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

NCT ID: NCT02831127

Last Updated: 2016-07-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Study Completion Date

2013-10-31

Brief Summary

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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

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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short message service group

Patients in this arm received conventional instructions plus short message reminder.

Group Type EXPERIMENTAL

short message service group

Intervention Type OTHER

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.

conventional group

Patients in this arm just received conventional instructions.

Group Type ACTIVE_COMPARATOR

conventional group

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Air Force Military Medical University, China

OTHER

Sponsor Role lead

Responsible Party

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Yanglin Pan

Associated professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yanglin Pan, MD

Role: PRINCIPAL_INVESTIGATOR

Xijing Hospital of Disgestive Diseases.The Fourth Military University

Locations

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Endoscopic center, Xijing Hospital of Digestive Diseases

Xi’an, Shanxi, China

Site Status

Countries

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China

References

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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.

Reference Type DERIVED
PMID: 27565717 (View on PubMed)

Other Identifiers

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20160707-1

Identifier Type: -

Identifier Source: org_study_id

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