Adaptive Intervention to Maximize Colorectal Screening in Safety Net Populations
AIMSS
2 other identifiers
interventional
500
1 country
1
Brief Summary
The goal of this study is to find the best ways to increase colorectal cancer (CRC) screening.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable colorectal-cancer
Started Jan 2018
Longer than P75 for not_applicable colorectal-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 29, 2017
CompletedFirst Posted
Study publicly available on registry
April 4, 2017
CompletedStudy Start
First participant enrolled
January 22, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2022
CompletedOctober 15, 2024
May 1, 2020
4.6 years
March 29, 2017
October 8, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
CRC screening completion rate
Rate of participants who receive CRC screening during study participation
12-14 Months
Secondary Outcomes (1)
Cost analysis of each intervention pathway
14 Months
Study Arms (4)
HE + HE
ACTIVE COMPARATORParticipants receive up to two interventions. Participants receive HE initially and then a second time if not screened after 6 months.
HE + I2
ACTIVE COMPARATORParticipants receive up to two interventions. Participants receive HE initially and then I2 if not screened after 6 months.
I2 + I2
EXPERIMENTALParticipants receive up to two interventions. Participants receive I2 initially and then a second time if not screened after 6 months.
I2 + HE
ACTIVE COMPARATORParticipants receive up to two interventions. Participants receive I2 initially and then HE if not screened after 6 months.
Interventions
A touch screen computer delivered "implementation intentions" (I2) intervention on CRC screening. "Implementation intentions" are the exact steps (the when, what, where, how) one will take to complete a test (the date and time, at home or at the doctor's office, with what supplies, etc.).
Standard of care approach that will provide basic information on CRC screening.
Eligibility Criteria
You may qualify if:
- Have a home address and access to a working telephone
- Pass Mini-Cog assessment
You may not qualify if:
- FIT (fecal immunochemical test) test within 1 year, Sigmoidoscopy or Barium enema within 5 years, or Colonoscopy within 10 years
- Acute medical illness,
- current GI bleed
- history of adenomatous polyps
- Colorectal Cancer
- st degree relative with CRC \< age 60 years
- inherited polyposis/non-polyposis syndrome
- inflammatory bowel disease
- Another household member enrolled in the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Kansas Medical Center
Kansas City, Kansas, 66160, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Allen Greiner, MD, MPH
University of Kansas Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 29, 2017
First Posted
April 4, 2017
Study Start
January 22, 2018
Primary Completion
August 31, 2022
Study Completion
September 30, 2022
Last Updated
October 15, 2024
Record last verified: 2020-05