Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 68 of 662 for:    SMS

Effect of Short Message Service Intervention on Stent Removal/Exchange Adherence in Patients With Benign Pancreaticobiliary Diseases

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02041390
Recruitment Status : Completed
First Posted : January 22, 2014
Last Update Posted : January 22, 2014
Sponsor:
Information provided by (Responsible Party):
Yanglin Pan, Fourth Military Medical University

Brief Summary:

Endoscopic implantation of plastic or covered metal stents is widely used in a variety of benign pancreaticobiliary diseases, including duct stricture, large or difficult stones, bile or pancreatic juice leak, etc. There are some late-stage adverse events after stent insertion, such as stent occlusion, proximal or distal migration, secondary duct injury and failure of stent removal, etc. The longer the stents were inserted, more likely the adverse events would happen.

Although the optimal time of stent placement has not been well established, it has been recommended that plastic stent should be removed/exchanged within 3-4 months and covered metal stent be removed within 6 months. However, it was not uncommon that patients with stent implantation did not follow the recommendation of further stent management by endoscopists.

Many methods have been used to improve the adherence of patients in medical service. With the advance of mobile technology and popular use of mobile phones, it was believed that the patient-centered outcome could be improved by mobile telecommunication with the timely support of a patient by a health professional. Thus we hypothesize that mobile technology, reminding the patients the necessity of stent management in time by short message service (SMS), might increase the patient adherence in patients with benign pancreaticobiliary diseases after ERCP.


Condition or disease Intervention/treatment Phase
Short Message Service Adherence Stent Exchange ERCP Biliary Stricture Other: SMS reminder Other: Conventional reminder Not Applicable

Layout table for study information
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: Effect of Short Message Service Intervention on Stent Removal/Exchange Adherence in Patients With Benign Pancreaticobiliary Diseases: a Prospectively Randomized, Controlled Study
Study Start Date : September 2012
Actual Primary Completion Date : October 2013
Actual Study Completion Date : January 2014

Arm Intervention/treatment
Experimental: SMS group
Patients in SMS group will receive reminding by additional SMS messages monthly after stent implantation.
Other: SMS reminder
Each month after stent implantation, one investigator sent a text massage 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 back to the hospital for stent management. Patients were requested to response by SMS and were encouraged to contact with the investigator if they had any questions about stent management.

Other: Conventional reminder
After stent implantation, all patients received oral instruction about further management. If single or multiple plastic stents were inserted, patients were informed back to our hospital at 3 months for stent removal/exchange; if FCSEMS was inserted, they were informed back to the hospital at 6 months.

Active Comparator: Conventional reminder group
Patients in control group will not receive additional SMS reminder monthly after stent implantation.
Other: Conventional reminder
After stent implantation, all patients received oral instruction about further management. If single or multiple plastic stents were inserted, patients were informed back to our hospital at 3 months for stent removal/exchange; if FCSEMS was inserted, they were informed back to the hospital at 6 months.




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 (4 months for plastic stent or 7 months for covered stent).


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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   80 Years to 90 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients more than 18 years old with plastic or covered stent implantation for the drainage of bile or pancreatic juice.

Exclusion Criteria:

  • primary or secondary sclerosing cholangitis;
  • malignant or suspected malignant stricture of biliary or pancreatic duct;
  • implantation of pancreatic duct 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): NCT02041390


Locations
Layout table for location information
China, Shaanxi
Xijing Hospital of Digestive Diseases
Xi'an, Shaanxi, China, 710032
Sponsors and Collaborators
Fourth Military Medical University

Publications:

Layout table for additonal information
Responsible Party: Yanglin Pan, Associated professor, Fourth Military Medical University
ClinicalTrials.gov Identifier: NCT02041390     History of Changes
Other Study ID Numbers: 20120920-5
20120920-5 ( Other Identifier: Institutional Review Board of Xijing Hospital )
First Posted: January 22, 2014    Key Record Dates
Last Update Posted: January 22, 2014
Last Verified: January 2014
Additional relevant MeSH terms:
Layout table for MeSH terms
Constriction, Pathologic
Pathological Conditions, Anatomical