Positive Psychosocial Intervention for Dementia

(IPPI Trial)

No longer 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment called Individualized Positive Psychosocial Interaction (IPPI) for nursing home residents with dementia who also experience distress or depression. The researchers aim to determine the practicality of offering these interactions and tracking changes using health records. Residents will engage in two brief, enjoyable activities each week for six months. Ideal candidates are those who have lived in a nursing home long-term and exhibit signs of sadness or behavior issues, such as feeling down or refusing care. As an unphased trial, this study provides a unique opportunity to contribute to innovative care approaches for dementia.

Do I have to stop taking my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It focuses on psychosocial interventions, so it's likely you can continue your medications, but you should confirm with the trial organizers.

What prior data suggests that the Individualized Positive Psychosocial Interaction is safe for nursing home residents with dementia?

Research has shown that the Individualized Positive Psychosocial Interaction (IPPI) is a safe method with very low risk. Past studies found that the IPPI meets the needs and desires of people in nursing homes. It helps caregivers have positive interactions with residents who have dementia.

Evidence indicates that person-centered care methods, like the IPPI, can reduce negative symptoms such as agitation and depression. They also improve the overall quality of life for people with dementia. These findings suggest that the IPPI is a well-tolerated and low-risk way to enhance the well-being of dementia patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Positive Psychosocial Interaction for dementia because it offers a personalized approach that focuses on enhancing the well-being of individuals with dementia through positive engagement. Unlike standard treatments that often rely on medications like cholinesterase inhibitors or memantine to manage symptoms, this intervention centers around meaningful interactions tailored to the individual's preferences and routines. This approach is unique as it aims to improve the quality of life and emotional health of dementia patients by fostering positive experiences, which could potentially complement existing medical treatments and offer a more holistic care strategy.

What evidence suggests that the Individualized Positive Psychosocial Interaction is effective for dementia?

Research shows that the Individualized Positive Psychosocial Interaction (IPPI), which participants in this trial will receive, helps people with dementia in nursing homes. In earlier studies, residents who participated in IPPI felt happier, enjoyed themselves more, and were more alert. These studies also found that their distress decreased over time, especially after three and six months of the program. Additionally, 65% of nursing homes successfully used IPPI with residents who had moderate to severe dementia. These findings suggest that IPPI can improve the well-being and mood of residents with dementia. ^{3 6 7 8 9}

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12272948/

An Embedded Pragmatic Clinical Trial of the Individualized ... The IPPI program is an effective person-centered intervention for PLWD in nursing homes. It can be integrated into care and improve resident mood.

2. aging.ohio.gov aging.ohio.gov/agencies-and-service-providers/nursing-home-quality-improvement/Nursing+Home+Quality+Improvement+Current+Projects/IPPI-2021

Individualized Positive Psychosocial Intervention (IPPI) We found that nursing home residents receiving the IPPI intervention experienced higher well-being as evidenced by more pleasure, alertness, ...

3. tandfonline.com tandfonline.com/doi/full/10.1080/07317115.2024.2317403

Full article: Evaluating the Implementation of the ... Overall, 65% of NHs successfully implemented the IPPI QIP with people living with moderate to severe dementia. Clinical Implications. Given the ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1525861025002178

An Embedded Pragmatic Clinical Trial of the Individualized ... MDS 3.0 data were able to show change over time in symptoms of distress from baseline to 3 months and 6 months, with most improving during the intervention ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT05980299

Study Details | NCT05980299 | Testing the Feasibility of ... The primary outcome measure will consist of a single variable indicating improvement, no change, or worsening of a staff-targeted behavior of distress of each ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39262343/

"I think we just saw happier residents": nursing home ... Results illustrate that the IPPI program successfully aligns with stakeholder priorities, is a safe intervention with minimal risk, ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5322939/

Effectiveness of person-centered care on people with ... Person-centered care interventions were shown to reduce agitation, neuropsychiatric symptoms, and depression and to improve the quality of life.

8. sciencedirect.com sciencedirect.com/science/article/pii/S1041610224003193

The value of personalized psychosocial interventions to ... This updated systematic review will focus on studies reporting the effect of personalized psychosocial interventions on key BPSD in care homes.

9. alz-journals.onlinelibrary.wiley.com alz-journals.onlinelibrary.wiley.com/doi/full/10.1002/trc2.70024

Two new positive psychosocial measures for persons living ... People with dementia developed individualized coping strategies and adapted tasks and environments to facilitate success and build resilience.