Colon Cancer ScreeningNCT01648504
Johns Hopkins Interactive eGuide to Colonoscopy and Ipad Office Education to Improve Colonoscopy
A study testing eGuide to Colonoscopy and in office ipad education in people with Colon Cancer Screening and Colon Cancer Surveillance, run by Johns Hopkins University at 1 site in United States.
Trial summary
The investigators will attempt to improve the patient experience before colonoscopy. The investigators will provide an in-office ipad video series and an electronic web guide to help patients learn all the best ways to prepare for colonoscopy. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Colon Cancer Screening, Colon Cancer Surveillance
- What is being tested?
- eGuide to Colonoscopy and in office ipad education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2012to Sep 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 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Undergoing Colonoscopy at Johns Hopkins
- Ages 18 to 90
- Access to email (themselves or designee)
- Access to internet outside of physician visit
Who cannot join
- Unable to consent
- Unwilling to participate
- Unable to care for themselves
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Integration of an Electronic Education System Into Colonoscopy: Improving Education, Consent and Compliance of Patients at Colonoscopy With an Ipad-based Secure Video Intervention
The investigators will attempt to improve the patient experience before colonoscopy. The investigators will provide an in-office ipad video series and an electronic web guide to help patients learn all the best ways to prepare for colonoscopy. The investigators will then follow the patients who receive this eGuide to colonoscopy and observe whether or not they enjoyed the additional access to information from their providers, and will monitor whether or not they were better prepared for their colonoscopy.
Read the detailed description
This study would assess the ability of an e-intervention in patient education and instructions during peri-procedure and procedural day visits to improve the experience of gastroenterology procedures. This study would seek to show that through this alternative educational measure, there would be an increased show rate to colonoscopy appointments, an increased preparation quality, and an increase in patient understanding and satisfaction with the colonoscopy procedure. The investigators will attempt to track procedure completion rate and polyp detection rate for individual providers.
The e-intervention would be multimodal. In the pre-procedure setting, ipad would be able to provide a viewpoint for the video education, a template for the patients (or caregivers) to send themselves links to appropriate instructions to remind them of their obligations by secure email. This e-intervention would supplement traditional printed and website accessible instructions.
- Conditions
- Colon Cancer Screening, Colon Cancer Surveillance
- Being tested
- eGuide to Colonoscopy and in office ipad education
- Keywords
- Colonoscopy, Screening colonoscopy, Electronic education, Ipad, Patient education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eGuide to Colonoscopy and in office ipad educationOther
Also called Educational intervention with eGuide to colonoscopy
The investigators will follow patients who receive in office Ipad video education and at home web portal access to the Johns Hopkins eGuide to Colonoscopy.
| Study group | Role | What they receive |
|---|---|---|
| Intervention with eGuide to colonoscopy | Experimental | The investigators will prospectively enroll and follow patients who receive the eGuide to Colonoscopy and determine benefit and satisfaction with the intervention as part of a pilot study. Receives: Other: eGuide to Colonoscopy and in office ipad education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Completion rate of colonoscopy procedure
Could the colonoscopy be completed in its entirety on the date scheduled?
Measured: 1 day
Secondary outcomes (3)
preparation quality
What was the quality of preparation as measured on the day of colonoscopy, preferably by the Boston Bowel Preparation score.
Measured: one day
adenoma detection rate by provider
Measurement of adenoma detection rate by provider for study patients.
Measured: 6 months
Patient satisfaction
An individual patient satisfaction survey will be provided to patients via the eGuide to Colonoscopy web-portal and will assess their enjoyment and understanding. A patient satisfaction survey is employed by the division to random patients over a three month period. We will assess both of these to determine patient satisfaction with the study intervention.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2012 (estimated)
- Study startJun 2012
- Primary completionSep 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon Cancer ScreeningStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Krames Staywell Corporation
- Responsible party
- Principal investigator, Ellen Stein, MD, Johns Hopkins University
- Investigators
- Ellen M Stein, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01648504
- Sponsor's protocol ID
- NA_00070166
- Status last verified
- Mar 2014
- First submitted
- 17 Jul 2012
- Last updated
- 27 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integration of an Electronic Education System Into Colonoscopy: Improving Education, Consent and Compliance of Patients at Colonoscopy With an Ipad-based Secure Video Intervention
- ClinicalTrials.gov ID
- NCT01648504
- Acronym / sponsor ID
- NA_00070166
- Conditions
- Colon Cancer Screening, Colon Cancer Surveillance
- Keywords
- Colonoscopy, Screening colonoscopy, Electronic education, Ipad, Patient education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Krames Staywell Corporation
- Study start
- Jun 2012
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 24 Jul 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 investigators will attempt to improve the patient experience before colonoscopy. The investigators will provide an in-office ipad video series and an electronic web guide to help patients learn all the best ways to prepare for colonoscopy. The investigators will then follow the patients who receive this eGuide to colonoscopy and observe whether or not they enjoyed the additional access to information from their providers, and will monitor whether or not they were better prepared for their colonoscopy.
Detailed description
This study would assess the ability of an e-intervention in patient education and instructions during peri-procedure and procedural day visits to improve the experience of gastroenterology procedures. This study would seek to show that through this alternative educational measure, there would be an increased show rate to colonoscopy appointments, an increased preparation quality, and an increase in patient understanding and satisfaction with the colonoscopy procedure. The investigators will attempt to track procedure completion rate and polyp detection rate for individual providers.
The e-intervention would be multimodal. In the pre-procedure setting, ipad would be able to provide a viewpoint for the video education, a template for the patients (or caregivers) to send themselves links to appropriate instructions to remind them of their obligations by secure email. This e-intervention would supplement traditional printed and website accessible instructions.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention with eGuide to colonoscopy | Experimental | Other: eGuide to Colonoscopy and in office ipad educationThe investigators will prospectively enroll and follow patients who receive the eGuide to Colonoscopy and determine benefit and satisfaction with the intervention as part of a pilot study. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Undergoing Colonoscopy at Johns Hopkins
- Ages 18 to 90
- Access to email (themselves or designee)
- Access to internet outside of physician visit
Key exclusion criteria (3 listed)
- Unable to consent
- Unwilling to participate
- Unable to care for themselves
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 |
|---|---|---|
| eGuide to Colonoscopy and in office ipad educationAlso: Educational intervention with eGuide to colonoscopyThe investigators will follow patients who receive in office Ipad video education and at home web portal access to the Johns Hopkins eGuide to Colonoscopy. | Other | Intervention with eGuide to colonoscopy |
Primary outcome
Completion rate of colonoscopy procedure
Time frame: 1 day
Could the colonoscopy be completed in its entirety on the date scheduled?
3 secondary outcomes
preparation quality
Time frame: one day
adenoma detection rate by provider
Time frame: 6 months
Patient satisfaction
Time frame: 3 months
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 27 Mar 2014.
- Johns Hopkins University Division of GastroenterologyLink provided by the sponsor.
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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.
Ellen M Stein, MD principal investigator
Johns Hopkins 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 eGuide to Colonoscopy and in office ipad education in people with Colon Cancer Screening and Colon Cancer Surveillance, run by Johns Hopkins University at 1 site in United States.
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 4 inclusion and 3 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 27 Mar 2014. 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 United States. 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?
Completion rate of colonoscopy procedure (time frame: 1 day). 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 27 Mar 2014.