Improving a bowel-care questionnaire for people with spinal cord injury using clinic feedback and digital follow-up
| ISRCTN | ISRCTN17683580 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17683580 |
- Submission date
- 22/08/2025
- Registration date
- 22/08/2025
- Last edited
- 22/08/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Digestive System
Plain English summary of protocol
Background and study aims
People living with spinal cord injury often have ongoing bowel-management difficulties that affect daily life. This study tests whether adding structured digital feedback (brief weekly check-ins and tailored prompts) to a bowel-difficulty patient-reported measure makes care more effective over 12 weeks compared with standard clinic administration without digital prompts.
Who can participate?
Adults (18 years or older) with a spinal cord injury of at least 6 months’ duration who use a stable bowel-care routine and can complete the bowel-difficulty questionnaire, and who provide written informed consent.
What does the study involve?
Participants join one of two groups at a single hospital. One group completes the bowel-difficulty measure with digital feedback via a secure mobile/web system plus usual care; the other completes the measure in the standard clinic way without digital prompts (usual care continues for both groups). Everyone completes the measure at the start and again at 12 weeks. Some may also complete a short mid-point check at week 6 and brief 7-day diaries about bowel events. No medicines, devices, or procedures are given by the study.
What are the possible benefits and risks of participating?
There may be no direct benefit, but the digital approach could help some people track symptoms and communicate with the clinic between visits. Risks are minimal and relate mainly to the time and possible discomfort of answering personal questions. Participation will not change usual medical care.
Where is the study run from?
Rehabilitation Department, Hebei Medical University Third Hospital, Shijiazhuang, Hebei, China.
When is the study starting and how long is it expected to run for?
September 2024 to September 2025.
Who is funding the study?
Guidance Topic of the Hebei Provincial Health Commission (20242297).
Who is the main contact?
Wei Jing, 38500659@hebmu.edu.com
Contact information
Public, Scientific, Principal Investigator
Rehabilitation Department, Hebei Medical University Third Hospital
Shijiazhuang
050000
China
| Phone | +86-0311-86265523 |
|---|---|
| zhangfeng4134@163.com |
Study information
| Study design | Single-centre prospective interventional two-arm non-randomized controlled open-label study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Quality of life, Treatment, Efficacy |
| Scientific title | Adults with spinal cord injury: clinical feedback–integrated patient-reported bowel-difficulty measure versus standard administration for 12-week applicability and responsiveness |
| Study acronym | REFINE-IMD |
| Study objectives | Objective: to optimise the Spinal Cord Injury Quality of Life Intestinal Management Difficulty scale by integrating structured clinical and digital feedback, revising and psychometrically recalibrating items (content validity indices and Rasch diagnostics), and then evaluating the tool’s sensitivity/responsiveness in longitudinal clinical use. Primary hypothesis: adding structured clinical/digital feedback to scale administration will produce a greater 12-week improvement (decrease) in the bowel-difficulty total score compared with standard administration. Secondary hypotheses: feedback-integrated administration will (i) show superior responsiveness (e.g., higher standardised response mean and larger effect size) and stronger anchor validity versus standard administration; (ii) demonstrate better construct validity with clinical anchors (patient global rating of change and bowel-diary metrics) at 12 weeks; and (iii) improve feasibility/acceptability (completion/adherence) without increasing adverse events. |
| Ethics approval(s) |
Approved 20/12/2024, Hebei Medical University Third Hospital Ethics Committee (Rehabilitation Department, Hebei Medical University Third Hospital, Shijiazhuang, Hebei 050000, China, Shijiazhuang, 050000, China; +86-0311-86265523; fad@hebmu.edu.cn), ref: AD2024-077 |
| Health condition(s) or problem(s) studied | Bowel management difficulties in adults living with spinal cord injury. |
| Intervention | 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 weeks. In the digital-feedback arm, participants complete the measure via a secure mobile/web platform at baseline and receive automated, tailored prompts and weekly check-ins; 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 clinic practice (paper or clinic tablet) without digital prompts or interim feedback. Allocation is by clinic workflow and participant preference/technology access (no randomisation). All participants provide baseline demographics and injury details; 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 documented; no changes to clinical care are mandated by the protocol. |
| Intervention type | Behavioural |
| Primary outcome measure | 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 outcome measures | 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. |
| Overall study start date | 01/09/2024 |
| Completion date | 30/09/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 120 |
| Key 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. |
| Key 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. |
| Date of first enrolment | 01/01/2025 |
| Date of final enrolment | 30/06/2025 |
Locations
Countries of recruitment
- China
Study participating centre
050000
China
Sponsor information
Hospital/treatment centre
Rehabilitation Department
Shijiazhuang
050000
China
| Phone | +86-0311-86265523 |
|---|---|
| fad@hebmu.edu.cn | |
| Website | http://www.cthhmu.com/ |
"ROR" |
https://ror.org/004eknx63 |
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | 30/09/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Results will be submitted to a peer-reviewed rehabilitation or spinal cord injury journal and presented at national/international meetings in rehabilitation medicine and neuro-urology. A plain-English summary will be added to the ISRCTN record and shared via the Hebei Medical University Third Hospital website. After publication, we will post the final protocol, statistical analysis code, and de-identified summary tables on an open repository. |
| IPD sharing plan | The datasets generated and/or analysed during the current study will be available upon request from Wei Jing (Email: 38500659@hebmu.edu.com). De-identified IPD will include baseline demographics and injury characteristics, Intestinal Management Difficulty (IMD) scores at baseline/Week 6/Week 12, Patient Global Impression of Change at Week 12, 7-day bowel diary metrics, usability (SUS) at Week 12, adherence logs, and bowel-related healthcare visits and adverse events through Week 12. Data will become available 6 months after primary publication and remain available for 5 years. Access will be granted for methodologically sound, non-commercial projects with a prespecified analysis plan, evidence of local ethics approval, and a signed data-use agreement; dates will be offset and rare combinations suppressed to minimise re-identification risk. Where participant consent or local regulations limit sharing, only aggregate outputs will be provided. |
Editorial Notes
22/08/2025: Trial's existence confirmed by Hebei Medical University Third Hospital Ethics Committee.
