Positive Psychosocial Intervention for Dementia

(IPPI Trial)

Recruiting at 6 trial locations

Overseen By Katherine Abbott, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Miami University

Disqualifiers: Community living less than 6 months

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

130 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The goal of this clinical trial is to test the feasibility of the Individualized Positive Psychosocial Interaction (IPPI) with 108 nursing home residents living with dementia and distress or depressive symptoms. The main questions it aims to answer are: •is it feasible to deliver the IPPI and track impact through data collected in the electronic medical records. Care partners will engage eligible residents in 2 brief preference-based IPPIs per week over the course of 6 months.

Who Is on the Research Team?

Katherine Abbott, PhD

Principal Investigator

Miami University

Are You a Good Fit for This Trial?

This trial is for long-term nursing home residents with dementia and signs of distress or depression. Participants must have a low mental status score (0-12 on BIMS) and show certain behaviors like aggression, rejection of care, or restlessness. It's not for those planning to leave the nursing home within six months.

Inclusion Criteria

Have a score of 0-12 on the Brief Inventory for Mental Status (BIMS)

Be a long-term resident in a nursing home

Either (could be both) on their most recent Minimum Data Set (MDS) 3.0 assessment A score of 1 or higher on any of the 5 behavior items from MDS Section E (i.e., physical, verbal, other behavior, rejection of care, wandering) A score of 1 or higher on one of 5 MDS section D items (i.e., anhedonia, sad mood, poor self-esteem, poor appetite, restlessness)

Exclusion Criteria

Nursing home residents who are expected to live in the community for less than 6 months

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Training

Care partners are trained to deliver the IPPI and complete online training

2 months

Online training sessions

Treatment

Care partners deliver 2 IPPI sessions per week to residents

6 months

Follow-up

Participants are monitored for changes in distress and depressive symptoms

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Individualized Positive Psychosocial Interaction

Trial Overview The study tests if it's possible to regularly provide Individualized Positive Psychosocial Interaction (IPPI) to these residents over six months, and if this can be tracked using electronic medical records. Care partners will conduct two tailored IPPI sessions weekly.

How Is the Trial Designed?

Group I: experimental Experimental Treatment 1 Intervention

The experimental arm involves a brief positive interaction around a preferred activity or personal care routine.

Who Is Running the Clinical Trial?

Miami University

Lead Sponsor

Trials

16

Recruited

3,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Penn State University

Collaborator

Trials

380

Recruited

131,000+

Virginia Polytechnic Institute and State University

Collaborator

Trials

162

Recruited

26,900+

United Church Homes

Collaborator

Trials

1

Recruited

130+