HealthyNCT02831127
Mobile Messages Affects Adherence of Stent Removal or Exchange in Patients With Benign Pancreaticobiliary Diseases
A study testing short message service group and conventional group in people with Healthy, run by Air Force Military Medical University, China at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Healthy
- What is being tested?
- short message service group and conventional group
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteChina
- Study dates
- Feb 2012to Oct 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- be able to communicate via SMS by mobile phones of themselves or relatives living together
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Endoscopic center, Xijing Hospital of Digestive Diseases
Xi’an, Shanxi, 710032
About this study
Official title: 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.
- Conditions
- Healthy
- Being tested
- short message service group, conventional group
- Keywords
- short message service; adherence; stent exchange; ERCP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
short message service groupOther
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 groupOther
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 group | Role | What they receive |
|---|---|---|
| short message service group | Experimental | Patients in this arm received conventional instructions plus short message reminder. Receives: Other: short message service group |
| conventional group | Active comparator | Patients in this arm just received conventional instructions. Receives: Other: conventional group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence rate of biliary stent removal/exchange
Percentage of patients adherence to stent removal/exchange within appropriate time
Measured: up to 1 year
Secondary outcomes (1)
Stent-associated adverse event
Percentage of patients with stent-related adverse events, including cholangitis, stent migration and abdominal pain
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2016 (estimated)
- Study startFeb 2012
- Primary completionOct 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Air Force Military Medical University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yanglin Pan, Air Force Military Medical University, China
- Investigators
- Yanglin Pan, MD, Principal investigator, Xijing Hospital of Disgestive Diseases.The Fourth Military University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02831127
- Sponsor's protocol ID
- 20160707-1
- Status last verified
- Jul 2016
- First submitted
- 10 Jul 2016
- Last updated
- 13 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
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.
PubMed 27565717
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mobile Phone Reminder Messages Improves the Adherence of Stent Removal or Exchange in Patients With Benign Pancreaticobiliary Diseases
- ClinicalTrials.gov ID
- NCT02831127
- Acronym / sponsor ID
- 20160707-1
- Conditions
- Healthy
- Keywords
- short message service; adherence; stent exchange; ERCP
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Air Force Military Medical University, ChinaUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 13 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| short message service group | Experimental | Other: short message service groupPatients in this arm received conventional instructions plus short message reminder. |
| conventional group | Active comparator | Other: conventional groupPatients in this arm just received conventional instructions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- be able to communicate via SMS by mobile phones of themselves or relatives living together
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| short message service groupEach 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 | short message service group |
| conventional groupAfter 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 |
Primary outcome
Adherence rate of biliary stent removal/exchange
Time frame: up to 1 year
Percentage of patients adherence to stent removal/exchange within appropriate time
1 secondary outcome
Stent-associated adverse event
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2016.
- Derived from this study: PubMed 27565717Gu 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yanglin Pan, MD principal investigator
Xijing Hospital of Disgestive Diseases.The Fourth Military University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing short message service group and conventional group in people with Healthy, run by Air Force Military Medical University, China at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence rate of biliary stent removal/exchange (time frame: up to 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02831127, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2016.