Oct, 2026

Completion date

Aug 31, 2028

Anticipated

Primary completion date

Mar 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 55+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Admitted to the assisted living for short term care

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: FPCI-AL

The 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.

active comparator: Education Only (EO)

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.

Interventions

FPCI-AL

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)

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.

Primary outcome measure

  • Modified Quality of Interactions Scale [ Time Frame: Baseline, 4 months, 6 months ]

Central Contacts and Locations

Central contacts

Rachel McPherson, PhD, MA

410-706-3689rachelmcpherson@umaryland.edu

Locations

Caraway Assisted Living

Recruiting

Elkton, Maryland, United States, 21921

Contacts

Heather Zeiss

410-392-4455hzeiss@carawayassistedliving.com

More Information

Sponsor

University of Maryland, Baltimore

Last update posted

Oct 9, 2026

Last verified

Oct, 2026

Keywords

  • positive care interactions

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-10. This information was provided to ClinicalTrials.gov by University of Maryland, Baltimore on 2026-10-09. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.