Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
Not provided
Not provided
Not provided
Not provided
Colorectal cancer is a common but preventable condition, and increasing colorectal cancer screening is one of the most impactful public health contributions in the field of gastroenterology. Text messaging is a simple, cheap, and rapid method to reach patients that may improve adherence to colonoscopy appointments as well as simplify the process of bowel preparation. The purpose of the study is to evaluate the feasibility of a pilot bidirectional text messaging intervention on attendance for screening/surveillance colonoscopy and bowel preparation quality at an urban VA hospital. The goal is to improve adherence to colonoscopy among patients who are due for a repeat colonoscopy.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Text Message Intervention | Experimental | Participants in the experimental arm will receive a series of instructional and motivational text messages, which will be sent starting 7-14 days before and until the day of the colonoscopy procedure. |
|
| No Intervention | No Intervention | Participants will not receive text messages. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Text Message Instructions/Motivation | Behavioral | For instructional messages, earlier messages will remind patients of the colonoscopy appointment and later messages will help patients complete the bowel preparation process in real-time. Motivational messages will be sent along with instructional messages. |
| Measure | Description | Time Frame |
|---|---|---|
| National Annie Colonoscopy Survey Score | 7-item assessment of participant satisfaction with the "Annie" text intervention. Items are rated on a 5-point scale from 1 (strongly disagree) to 5 (strongly agree). The total score is the sum of responses and ranges from 7 to 35; higher scores indicate greater satisfaction with the intervention. | Day 21 (Up to 7 Days Post-Procedure) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Attend Scheduled Colonoscopy Appointment | Assessed via patient's electronic health record. | Up to Day 14 |
| Percentage of Participants Who Had Adequate Bowel Preparation at Colonoscopy Appointment |
Not provided
Inclusion Criteria:
• Has previously undergone a colonoscopy and is currently due for a repeat screening or surveillance colonoscopy at the VA.
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Peter Liang, MD | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New York Harbor Health Care System - Department of Veterans Affairs | New York | New York | 10010 | United States |
The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: peter.liang@nyulangone.org. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
The investigator who proposed to use the data will be granted access upon reasonable request. Requests should be directed to peter.liang@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Text Message Intervention | Participants in the experimental arm will receive a series of instructional and motivational text messages, which will be sent starting 7-14 days before and until the day of the colonoscopy procedure. Text Message Instructions/Motivation: For instructional messages, earlier messages will remind patients of the colonoscopy appointment and later messages will help patients complete the bowel preparation process in real-time. Motivational messages will be sent along with instructional messages. |
| FG001 | No Intervention | Participants will not receive text messages. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Text Message Intervention | Participants in the experimental arm will receive a series of instructional and motivational text messages, which will be sent starting 7-14 days before and until the day of the colonoscopy procedure. Text Message Instructions/Motivation: For instructional messages, earlier messages will remind patients of the colonoscopy appointment and later messages will help patients complete the bowel preparation process in real-time. Motivational messages will be sent along with instructional messages. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | National Annie Colonoscopy Survey Score | 7-item assessment of participant satisfaction with the "Annie" text intervention. Items are rated on a 5-point scale from 1 (strongly disagree) to 5 (strongly agree). The total score is the sum of responses and ranges from 7 to 35; higher scores indicate greater satisfaction with the intervention. | Control patients were not given text messaging intervention, therefore did not participate in the Annie text message survey. All intervention patients were encouraged to complete the survey, and 16 of 25 did. | Posted | Mean | Standard Deviation | Score on a scale | Day 21 (Up to 7 Days Post-Procedure) |
|
3 months
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Text Message Intervention | Participants in the experimental arm will receive a series of instructional and motivational text messages, which will be sent starting 7-14 days before and until the day of the colonoscopy procedure. Text Message Instructions/Motivation: For instructional messages, earlier messages will remind patients of the colonoscopy appointment and later messages will help patients complete the bowel preparation process in real-time. Motivational messages will be sent along with instructional messages. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Peter Liang, MD | NYU Langone Health | (212) 686-7500 | 5745 | peter.liang@nyulangone.org |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 27, 2023 | Aug 1, 2025 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 23, 2023 | Jul 1, 2024 | ICF_000.pdf |
Not provided
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
Assessed via patient's electronic health record.
| Up to Day 14 |
| BG001 | No Intervention | Participants will not receive text messages. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | No Intervention | Participants will not receive text messages. |
|
|
| Secondary | Percentage of Participants Who Attend Scheduled Colonoscopy Appointment | Assessed via patient's electronic health record. | Posted | Number | Percentage of Participants | Up to Day 14 |
|
|
|
| Secondary | Percentage of Participants Who Had Adequate Bowel Preparation at Colonoscopy Appointment | Assessed via patient's electronic health record. | Posted | Number | percentage of participants | Up to Day 14 |
|
|
|
| 0 |
| 25 |
| 0 |
| 25 |
| 0 |
| 25 |
| EG001 | No Intervention | Participants will not receive text messages. | 0 | 25 | 0 | 25 | 0 | 25 |
Not provided
Not provided
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |