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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
248

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • United States
    • Florida
      • Miami, Florida, United States, 33136
        • University of Miami
      • Tallahassee, Florida, United States, 32306
        • Florida State University
    • Georgia
      • Atlanta, Georgia, United States, 30332
        • Georgia Institute of Technology
    • Illinois
      • Urbana, Illinois, United States, 61801
        • University of Illinois at Urban-Champagne

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: PRISM 2.0 Condition
Exposing participants to the PRISM 2.0 interface.
Behavioral: PRISM 2.0 Condition
Access to the PRISM 2.0 program
Placebo Comparator: Tablet Condition
Exposing participants to the regular computer/tablet
Behavioral: Tablet Condition
Access to the tablet

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Weill Medical College of Cornell University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute on Aging (NIA)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 20, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 2, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 2, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 27, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 11, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 17, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 26, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 30, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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