NCT01497613

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2011

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

December 13, 2011

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 22, 2011

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
3.8 years until next milestone

Results Posted

Study results publicly available

January 29, 2018

Completed
Last Updated

January 23, 2019

Status Verified

January 1, 2019

Enrollment Period

2.9 years

First QC Date

December 13, 2011

Results QC Date

March 27, 2017

Last Update Submit

January 3, 2019

Conditions

Keywords

SocializationWell-beingQuality of LifeConnectivity

Outcome Measures

Primary Outcomes (6)

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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 Outcomes (10)

  • Change in Computer Comfort Measured by Computer Attitude - Comfort Subscale .

    baseline and 6 months

  • Changes in Technology Proficiency Measured by Technology Proficiency Scale

    baseline and 6 months

  • Change in Technology Adoption Measured by Technology Acceptance Questionnaire

    baseline and 6 months

  • Change in Computer Comfort Measured by Computer Attitude - Comfort Subscale .

    baseline and 12 months

  • Changes in Technology Proficiency Measured by Technology Proficiency Scale

    baseline and 12 months

  • +5 more secondary outcomes

Study Arms (2)

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.

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.

Behavioral: PRISM C: Computer Condition

Interventions

A specialized computer system designed to support social connectivity and access to resources; knowledge and prospective memory

PRISM C: Computer 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.

PRISM B: Notebook Condition

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • + 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
  • /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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Miami

Miami, Florida, 33136, United States

Location

Related Publications (6)

  • 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.

    PMID: 24107443BACKGROUND
  • 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.

    PMID: 25460342BACKGROUND
  • 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.

    PMID: 28575476BACKGROUND
  • 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.

    PMID: 31186624BACKGROUND
  • 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.

MeSH Terms

Conditions

Social Isolation

Condition Hierarchy (Ancestors)

Social BehaviorBehavior

Results Point of Contact

Title
Dr. Sara J. Czaja
Organization
University of Miami Miller School of Medicine

Study Officials

  • Sara J. Czaja, PhD

    University of Miami

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 13, 2011

First Posted

December 22, 2011

Study Start

February 1, 2011

Primary Completion

January 1, 2014

Study Completion

May 1, 2014

Last Updated

January 23, 2019

Results First Posted

January 29, 2018

Record last verified: 2019-01

Locations