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Use of Telehealth In-home Messaging to Improve GI (Gastrointestinal) Endoscopy Completion Rates (GIVER)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00310362
First Posted: April 3, 2006
Last Update Posted: April 24, 2015
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.
Information provided by (Responsible Party):
VA Office of Research and Development
Results First Submitted: September 16, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Health Services Research
Condition: Colorectal Cancer
Intervention: Behavioral: Use of IVR system to improve adherene to GI appointments and prep procedures

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Usual Care Usual care included nurse phone calls to participants 7 days prior to the scheduled appointment. Calls were intended as appointment reminders and opportunities for education on preparation procedures.
IVR3 Arm 2 (IVR3) included interactive voice response calls delivered to patients 3 days prior to the scheduled appointment. Calls were intended as appointment reminders and as interactive, but pre-recorded, opportunities for education on preparation procedures.
IVR7 Arm 3 (IVR7) included interactive voice response calls delivered to patients 7 days prior to the scheduled appointment. Calls were intended as appointment reminders and as interactive, but pre-recorded, opportunities for education on preparation procedures.

Participant Flow:   Overall Study
    Usual Care   IVR3   IVR7
STARTED   1199   1205   1206 
COMPLETED   1199   1205   1206 
NOT COMPLETED   0   0   0 



  Baseline Characteristics
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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.
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Reporting Groups
  Description
Usual Care Usual Care--Nurses telephoned patients 7 days prior to appointment to remind patients about scheduled GI appointment and to answer any questions.
IVR3 Arm 2 (IVR3) included interactive voice response calls delivered to patients 3 days prior to the scheduled appointment. Calls were intended as appointment reminders and as interactive, but pre-recorded, opportunities for education on preparation procedures..
IVR7 Arm 3 (IVR7) included interactive voice response calls delivered to patients 7 days prior to the scheduled appointment. Calls were intended as appointment reminders and as interactive, but pre-recorded, opportunities for education on preparation procedures.
Total Total of all reporting groups

Baseline Measures
   Usual Care   IVR3   IVR7   Total 
Overall Participants Analyzed 
[Units: Participants]
 1199   1205   1206   3610 
Age 
[Units: Years]
Mean (Standard Deviation)
 62.6  (9.9)   62.8  (10.2)   62.5  (10.2)   62.6  (10.1) 
Gender 
[Units: Participants]
       
Female   50   54   50   154 
Male   1149   1151   1156   3456 
Region of Enrollment 
[Units: Participants]
       
United States   1199   1205   1206   3610 


  Outcome Measures

1.  Primary:   Appointment Nonadherence-colonoscopy   [ Time Frame: 3 months ]

2.  Secondary:   Nonattendance-flexible Sigmoidoscopy   [ Time Frame: 3 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

3.  Secondary:   Preparation Nonadherence-colonoscopy   [ Time Frame: 3 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

4.  Secondary:   Preparation Non-adherence-flexible Sigmoidoscopy   [ Time Frame: 3 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Joan Griffin
Organization: MInneapolis VA Health Care System
phone: 507-538-1490
e-mail: griffin.joan@mayo.edu


Publications of Results:

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00310362     History of Changes
Other Study ID Numbers: IIR 03-295
First Submitted: March 30, 2006
First Posted: April 3, 2006
Results First Submitted: September 16, 2014
Results First Posted: September 25, 2014
Last Update Posted: April 24, 2015