- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03116399
PRISM 2.0 in Diverse Living Contexts
June 30, 2022 updated by: Weill Medical College of Cornell University
PRISM 2.0 in Diverse Living Contexts With Diverse Populations of Older Adults
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
248
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Florida
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Miami, Florida, United States, 33136
- University of Miami
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Tallahassee, Florida, United States, 32306
- Florida State University
-
-
Georgia
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Atlanta, Georgia, United States, 30332
- Georgia Institute of Technology
-
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Illinois
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Urbana, Illinois, United States, 61801
- University of Illinois at Urban-Champagne
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
65 years and older (Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: PRISM 2.0 Condition
Exposing participants to the PRISM 2.0 interface.
|
Access to the PRISM 2.0 program
|
|
Placebo Comparator: Tablet Condition
Exposing participants to the regular computer/tablet
|
Access to the tablet
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Functional Health/Well-being as Measured by Modified SF-36, a Self-report Measure of Functional Health and Well-being.
Time Frame: Baseline, 6 month follow-up and 9 month follow-up
|
Higher score means better functional health/well-being.
A lower score reflects poorer health.
Range (0-1400)
|
Baseline, 6 month follow-up and 9 month follow-up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
Time Frame: Baseline, 6 month follow-up and 9 month follow-up
|
Higher score indicates a greater degree of loneliness.
A lower score reflects a lower degree of loneliness.
Range (0-80)
|
Baseline, 6 month follow-up and 9 month follow-up
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Sara J. Czaja, PhD, Weill Medical College of Cornell University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 20, 2017
Primary Completion (Actual)
March 2, 2021
Study Completion (Actual)
March 2, 2021
Study Registration Dates
First Submitted
March 27, 2017
First Submitted That Met QC Criteria
April 11, 2017
First Posted (Actual)
April 17, 2017
Study Record Updates
Last Update Posted (Actual)
July 26, 2022
Last Update Submitted That Met QC Criteria
June 30, 2022
Last Verified
June 1, 2022
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 1811019713
- 3P01AG017211 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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