Trial Outcomes & Findings for PRISM 2.0 in Diverse Living Contexts (NCT NCT03116399)
NCT ID: NCT03116399
Last Updated: 2022-07-26
Results Overview
Higher score means better functional health/well-being. A lower score reflects poorer health. Range (0-1400)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
248 participants
Primary outcome timeframe
Baseline, 6 month follow-up and 9 month follow-up
Results posted on
2022-07-26
Participant Flow
Participants were recruited based on response to study recruitment efforts (e.g., flyers, mailings, etc.) at 3 research centers between April 2017 and March 2020.
Participant milestones
| Measure |
PRISM 2.0 Condition
Exposing participants to the PRISM 2.0 interface.
PRISM 2.0 Condition: Access to the PRISM 2.0 program
|
Tablet Condition
Exposing participants to the regular computer/tablet
Tablet Condition: Access to the tablet
|
|---|---|---|
|
Overall Study
STARTED
|
128
|
120
|
|
Overall Study
6-month
|
98
|
108
|
|
Overall Study
9-month
|
91
|
101
|
|
Overall Study
COMPLETED
|
88
|
96
|
|
Overall Study
NOT COMPLETED
|
40
|
24
|
Reasons for withdrawal
| Measure |
PRISM 2.0 Condition
Exposing participants to the PRISM 2.0 interface.
PRISM 2.0 Condition: Access to the PRISM 2.0 program
|
Tablet Condition
Exposing participants to the regular computer/tablet
Tablet Condition: Access to the tablet
|
|---|---|---|
|
Overall Study
Death
|
8
|
3
|
|
Overall Study
Lost to Follow-up
|
7
|
11
|
|
Overall Study
Investigator Decision
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
24
|
9
|
Baseline Characteristics
Two participants in the PRISM 2.0 Condition did not report this measure.
Baseline characteristics by cohort
| Measure |
PRISM 2.0 Condition
n=125 Participants
Exposing participants to the PRISM 2.0 interface.
PRISM 2.0 Condition: Access to the PRISM 2.0 program
|
Tablet Condition
n=120 Participants
Exposing participants to the regular computer/tablet
Tablet Condition: Access to the tablet
|
Total
n=245 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=125 Participants
|
0 Participants
n=120 Participants
|
0 Participants
n=245 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=125 Participants
|
3 Participants
n=120 Participants
|
3 Participants
n=245 Participants
|
|
Age, Categorical
>=65 years
|
125 Participants
n=125 Participants
|
117 Participants
n=120 Participants
|
242 Participants
n=245 Participants
|
|
Age, Continuous
|
76 years
n=125 Participants
|
75 years
n=120 Participants
|
76 years
n=245 Participants
|
|
Sex: Female, Male
Female
|
100 Participants
n=123 Participants • Two participants in the PRISM 2.0 Condition did not report this measure.
|
89 Participants
n=120 Participants • Two participants in the PRISM 2.0 Condition did not report this measure.
|
189 Participants
n=243 Participants • Two participants in the PRISM 2.0 Condition did not report this measure.
|
|
Sex: Female, Male
Male
|
23 Participants
n=123 Participants • Two participants in the PRISM 2.0 Condition did not report this measure.
|
31 Participants
n=120 Participants • Two participants in the PRISM 2.0 Condition did not report this measure.
|
54 Participants
n=243 Participants • Two participants in the PRISM 2.0 Condition did not report this measure.
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
21 Participants
n=125 Participants
|
2 Participants
n=120 Participants
|
23 Participants
n=245 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
100 Participants
n=125 Participants
|
115 Participants
n=120 Participants
|
215 Participants
n=245 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=125 Participants
|
3 Participants
n=120 Participants
|
7 Participants
n=245 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=125 Participants
|
0 Participants
n=120 Participants
|
0 Participants
n=245 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=125 Participants
|
0 Participants
n=120 Participants
|
0 Participants
n=245 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=125 Participants
|
0 Participants
n=120 Participants
|
0 Participants
n=245 Participants
|
|
Race (NIH/OMB)
Black or African American
|
26 Participants
n=125 Participants
|
20 Participants
n=120 Participants
|
46 Participants
n=245 Participants
|
|
Race (NIH/OMB)
White
|
84 Participants
n=125 Participants
|
94 Participants
n=120 Participants
|
178 Participants
n=245 Participants
|
|
Race (NIH/OMB)
More than one race
|
5 Participants
n=125 Participants
|
2 Participants
n=120 Participants
|
7 Participants
n=245 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
10 Participants
n=125 Participants
|
4 Participants
n=120 Participants
|
14 Participants
n=245 Participants
|
|
Region of Enrollment
United States
|
125 participants
n=125 Participants
|
120 participants
n=120 Participants
|
245 participants
n=245 Participants
|
|
Functional Health/Well-being as Measured by Modified SF-36, a Self-report Measure
|
855 units on a scale
n=117 Participants • 8 participants in the PRISM 2.0 Condition and 5 participants in the Tablet Condition did not have SF-36 data at baseline.
|
865 units on a scale
n=115 Participants • 8 participants in the PRISM 2.0 Condition and 5 participants in the Tablet Condition did not have SF-36 data at baseline.
|
857.5 units on a scale
n=232 Participants • 8 participants in the PRISM 2.0 Condition and 5 participants in the Tablet Condition did not have SF-36 data at baseline.
|
|
Loneliness as Measured by Loneliness Scale, a 20-item Scale to Measure One's Subjective Feelings
|
39 units on a scale
n=120 Participants • 5 participants in the PRISM 2.0 Condition and 2 participants in the Tablet Condition did not report Loneliness data at baseline.
|
39 units on a scale
n=118 Participants • 5 participants in the PRISM 2.0 Condition and 2 participants in the Tablet Condition did not report Loneliness data at baseline.
|
39 units on a scale
n=238 Participants • 5 participants in the PRISM 2.0 Condition and 2 participants in the Tablet Condition did not report Loneliness data at baseline.
|
PRIMARY outcome
Timeframe: Baseline, 6 month follow-up and 9 month follow-upPopulation: Eleven participants in the PRISM 2.0 arm and 5 participants in the Tablet arm at baseline, 13 participants in the PRISM 2.0 arm and 14 participants in the Tablet arm at the 6-month time point, and 10 participants in the PRISM 2.0 arm and 11 participants in the Tablet arm at 9-month did not complete this measure.
Higher score means better functional health/well-being. A lower score reflects poorer health. Range (0-1400)
Outcome measures
| Measure |
PRISM 2.0 Condition
n=117 Participants
Exposing participants to the PRISM 2.0 interface.
PRISM 2.0 Condition: Access to the PRISM 2.0 program
|
Tablet Condition
n=115 Participants
Exposing participants to the regular computer/tablet
Tablet Condition: Access to the tablet
|
|---|---|---|
|
Change in Functional Health/Well-being as Measured by Modified SF-36, a Self-report Measure of Functional Health and Well-being.
Baseline
|
855 units on a scale
Interval 765.0 to 970.0
|
865 units on a scale
Interval 785.0 to 950.0
|
|
Change in Functional Health/Well-being as Measured by Modified SF-36, a Self-report Measure of Functional Health and Well-being.
6-month
|
900 units on a scale
Interval 775.0 to 990.0
|
870 units on a scale
Interval 775.0 to 970.0
|
|
Change in Functional Health/Well-being as Measured by Modified SF-36, a Self-report Measure of Functional Health and Well-being.
9-month
|
860 units on a scale
Interval 725.0 to 960.0
|
857.5 units on a scale
Interval 775.0 to 960.0
|
SECONDARY outcome
Timeframe: Baseline, 6 month follow-up and 9 month follow-upPopulation: Data is unavailable for 8 participants in the PRISM 2.0 arm and 2 participants in the Tablet arm at baseline as they did not complete this measure. Missing data is due to normal attrition and special circumstances associated with the COVID-19 pandemic.
Higher score indicates a greater degree of loneliness. A lower score reflects a lower degree of loneliness. Range (0-80)
Outcome measures
| Measure |
PRISM 2.0 Condition
n=120 Participants
Exposing participants to the PRISM 2.0 interface.
PRISM 2.0 Condition: Access to the PRISM 2.0 program
|
Tablet Condition
n=118 Participants
Exposing participants to the regular computer/tablet
Tablet Condition: Access to the tablet
|
|---|---|---|
|
Change in Loneliness as Measured by Loneliness Scale, a 20-item Scale to Measure One's Subjective Feelings of Loneliness and Feelings of Social Isolation.
Baseline
|
39 units on a scale
Interval 33.0 to 46.0
|
39 units on a scale
Interval 33.0 to 48.0
|
|
Change in Loneliness as Measured by Loneliness Scale, a 20-item Scale to Measure One's Subjective Feelings of Loneliness and Feelings of Social Isolation.
6 month
|
37 units on a scale
Interval 30.0 to 46.0
|
36 units on a scale
Interval 31.0 to 43.0
|
|
Change in Loneliness as Measured by Loneliness Scale, a 20-item Scale to Measure One's Subjective Feelings of Loneliness and Feelings of Social Isolation.
9 month
|
35 units on a scale
Interval 29.0 to 44.0
|
33 units on a scale
Interval 29.0 to 41.0
|
Adverse Events
PRISM 2.0 Condition
Serious events: 5 serious events
Other events: 9 other events
Deaths: 8 deaths
Tablet Condition
Serious events: 3 serious events
Other events: 7 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
PRISM 2.0 Condition
n=128 participants at risk
Exposing participants to the PRISM 2.0 interface.
PRISM 2.0 Condition: Access to the PRISM 2.0 program
|
Tablet Condition
n=120 participants at risk
Exposing participants to the regular computer/tablet
Tablet Condition: Access to the tablet
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Asthma Attack
|
0.00%
0/128 • 1 year
|
0.83%
1/120 • 1 year
|
|
Reproductive system and breast disorders
Breast cancer
|
0.00%
0/128 • 1 year
|
0.83%
1/120 • 1 year
|
|
Cardiac disorders
Heart Conditions
|
1.6%
2/128 • 1 year
|
0.83%
1/120 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Hip Hematoma
|
0.78%
1/128 • 1 year
|
0.00%
0/120 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Spinal Surgery
|
0.78%
1/128 • 1 year
|
0.00%
0/120 • 1 year
|
|
Blood and lymphatic system disorders
Anemia
|
0.78%
1/128 • 1 year
|
0.00%
0/120 • 1 year
|
Other adverse events
| Measure |
PRISM 2.0 Condition
n=128 participants at risk
Exposing participants to the PRISM 2.0 interface.
PRISM 2.0 Condition: Access to the PRISM 2.0 program
|
Tablet Condition
n=120 participants at risk
Exposing participants to the regular computer/tablet
Tablet Condition: Access to the tablet
|
|---|---|---|
|
Psychiatric disorders
Self-reported depression
|
5.5%
7/128 • 1 year
|
3.3%
4/120 • 1 year
|
|
Cardiac disorders
Heart Attack
|
0.00%
0/128 • 1 year
|
0.83%
1/120 • 1 year
|
|
Gastrointestinal disorders
Bleeding Ulcer
|
0.78%
1/128 • 1 year
|
0.00%
0/120 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Broken Hand
|
0.00%
0/128 • 1 year
|
0.83%
1/120 • 1 year
|
|
Cardiac disorders
Pacemaker Surgery
|
0.00%
0/128 • 1 year
|
0.83%
1/120 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Spinal problems
|
1.6%
2/128 • 1 year
|
0.00%
0/120 • 1 year
|
Additional Information
Sara J. Czaja, PhD
Weill Medical College of Cornell University
Phone: 646-962-7141
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place