Social Isolation in Older AdultsNCT03116399
PRISM 2.0 in Diverse Living Contexts
A study testing PRISM 2.0 Condition and Tablet Condition in people with Social Isolation in Older Adults, run by Weill Medical College of Cornell University at 4 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Social Isolation in Older Adults
- What is being tested?
- PRISM 2.0 Condition and Tablet Condition
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 248 participants
- Where
- 4 sitesUnited States
- Study dates
- 20 Apr 2017to 2 Mar 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Georgia Institute of Technology
Atlanta, Georgia, 30332
University of Miami
Miami, Florida, 33136
Florida State University
Tallahassee, Florida, 32306
University of Illinois at Urban-Champagne
Urbana, Illinois, 61801
About this study
Official title: 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.
Read the 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.
- Conditions
- Social Isolation in Older Adults
- Being tested
- PRISM 2.0 Condition, Tablet Condition
- Keywords
- Older adults, Social Support, Technology uptake
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRISM 2.0 ConditionBehavioural
Access to the PRISM 2.0 program
Tablet ConditionBehavioural
Access to the tablet
| Study group | Role | What they receive |
|---|---|---|
| PRISM 2.0 Condition | Experimental | Exposing participants to the PRISM 2.0 interface. Receives: Behavioral: PRISM 2.0 Condition |
| Tablet Condition | Placebo comparator | Exposing participants to the regular computer/tablet Receives: Behavioral: Tablet Condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Baseline, 6 month follow-up and 9 month follow-up
Secondary outcomes (1)
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)
Measured: Baseline, 6 month follow-up and 9 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2017
- Study start20 Apr 2017
- Primary completion2 Mar 2021
- Study completion2 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Social Isolation in Older AdultsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 248 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Sara J. Czaja, PhD, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03116399
- Sponsor's protocol ID
- 1811019713
- Other IDs
- 3P01AG017211
- Status last verified
- Jun 2022
- First submitted
- 27 Mar 2017
- Last updated
- 26 Jul 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Czaja SJ, Charness N, Rogers WA, Sharit J, Moxley JH, Boot WR. The Benefits of Technology for Engaging Aging Adults: Findings From the PRISM 2.0 Trial. Innov Aging. 2024 Apr 25;8(6):igae042. doi: 10.1093/geroni/igae042. eCollection 2024.
PubMed 38854853
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PRISM 2.0 in Diverse Living Contexts With Diverse Populations of Older Adults
- ClinicalTrials.gov ID
- NCT03116399
- Acronym / sponsor ID
- 1811019713
- Conditions
- Social Isolation in Older Adults
- Keywords
- Older adults, Social Support, Technology uptake
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 248 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 20 Apr 2017 (actual)
- Primary completion
- 2 Mar 2021 (actual)
- Study completion
- 2 Mar 2021 (actual)
- First posted
- 17 Apr 2017 (actual)
- Results
- Posted 3 May 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PRISM 2.0 Condition | Experimental | Behavioral: PRISM 2.0 ConditionExposing participants to the PRISM 2.0 interface. |
| Tablet Condition | Placebo comparator | Behavioral: Tablet ConditionExposing participants to the regular computer/tablet |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PRISM 2.0 ConditionAccess to the PRISM 2.0 program | Behavioural | PRISM 2.0 Condition |
| Tablet ConditionAccess to the tablet | Behavioural | Tablet Condition |
Primary outcome
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)
1 secondary outcome
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38854853Czaja SJ, Charness N, Rogers WA, Sharit J, Moxley JH, Boot WR. The Benefits of Technology for Engaging Aging Adults: Findings From the PRISM 2.0 Trial. Innov Aging. 2024 Apr 25;8(6):igae042. doi: 10.1093/geroni/igae042. eCollection 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sara J. Czaja, PhD principal investigator
Weill Medical College of Cornell University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PRISM 2.0 Condition and Tablet Condition in people with Social Isolation in Older Adults, run by Weill Medical College of Cornell University at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 May 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03116399, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2022.