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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00310362
First received: March 30, 2006
Last updated: September 22, 2014
Last verified: September 2014
Results First Received: September 16, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Subject);   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  
Number of Participants  
[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.   Safety Issue:   No

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

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


  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: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00310362     History of Changes
Other Study ID Numbers: IIR 03-295
Study First Received: March 30, 2006
Results First Received: September 16, 2014
Last Updated: September 22, 2014
Health Authority: United States: Federal Government