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Trial record 1 of 1 for:    NCT02831127
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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

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.

Condition or disease Intervention/treatment Phase
Healthy Other: short message service group Other: conventional group Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Mobile Phone Reminder Messages Improves the Adherence of Stent Removal or Exchange in Patients With Benign Pancreaticobiliary Diseases
Study Start Date : February 2012
Actual Primary Completion Date : October 2013
Actual Study Completion Date : October 2013

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.




Primary Outcome Measures :
  1. Adherence rate of biliary stent removal/exchange [ Time Frame: up to 1 year ]
    Percentage of patients adherence to stent removal/exchange within appropriate time


Secondary Outcome Measures :
  1. Stent-associated adverse event [ Time Frame: 1 year ]
    Percentage of patients with stent-related adverse events, including cholangitis, stent migration and abdominal pain



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02831127


Locations
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China, Shanxi
Endoscopic center, Xijing Hospital of Digestive Diseases
Xi'an, Shanxi, China, 710032
Sponsors and Collaborators
Fourth Military Medical University
Investigators
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Principal Investigator: Yanglin Pan, MD Xijing Hospital of Disgestive Diseases.The Fourth Military University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Yanglin Pan, Associated professor, Fourth Military Medical University
ClinicalTrials.gov Identifier: NCT02831127     History of Changes
Other Study ID Numbers: 20160707-1
First Posted: July 13, 2016    Key Record Dates
Last Update Posted: July 13, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Yanglin Pan, Fourth Military Medical University:
short message service; adherence; stent exchange; ERCP