NCT07378800

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
25mo left

Started Feb 2026

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress19%
Feb 2026Aug 2028

First Submitted

Initial submission to the registry

January 22, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 30, 2026

Completed
6 days until next milestone

Study Start

First participant enrolled

February 5, 2026

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2028

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2028

Last Updated

July 28, 2026

Status Verified

July 1, 2026

Enrollment Period

2.2 years

First QC Date

January 22, 2026

Last Update Submit

July 27, 2026

Conditions

Keywords

positive care interactions

Outcome Measures

Primary Outcomes (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.

    Baseline, 4 months, 6 months

Secondary Outcomes (3)

  • Neuropsychiatric Inventory Questionnaire

    Baseline, 4 months, 6 months

  • Resistiveness to Care Scale

    Baseline, 4 months, 6 months

  • Resident Engagement with Staff During Care Interactions

    Baseline, 4 months, 6 months

Study Arms (2)

FPCI-AL

EXPERIMENTAL

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.

Behavioral: FPCI-AL

Education Only (EO)

ACTIVE COMPARATOR

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.

Behavioral: Education Only (EO)

Interventions

FPCI-ALBEHAVIORAL

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.

FPCI-AL

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.

Education Only (EO)

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Admitted to the assisted living for short term care

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Lorien Harmony Hall

Columbia, Maryland, 21044, United States

Location

Lorien Taneytown

Taneytown, Maryland, 21787, United States

Location

MeSH Terms

Conditions

Dementia

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

January 22, 2026

First Posted

January 30, 2026

Study Start

February 5, 2026

Primary Completion (Estimated)

March 31, 2028

Study Completion (Estimated)

August 31, 2028

Last Updated

July 28, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations