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A Personalized Reminder Information and Social Management System (PRISM)

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ClinicalTrials.gov Identifier: NCT01497613
Recruitment Status : Completed
First Posted : December 22, 2011
Results First Posted : January 29, 2018
Last Update Posted : January 29, 2018
Sponsor:
Information provided by (Responsible Party):
Sara J Czaja, University of Miami

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.

Condition or disease Intervention/treatment Phase
Social Isolation Social Support (Formal and Informal) Well-being/Quality of Life Behavioral: PRISM C: Computer Condition Behavioral: PRISM B: Notebook Condition Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Study Start Date : February 2011
Actual Primary Completion Date : January 2014
Actual Study Completion Date : May 2014

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Change in Social Isolation Measured by Friendship Scale [ Time Frame: Baseline and 6th month ]
    Lower score means less social isolation. Range (0-24) .

  2. Change in Level of Social Support Measured by Social Support Scale [ Time Frame: Baseline and 6th month ]
    Higher score means more social support. Range (6-36).

  3. Change Overall Well-being Measured by SF-36 Overall Well-being Subscale [ Time Frame: Baseline and 6th month ]
    Higher score indicates more peaceful, full, and calm. Range (0-100)

  4. Change in Social Isolation Measured by Friendship Scale [ Time Frame: Baseline and 12th month ]
    Lower score means less social isolation. Range (0-24) .

  5. Change in Level of Social Support Measured by Social Support Scale [ Time Frame: Baseline and 12th month ]
    Higher score means more social support. Range (6-36).

  6. Change Overall Well-being Measured by SF-36 Overall Well-being Subscale [ Time Frame: Baseline and 12th month ]
    Higher score means more peaceful, happy and calm. Range (0-100).


Secondary Outcome Measures :
  1. Change in Computer Comfort Measured by Computer Attitude - Comfort Subscale . [ Time Frame: baseline and 6 months ]
    Higher score means more computer comfort. Range (5-25).

  2. Changes in Technology Proficiency Measured by Technology Proficiency Scale [ Time Frame: baseline and 6 months ]
    Higher scores means more computer proficiency. Range (6-30)

  3. Change in Technology Adoption Measured by Technology Acceptance Questionnaire [ Time Frame: baseline and 6 months ]
    Higher score means more acceptance. Range (1-7)

  4. Change in Computer Comfort Measured by Computer Attitude - Comfort Subscale . [ Time Frame: baseline and 12 months ]
    Higher score means more computer comfort. Range (5-25)

  5. Changes in Technology Proficiency Measured by Technology Proficiency Scale [ Time Frame: baseline and 12 months ]
    A higher score means more computer proficiency. Range (6-30)

  6. Change in Technology Adoption Measured by Technology Acceptance Questionnaire [ Time Frame: baseline and 12 months ]
    Higher score means more acceptance. Range (1-7)

  7. Change in Computer Interest Measured by Computer Attitude - Interest Subscale [ Time Frame: Baseline and 6th month follow-up ]
    Higher score means more interest towards computer. Range (5-25)

  8. Change in Computer Interest Measured by Computer Attitude - Interest Subscale [ Time Frame: Baseline and 12th month follow-up ]
    Higher score means more interest towards computer. Range (5-25)

  9. Change in Computer Efficacy Measured by Computer Attitude - Efficacy Subscale [ Time Frame: Baseline and 6th month follow-up ]
    Higher score means more efficacy towards computer. Range (5-25)

  10. Change in Computer Efficacy Measured by Computer Attitude - Efficacy Subscale [ Time Frame: Baseline and 12th month follow-up ]
    Higher score means more efficacy towards computer. Range (5-25)



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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications of Results:
Other Publications:
Responsible Party: Sara J Czaja, Professor, University of Miami
ClinicalTrials.gov Identifier: NCT01497613     History of Changes
Other Study ID Numbers: 20100482
First Posted: December 22, 2011    Key Record Dates
Results First Posted: January 29, 2018
Last Update Posted: January 29, 2018
Last Verified: July 2017

Keywords provided by Sara J Czaja, University of Miami:
Socialization
Well-being
Quality of Life
Connectivity