What side effects are associated with this type of intervention?

Non-pharmacological interventions like those in the PPCI trial, which focus on stakeholder engagement, environment and policy assessments, staff education, and ongoing support, generally do not have physical side effects. However, they can present implementation challenges such as resistance to change from staff, the need for continuous training and support, potential initial increases in workload, and the requirement for sustained commitment from all stakeholders. These challenges can impact the effectiveness and sustainability of the interventions if not properly managed.

What prior FDA approvals exist?

There are no specific FDA approvals for non-pharmacological treatments like the Promoting Positive Care Interactions (PPCI) approach, which focuses on optimizing care interactions through stakeholder engagement, environment and policy assessments, staff education, and ongoing support. Most FDA approvals are for pharmacological treatments. However, non-pharmacological interventions such as behavioral management, staff training, and supportive care strategies are widely recognized and recommended in clinical practice for improving caregiver interactions and patient outcomes.

What other types of research exist?

Promising, novel alternatives to PPCI for optimizing care interactions in 2024 include: 1) Integrating technology-based solutions such as telehealth and mobile health applications to provide real-time support and education to caregivers. 2) Implementing virtual reality (VR) training programs for caregivers to simulate real-life scenarios and improve their skills in a controlled environment. 3) Utilizing artificial intelligence (AI) to personalize care plans and provide predictive analytics for better decision-making. 4) Adopting community-based participatory research (CBPR) approaches to involve caregivers and patients in the development and evaluation of care interventions. 5) Enhancing interdisciplinary team-based care models that include regular feedback loops and continuous professional development for caregivers.

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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

No Placebo-Only Group

Summary

This trial tests a program called Promoting Positive Care Interactions (PPCI) to improve how staff in assisted living facilities interact with residents who have dementia. The program includes setting goals, assessing the environment, educating staff, and providing ongoing support. It aims to replace negative interactions with positive ones, benefiting both residents and staff.

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.

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.

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline and 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Interventional procedure

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

Secondary study objectives

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 more

Other study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Non-pharmacological treatments for caregivers, such as those studied in the Promoting Positive Care Interactions (PPCI) trial, focus on improving care interactions through stakeholder engagement, environment and policy assessments, staff education, and ongoing support. These approaches aim to create a supportive and well-informed caregiving environment, which can reduce caregiver stress, improve job satisfaction, and enhance the overall well-being of both caregivers and patients. By addressing these factors, caregivers are better equipped to provide high-quality care, leading to improved outcomes for patients.

Open science in dementia care embedded pragmatic clinical trials.Revealing hidden depression in older people: a qualitative study within a randomised controlled trial.PerCEN: a cluster randomized controlled trial of person-centered residential care and environment for people with dementia.