Digital nudging for adherence to colonoscopy screening: a study based on the MINDSPACE framework

ISRCTN ISRCTN14407050
DOI https://doi.org/10.1186/ISRCTN14407050
Sponsor National Health Commission of the People's Republic of China
Funder National Health Commission of the People's Republic of China
Submission date
15/01/2026
Registration date
04/02/2026
Last edited
19/01/2026
Recruitment status
Not yet recruiting
Overall study status
Ongoing
Condition category
Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Yan Wei
Scientific, Principal investigator, Public

Fudan University
Shanghai
200032
China

Phone +86 (0)18930749707
Email yanwei@fudan.edu.cn
Mr Haichuan Guo
Public

Fudan University
Shanghai
200032
China

Phone +86 (0)18669462376
Email 24211020126@m.fudan.edu.cn

Study information

Primary study designInterventional
AllocationRandomized controlled trial
MaskingBlinded (masking used)
ControlPlacebo
AssignmentCluster
PurposeDiagnostic, Health services research
Scientific titleDesign and effectiveness evaluation of a digital nudging tool for improving colorectal cancer screening adherence among community residents: a case study of Shanghai, China
Study objectives
Ethics approval(s)

Approved 13/01/2026, Ethics Committee of the School of Public Health (Fudan University, Shanghai, 200032, China; +86 (0)21 5423 7148; gwkyb@fudan.edu.cn), ref: H2026009

Health condition(s) or problem(s) studiedColorectal cancer
InterventionStudy sites were randomly assigned to either a digital decision aid intervention group or a usual care control group. The intervention consisted of two components:
1. Training for Healthcare Providers: Medical staff in the intervention group received a 4–5 hour training session on using the decision aid and related clinician-patient communication skills prior to implementation.
2. Digital Decision Aid Implementation: The digital tool was used during outpatient colorectal cancer screening consultations to support the pre-colonoscopy decision-making process. Its primary content involved educating residents about colorectal cancer and colonoscopy screening.
Intervention typeBehavioural
Primary outcome measure(s)
  1. Decision whether to undergo colonoscopy screening measured using telephone follow-up survey at 3 months post-intervention
Key secondary outcome measure(s)

1. Residents' knowledge and cognitive level, using a question-and-answer scale designed by the research team at baseline, immediately post-intervention, and 3 months post-intervention. Residents need to judge whether 10 descriptions about colorectal cancer and cancer screening diagnosis are correct, and their knowledge level will be determined based on the accuracy rate.
2. Decision conflict level, measured using the Chinese version of the Decisional Conflict Scale at baseline, immediately post-intervention, and 3 months post-intervention
3. Decision self-confidence, measured using the Chinese version of the Decision Self-Efficacy scale at baseline, immediately post-intervention, and 3 months post-intervention
4. Decision regret degree, measured using the Chinese version of the Decision Regret Scale at at 3 months post-intervention
5. Residents' satisfaction with the intervention tools, measured using the Chinese version of the Decision Preparation scale at 3 months post-intervention
6. Diagnostic preference, measured using a self-designed scale at baseline, immediately post-intervention, and 3 months post-intervention
7. Residents' expectations regarding shared decision-making measured using the Chinese version of the shared decision-making scale 9-item Shared Decision Making Questionnaire (SDM-Q-9) at baseline and 3 months post-intervention

Completion date31/12/2026

Eligibility

Participant type(s)
Age groupMixed
Lower age limit50 Years
Upper age limit100 Years
SexAll
Target sample size at registration1000
Key inclusion criteria1. Permanent residents of Shanghai (including individuals with local household registration and non-local residents who have lived in Shanghai for over 6 months).
2. Individuals eligible according to the Shanghai Community Colorectal Cancer Screening Implementation Plan.
3. Individuals enrolled in any of Shanghai's basic medical insurance or healthcare security schemes.
Key exclusion criteria1. Individuals who have previously undergone colonoscopy and were confirmed to be at no risk for colorectal cancer.
2. Individuals whose health status is unsuitable for colonoscopy.
3. Individuals with cognitive impairment that prevents participation in follow-up and questionnaire surveys.
4. Individuals with a confirmed diagnosis of colorectal cancer.
5. Individuals with a confirmed diagnosis of other high-risk diseases where the mortality risk is too high for them to be suitable for colonoscopy screening.
Date of first enrolment01/03/2026
Date of final enrolment31/08/2026

Locations

Countries of recruitment

  • China

Study participating centres

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot expected to be made available
IPD sharing plan

Editorial Notes

15/01/2026: Study's existence confirmed by the Ethics Committee of the School of Public Health.