DRIV - Health Online for People With Spinal Cord Injury

Overview This study evaluates the DRIV program, a 10-week web-based health-promotion course designed for individuals living long-term with spinal cord injury (SCI). The Detailed Description below outlines the study's operational procedures, design, data-collection flow, and analytic approach. It intentionally avoids content already provided in sections such as background, significance, eligibility criteria, and outcome measures.

Study Design The study uses a prospective intervention design with a waitlist control group. All individuals who register for the DRIV course are placed on a waitlist. For each course cycle, 8-12 individuals are invited to participate in that round and make up the intervention cohort. Individuals remaining on the waitlist are invited to serve as controls, with the guarantee that they will later be offered participation in a future course cycle.

Participants are not blinded to their group assignment, as the intervention consists of an educational course requiring active engagement.

Intervention Procedures

The intervention is the 10-week DRIV online course, delivered via Zoom. Each weekly session includes:

A topic-specific lecture (e.g., adapted physical activity, nutrition, stress management).

Facilitated discussions based on a study-circle model. Structured goal-setting and behavioral-change strategies. Weekly home assignments and optional adapted exercise sessions.

All course participants (regardless of research participation) receive identical program content. Study participants additionally complete standardized assessments at specified timepoints.

Control Procedures Control participants receive no intervention during their 10-week control period and continue their usual activities. They complete the same baseline and 10-week assessments as the intervention group, allowing comparison of changes over an equivalent time frame. Once their control period ends, they are offered a place in the next DRIV course but are not included again as new study controls.

Measurement Schedule

Study participants complete assessments at the following timepoints:

• T1 (Baseline): Prior to course start (or at the equivalent time for controls).
• T2 (10 weeks): Immediately after the intervention period (or after 10 weeks on the waitlist for controls).
• T3 (6-month follow-up): Six months after course completion (intervention group only).

All assessments are self-administered digitally via REDCap. Participants in both groups wear an accelerometer for 7 days at T1 and T2; only intervention participants repeat this at T3.

Data Collection Procedures

• Survey invitations are distributed individually by email with unique coded links.
• Participants self-measure height, weight, and waist circumference using standardized written instructions.
• Accelerometers are mailed to participants with instructions and returned for data upload.
• All questionnaire and accelerometer data are automatically labeled with the participant's study code.

No identifiable data are stored within the analytic dataset. The code key linking identities to study codes is stored separately by the PI in secure, locked storage.

Data Management Coded data from REDCap and accelerometers are exported to a secure institutional OneDrive project folder. Only authorized research team members have access. Data integrity is monitored through routine checks for completeness, timestamp accuracy, and device-return compliance. Any discrepancies are documented and resolved prior to analysis.

Statistical Approach

Data analysis will follow these steps:

1. Descriptive analyses Summaries of baseline characteristics and distribution checks for all continuous and categorical variables.
2. Within-group analyses Change over time within the intervention group (T1→T2 and T1→T3) using appropriate paired methods depending on variable type and distribution.
3. Between-group comparison at 10 weeks Comparison of change from T1→T2 between intervention and control participants to distinguish intervention-related effects from natural variation.

Exploratory analyses

1. Associations between baseline characteristics and degree of change. Relationships between changes in different domains (e.g., self-efficacy vs. physical activity). Sensitivity analyses for missing data or partial adherence.
2. Analyses are primarily exploratory due to the multifactorial outcome structure and modest sample size.

Sample Size Considerations The study aims to recruit approximately 30 intervention participants and 30 controls across multiple course iterations. This sample size is considered feasible and adequate for detecting meaningful changes in key behavioral and psychosocial measures based on effect sizes reported in previous SCI health-behavior studies. Recruitment continues until target numbers are achieved.

Participant Flow and Adherence Tracking Adherence to program components (session attendance, assignment completion) is recorded through weekly logs maintained by the course leader. Completion of T1-T2-T3 assessments is monitored through REDCap timestamps. Dropout or non-completion is documented with reason if provided.

Ethical and Data-Protection Procedures

All participants provide written informed consent prior to data collection. The intervention is voluntary and declining research participation does not restrict course participation.

All handling of personal data complies with GDPR and institutional policies. Risks are minimal, limited to potential discomfort reflecting on lifestyle habits or wearing an activity monitor.