- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01497613
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
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
300
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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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:
- 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 |
Intervention / Treatment |
---|---|
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.
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Telephone check-in calls and a notebook that contains information about community resources, games; topics of interests to seniors; a calendar and contact list.
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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.
|
A specialized computer system designed to support social connectivity and access to resources; knowledge and prospective memory
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What is the study measuring?
Primary Outcome Measures
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
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
Investigators
- 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
- Boot WR, Charness N, Czaja SJ, Sharit J, Rogers WA, Fisk AD, Mitzner T, Lee CC, Nair S. Computer proficiency questionnaire: assessing low and high computer proficient seniors. Gerontologist. 2015 Jun;55(3):404-11. doi: 10.1093/geront/gnt117. Epub 2013 Oct 9.
- Czaja SJ, Boot WR, Charness N, A Rogers W, Sharit J, Fisk AD, Lee CC, Nair SN. The personalized reminder information and social management system (PRISM) trial: rationale, methods and baseline characteristics. Contemp Clin Trials. 2015 Jan;40:35-46. doi: 10.1016/j.cct.2014.11.004. Epub 2014 Nov 8.
- Yoon JS, Charness N, Boot WR, Czaja SJ, Rogers WA. Depressive Symptoms as a Predictor of Memory Complaints in the PRISM Sample. J Gerontol B Psychol Sci Soc Sci. 2019 Jan 10;74(2):254-263. doi: 10.1093/geronb/gbx070.
- Mitzner TL, Rogers WA, Fisk AD, Boot WR, Charness N, Czaja SJ, Sharit J. Predicting Older Adults' Perceptions about a Computer System Designed for Seniors. Univers Access Inf Soc. 2016 Jun;15(2):271-280. doi: 10.1007/s10209-014-0383-y. Epub 2014 Sep 7.
- Czaja SJ, Boot WR, Charness N, Rogers WA, Sharit J. Improving Social Support for Older Adults Through Technology: Findings From the PRISM Randomized Controlled Trial. Gerontologist. 2018 May 8;58(3):467-477. doi: 10.1093/geront/gnw249.
- Mitzner TL, Savla J, Boot WR, Sharit J, Charness N, Czaja SJ, Rogers WA. Technology Adoption by Older Adults: Findings From the PRISM Trial. Gerontologist. 2019 Jan 9;59(1):34-44. doi: 10.1093/geront/gny113.
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
February 1, 2011
Primary Completion (Actual)
January 1, 2014
Study Completion (Actual)
May 1, 2014
Study Registration Dates
First Submitted
December 13, 2011
First Submitted That Met QC Criteria
December 21, 2011
First Posted (Estimate)
December 22, 2011
Study Record Updates
Last Update Posted (Actual)
January 23, 2019
Last Update Submitted That Met QC Criteria
January 3, 2019
Last Verified
January 1, 2019
More Information
Terms related to this study
Other Study ID 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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