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Mobile Messages Affects Adherence of Stent Removal or Exchange in Patients With Benign Pancreaticobiliary Diseases

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ClinicalTrials.gov Identifier: NCT02831127
Recruitment Status : Completed
First Posted : July 13, 2016
Last Update Posted : July 13, 2016
Sponsor:
Information provided by (Responsible Party):
Yanglin Pan, Fourth Military Medical University

Tracking Information
First Submitted Date  ICMJE July 10, 2016
First Posted Date  ICMJE July 13, 2016
Last Update Posted Date July 13, 2016
Study Start Date  ICMJE February 2012
Actual Primary Completion Date October 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 10, 2016)
Adherence rate of biliary stent removal/exchange [ Time Frame: up to 1 year ]
Percentage of patients adherence to stent removal/exchange within appropriate time
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: July 10, 2016)
Stent-associated adverse event [ Time Frame: 1 year ]
Percentage of patients with stent-related adverse events, including cholangitis, stent migration and abdominal pain
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Mobile Messages Affects Adherence of Stent Removal or Exchange in Patients With Benign Pancreaticobiliary Diseases
Official Title  ICMJE Mobile Phone Reminder Messages Improves the Adherence of Stent Removal or Exchange in Patients With Benign Pancreaticobiliary Diseases
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Healthy
Intervention  ICMJE
  • Other: short message service group
    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.
  • Other: conventional group
    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.
Study Arms  ICMJE
  • Experimental: short message service group
    Patients in this arm received conventional instructions plus short message reminder.
    Intervention: Other: short message service group
  • Active Comparator: conventional group
    Patients in this arm just received conventional instructions.
    Intervention: Other: conventional group
Publications * Gu Y, Wang L, Zhao L, Liu Z, Luo H, Tao Q, Zhang R, He S, Wang X, Huang R, Zhang L, Pan Y, Guo X. Effect of mobile phone reminder messages on adherence of stent removal or exchange in patients with benign pancreaticobiliary diseases: a prospectively randomized, controlled study. BMC Gastroenterol. 2016 Aug 26;16:105. doi: 10.1186/s12876-016-0522-4.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 10, 2016)
48
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2013
Actual Primary Completion Date October 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02831127
Other Study ID Numbers  ICMJE 20160707-1
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Yanglin Pan, Fourth Military Medical University
Study Sponsor  ICMJE Fourth Military Medical University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Yanglin Pan, MD Xijing Hospital of Disgestive Diseases.The Fourth Military University
PRS Account Fourth Military Medical University
Verification Date July 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP