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

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

Tracking Information

• First Submitted Date: July 10, 2016
• First Posted Date: July 13, 2016
• Last Update Posted Date: July 13, 2016
• Study Start Date: February 2012
• Actual Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Mobile Messages Affects Adherence of Stent Removal or Exchange in Patients With Benign Pancreaticobiliary Diseases
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Investigator, Outcomes Assessor); Primary Purpose: Prevention
• Condition: Healthy

Intervention

• 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

• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: July 10, 2016): 48
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: October 2013
• Actual Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: China

Administrative Information

• NCT Number: NCT02831127
• Other Study ID Numbers: 20160707-1
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Responsible Party: Yanglin Pan, Air Force Military Medical University, China
• Study Sponsor: Air Force Military Medical University, China
• Collaborators: Not Provided

Investigators

• Principal Investigator: Yanglin Pan, MD; Xijing Hospital of Disgestive Diseases.The Fourth Military University

• PRS Account: Air Force Military Medical University, China
• Verification Date: July 2016