A Personalized Reminder Information and Social Management System (PRISM)

January 3, 2019 updated by: Sara J Czaja, University of Miami

Personalized Reminder Information and Social Management System - PRISM

Although technology offers great potential for enhancing the health and well-being of older adults, robust studies are needed to quantify the value of technology and further the investigators understanding of barriers to technology access among older adults and of strategies that are effective in removing these barriers. This cross-site randomized field trial will evaluate a simple to use Personalized Reminder Information and Social Management System (PRISM) designed to support social connectivity, memory, skill building and resource access for older adults. The PRISM system (PRISM C condition) will be compared to an notebook information control condition (PRISM B condition). The target population is older adults who live at home alone and are at risk for isolation. The goal of the study is to gather systematic evidence about the value of technology for older adults and to identify factors that affect use and usability, acceptance and technology adoption. The investigators will also gather longitudinal data on the benefits of the system. Participants aged 65 - 85 years (100 per site) will be randomly assigned following baseline assessment to one of two conditions: PRISM C condition where participants receive the technology system or the PRISM B condition only control where participants receive a notebook that includes information similar to that provided in PRISM C (e.g., resource guide). The categories of information provided in the notebook is similar to the features provided on the system. Participants will include males and females who do not have a home computer and who have limited Internet experience. The intervention period is 12 months. A battery of measures that includes demographic information, attitudes towards technology (including computer self-efficacy and computer comfort), technology, computer and Internet experience, functional independence and well-being, emotional well-being social support/isolation, and quality of life will be administered at baseline, and 6 and 12 months post randomization. In addition, the investigators will assess cognitive abilities at baseline and twelve months. The investigators will also gather data regarding technology use and social interactions via a brief telephone interview at 18 months post randomization.

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.

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.
300

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

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:

  • 65+ years
  • Live alone in the community in an independent residence
  • Minimum computer and Internet use in the past three months
  • English speaking
  • Able to read English at the 6th grade level
  • Has a telephone
  • 20/60 Vision with or without correction
  • Not employed or volunteering more than 5 hrs/week
  • Does not spend more than 10 hrs./week at a Senior Center or Formal organization
  • Planning to remain in the area in same living arrangements for duration of intervention period

Exclusion Criteria:

  • Blind or deaf
  • Cognitively impaired (MMSE) < 26
  • Fuld Object Memory Test < 20 or 19
  • Terminal illness
  • Severe motor impairment

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: Single

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.
Active Comparator: PRISM B: Notebook Condition
Telephone check-in calls and a notebook containing similar categories of information as the features on the PRISM C computer system such as a resource guide; games; classroom and information, calendar.
Behavioral: PRISM B: Notebook Condition
Telephone check-in calls and a notebook that contains information about community resources, games; topics of interests to seniors; a calendar and contact list.
Experimental: PRISM C: Computer Condition
A computer-based system designed to support socialization and access to resources; knowledge and prospective memory. The system is placed in the homes of those randomized to the condition for 12 months.
Behavioral: PRISM C: Computer Condition
A specialized computer system designed to support social connectivity and access to resources; knowledge and prospective memory

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 Social Isolation Measured by Friendship Scale
Time Frame: Baseline and 6th month
Measures the level of social isolation from baseline to 6th month follow-up. Lower score means less social isolation. Range (0-24) .
Baseline and 6th month
Change in Level of Social Support Measured by Social Support Scale
Time Frame: Baseline and 6th month
Measures the level of social support from baseline to 6th month follow-up. Higher score means more social support. Range (6-36).
Baseline and 6th month
Change Overall Well-being Measured by SF-36 Overall Well-being Subscale
Time Frame: Baseline and 6th month
Use the SF-36 scale to measure the overall well-being from baseline to 6th month follow-up. Higher score indicates more peaceful, happy, and calm. Range (0-100)
Baseline and 6th month
Change in Social Isolation Measured by Friendship Scale
Time Frame: Baseline and 12th month
Measures the level of social isolation from baseline to 12th month follow-up. Lower score means less social isolation. Range (0-24) .
Baseline and 12th month
Change in Level of Social Support Measured by Social Support Scale
Time Frame: Baseline and 12th month
Measures the level of social support from baseline to 12th month follow-up. Higher score means more social support. Range (6-36).
Baseline and 12th month
Change Overall Well-being Measured by SF-36 Overall Well-being Subscale
Time Frame: Baseline and 12th month
Use the SF-36 to measure the overall well-being from baseline to 12th month follow-up. Higher score means more peaceful, happy and calm. Range (0-100).
Baseline and 12th month

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 Computer Comfort Measured by Computer Attitude - Comfort Subscale .
Time Frame: baseline and 6 months
Use the computer attitude scale to measure the level of computer comfort from baseline to 6th month follow-up. Higher score means more computer comfort. Range (5-25).
baseline and 6 months
Changes in Technology Proficiency Measured by Technology Proficiency Scale
Time Frame: baseline and 6 months
Measures the level of technology proficiency from baseline to 6th month follow-up. Higher scores means more computer proficiency. Range (6-30)
baseline and 6 months
Change in Technology Adoption Measured by Technology Acceptance Questionnaire
Time Frame: baseline and 6 months
Measure the level of technology adoption from baseline to 6th month follow-up. Higher score means more acceptance. Range (6-42)
baseline and 6 months
Change in Computer Comfort Measured by Computer Attitude - Comfort Subscale .
Time Frame: baseline and 12 months
Use the computer attitude scale to measure the level of computer comfort from baseline to 12th month follow-up. Higher score means more computer comfort. Range (5-25)
baseline and 12 months
Changes in Technology Proficiency Measured by Technology Proficiency Scale
Time Frame: baseline and 12 months
Measures the level of technology proficiency from baseline to 12th month follow-up. A higher score means more computer proficiency. Range (6-30)
baseline and 12 months
Change in Technology Adoption Measured by Technology Acceptance Questionnaire
Time Frame: baseline and 12 months
Measures the level of technology adoption from baseline to 12th month follow-up. Higher score means more acceptance. Range (6-42)
baseline and 12 months
Change in Computer Interest Measured by Computer Attitude - Interest Subscale
Time Frame: Baseline and 6th month follow-up
Use the computer attitude scale to measure the level of computer interest from baseline to 6th month follow-up. Higher score means more interest towards computer. Range (5-25)
Baseline and 6th month follow-up
Change in Computer Interest Measured by Computer Attitude - Interest Subscale
Time Frame: Baseline and 12th month follow-up
Use the computer attitude scale to measure the level of computer interest from baseline to 12th month follow-up. Higher score means more interest towards computer. Range (5-25)
Baseline and 12th month follow-up
Change in Computer Efficacy Measured by Computer Attitude - Efficacy Subscale
Time Frame: Baseline and 6th month follow-up
Use the computer attitude scale to measure the level of computer efficacy from baseline to 12th month follow-up. Higher score means more efficacy towards computer. Range (5-25)
Baseline and 6th month follow-up
Change in Computer Efficacy Measured by Computer Attitude - Efficacy Subscale
Time Frame: Baseline and 12th month follow-up
Use the computer attitude scale to measure the level of computer efficacy from baseline to 12th month follow-up. Higher score means more efficacy towards computer. Range (5-25)
Baseline and 12th 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.
University of Miami

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, University of Miami

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

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.
February 1, 2011

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.
January 1, 2014

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.
May 1, 2014

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).
December 13, 2011

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.
December 21, 2011

First Posted (Estimate)

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.
December 22, 2011

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.
January 23, 2019

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.
January 3, 2019

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.
January 1, 2019

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.
  • 20100482

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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