A Personalized Reminder Information and Social Management System (PRISM)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Sara J Czaja, University of Miami
ClinicalTrials.gov Identifier:
NCT01497613
First received: December 13, 2011
Last updated: September 13, 2013
Last verified: September 2013

December 13, 2011
September 13, 2013
February 2011
January 2014   (final data collection date for primary outcome measure)
  • Change in degree of social isolation (baseline to 6th mth) [ Time Frame: Baseline and 6th month ] [ Designated as safety issue: No ]
    Feelings of loneliness; lack of connectivity.
  • Change in level of social support (baseline to 6th mth) [ Time Frame: Baseline and 6th month ] [ Designated as safety issue: No ]
    Access to formal and informal resources. Perceptions of others available to provide instrumental and emotional support. Knowledge of available support resources.
  • Change overall well-being (baseline to 6th mth) [ Time Frame: Baseline and 6th month ] [ Designated as safety issue: No ]
    Level of emotional distress; satisfaction with life and various aspects of life; perceptions of quality of life.
  • Change in degree of social isolation (baseline to 12mth) [ Time Frame: Baseline and 12th month ] [ Designated as safety issue: No ]
    Feelings of loneliness; lack of connectivity.
  • Change in level of social support (baseline to 12th mth) [ Time Frame: Baseline and 12th month ] [ Designated as safety issue: No ]
    Access to formal and informal resources. Perceptions of others available to provide instrumental and emotional support. Knowledge of available support resources.
  • Change overall well-being (baseline to 12th mth) [ Time Frame: Baseline and 12th month ] [ Designated as safety issue: No ]
    Level of emotional distress; satisfaction with life and various aspects of life; perceptions of quality of life.
Same as current
Complete list of historical versions of study NCT01497613 on ClinicalTrials.gov Archive Site
  • Change in attitudes towards technology (baseline to 6th mth) [ Time Frame: baseline and 6 months ] [ Designated as safety issue: No ]
    Perceptions regarding comfort with technology; technology efficacy and interest in technology.
  • Change in technology proficiency (baseline to 6th mth) [ Time Frame: baseline and 6 months ] [ Designated as safety issue: No ]
    Knowledge of and ratings of computer and Internet skills.
  • Change in technology adoption (baseline to 6th mth) [ Time Frame: baseline and 6 months ] [ Designated as safety issue: No ]
    Willingness to use technology and actual use of technology
  • Change in attitudes towards technology (baseline to 12th mth) [ Time Frame: baseline and 12 months ] [ Designated as safety issue: No ]
    Perceptions regarding comfort with technology; technology efficacy and interest in technology.
  • Change in technology proficiency (baseline to 12th mth) [ Time Frame: baseline and 12 months ] [ Designated as safety issue: No ]
    Knowledge of and ratings of computer and Internet skills.
  • Change in technology adoption (baseline to 12th mth) [ Time Frame: baseline and 12 months ] [ Designated as safety issue: No ]
    Willingness to use technology and actual use of technology
Same as current
Not Provided
Not Provided
 
A Personalized Reminder Information and Social Management System
Not Provided

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
  • Social Isolation
  • Social Support (Formal and Informal)
  • Well-being/Quality of Life
  • Behavioral: PRISM C: Computer Condition
    A specialized computer system designed to support social connectivity and access to resources; knowledge and prospective memory
  • Behavioral: 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.
  • 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.
    Intervention: Behavioral: PRISM B: Notebook Condition
  • 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.
    Intervention: Behavioral: PRISM C: Computer Condition
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
300
May 2014
January 2014   (final data collection date for primary outcome measure)

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
Both
65 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01497613
P01-AG017211
Yes
Sara J Czaja, University of Miami
University of Miami
Not Provided
Principal Investigator: Sara J. Czaja, PhD University of Miami
University of Miami
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP