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Text Reminders to Immunize in a Managed Care Organization (TRIO)

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ClinicalTrials.gov Identifier: NCT01806714
Recruitment Status : Completed
First Posted : March 7, 2013
Results First Posted : June 26, 2017
Last Update Posted : June 26, 2017
Sponsor:
Information provided by (Responsible Party):
Cynthia Rand, University of Rochester

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Health Services Research
Condition: Human Papilloma Virus
Interventions: Other: Text-based reminder for recommended HPV vaccine or WCC
Other: Non-specific text-based reminder (general health tip)

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
4182 subjects met eligibility but only a subset were enrolled to receive the intervention because they has functional phone numbers

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
For this study, there was a waiver of consent; 4182 subjects met eligibility but only a subset were enrolled to receive the intervention because they has functional phone numbers.

Reporting Groups
  Description
Text-based Reminder for HPV Vaccine/WCC

Parents of adolescents will receive text-based reminders if their adolescent is due for HPV vaccine (dose 1, 2 or 3) or well child care visit

Text-based reminder for recommended HPV vaccine or well care visit

Control Arm

Parents of adolescents receive preventive health tips via text messages (not specific to services for which child is due)

Non-specific text-based reminder (general health tip): Parents of adolescents receive preventive health tips via text messages (not specific to services for which child is due)


Participant Flow:   Overall Study
    Text-based Reminder for HPV Vaccine/WCC   Control Arm
STARTED   2093   2089 
COMPLETED   1893   1919 
NOT COMPLETED   200   170 
No functioning phone number                200                170 



  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
Text-based Reminder for HPV Vaccine/WCC

Parents of adolescents will receive text-based reminders if their adolescent is due for HPV vaccine (dose 1, 2 or 3) or well child care visit

Text-based reminder for recommended HPV vaccine or well care visit

Control Arm

Parents of adolescents receive preventive health tips via text messages (not specific to services for which child is due)

Non-specific text-based reminder (general health tip): Parents of adolescents receive preventive health tips via text messages (not specific to services for which child is due)

Total Total of all reporting groups

Baseline Measures
   Text-based Reminder for HPV Vaccine/WCC   Control Arm   Total 
Overall Participants Analyzed 
[Units: Participants]
 1893   1919   3812 
Age, Customized 
[Units: Participants]
     
11 year olds   428   407   835 
12 year olds   341   380   721 
13 year olds   307   324   631 
14 year olds   281   288   569 
15 year olds   271   270   541 
16 year olds   265   250   515 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      863  45.6%      868  45.2%      1731  45.4% 
Male      1030  54.4%      1051  54.8%      2081  54.6% 


  Outcome Measures

1.  Primary:   Percentage of Participants Receiving HPV Vaccination (Dose 1)   [ Time Frame: 9 months ]

2.  Secondary:   Percentage of Participants Receiving HPV Vaccination (Dose 2)   [ Time Frame: 9 months ]

3.  Secondary:   Percentage of Participants Receiving HPV Vaccination (Dose 3)   [ Time Frame: 9 months ]


  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. Cynthia Rand
Organization: University of Rochester
phone: 585 275-9316
e-mail: cynthia_rand@urmc.rochester.edu



Responsible Party: Cynthia Rand, University of Rochester
ClinicalTrials.gov Identifier: NCT01806714     History of Changes
Other Study ID Numbers: 056103-002
First Submitted: March 5, 2013
First Posted: March 7, 2013
Results First Submitted: December 30, 2015
Results First Posted: June 26, 2017
Last Update Posted: June 26, 2017