Mobile Messages Affects Adherence of Stent Removal or Exchange in Patients With Benign Pancreaticobiliary Diseases
July 10, 2016 updated by: Yanglin Pan, Air Force Military Medical University, China
Mobile Phone Reminder Messages Improves the Adherence of Stent Removal or Exchange in Patients With Benign Pancreaticobiliary Diseases
Plastic and covered metal stents need to be removed or exchanged within appropriate time in case of undesirable complications.
However, it is not uncommon that patients does not follow the recommendation for further stent management after ERCP.
we hopothesized that short message service (SMS) intervention monthly could improve the adherence in patients with benign pancreaticobiliary after ERCP.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
48
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Shanxi
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Xi'an, Shanxi, China, 710032
- Endoscopic center, Xijing Hospital of Digestive Diseases
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- be able to communicate via SMS by mobile phones of themselves or relatives living together
Exclusion Criteria:
- primary or secondary sclerosing cholangitis (PSC)
- malignant or suspected malignant stricture of biliary or pancreatic duct
- implantation of pancreatic duct (PD) stent for prevention of post-ERCP pancreatitis
- expected survival time less than 6 months
- plan of surgery within 6 months
- pregnant or lactating women
- patients who could not give informed consent.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: short message service group
Patients in this arm received conventional instructions plus short message reminder.
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Each month after stent implantation, the investigator sent a text message by SMS to inform patients the necessity of regular stent removal/exchange and the disadvantage of delayed management, and to remind them the appropriate date to come back to the hospital for stent management.
Patients were requested to respond by SMS and were encouraged to contact the investigator if they had any questions about stent management.
Besides, patients received conventional reminder:After stent implantation, all patients received oral and written instructions about further management.
If single or multiple plastic stents were inserted, patients were informed to come back to the hospital at 3 months for stent removal/exchange; if FCSEMS was inserted, they were informed to come back to the hospital at 6 months after ERCP.
|
|
Active Comparator: conventional group
Patients in this arm just received conventional instructions.
|
After stent implantation, all patients received oral and written instructions about further management.
If single or multiple plastic stents were inserted, patients were informed to come back to the hospital at 3 months for stent removal/exchange; if FCSEMS was inserted, they were informed to come back to the hospital at 6 months after ERCP.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Adherence rate of biliary stent removal/exchange
Time Frame: up to 1 year
|
Percentage of patients adherence to stent removal/exchange within appropriate time
|
up to 1 year
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Stent-associated adverse event
Time Frame: 1 year
|
Percentage of patients with stent-related adverse events, including cholangitis, stent migration and abdominal pain
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Yanglin Pan, MD, Xijing Hospital of Disgestive Diseases.The Fourth Military University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2012
Primary Completion (Actual)
October 1, 2013
Study Completion (Actual)
October 1, 2013
Study Registration Dates
First Submitted
July 10, 2016
First Submitted That Met QC Criteria
July 10, 2016
First Posted (Estimate)
July 13, 2016
Study Record Updates
Last Update Posted (Estimate)
July 13, 2016
Last Update Submitted That Met QC Criteria
July 10, 2016
Last Verified
July 1, 2016
More Information
Terms related to this study
Other Study ID Numbers
- 20160707-1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.