Effectiveness of SMS to Fix PC IntervalNCT01675739
Effectiveness of Fixed PC Interval Using SMS for Afternoon Colonoscopy
A study testing Short message service of mobile phone (SMS) and polyethylene glycol (PEG) in people with Effectiveness of SMS to Fix PC Interval, run by Inje University at 1 site in South Korea.
Trial summary
The purpose of this study is to evaluate the effectiveness of SMS (short message service of mobile phone) reminder to fix PC interval for bowel preparation in afternoon colonoscopy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Effectiveness of SMS to Fix PC Interval
- What is being tested?
- Short message service of mobile phone (SMS) and polyethylene glycol (PEG)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 280 participants
- Where
- 1 siteSouth Korea
- Study dates
- Oct 2011to Apr 2012
- 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
- 18 and 80 years who were scheduled for afternoon colonoscopy (screening or surveillance)
Who cannot join
- unavailable mobile phone nor SMS
- age younger than 18 years
- pregnancy
- breastfeeding
- history of large-bowel resection
- renal failure (serum creatinine ≥ 3.0 mg/dL [normal 0.8-1.4])
Show all 9Show fewer
- drug addiction or major psychiatric illness
- allergy to PEG
- refusal to participate in the study.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Internal Medicine, Haeundae Paik Hospital, Inje University, College of Medicine
Busan, 612-030
About this study
Official title: Effectiveness of Fixed Preparation-to-Colonoscopy Interval Using Short Message Service (SMS) for Afternoon Colonoscopy: a Randomized Control Study
The purpose of this study is to evaluate the effectiveness of SMS (short message service of mobile phone) reminder to fix PC interval for bowel preparation in afternoon colonoscopy.
Read the detailed description
Bowel preparation quality for colonoscopy is influenced by several factors and preparation-to-colonoscopy (PC) interval is one of the important factors. The bowel preparation with split-dose PEG (polyethylene glycol) is an obviously uncomfortable process, it is usually difficult to ingest PEG in time. Therefore, the investigators conducted a prospective randomized control study to evaluate the effectiveness of fixed PC interval for satisfactory bowel preparation in the afternoon colonoscopy using mobile phone short message service (SMS), which reported that it could increase patient's compliance in other practical era
- Conditions
- Effectiveness of SMS to Fix PC Interval
- Being tested
- Short message service of mobile phone (SMS), polyethylene glycol (PEG)
- Keywords
- colonoscopy, bowel preparation, short message service
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Short message service of mobile phone (SMS)Behavioural
In SMS group, patients took 1st dose polyethylene glycol (PEG) 2L at 6-8pm the day before colonoscopy and then start to take 2nd dose PEG 2L after receiving Short message service of mobile phone (SMS) 6hours before afternoon colonoscopy.
polyethylene glycol (PEG)Drug
Also called Colyte
No-SMS group took 1st 2L of PEG solution at 6-8 PM on the day before colonoscopy and started drinking the 2nd 2L PEG at about 6hours before the day of the colonoscopy.
SMS group took 1st 2L PEG as same manner of No-SMS group and then started drinking the 2nd 2L PEG at about 6hours before the day of the colonoscopy after receiving scheduled SMS
| Study group | Role | What they receive |
|---|---|---|
| No-SMS group | Active comparator | In No-SMS group took 1st 2L of PEG solution at 6-8 PM on the day before colonoscopy and started drinking the 2nd 2L PEG at about 6hours before the day of the colonoscopy without SMS. Receives: Drug: polyethylene glycol (PEG) |
| SMS group | Experimental | Patients in SMS group took 1st 2L PEG as same manner of No-SMS group and then started drinking the 2nd 2L PEG at about 6hours before the day of the colonoscopy after receiving scheduled short message service(SMS) Receives: Behavioral: Short message service of mobile phone (SMS); Drug: polyethylene glycol (PEG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
the Ottawa bowel preparation scale
This scale assesses cleanliness and fluid volume respectively and presents the total score as sum of these two values. Cleanliness was assessed for the right colon (cecum, ascending colon), midcolon (transverse, descending colon), and the rectosigmoid colon; each colon section was individually rated from 0 to 4 (0 = no liquid, 1 = minimal liquid, no suction required, 2 = suction required to see mucosa, 3 = wash and suction required, 4 = solid stool, not washable). Fluid quantity was rated from 0 to 2 for the entire colon (0 = minimal, 1 = moderate, 2 = large). The Ottawa Scale scores range from 0 (perfect) to 14 (solid stool in each colon segment and large amount of fluid).
Measured: at the end of time of the colonoscopic examination (about 30 minutes-1hour)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2012 (estimated)
- Study startOct 2011
- Primary completionApr 2012
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Effectiveness of SMS to Fix PC IntervalStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 280 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inje University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jongha Park, Inje University
- Investigators
- Tae Oh Kim, Principal investigator, Department of Internal Medicine, Haeundae Paik Hospital, Inje University, College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01675739
- Sponsor's protocol ID
- SMS-CFS
- Status last verified
- Aug 2012
- First submitted
- 28 Aug 2012
- Last updated
- 30 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Fixed Preparation-to-Colonoscopy Interval Using Short Message Service (SMS) for Afternoon Colonoscopy: a Randomized Control Study
- ClinicalTrials.gov ID
- NCT01675739
- Acronym / sponsor ID
- SMS-CFS
- Conditions
- Effectiveness of SMS to Fix PC Interval
- Keywords
- colonoscopy, bowel preparation, short message service
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 280 participants (actual)
- Lead sponsor
- Inje UniversityUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 30 Aug 2012 (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.
The purpose of this study is to evaluate the effectiveness of SMS (short message service of mobile phone) reminder to fix PC interval for bowel preparation in afternoon colonoscopy.
Detailed description
Bowel preparation quality for colonoscopy is influenced by several factors and preparation-to-colonoscopy (PC) interval is one of the important factors. The bowel preparation with split-dose PEG (polyethylene glycol) is an obviously uncomfortable process, it is usually difficult to ingest PEG in time. Therefore, the investigators conducted a prospective randomized control study to evaluate the effectiveness of fixed PC interval for satisfactory bowel preparation in the afternoon colonoscopy using mobile phone short message service (SMS), which reported that it could increase patient's compliance in other practical era
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No-SMS group | Active comparator | Drug: polyethylene glycol (PEG)In No-SMS group took 1st 2L of PEG solution at 6-8 PM on the day before colonoscopy and started drinking the 2nd 2L PEG at about 6hours before the day of the colonoscopy without SMS. |
| SMS group | Experimental | Behavioral: Short message service of mobile phone (SMS), Drug: polyethylene glycol (PEG)Patients in SMS group took 1st 2L PEG as same manner of No-SMS group and then started drinking the 2nd 2L PEG at about 6hours before the day of the colonoscopy after receiving scheduled short message service(SMS) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 18 and 80 years who were scheduled for afternoon colonoscopy (screening or surveillance)
Key exclusion criteria (9 listed)
- unavailable mobile phone nor SMS
- age younger than 18 years
- pregnancy
- breastfeeding
- history of large-bowel resection
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 of mobile phone (SMS)In SMS group, patients took 1st dose polyethylene glycol (PEG) 2L at 6-8pm the day before colonoscopy and then start to take 2nd dose PEG 2L after receiving Short message service of mobile phone (SMS) 6hours before afternoon colonoscopy. | Behavioural | SMS group |
| polyethylene glycol (PEG)Also: ColyteNo-SMS group took 1st 2L of PEG solution at 6-8 PM on the day before colonoscopy and started drinking the 2nd 2L PEG at about 6hours before the day of the colonoscopy. SMS group took 1st 2L PEG as same manner of No-SMS group and then started drinking the 2nd 2L PEG at about 6hours before the day of the colonoscopy after receiving scheduled SMS | Drug | No-SMS group, SMS group |
Primary outcome
the Ottawa bowel preparation scale
Time frame: at the end of time of the colonoscopic examination (about 30 minutes-1hour)
This scale assesses cleanliness and fluid volume respectively and presents the total score as sum of these two values. Cleanliness was assessed for the right colon (cecum, ascending colon), midcolon (transverse, descending colon), and the rectosigmoid colon; each colon section was individually rated from 0 to 4 (0 = no liquid, 1 = minimal liquid, no suction required, 2 = suction required to see mucosa, 3 = wash and suction required, 4 = solid stool, not washable). Fluid quantity was rated from 0 to 2 for the entire colon (0 = minimal, 1 = moderate, 2 = large). The Ottawa Scale scores range from 0 (perfect) to 14 (solid stool in each colon segment and large amount of fluid).
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 30 Aug 2012.
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.
Tae Oh Kim principal investigator
Department of Internal Medicine, Haeundae Paik Hospital, Inje University, College of Medicine
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 of mobile phone (SMS) and polyethylene glycol (PEG) in people with Effectiveness of SMS to Fix PC Interval, run by Inje University at 1 site in South Korea.
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 9 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 30 Aug 2012. 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 South Korea. 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?
the Ottawa bowel preparation scale (time frame: at the end of time of the colonoscopic examination (about 30 minutes-1hour)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Aug 2012.