Trials Sponsors Conditions Drugs Pricing

Conditions

Alzheimer Disease and Related Dementias

Keywords

DementiaCare InteractionsCommunicationAssisted LivingLong-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
+5 more secondary outcomes

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

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

PPCI-Staff Education Only (EO)Behavioral

Eligibility Criteria

Age65 Years+

Sexall

Healthy VolunteersNo

Age GroupsOlder 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

Sponsors & Collaborators

Penn State University
Otherlead

Study Sites (1)

The Pennsylvania State University

University Park, Pennsylvania, 16802, United States

MeSH Terms

Conditions

Alzheimer DiseaseDementiaCommunication

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental DisordersBehavior

Study Officials

Anju Paudel, Assistant Professor
Penn State University
PRINCIPAL INVESTIGATOR

Enrollment

130 participants (actual enrollment reported by the registry).

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

Actual (reported)

Promoting Positive Care Interactions (PPCI) in Assisted Living

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (10)

Other Outcomes (1)

Study Arms (2)

PPCI Arm

PPCI-Staff Education Only Arm

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (10)

Other Outcomes (1)

Study Arms (2)

PPCI Arm

PPCI-Staff Education Only Arm

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations