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A Personalized Reminder Information and Social Management System (PRISM)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sara J Czaja, University of Miami
ClinicalTrials.gov Identifier:
NCT01497613
First received: December 13, 2011
Last updated: November 14, 2014
Last verified: November 2014
  Purpose

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.


Condition Intervention
Social Isolation
Social Support (Formal and Informal)
Well-being/Quality of Life
Behavioral: PRISM C: Computer Condition
Behavioral: PRISM B: Notebook Condition

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention

Resource links provided by NLM:


Further study details as provided by University of Miami:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Enrollment: 300
Study Start Date: February 2011
Study Completion Date: May 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.
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.
Behavioral: PRISM C: Computer Condition
A specialized computer system designed to support social connectivity and access to resources; knowledge and prospective memory

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01497613

Locations
United States, Florida
University of Miami
Miami, Florida, United States, 33136
Sponsors and Collaborators
University of Miami
Investigators
Principal Investigator: Sara J. Czaja, PhD University of Miami
  More Information

No publications provided

Responsible Party: Sara J Czaja, Professor, University of Miami
ClinicalTrials.gov Identifier: NCT01497613     History of Changes
Other Study ID Numbers: 20100482
Study First Received: December 13, 2011
Last Updated: November 14, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Miami:
Socialization
Well-being
Quality of Life
Connectivity

ClinicalTrials.gov processed this record on November 27, 2014