Bowel management difficulties in adults living with spinal cord injury. Digestive System
Conditions
Interventions
This single-centre, two-arm, non-randomised interventional study compares structured digital-feedback administration of a patient-reported bowel-difficulty measure with standard administration over 12
flagged responses are reviewed by the rehabilitation clinic team with feedback provided during routine visits or secure messages. In the standard arm, participants complete the measure per usual clini
outcomes are collected at baseline and Week 12 (with an optional mid-point check at Week 6 where feasible). Adverse events related to study procedures (e.g., distress from surveys) are monitored and d
no changes to clinical care are mandated by the protocol.
Sponsors
Third Hospital of Hebei Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age =18 years (adult patients). 2. Confirmed spinal cord injury sustained =6 months before enrolment, verified by neuroimaging and physician documentation. 3. Consistent bowel-care regimen for =3 months prior to baseline. 4. Neurogenic Bowel Dysfunction (NBD) Score =10 (moderate–severe bowel dysfunction). 5. Able to complete the SCI-QOL Intestinal Management Difficulty subscale independently. 6. Provides written informed consent.
Exclusion criteria
Exclusion criteria: 1. Age <18 years. 2. Spinal cord injury <6 months since onset or progressive neurological disease (e.g., new demyelinating disorder). 3. Inability to provide informed consent or to complete study questionnaires in the study language (with or without reasonable assistance). 4. Unstable medical condition likely to preclude 12-week follow-up (e.g., planned major surgery affecting bowel function, anticipated prolonged hospitalisation elsewhere). 5. Active gastrointestinal infection or acute inflammatory bowel disease flare at baseline. 6. Permanent ostomy or other bowel diversion that makes the Intestinal Management Difficulty scale inapplicable. 7. Concurrent enrolment in another interventional study targeting bowel or continence outcomes during Weeks 0–12. 8. Major change planned to bowel-care regimen (new medications, devices, or programmes) mandated by another protocol during Weeks 0–12.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Patient-reported bowel-difficulty total score measured using the Spinal Cord Injury Quality of Life Intestinal Management Difficulty scale at baseline and Week 12; primary endpoint is the change from baseline to Week 12. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Patient Global Impression of Change (7-point PGIC) measured using a single-item global rating at Week 12. 2. Intestinal Management Difficulty (IMD) total score measured using the SCI-QOL IMD scale at baseline and Week 6; endpoint is the change from baseline to Week 6. 3. Minimal clinically important improvement (MCII) in IMD score measured using anchor-based calibration to PGIC (“much improved” or better) at Week 12; endpoint is the proportion achieving MCII. 4. Incontinence episodes per week measured using a 7-day bowel diary at baseline and Week 12; endpoint is the change baseline?Week 12. 5. Time required per bowel-care session (minutes) measured using a 7-day bowel diary at baseline and Week 12; endpoint is the change baseline?Week 12. 6. Completion/adherence rate to scheduled check-ins measured using platform analytics over Weeks 0–12; endpoint is the percentage of planned entries completed. 7. Usability/acceptability measured using the System Usability Scale (SUS) at Week 12; endpoint is the SUS total score. 8. Unscheduled clinic or emergency visits for bowel-related problems measured using hospital records over Weeks 0–12; endpoint is the number of visits. 9. Adverse events related to study procedures (e.g., distress from surveys) measured using a standard adverse-event log over Weeks 0–12; endpoint is any event and total events. | — |
Countries
China
Contacts
Public ContactFeng Zhang
Outcome results
None listed