Promoting Positive Care Interactions (PPCI) in Assisted Living

NCT05618834 | Completed DMC

• 1 other identifier: STUDY00021256
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

Brief Summary

The overall aim of this study is to pilot test Promoting Positive Care Interactions (PPCI) with the goal of establishing a feasible and culturally responsive approach to optimize care interactions between staff (nursing, activity, housekeeping, and dining service staff) and residents with ADRD in assisted living facilities (ALFs), and further improve select resident, staff, and facility outcomes. PPCI is a non- pharmacological four-step approach consisting of (1) stakeholder engagement in developing facility specific goals; (2) environment and policy assessments; (3) flexible staff education; and (4) ongoing mentorship, motivation, and support (in-person visits and text messages) for staff to optimize care interactions.

Conditions

Alzheimer Disease and Related Dementias

Keywords

Dementia; Care Interactions; Communication; Assisted Living; Long-Term Care

Outcome Measures

Primary Outcomes (2)

• The degree to which the intervention can be implemented as intended assessed by Feasibility of Intervention Measure (FIM) Questionnaire

  4 items answered on a 5-point ordinal scale ranging from 'completely disagree' to 'completely agree'; range = 4 to 20 and higher scores are better

  six-months post intervention

• The degree to which the intervention is acceptable assessed by Acceptability of Intervention Measure (AIM) Questionnaire

  4 items answered on a 5-point ordinal scale ranging from 'completely disagree' to 'completely agree'; range = 4 to 20 and higher scores are better

  six-months post intervention

Secondary Outcomes (10)

• Well-being assessed by Quality of Life in Late-stage Dementia (QUALID) Scale

  baseline and 6 months

• Level of agitation assessed by Cohen-Mansfield Agitation Inventory (CMAI-short form)

  baseline and 6 months

• Frequency and intensity of resistive behaviors assessed by Resistiveness to Care (RTC) Scale

  baseline and 6 months

• Knowledge of person-centered behavioral approaches for managing behavioral symptoms of distress assessed by Knowledge of Person-Centered Behavioral Approaches for BPSD

  baseline and 6 months

• Perceived competence in dementia care assessed by Sense of Competence in Dementia Care Staff (SCIDS)

  baseline and 6 months

Other Outcomes (1)

• Cultural responsiveness assessed by a questionaire based on the ecological model (EM) domains: language, persons, metaphors, goals, content, concepts, methods, & context of PPCI

  six-months post intervention

Study Arms (2)

PPCI Arm

EXPERIMENTAL

The ALF/PCH assigned as treatments will receive the four steps of PPCI including, stakeholder engagement and facility goal development, environment and policy assessment, staff education, and ongoing mentorship/motivation and support over a period of six-months by a research nurse facilitator (RNF), a registered nurse (RN) with prior experience in long-term care. The RNF will work with an identified internal/facility champion monthly to implement the four steps of PPCI.

Behavioral: Promoting Positive Care Interactions (PPCI)

PPCI-Staff Education Only Arm

ACTIVE COMPARATOR

The ALF/PCH assigned as controls will receive PPCI-staff education only (EO). The EO will include a 30-45 min in-service session and monthly f/u visits for booster education. The education content and process will be the same as outlined in Step 3 of the PPCI for treatment sites.

Behavioral: PPCI-Staff Education Only (EO)

Interventions

PPCI-Staff Education Only (EO) BEHAVIORAL

The EO will include a 30-45 min in-service session and monthly f/u visits for booster education. The education content and process will be the same as outlined in Step 3 of the PPCI for treatment sites.

PPCI-Staff Education Only Arm

Promoting Positive Care Interactions (PPCI) BEHAVIORAL

The PPCI consists of four steps: (1) stakeholder engagement in developing facility specific goals; (2) environment and policy assessments; (3) flexible staff education; and (4) ongoing mentorship, motivation, and support (in-person visits and text messages) for staff to optimize care interactions. A research nurse facilitator (RNF), a registered nurse (RN) with prior experience in long-term care will work with an identified internal champion monthly to implement the four steps of PPCI. The PPCI intervention comprehensively focuses on intrapersonal, interpersonal, organizational, and environmental/policy factors to bring together evidence and key stakeholders to optimize daily care interactions in assisted living.

PPCI Arm

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Assisted Living Facility (ALF) will be included in the study if they:
• have at least 20 or more beds
• are able to identify a facility champion, and
• express a willingness to actively partner in an initiative to change practice at their institution
• Staff will be included in the study if they:
• are able to communicate in English, and
• work at least 16 hours a week at the facility at the time of recruitment in nursing, activities, housekeeping, or dining service roles
• Residents will be included in the study if they:
• are 65 years old or greater
• are living at the facility at the time of recruitment, and
• have a diagnosis of ADRD and Saint Louis University Mental Status Exam (SLUMS) score of 20 or less (high school education)/ 19 or less (less than high school education) suggesting ADRD

You may not qualify if:

• Assisted Living Facility (ALF) will be excluded from the study if they:
• have less than 20 beds
• are unable to identify a facility champion, and
• do not express a willingness to actively partner in an initiative to change practice at their institution
• Staff will be included in the study if they:
• are unable to communicate in English, and
• work less than16 hours a week at the facility at the time of recruitment in nursing, activities, housekeeping, or dining service roles
• Residents will be included in the study if they:
• are less than 65 years old
• are not living at the facility at the time of recruitment, and
• do not have a diagnosis of ADRD and Saint Louis University Mental Status Exam (SLUMS) score of 20 or less (high school education)/ 19 or less (less than high school education) suggesting ADRD

Sponsors & Collaborators

• Penn State University: lead

Study Sites (1)

The Pennsylvania State University

University Park, Pennsylvania, 16802, United States

Location

MeSH Terms

Conditions

Alzheimer Disease; Dementia; Communication

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Behavior

Study Officials

• Anju Paudel, Assistant Professor

  Penn State University

  PRINCIPAL INVESTIGATOR

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: October 31, 2022
• First Posted: November 16, 2022
• Study Start: March 3, 2025
• Primary Completion: December 8, 2025
• Study Completion: March 11, 2026
• Last Updated: April 27, 2026

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)