Social Isolation Clinical Trial
— PRISMOfficial title:
Personalized Reminder Information and Social Management System - PRISM
| NCT number | NCT01497613 |
| Other study ID # | 20100482 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | February 2011 |
| Est. completion date | May 2014 |
| Verified date | January 2019 |
| Source | University of Miami |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 300 |
| Est. completion date | May 2014 |
| Est. primary completion date | January 2014 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 65 Years and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | University of Miami | Miami | Florida |
| Lead Sponsor | Collaborator |
|---|---|
| University of Miami |
United States,
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. — View Citation
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. — View Citation
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. — View Citation
Mitzner, T. L., Rogers, W. A., Fisk, A., Boot, W. R., Charness, N., Czaja, S. J., & Sharit, J. (2016). Predicting Older Adults' Perceptions about a Computer System Designed for Seniors. Universal Access in the Information Society, 15(2), 271-280. DOI 10.1007/s10209-014-0383-y.
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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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) . | Baseline and 6th month | |
| Primary | 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). | Baseline and 6th month | |
| Primary | 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) | Baseline and 6th month | |
| Primary | 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) . | Baseline and 12th month | |
| Primary | 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). | Baseline and 12th month | |
| Primary | 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). | Baseline and 12th month | |
| Secondary | 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). | baseline and 6 months | |
| Secondary | 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) | baseline and 6 months | |
| Secondary | 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) | baseline and 6 months | |
| Secondary | 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) | baseline and 12 months | |
| Secondary | 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) | baseline and 12 months | |
| Secondary | 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) | baseline and 12 months | |
| Secondary | 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) | Baseline and 6th month follow-up | |
| Secondary | 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) | Baseline and 12th month follow-up | |
| Secondary | 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) | Baseline and 6th month follow-up | |
| Secondary | 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) | Baseline and 12th month follow-up |
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