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PPCI for Dementia (PPCI Trial)
N/A
Waitlist Available
Led By Anju Paudel, Assistant Professor
Research Sponsored by Penn State University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and 6 months
Awards & highlights
PPCI Trial Summary
This trial tests an approach to improve care interactions between staff and residents with dementia in assisted living facilities, to benefit both staff and residents.
Who is the study for?
This trial is for assisted living facilities with 20+ beds willing to partner in practice change, and their staff who speak English and work at least 16 hours weekly. It's also for residents aged 65+, diagnosed with Alzheimer's or dementia (ADRD), having specific scores on a mental status exam indicating ADRD.Check my eligibility
What is being tested?
The study tests the Promoting Positive Care Interactions (PPCI) program aiming to improve interactions between staff and residents with ADRD in assisted living. PPCI includes goal setting, assessing policies, flexible education for staff, plus ongoing mentorship through visits and texts.See study design
What are the potential side effects?
Since PPCI is a non-drug approach focusing on social interaction improvements rather than medication, it does not have traditional side effects like pharmaceutical interventions.
PPCI Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ six-months post intervention
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~six-months post intervention
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Interventional procedure
The degree to which the intervention is acceptable assessed by Acceptability of Intervention Measure (AIM) Questionnaire
Secondary outcome measures
Frequency and intensity of resistive behaviors assessed by Resistiveness to Care (RTC) Scale
Knowledge of person-centered behavioral approaches for managing behavioral symptoms of distress assessed by Knowledge of Person-Centered Behavioral Approaches for BPSD
Level of agitation assessed by Cohen-Mansfield Agitation Inventory (CMAI-short form)
+7 moreOther outcome measures
Cultural responsiveness assessed by a questionaire based on the ecological model (EM) domains: language, persons, metaphors, goals, content, concepts, methods, & context of PPCI
PPCI Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: PPCI ArmExperimental Treatment1 Intervention
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.
Group II: PPCI-Staff Education Only ArmActive Control1 Intervention
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.
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Who is running the clinical trial?
Penn State UniversityLead Sponsor
355 Previous Clinical Trials
125,637 Total Patients Enrolled
Anju Paudel, Assistant ProfessorPrincipal InvestigatorPenn State University
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I work at least 16 hours a week in nursing, activities, housekeeping, or dining services and can communicate in English.My care facility is large, has a leader for change, and is open to new practices.I am under 65, not living in a facility, and do not have a diagnosis or low SLUMS score indicating ADRD.My care facility is small and cannot or will not commit to new health initiatives.I work less than 16 hours a week or cannot communicate in English.I am 65 or older, live in a facility, and have a diagnosis of ADRD with a low SLUMS score.
Research Study Groups:
This trial has the following groups:- Group 1: PPCI-Staff Education Only Arm
- Group 2: PPCI Arm
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the main aim of this experimental research?
"The primary evaluation of this intervention, which will be conducted 6 months following administration is the Feasibility Intervention Measure (FIM) Questionnaire. Secondary outcomes that shall also be monitored include Cohen-Mansfield Agitation Inventory (CMAI), Quality of Life in Late-stage Dementia Scale (QUALID), and Positive Affect Index (PAI). All these metrics are scored on a range from 5 to 70 points; lower scores for CMAI and higher scores for QUALID & PAI denote better results."
Answered by AI
Are recruiting efforts for this clinical investigation currently underway?
"Unfortunately, the trial is not currently taking on new patients. Initially posted on February 1st 2023 and last revised November 8th 2022; however, there are 769 other medical studies actively searching for candidates in this moment."
Answered by AI
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