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PRISM 2.0 in Diverse Living Contexts

PRISM 2.0 in Diverse Living Contexts With Diverse Populations of Older Adults

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03116399
Enrollment
248
Registered
2017-04-17
Start date
2017-04-20
Completion date
2021-03-02
Last updated
2022-07-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Social Isolation in Older Adults

Keywords

Older adults, Social Support, Technology uptake

Brief summary

The focus of the study is to evaluate the expanded version of PRISM 1.0 for a broad array of seniors with different needs and circumstances. The aims of the study are to: 1) obtain information on perceptions of the usefulness and usability of PRISM 2.0 and interface design issues; 2) examine the impact of access to PRISM 2.0 on social connectivity, engagement, social support, and perceived loneliness; 3) examine the impact of access to PRISM 2.0 on perceived isolation, well-being, and quality of life; 4) examine the impact of access PRISM 2.0 on computer attitudes, self-efficacy, technology proficiency and technology uptake; 5) gather data on usefulness of system features and if these vary by living condition; and 6) examine, in our statistical models, the influence of factors such as age, cognitive abilities, ethnicity, education on system use and outcomes.

Detailed description

This study is part of the CREATE center. The focus of the study is to evaluate the expanded version of PRISM 1.0 for a broad array of seniors with different needs and circumstances. The aims of the study are to: 1) obtain information on perceptions of the usefulness and usability of PRISM 2.0 and interface design issues; 2) examine the impact of access to PRISM 2.0 on social connectivity, engagement, social support, and perceived loneliness; 3) examine the impact of access to PRISM 2.0 on perceived isolation, wellbeing, and quality of life; 4) examine the impact of access PRISM 2.0 on computer attitudes, self-efficacy, technology proficiency and technology uptake; 5) gather data on usefulness of system features and if these vary by living condition; and 6) examine, in our statistical models, the influence of factors such as age, cognitive abilities, ethnicity, education on system use and outcomes. The design of the PRISM 2.0 is well grounded and the chosen features will be based on: 1) the findings from the PRISM 1.0 trial; 2) the cognitive, human factors and engineering; 3) emerging findings in aging (e.g., findings related to technology acceptance, social isolation, social networks, life engagement); 4) existing theories of aging (e.g., Stress-Process Model; Active Theory; Social Isolation/Engagement; 5) findings regarding the benefits of technology for seniors; 6) findings from previous work from CREATE regarding interface design, training, provision of environmental support, and the needs of older adults; 7) recent findings regarding Internet use among older adults; 8) findings from our prior focus groups on barriers to access of technology and technology preferences; 9) findings from our technology-based community intervention programs with older adults; 10) existing models of technology adoption and diffusion; 11) the literature on implementation science our planned focus groups and pilot testing of PRISM 2.0.

Interventions

BEHAVIORALPRISM 2.0 Condition

Access to the PRISM 2.0 program

BEHAVIORALTablet Condition

Access to the tablet

Sponsors

National Institute on Aging (NIA)
CollaboratorNIH
Weill Medical College of Cornell University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Age 65+ years * Able to read English at the 6th grade level * Passing score of Social Isolation Screening * Passing score of brief Technology Proficiency Screen * Passing score of Telephone Interview for Cognitive Status (TICS) * Passing score of Woodcock Johnson Reading Comprehension (Spanish equivalent) * Passing score of Fuld Object Memory Evaluation

Exclusion criteria

* Blind or deaf * Has terminal Illness or severe motor impairment * Significant use of computer/Internet/email in the home or elsewhere * Working for a paid more than 5 hours/week * Participate as formal volunteer more than 5 hours/week * Attend senior center or another formal organization for than 10 hours/week

Design outcomes

Primary

MeasureTime frameDescription
Change in Functional Health/Well-being as Measured by Modified SF-36, a Self-report Measure of Functional Health and Well-being.Baseline, 6 month follow-up and 9 month follow-upHigher score means better functional health/well-being. A lower score reflects poorer health. Range (0-1400)

Secondary

MeasureTime frameDescription
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, 6 month follow-up and 9 month follow-upHigher score indicates a greater degree of loneliness. A lower score reflects a lower degree of loneliness. Range (0-80)

Countries

United States

Participant flow

Recruitment details

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.

Participants by arm

ArmCount
PRISM 2.0 Condition
Exposing participants to the PRISM 2.0 interface. PRISM 2.0 Condition: Access to the PRISM 2.0 program
125
Tablet Condition
Exposing participants to the regular computer/tablet Tablet Condition: Access to the tablet
120
Total245

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyDeath83
Overall StudyInvestigator Decision11
Overall StudyLost to Follow-up711
Overall StudyWithdrawal by Subject249

Baseline characteristics

CharacteristicTablet ConditionPRISM 2.0 ConditionTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
117 Participants125 Participants242 Participants
Age, Categorical
Between 18 and 65 years
3 Participants0 Participants3 Participants
Age, Continuous75 years76 years76 years
Ethnicity (NIH/OMB)
Hispanic or Latino
2 Participants21 Participants23 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
115 Participants100 Participants215 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
3 Participants4 Participants7 Participants
Functional Health/Well-being as Measured by Modified SF-36, a Self-report Measure865 units on a scale855 units on a scale857.5 units on a scale
Loneliness as Measured by Loneliness Scale, a 20-item Scale to Measure One's Subjective Feelings39 units on a scale39 units on a scale39 units on a scale
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
20 Participants26 Participants46 Participants
Race (NIH/OMB)
More than one race
2 Participants5 Participants7 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
4 Participants10 Participants14 Participants
Race (NIH/OMB)
White
94 Participants84 Participants178 Participants
Region of Enrollment
United States
120 participants125 participants245 participants
Sex: Female, Male
Female
89 Participants100 Participants189 Participants
Sex: Female, Male
Male
31 Participants23 Participants54 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
8 / 1283 / 120
other
Total, other adverse events
9 / 1287 / 120
serious
Total, serious adverse events
5 / 1283 / 120

Outcome results

Primary

Change in Functional Health/Well-being as Measured by Modified SF-36, a Self-report Measure of Functional Health and Well-being.

Higher score means better functional health/well-being. A lower score reflects poorer health. Range (0-1400)

Time frame: Baseline, 6 month follow-up and 9 month follow-up

Population: 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.

ArmMeasureGroupValue (MEDIAN)
PRISM 2.0 ConditionChange in Functional Health/Well-being as Measured by Modified SF-36, a Self-report Measure of Functional Health and Well-being.Baseline855 units on a scale
PRISM 2.0 ConditionChange in Functional Health/Well-being as Measured by Modified SF-36, a Self-report Measure of Functional Health and Well-being.6-month900 units on a scale
PRISM 2.0 ConditionChange in Functional Health/Well-being as Measured by Modified SF-36, a Self-report Measure of Functional Health and Well-being.9-month860 units on a scale
Tablet ConditionChange in Functional Health/Well-being as Measured by Modified SF-36, a Self-report Measure of Functional Health and Well-being.Baseline865 units on a scale
Tablet ConditionChange in Functional Health/Well-being as Measured by Modified SF-36, a Self-report Measure of Functional Health and Well-being.6-month870 units on a scale
Tablet ConditionChange in Functional Health/Well-being as Measured by Modified SF-36, a Self-report Measure of Functional Health and Well-being.9-month857.5 units on a scale
Secondary

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.

Higher score indicates a greater degree of loneliness. A lower score reflects a lower degree of loneliness. Range (0-80)

Time frame: Baseline, 6 month follow-up and 9 month follow-up

Population: 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.

ArmMeasureGroupValue (MEDIAN)
PRISM 2.0 ConditionChange in Loneliness as Measured by Loneliness Scale, a 20-item Scale to Measure One's Subjective Feelings of Loneliness and Feelings of Social Isolation.Baseline39 units on a scale
PRISM 2.0 ConditionChange 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 month37 units on a scale
PRISM 2.0 ConditionChange 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 month35 units on a scale
Tablet ConditionChange in Loneliness as Measured by Loneliness Scale, a 20-item Scale to Measure One's Subjective Feelings of Loneliness and Feelings of Social Isolation.Baseline39 units on a scale
Tablet ConditionChange 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 month36 units on a scale
Tablet ConditionChange 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 month33 units on a scale

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026