ClinicalTrials.gov
ClinicalTrials.gov Menu

A Personalized Reminder Information and Social Management System (PRISM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Prevention
Conditions: Social Isolation
Social Support (Formal and Informal)
Well-being/Quality of Life
Interventions: Behavioral: PRISM C: Computer Condition
Behavioral: PRISM B: Notebook Condition

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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.

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.

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.

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


Participant Flow:   Overall Study
    PRISM B: Notebook Condition   PRISM C: Computer Condition
STARTED   150   150 
COMPLETED   113   131 
NOT COMPLETED   37   19 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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.

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.

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.

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

Total Total of all reporting groups

Baseline Measures
   PRISM B: Notebook Condition   PRISM C: Computer Condition   Total 
Overall Participants Analyzed 
[Units: Participants]
 150   150   300 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      0   0.0%      0   0.0%      0   0.0% 
>=65 years      150 100.0%      150 100.0%      300 100.0% 
Age 
[Units: Years]
Mean (Standard Deviation)
 75.34  (7.4)   76.97  (7.3)   76.15  (7.4) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      115  76.7%      119  79.3%      234  78.0% 
Male      35  23.3%      31  20.7%      66  22.0% 
Region of Enrollment 
[Units: Participants]
     
United States   150   150   150 


  Outcome Measures

1.  Primary:   Change in Social Isolation Measured by Friendship Scale   [ Time Frame: Baseline and 6th month ]

2.  Primary:   Change in Level of Social Support Measured by Social Support Scale   [ Time Frame: Baseline and 6th month ]

3.  Primary:   Change Overall Well-being Measured by SF-36 Overall Well-being Subscale   [ Time Frame: Baseline and 6th month ]

4.  Primary:   Change in Social Isolation Measured by Friendship Scale   [ Time Frame: Baseline and 12th month ]

5.  Primary:   Change in Level of Social Support Measured by Social Support Scale   [ Time Frame: Baseline and 12th month ]

6.  Primary:   Change Overall Well-being Measured by SF-36 Overall Well-being Subscale   [ Time Frame: Baseline and 12th month ]

7.  Secondary:   Change in Computer Comfort Measured by Computer Attitude - Comfort Subscale .   [ Time Frame: baseline and 6 months ]

8.  Secondary:   Changes in Technology Proficiency Measured by Technology Proficiency Scale   [ Time Frame: baseline and 6 months ]

9.  Secondary:   Change in Computer Comfort Measured by Computer Attitude - Comfort Subscale .   [ Time Frame: baseline and 12 months ]

10.  Secondary:   Changes in Technology Proficiency Measured by Technology Proficiency Scale   [ Time Frame: baseline and 12 months ]

11.  Secondary:   Change in Computer Interest Measured by Computer Attitude - Interest Subscale   [ Time Frame: Baseline and 6th month follow-up ]

12.  Secondary:   Change in Computer Interest Measured by Computer Attitude - Interest Subscale   [ Time Frame: Baseline and 12th month follow-up ]

13.  Secondary:   Change in Computer Efficacy Measured by Computer Attitude - Efficacy Subscale   [ Time Frame: Baseline and 6th month follow-up ]

14.  Secondary:   Change in Computer Efficacy Measured by Computer Attitude - Efficacy Subscale   [ Time Frame: Baseline and 12th month follow-up ]

15.  Secondary:   Change in Technology Adoption Measured by Technology Acceptance Questionnaire   [ Time Frame: baseline and 6 months ]
Results not yet reported.   Anticipated Reporting Date:   12/2017  

16.  Secondary:   Change in Technology Adoption Measured by Technology Acceptance Questionnaire   [ Time Frame: baseline and 12 months ]
Results not yet reported.   Anticipated Reporting Date:   12/2017  


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Sara J. Czaja
Organization: University of Miami Miller School of Medicine
phone: 305-355-9068
e-mail: sczaja@med.miami.edu


Publications of Results:
Other Publications:

Responsible Party: Sara J Czaja, University of Miami
ClinicalTrials.gov Identifier: NCT01497613     History of Changes
Other Study ID Numbers: 20100482
First Submitted: December 13, 2011
First Posted: December 22, 2011
Results First Submitted: March 27, 2017
Results First Posted: January 29, 2018
Last Update Posted: January 29, 2018