Trial Outcomes & Findings for Testing the Feasibility of the Individualized Positive Psychosocial Intervention (IPPI) (NCT NCT05980299)
NCT ID: NCT05980299
Last Updated: 2025-11-03
Results Overview
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)
COMPLETED
NA
200 participants
6 Months
2025-11-03
Participant Flow
Participant milestones
| Measure |
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.
|
Staff Care Partners
Staff delivering the IPPIs
|
|---|---|---|
|
Overall Study
STARTED
|
130
|
70
|
|
Overall Study
COMPLETED
|
93
|
60
|
|
Overall Study
NOT COMPLETED
|
37
|
10
|
Reasons for withdrawal
| Measure |
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.
|
Staff Care Partners
Staff delivering the IPPIs
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
10
|
|
Overall Study
Death
|
28
|
0
|
|
Overall Study
Discharged from Nursing Home
|
9
|
0
|
Baseline Characteristics
Results for each Arm/Group are presented in separate Rows
Baseline characteristics by cohort
| Measure |
experimental
n=130 Participants
The experimental arm involves a brief positive interaction around a preferred activity or personal care routine.
|
Staff Care partner
n=70 Participants
staff care partners delivering the IPPI
|
Total
n=200 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
Resident
|
84.44 years
STANDARD_DEVIATION 8.21 • n=130 Participants • Results for each Arm/Group are presented in separate Rows
|
—
|
84.44 years
STANDARD_DEVIATION 8.21 • n=130 Participants • Results for each Arm/Group are presented in separate Rows
|
|
Age, Continuous
Staff Care Partner
|
—
|
40.35 years
STANDARD_DEVIATION 13.94 • n=70 Participants • Results for each Arm/Group are presented in separate Rows
|
40.35 years
STANDARD_DEVIATION 13.94 • n=70 Participants • Results for each Arm/Group are presented in separate Rows
|
|
Sex: Female, Male
Female
|
96 Participants
n=130 Participants
|
63 Participants
n=70 Participants
|
159 Participants
n=200 Participants
|
|
Sex: Female, Male
Male
|
34 Participants
n=130 Participants
|
7 Participants
n=70 Participants
|
41 Participants
n=200 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=130 Participants
|
5 Participants
n=70 Participants
|
6 Participants
n=200 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
117 Participants
n=130 Participants
|
64 Participants
n=70 Participants
|
181 Participants
n=200 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
12 Participants
n=130 Participants
|
1 Participants
n=70 Participants
|
13 Participants
n=200 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=130 Participants
|
0 Participants
n=70 Participants
|
0 Participants
n=200 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=130 Participants
|
0 Participants
n=70 Participants
|
0 Participants
n=200 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=130 Participants
|
1 Participants
n=70 Participants
|
1 Participants
n=200 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=130 Participants
|
4 Participants
n=70 Participants
|
4 Participants
n=200 Participants
|
|
Race (NIH/OMB)
White
|
117 Participants
n=130 Participants
|
61 Participants
n=70 Participants
|
178 Participants
n=200 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=130 Participants
|
2 Participants
n=70 Participants
|
4 Participants
n=200 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
11 Participants
n=130 Participants
|
2 Participants
n=70 Participants
|
13 Participants
n=200 Participants
|
|
Marital Status
Never Married
|
9 Participants
n=130 Participants • We did not ask staff care partners about their marital status
|
0 Participants
n=70 Participants • We did not ask staff care partners about their marital status
|
9 Participants
n=200 Participants • We did not ask staff care partners about their marital status
|
|
Marital Status
Married
|
31 Participants
n=130 Participants • We did not ask staff care partners about their marital status
|
0 Participants
n=70 Participants • We did not ask staff care partners about their marital status
|
31 Participants
n=200 Participants • We did not ask staff care partners about their marital status
|
|
Marital Status
Widowed
|
70 Participants
n=130 Participants • We did not ask staff care partners about their marital status
|
0 Participants
n=70 Participants • We did not ask staff care partners about their marital status
|
70 Participants
n=200 Participants • We did not ask staff care partners about their marital status
|
|
Marital Status
Divorced
|
19 Participants
n=130 Participants • We did not ask staff care partners about their marital status
|
0 Participants
n=70 Participants • We did not ask staff care partners about their marital status
|
19 Participants
n=200 Participants • We did not ask staff care partners about their marital status
|
|
Marital Status
Missing
|
1 Participants
n=130 Participants • We did not ask staff care partners about their marital status
|
70 Participants
n=70 Participants • We did not ask staff care partners about their marital status
|
71 Participants
n=200 Participants • We did not ask staff care partners about their marital status
|
|
Length of Stay
|
16.79 Months
STANDARD_DEVIATION 22.18 • n=130 Participants • This variable is not applicable for staff care partners
|
—
|
16.79 Months
STANDARD_DEVIATION 22.18 • n=130 Participants • This variable is not applicable for staff care partners
|
|
Cognition
|
4.68 units on a scale
STANDARD_DEVIATION 3.64 • n=130 Participants • Variable not applicable for Staff Care Partners
|
—
|
4.68 units on a scale
STANDARD_DEVIATION 3.64 • n=130 Participants • Variable not applicable for Staff Care Partners
|
PRIMARY outcome
Timeframe: 6 MonthsThe 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.
Outcome measures
| Measure |
experimental
n=18 Participants
The experimental arm involves a brief positive interaction around a preferred activity or personal care routine.
|
|---|---|
|
Change in Physical Behavioral Symptoms Directed Toward Others
Symptoms stayed stable
|
4 Participants
|
|
Change in Physical Behavioral Symptoms Directed Toward Others
symptoms improved
|
13 Participants
|
|
Change in Physical Behavioral Symptoms Directed Toward Others
symptoms worsened
|
1 Participants
|
PRIMARY outcome
Timeframe: 6 MonthsThe 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.
Outcome measures
| Measure |
experimental
n=20 Participants
The experimental arm involves a brief positive interaction around a preferred activity or personal care routine.
|
|---|---|
|
Change in Verbal Behavior Symptoms Directed Towards Others
Symptoms stayed stable
|
5 Participants
|
|
Change in Verbal Behavior Symptoms Directed Towards Others
symptoms improved
|
12 Participants
|
|
Change in Verbal Behavior Symptoms Directed Towards Others
symptoms worsened
|
3 Participants
|
PRIMARY outcome
Timeframe: 6 MonthsThe 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.
Outcome measures
| Measure |
experimental
n=18 Participants
The experimental arm involves a brief positive interaction around a preferred activity or personal care routine.
|
|---|---|
|
Change in Other Behavioral Symptoms Not Directed Towards Others
Symptoms stayed stable
|
0 Participants
|
|
Change in Other Behavioral Symptoms Not Directed Towards Others
symptoms improved
|
18 Participants
|
|
Change in Other Behavioral Symptoms Not Directed Towards Others
symptoms worsened
|
0 Participants
|
PRIMARY outcome
Timeframe: 6 MonthsThe 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.
Outcome measures
| Measure |
experimental
n=13 Participants
The experimental arm involves a brief positive interaction around a preferred activity or personal care routine.
|
|---|---|
|
Change in Rejection of Care
Symptoms stayed stable
|
5 Participants
|
|
Change in Rejection of Care
symptoms improved
|
8 Participants
|
|
Change in Rejection of Care
symptoms worsened
|
0 Participants
|
PRIMARY outcome
Timeframe: 6 MonthsThe 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.
Outcome measures
| Measure |
experimental
n=12 Participants
The experimental arm involves a brief positive interaction around a preferred activity or personal care routine.
|
|---|---|
|
Change in Wandering
Symptoms stayed stable
|
3 Participants
|
|
Change in Wandering
symptoms improved
|
8 Participants
|
|
Change in Wandering
symptoms worsened
|
1 Participants
|
PRIMARY outcome
Timeframe: 6 MonthsThe 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)
Outcome measures
| Measure |
experimental
n=18 Participants
The experimental arm involves a brief positive interaction around a preferred activity or personal care routine.
|
|---|---|
|
Change in Little Interest or Pleasure in Doing Things
Symptoms stayed stable
|
3 Participants
|
|
Change in Little Interest or Pleasure in Doing Things
symptoms improved
|
15 Participants
|
|
Change in Little Interest or Pleasure in Doing Things
symptoms worsened
|
0 Participants
|
PRIMARY outcome
Timeframe: 6 MonthsThe 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.
Outcome measures
| Measure |
experimental
n=23 Participants
The experimental arm involves a brief positive interaction around a preferred activity or personal care routine.
|
|---|---|
|
Change in Feeling Down, Depressed or Hopeless
Symptoms stayed stable
|
2 Participants
|
|
Change in Feeling Down, Depressed or Hopeless
symptoms improved
|
20 Participants
|
|
Change in Feeling Down, Depressed or Hopeless
symptoms worsened
|
1 Participants
|
Adverse Events
experimental
Staff care partners
Serious adverse events
| Measure |
experimental
n=130 participants at risk
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.
|
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
|
|---|---|---|
|
General disorders
Advanced Dementia
|
21.5%
28/130 • Number of events 28 • 6 months
Definitions do not differ
|
—
0/0 • 6 months
Definitions do not differ
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place