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| ID | Type | Description | Link |
|---|---|---|---|
| U54AG063546 | U.S. NIH Grant/Contract | View source | |
| 403853 | Other Identifier | Miami University Index |
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| Name | Class |
|---|---|
| United Church Homes | UNKNOWN |
| Penn State University | OTHER |
| Virginia Polytechnic Institute and State University | OTHER |
| National Institute on Aging (NIA) |
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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.
Specific Aims. Psychological and behavioral symptoms of distress (BPSD) expressed by people living with dementia (PLWD) are challenging to respond to in nursing home (NH) care. Experienced by 78% of PLWD, BPSD can include wandering, persistent vocalizations, and resistance or refusal of care.1 In addition, 30% of NH residents experience depressive symptoms2 and among those with depressive symptoms, 47% also have dementia.3 Together, these conditions will be referred to as distress throughout this proposal. Without appropriate guidance or training, care partners (e.g., Certified Nursing Assistants) struggle to prevent or positively remediate distress experienced by PLWD. The Individualized Positive Psychosocial Intervention (IPPI) is an evidence-based program designed to support care partners in engaging PLWD with brief (i.e.,10 minute) one-to-one preference-based activities. IPPI is designed to enhance well-being and reduce negative emotional and behavioral responses using non-pharmacological approaches that align care with residents' preferences recorded in Section F of the MDS (e.g., choose what clothes to wear). Specifically, in our IPPI randomized controlled trial (RCT) effectiveness trial,4 NH residents receiving the IPPI program delivered by care partners experienced more pleasure, alertness, engagement, and positive verbal behavior compared with the usual care group.
Our goal with this proposal is to partner with United Church Homes (UCH), a 106-year-old nonprofit national senior living provider to conduct a full implementation feasibility pilot of the IPPI program with long-stay residents in 9 of their NHs. Our objective is to conduct a pilot study to evaluate 1) the ability of staff to identify residents who are optimal for the IPPI, 2) implementation of IPPI, and 3) the impact on pragmatic clinical outcome measures (BPSD and depressive symptoms). Staff champions will be identified by the stakeholder team in each NH (e.g., Director of Nursing, Activity Professional) and trained to identify residents optimal for the IPPI (i.e., experiencing cognitive impairment (Minimum Data Set (MDS) Brief Inventory for Mental Status (BIMS) score 0-12) as well as documentation (MDS Section E or D) of distress within the past 3-months. Distress is indicated by a 1 or higher on any of the 5 behavior items from MDS Section E (i.e., physical, verbal, other behavior, rejection of care, wandering) and/or 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).
Care partners of identified residents will be invited to be trained to deliver IPPI. The investigators anticipate that each NH will initiate engagement with 4-5 residents per month for each of 3 consecutive months (12-15 residents per NH) in addition to 3-4 care partners who will deliver the IPPI. Resident initiation in the program will occur on a rolling basis (i.e., initiating intervention activities for a given resident when he/she is due for a routine quarterly care plan review). Each selected resident will then receive 2 IPPI sessions per week for 6 months. The project seeks to achieve the following specific aims:
Aim 1. To conduct a pilot embedded Pragmatic Clinical Trial (ePCT) to evaluate and establish the feasibility of implementing the IPPI program in 9 NHs among 108-135 residents. Quantitative implementation endpoints indicating success include (a) that staff in each community will be able to identify and engage 12-15 residents experiencing both dementia (e.g., BIMS 0-12) and distress (either BPSD or depressive symptoms) within the past 2 weeks, measured by a count of participants; (b) that all the implementation team members (champions and care partners) can complete the online training within the first two months of initiating implementation, as indicated by the learning management system; (c) that the implementation team will be able to (i) review existing data from Section F of the MDS for all selected residents; (ii) identify a match between a resident's important preferences and 1-2 IPPI protocols; (iii) identify a targeted expression of distress as measured by documentation in the electronic medical record; and (d) that staff can conduct at least 2 ten-minute sessions per week, per targeted resident with fidelity over the course of 6 months as measured in the electronic medial record (EMR). Qualitative data to evaluate implementation will be ascertained from semi-structured interviews with implementation team members in each community to assess acceptability, feasibility, and appropriateness as well as facilitators and barriers to fidelity of the IPPI sessions.
Aim 2. To establish the feasibility of tracking intervention impact on a primary clinical outcome of a targeted behavior (identified by staff) through the MDS Section E (E0200A, B or C; or E0800) or MDS Section D (Patient Health Questionnaire (PHQ-9) items of anhedonia, sad mood, poor self-esteem, poor appetite, or restlessness). 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 resident receiving the intervention, tracked pre- and post-IPPI intervention using routinely collected data in the EMR. Secondary staff outcomes will include knowledge of emotion-focused communication and staff reported self-efficacy in applying the communication skills.
IMPACT: The IPPI program teaches care partners strategies to better identify and manage their own feelings and those of PLWD through our emotion-focused communication course. In addition, the program provides highly structured and feasible protocols to guide short but impactful interactions with PLWD designed to prevent and remediate distress (i.e., BPSD and symptoms of depression). Findings from this pilot study will guide the implementation, approach, and power needed for a full-scale Stage IV effectiveness ePCT study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| experimental | Experimental | The experimental arm involves a brief positive interaction around a preferred activity or personal care routine. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Individualized Positive Psychosocial Interaction | Behavioral | The intervention involves a brief positive interaction around a preferred activity or personal care routine. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Physical Behavioral Symptoms Directed Toward Others | The investigators are using a person-centered outcome measure. If the participant has an indicate of 1 or more on any of the following items that indicate distress at baseline: Minimum Data Set (MDS) Section E or MDS Section D (Patient Health Questionnaire (PHQ-9). The investigators looked at the same variable 6 months later to see if the symptom remained stable, improved, or worsened. | 6 Months |
| Change in Verbal Behavior Symptoms Directed Towards Others | The investigators are using a person-centered outcome measure. If the participant has an indicate of 1 or more on any of the following items that indicate distress at baseline: Minimum Data Set (MDS) Section E or MDS Section D (Patient Health Questionnaire (PHQ-9). The investigators looked at the same variable 6 months later to see if the symptom remained stable, improved, or worsened. | 6 Months |
| Change in Other Behavioral Symptoms Not Directed Towards Others | The investigators are using a person-centered outcome measure. If the participant has an indicate of 1 or more on any of the following items that indicate distress at baseline: Minimum Data Set (MDS) Section E or MDS Section D (Patient Health Questionnaire (PHQ-9). The investigators looked at the same variable 6 months later to see if the symptom remained stable, improved, or worsened. | 6 Months |
| Change in Rejection of Care | The investigators are using a person-centered outcome measure. If the participant has an indicate of 1 or more on any of the following items that indicate distress at baseline: Minimum Data Set (MDS) Section E or MDS Section D (Patient Health Questionnaire (PHQ-9). The investigators looked at the same variable 6 months later to see if the symptom remained stable, improved, or worsened. | 6 Months |
| Change in Wandering |
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Inclusion Criteria:
Eligibility for Individualized Positive Psychosocial Interaction (IPPI)
Exclusion Criteria: Nursing home residents who are expected to live in the community for less than 6 months.
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| Name | Affiliation | Role |
|---|---|---|
| Katherine Abbott, PhD | Miami University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Trinity Community at Beavercreek | Beavercreek | Ohio | 45440 | United States | ||
| The Chapel Hill Community |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24304555 | Background | Van Haitsma KS, Curyto K, Abbott KM, Towsley GL, Spector A, Kleban M. A randomized controlled trial for an individualized positive psychosocial intervention for the affective and behavioral symptoms of dementia in nursing home residents. J Gerontol B Psychol Sci Soc Sci. 2015 Jan;70(1):35-45. doi: 10.1093/geronb/gbt102. Epub 2013 Dec 4. | |
| 40460889 | Result | Abbott KM, Heid AR, Noble M, Kotterman A, Unroe K, Van Haitsma K. An Embedded Pragmatic Clinical Trial of the Individualized Positive Psychosocial Interaction (IPPI) Program. J Am Med Dir Assoc. 2025 Aug;26(8):105700. doi: 10.1016/j.jamda.2025.105700. Epub 2025 Jun 12. |
| Label | URL |
|---|---|
| IPPI program | View source |
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There is not a plan to make individual participant data (IPT) available.
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| ID | Title | Description |
|---|---|---|
| FG000 | experimental | The experimental arm involves a brief positive interaction around a preferred activity or personal care routine. Individualized Positive Psychosocial Interaction: The intervention involves a brief positive interaction around a preferred activity or personal care routine. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 13, 2023 |
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| NIH |
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The investigators are using a person-centered outcome measure. If the participant has an indicate of 1 or more on any of the following items that indicate distress at baseline: Minimum Data Set (MDS) Section E or MDS Section D (Patient Health Questionnaire (PHQ-9). The investigators looked at the same variable 6 months later to see if the symptom remained stable, improved, or worsened. |
| 6 Months |
| Change in Little Interest or Pleasure in Doing Things | The investigators are using a person-centered outcome measure. If the participant has an indicate of 1 or more on any of the following items that indicate distress: Minimum Data Set (MDS) Section E (E0200A, B or C; or E0800) or MDS Section D (Patient Health Questionnaire (PHQ-9) | 6 Months |
| Change in Feeling Down, Depressed or Hopeless | The investigators are using a person-centered outcome measure. If the participant has an indicate of 1 or more on any of the following items that indicate distress at baseline: Minimum Data Set (MDS) Section E or MDS Section D (Patient Health Questionnaire (PHQ-9). The investigators looked at the same variable 6 months later to see if the symptom remained stable, improved, or worsened. | 6 Months |
| Canal Fulton |
| Ohio |
| 44614 |
| United States |
| The Trinity Community at Fairborn | Fairborn | Ohio | 45324 | United States |
| The Four Winds Community | Jackson | Ohio | 45640 | United States |
| The Harmar Place Community | Marietta | Ohio | 45750 | United States |
| SEM Haven | Milford | Ohio | 45150 | United States |
| The Parkvue Community | Sandusky | Ohio | 44870 | United States |
| 41106430 | Derived | Heid AR, Noble M, Van Haitsma K, Abbott KM. Alignment of Minimum Data Set 3.0 Ratings With Staff Care Partner Reports of Symptoms of Distress for Nursing Home Residents. J Am Med Dir Assoc. 2025 Dec;26(12):105928. doi: 10.1016/j.jamda.2025.105928. Epub 2025 Oct 27. |
| Staff Care Partners |
Staff delivering the IPPIs |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | experimental | The experimental arm involves a brief positive interaction around a preferred activity or personal care routine. |
| BG001 | Staff Care partner | staff care partners delivering the IPPI |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Results for each Arm/Group are presented in separate Rows | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants | No |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
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| Race (NIH/OMB) | Count of Participants | Participants | No |
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| Marital Status | We did not ask staff care partners about their marital status | Count of Participants | Participants | No |
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| Length of Stay | Number of months residing in nursing home | This variable is not applicable for staff care partners | Mean | Standard Deviation | Months |
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| Cognition | Brief Interview for Mental Status (BIMS) is a scale that ranges from 0-15 with higher values indicating more cognitive capacity and 0-12 indicating cognitive impairment. For our sample, the range was 0-12. | Variable not applicable for Staff Care Partners | Mean | Standard Deviation | units on a scale |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Physical Behavioral Symptoms Directed Toward Others | The investigators are using a person-centered outcome measure. If the participant has an indicate of 1 or more on any of the following items that indicate distress at baseline: Minimum Data Set (MDS) Section E or MDS Section D (Patient Health Questionnaire (PHQ-9). The investigators looked at the same variable 6 months later to see if the symptom remained stable, improved, or worsened. | Posted | Count of Participants | Participants | 6 Months |
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| Primary | Change in Verbal Behavior Symptoms Directed Towards Others | The investigators are using a person-centered outcome measure. If the participant has an indicate of 1 or more on any of the following items that indicate distress at baseline: Minimum Data Set (MDS) Section E or MDS Section D (Patient Health Questionnaire (PHQ-9). The investigators looked at the same variable 6 months later to see if the symptom remained stable, improved, or worsened. | Posted | Count of Participants | Participants | 6 Months |
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| Primary | Change in Other Behavioral Symptoms Not Directed Towards Others | The investigators are using a person-centered outcome measure. If the participant has an indicate of 1 or more on any of the following items that indicate distress at baseline: Minimum Data Set (MDS) Section E or MDS Section D (Patient Health Questionnaire (PHQ-9). The investigators looked at the same variable 6 months later to see if the symptom remained stable, improved, or worsened. | Posted | Count of Participants | Participants | 6 Months |
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| Primary | Change in Rejection of Care | The investigators are using a person-centered outcome measure. If the participant has an indicate of 1 or more on any of the following items that indicate distress at baseline: Minimum Data Set (MDS) Section E or MDS Section D (Patient Health Questionnaire (PHQ-9). The investigators looked at the same variable 6 months later to see if the symptom remained stable, improved, or worsened. | Posted | Count of Participants | Participants | 6 Months |
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| Primary | Change in Wandering | The investigators are using a person-centered outcome measure. If the participant has an indicate of 1 or more on any of the following items that indicate distress at baseline: Minimum Data Set (MDS) Section E or MDS Section D (Patient Health Questionnaire (PHQ-9). The investigators looked at the same variable 6 months later to see if the symptom remained stable, improved, or worsened. | Posted | Count of Participants | Participants | 6 Months |
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| Primary | Change in Little Interest or Pleasure in Doing Things | The investigators are using a person-centered outcome measure. If the participant has an indicate of 1 or more on any of the following items that indicate distress: Minimum Data Set (MDS) Section E (E0200A, B or C; or E0800) or MDS Section D (Patient Health Questionnaire (PHQ-9) | Posted | Count of Participants | Participants | 6 Months |
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| Primary | Change in Feeling Down, Depressed or Hopeless | The investigators are using a person-centered outcome measure. If the participant has an indicate of 1 or more on any of the following items that indicate distress at baseline: Minimum Data Set (MDS) Section E or MDS Section D (Patient Health Questionnaire (PHQ-9). The investigators looked at the same variable 6 months later to see if the symptom remained stable, improved, or worsened. | Posted | Count of Participants | Participants | 6 Months |
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6 months
Definitions do not differ
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | experimental | The experimental arm involves a brief positive interaction around a preferred activity or personal care routine. Individualized Positive Psychosocial Interaction: The intervention involves a brief positive interaction around a preferred activity or personal care routine. | 28 | 130 | 28 | 130 | 0 | 130 |
| EG001 | Staff care partners | Staff completing an emotion-focused communication training and facilitating IPPIs with residents Staff Care Partners were not assessed for All-Cause Mortality, Serious, and Other [Not Including Serious] Adverse Events | 0 | 0 | 0 | 0 | 0 | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Advanced Dementia | General disorders | Systematic Assessment | 28 individuals passed away due to advanced dementia |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Katherine Abbott | Miami University | 513-529-0869 | abbottkm@miamioh.edu |
| Aug 12, 2025 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D003863 | Depression |
| D001519 | Behavior |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
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| Title | Denominators | Categories | ||||
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| Symptoms stayed stable |
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| symptoms improved |
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| symptoms worsened |
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