Social IsolationPRISMNCT01497613
A Personalized Reminder Information and Social Management System
A study testing PRISM C: Computer Condition and PRISM B: Notebook Condition in people with Social Isolation and Social Support (Formal and Informal), run by University of Miami at 1 site in United States.
Trial summary
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… 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, Social Support (Formal and Informal), Well-being/Quality of Life
- What is being tested?
- PRISM C: Computer Condition and PRISM B: Notebook Condition
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2011to May 2014
- 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
- 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
Show all 10Show fewer
- 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
Who cannot join
- Blind or deaf
- Cognitively impaired (MMSE) < 26
- Fuld Object Memory Test < 20 or 19
- Terminal illness
- Severe motor impairment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Being tested
- PRISM C: Computer Condition, PRISM B: Notebook Condition
- Keywords
- Socialization, Well-being, Quality of Life, Connectivity
- Medical subject headings
- Social Isolation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRISM C: Computer ConditionBehavioural
A specialized computer system designed to support social connectivity and access to resources; knowledge and prospective memory
PRISM B: Notebook ConditionBehavioural
Telephone check-in calls and a notebook that contains information about community resources, games; topics of interests to seniors; a calendar and contact list.
| Study group | Role | What they receive |
|---|---|---|
| PRISM B: Notebook Condition | Active comparator | 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. Receives: Behavioral: PRISM B: Notebook Condition |
| PRISM C: Computer Condition | Experimental | 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. Receives: Behavioral: PRISM C: Computer Condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Social Isolation Measured by Friendship Scale
Measures the level of social isolation from baseline to 6th month follow-up. Lower score means less social isolation. Range (0-24) .
Measured: Baseline and 6th month
Change in Level of Social Support Measured by Social Support Scale
Measures the level of social support from baseline to 6th month follow-up. Higher score means more social support. Range (6-36).
Measured: Baseline and 6th month
Change Overall Well-being Measured by SF-36 Overall Well-being Subscale
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)
Measured: Baseline and 6th month
Change in Social Isolation Measured by Friendship Scale
Measures the level of social isolation from baseline to 12th month follow-up. Lower score means less social isolation. Range (0-24) .
Measured: Baseline and 12th month
Change in Level of Social Support Measured by Social Support Scale
Measures the level of social support from baseline to 12th month follow-up. Higher score means more social support. Range (6-36).
Measured: Baseline and 12th month
Change Overall Well-being Measured by SF-36 Overall Well-being Subscale
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).
Measured: Baseline and 12th month
Secondary outcomes (10)
Change in Computer Comfort Measured by Computer Attitude - Comfort Subscale .
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).
Measured: baseline and 6 months
Changes in Technology Proficiency Measured by Technology Proficiency Scale
Measures the level of technology proficiency from baseline to 6th month follow-up. Higher scores means more computer proficiency. Range (6-30)
Measured: baseline and 6 months
Change in Technology Adoption Measured by Technology Acceptance Questionnaire
Measure the level of technology adoption from baseline to 6th month follow-up. Higher score means more acceptance. Range (6-42)
Measured: baseline and 6 months
Change in Computer Comfort Measured by Computer Attitude - Comfort Subscale .
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)
Measured: baseline and 12 months
Changes in Technology Proficiency Measured by Technology Proficiency Scale
Measures the level of technology proficiency from baseline to 12th month follow-up. A higher score means more computer proficiency. Range (6-30)
Measured: baseline and 12 months
Change in Technology Adoption Measured by Technology Acceptance Questionnaire
Measures the level of technology adoption from baseline to 12th month follow-up. Higher score means more acceptance. Range (6-42)
Measured: baseline and 12 months
Change in Computer Interest Measured by Computer Attitude - Interest Subscale
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)
Measured: Baseline and 6th month follow-up
Change in Computer Interest Measured by Computer Attitude - Interest Subscale
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)
Measured: Baseline and 12th month follow-up
Change in Computer Efficacy Measured by Computer Attitude - Efficacy Subscale
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)
Measured: Baseline and 6th month follow-up
Change in Computer Efficacy Measured by Computer Attitude - Efficacy Subscale
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)
Measured: Baseline and 12th 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 posted22 Dec 2011 (estimated)
- Study startFeb 2011
- Primary completionJan 2014
- Study completionMay 2014
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 (6)Papers the sponsor has linked to this study.
- Other trials for Social IsolationStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara J Czaja, University of Miami
- Investigators
- Sara J. Czaja, PhD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01497613
- Sponsor's protocol ID
- 20100482
- Acronym
- PRISM
- Status last verified
- Jan 2019
- First submitted
- 13 Dec 2011
- Last updated
- 23 Jan 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
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.
PubMed 24107443Czaja 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.
PubMed 25460342Yoon 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.
PubMed 28575476Mitzner 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.
PubMed 31186624Czaja 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.
PubMed 28201730Mitzner 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.
PubMed 30265294
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalized Reminder Information and Social Management System - PRISM
- ClinicalTrials.gov ID
- NCT01497613
- Acronym / sponsor ID
- PRISM / 20100482
- Keywords
- Socialization, Well-being, Quality of Life, Connectivity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- Jan 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 22 Dec 2011 (estimated)
- Results
- Posted 29 Jan 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PRISM B: Notebook Condition | Active comparator | Behavioral: PRISM B: Notebook ConditionTelephone 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. |
| PRISM C: Computer Condition | Experimental | Behavioral: PRISM C: Computer ConditionA 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (5 listed)
- Blind or deaf
- Cognitively impaired (MMSE) < 26
- Fuld Object Memory Test < 20 or 19
- Terminal illness
- Severe motor impairment
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 C: Computer ConditionA specialized computer system designed to support social connectivity and access to resources; knowledge and prospective memory | Behavioural | PRISM C: Computer Condition |
| PRISM B: Notebook ConditionTelephone check-in calls and a notebook that contains information about community resources, games; topics of interests to seniors; a calendar and contact list. | Behavioural | PRISM B: Notebook Condition |
Primary outcome
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) .
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).
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)
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) .
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).
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).
10 secondary outcomes
Change in Computer Comfort Measured by Computer Attitude - Comfort Subscale .
Time frame: baseline and 6 months
Changes in Technology Proficiency Measured by Technology Proficiency Scale
Time frame: baseline and 6 months
Change in Technology Adoption Measured by Technology Acceptance Questionnaire
Time frame: baseline and 6 months
Change in Computer Comfort Measured by Computer Attitude - Comfort Subscale .
Time frame: baseline and 12 months
Changes in Technology Proficiency Measured by Technology Proficiency Scale
Time frame: baseline and 12 months
Change in Technology Adoption Measured by Technology Acceptance Questionnaire
Time frame: baseline and 12 months
Change in Computer Interest Measured by Computer Attitude - Interest Subscale
Time frame: Baseline and 6th month follow-up
Change in Computer Interest Measured by Computer Attitude - Interest Subscale
Time frame: Baseline and 12th month follow-up
Change in Computer Efficacy Measured by Computer Attitude - Efficacy Subscale
Time frame: Baseline and 6th month follow-up
Change in Computer Efficacy Measured by Computer Attitude - Efficacy Subscale
Time frame: Baseline and 12th month follow-up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 24107443Boot 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.
- Background: PubMed 25460342Czaja 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.
- Background: PubMed 28575476Yoon 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.
- Background: PubMed 31186624Mitzner 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.
- Results publication: PubMed 28201730Czaja 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.
- Derived from this study: PubMed 30265294Mitzner 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.
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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
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PRISM C: Computer Condition and PRISM B: Notebook Condition in people with Social Isolation and Social Support (Formal and Informal), run by University of Miami at 1 site 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 10 inclusion and 5 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 23 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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 29 Jan 2018). 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 Social Isolation Measured by Friendship Scale (time frame: Baseline and 6th month). The study lists 6 primary outcomes in all. 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 NCT01497613, which also lists 6 linked publications.
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 23 Jan 2019.