Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date January 2019
Source University of Miami
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
PRISM C: Computer Condition
A specialized computer system designed to support social connectivity and access to resources; knowledge and prospective memory
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.

Locations

Country Name City State
United States University of Miami Miami Florida

Sponsors (1)

Lead Sponsor Collaborator
University of Miami

Country where clinical trial is conducted

United States, 

References & Publications (5)

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

Outcome

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
See also
  Status Clinical Trial Phase
Recruiting NCT05831475 - LEAPTogether: An Intergenerational Intervention to Address Loneliness and Social Isolation N/A
Completed NCT03291717 - Bridging Community Gaps Photovoice N/A
Recruiting NCT06175299 - Social Functions to Promote Home-based Cognitive Training N/A
Completed NCT04573972 - Using Social Connectedness to Increase Physical Activity N/A
Not yet recruiting NCT05031247 - Refugee Mental Health and Wellness Pilot Study N/A
Completed NCT02596672 - Promoting Walking in Older Adults Living in Independent Living Communities in Northern Ireland: A Feasibility Study. N/A
Active, not recruiting NCT05678985 - Evaluating Impact and Implementation of Choose to Move (Phase 4) N/A
Active, not recruiting NCT04072185 - PHYSICAL ACTIVITY AS A MEASURE OF IMPROVING THE EMOTIONAL STATE AND SOCIALIZATION IN THE ELDERLY N/A
Completed NCT06018974 - Digital Gaming Intervention for Older People in Long-term Care N/A
Recruiting NCT04897802 - Identification and Clinical Relevance of an Oxytocin Deficient State (GLP1 Study) Phase 4
Recruiting NCT06138301 - Telepsychiatry for Social Isolation in Youths N/A
Enrolling by invitation NCT06434298 - Provincial Scale-up of Choose to Move (CTM) Phase 4 N/A
Recruiting NCT05520450 - Telematic Support Group in Patients With Feelings of Loneliness and Social Isolation
Recruiting NCT05019053 - Acceptability/Feasibility of COVID-19 Intervention N/A
Completed NCT04567940 - ENRED@TE. Social Support in Southern Spain. Interventional Study N/A
Completed NCT04281654 - Effects of Arts Engagement on Physical Performance, Cognition, Social Isolation, and Self-Perception in Older Adults N/A
Completed NCT03472729 - AGE-ON 2.0: Expanding and Evaluating a Tablet Training Program for Older Adults N/A
Completed NCT03293823 - HARP-Project 1 Cognitive Training N/A
Completed NCT02835989 - Community Paramedicine at Home N/A
Completed NCT02041585 - Discharge Functional Status and Rehospitalization in the Elderly