Effect of Individualized Patient Education Including Drinking Advice Using an App
Primary Purpose
Colorectal Cancer
Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Smart phone patient education application
Sponsored by
About this trial
This is an interventional diagnostic trial for Colorectal Cancer focused on measuring Bowel preparation, Colonoscopy, Smart phone application, Patient satisfaction
Eligibility Criteria
Inclusion Criteria:
- Patients refered to our clinic for colonoscopy by general practitioner, colorectal cancer screening programme or outpatient clinic
- Use of regular sodium picosulfate bowel preparation scheme
- Possession of an Android or iOS smart phone
Exclusion Criteria:
- Emergency colonoscopy
- Hospitalized patients
Sites / Locations
- Maastricht University Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control
Intervention
Arm Description
patients receiving standard care (verbal and written instructions) before colonoscopy
Patients instructed to use a smart phone patient education app in addition standard care
Outcomes
Primary Outcome Measures
Boston Bowel Preparation Score
Boston Bowel Preparation Score (BBPS) is a validated scale for scoring bowel preparation. Each colonic segment (ascending, transverse, descending) is scored on a scale ranging from 0 to 3, in which a higher value means a cleaner bowel segment. The total score is the sum of the three segment scores (total range 0-9).
Secondary Outcome Measures
Patient satisfaction questionnaire
Patient satisfaction questionnaire. Several questions in our PSQ (patient satisfaction questionnaire) are based on the PSQ-18. We transformed items from the PSQ-18 to bowel preparation education purposes. The PSQ-18 yields separate scores for each of seven different subscales: General Satisfaction; Technical Quality; Interpersonal Manner; Communication; Financial Aspects; Time Spent with Doctor and Accessibility and Convenience (8, 9). Our PSQ contains items for General Satisfaction (items 3 and 6), Technical Quality (items 8 and 9), Communication (items 1 and 2), Time spent on education (item 7) and Convenience (items 4 and 5). Second, general questions are asked to determine if this was the first time patient received bowel preparation education. And last, for the app users we want to know how they rate the use of the app.
Caecal intubation rate
Total time from insertion of the endoscope to intubation of the caecum.
Adenoma detection rate
percentage of patient in each group in which one or more adenoma(s) are detected.
Full Information
NCT ID
NCT03677050
First Posted
September 14, 2018
Last Updated
December 4, 2019
Sponsor
Maastricht University Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT03677050
Brief Title
Effect of Individualized Patient Education Including Drinking Advice Using an App
Official Title
Effect of Individualized Patient Education Including Drinking Advice Using an App
Study Type
Interventional
2. Study Status
Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
September 14, 2018 (Actual)
Primary Completion Date
November 28, 2019 (Actual)
Study Completion Date
November 28, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Maastricht University Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Study evaluating the effect of a personalized smart phone application in addition to standard care on bowel preparation scores, compared to standard care alone.
Detailed Description
Picoprep is a low-volume bowel preparation used to optimize visualization of the colonic mucosa during colonoscopy. Patients referred for a colonoscopy will be scheduled for an intake. During this intake patients receive education about Picoprep and will be asked about their health condition (medical history, medication use). Standard a face-to-face education is given by an intake nurse or doctor. The producers of Picoprep, Ferring BV designed an app including a drinking schedule adapted to the timing of the coloscopy, aiming a lag time between intake of the last Picoprep dose and the scopy of 2-4 hours. We hypothesize that the Boston Bowel Preparation Scale and patient satisfaction will be higher in patients receiving standard education plus using the bowel preparation app versus patients receiving single standard education.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
Bowel preparation, Colonoscopy, Smart phone application, Patient satisfaction
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized clinical trial
Masking
Outcomes Assessor
Masking Description
colonoscopist accessing BBPS scores will be blinded; investigator will also assess BBPS scores (not blinded)
Allocation
Randomized
Enrollment
180 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
No Intervention
Arm Description
patients receiving standard care (verbal and written instructions) before colonoscopy
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Patients instructed to use a smart phone patient education app in addition standard care
Intervention Type
Other
Intervention Name(s)
Smart phone patient education application
Intervention Description
Smart phone patient education application including a personalized colonoscopy preparation scheme and information about the procedure.
Primary Outcome Measure Information:
Title
Boston Bowel Preparation Score
Description
Boston Bowel Preparation Score (BBPS) is a validated scale for scoring bowel preparation. Each colonic segment (ascending, transverse, descending) is scored on a scale ranging from 0 to 3, in which a higher value means a cleaner bowel segment. The total score is the sum of the three segment scores (total range 0-9).
Time Frame
During colonoscopy
Secondary Outcome Measure Information:
Title
Patient satisfaction questionnaire
Description
Patient satisfaction questionnaire. Several questions in our PSQ (patient satisfaction questionnaire) are based on the PSQ-18. We transformed items from the PSQ-18 to bowel preparation education purposes. The PSQ-18 yields separate scores for each of seven different subscales: General Satisfaction; Technical Quality; Interpersonal Manner; Communication; Financial Aspects; Time Spent with Doctor and Accessibility and Convenience (8, 9). Our PSQ contains items for General Satisfaction (items 3 and 6), Technical Quality (items 8 and 9), Communication (items 1 and 2), Time spent on education (item 7) and Convenience (items 4 and 5). Second, general questions are asked to determine if this was the first time patient received bowel preparation education. And last, for the app users we want to know how they rate the use of the app.
Time Frame
end of preparation procedure
Title
Caecal intubation rate
Description
Total time from insertion of the endoscope to intubation of the caecum.
Time Frame
during colonoscopy
Title
Adenoma detection rate
Description
percentage of patient in each group in which one or more adenoma(s) are detected.
Time Frame
during colonoscopy
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients refered to our clinic for colonoscopy by general practitioner, colorectal cancer screening programme or outpatient clinic
Use of regular sodium picosulfate bowel preparation scheme
Possession of an Android or iOS smart phone
Exclusion Criteria:
Emergency colonoscopy
Hospitalized patients
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
A.A.M. Masclee, Prof. MD
Organizational Affiliation
Maastricht University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maastricht University Medical Center
City
Maastricht
State/Province
Limburg
ZIP/Postal Code
6202AZ
Country
Netherlands
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
34420924
Citation
van der Zander QEW, Reumkens A, van de Valk B, Winkens B, Masclee AAM, de Ridder RJJ. Effects of a Personalized Smartphone App on Bowel Preparation Quality: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2021 Aug 19;9(8):e26703. doi: 10.2196/26703.
Results Reference
derived
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Effect of Individualized Patient Education Including Drinking Advice Using an App
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