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

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: Healthy
• Intervention / Treatment: Other: short message service group; Other: conventional group

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanxi
    • Xi'an, Shanxi, China, 710032
      • Endoscopic center, Xijing Hospital of Digestive Diseases

Participation Criteria

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

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: short message service group; Patients in this arm received conventional instructions plus short message reminder.	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.
Active Comparator: conventional group; Patients in this arm just received conventional instructions.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adherence rate of biliary stent removal/exchange	Percentage of patients adherence to stent removal/exchange within appropriate time	up to 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stent-associated adverse event	Percentage of patients with stent-related adverse events, including cholangitis, stent migration and abdominal pain	1 year

Collaborators and Investigators

• Sponsor: Air Force Military Medical University, China
• Investigators: Principal Investigator: Yanglin Pan, MD, Xijing Hospital of Disgestive Diseases.The Fourth Military University

Publications and helpful links

General 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(1):105. doi: 10.1186/s12876-016-0522-4.

Study record dates

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

• Keywords: short message service; adherence; stent exchange; ERCP
• Other Study ID Numbers: 20160707-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided