Codeveloping a Novel Intervention to Promote the Well-Being of Family Caregivers of Individuals With Spinal Cord Injury: Protocol for a Feasibility Randomized Control Trial
Bibliographic record
Abstract
BACKGROUND: Family caregivers of individuals with spinal cord injury (fcSCI) provide assistance with activities of daily living for individuals with spinal cord injury (SCI), which can include emotional support and physical assistance. Over time, providing daily support can put fcSCI at risk of experiencing caregiver burden. This burden can have a substantial impact on fcSCI's well-being. A direct predictor of the fcSCI burden is their appraisal of their ability to cope with the individual with SCI. Therefore, supporting fcSCI's access to education relevant to their role and the health and well-being of the individual with SCI can help decrease this burden. OBJECTIVE: The purpose of this study is to evaluate the fidelity of the COMPANION intervention and its study protocol designed to improve outcomes for fcSCI. METHODS: Recruitment began in June 2024 and is ongoing. Data collection was completed in April 2025. The fcSCI randomized into the intervention group have been given access to COMPANION after randomization. Data collection for both participant groups (COMPANION and control) will be performed after randomization and will be performed again after 3 months (T2) and 6 months (T3) to capture the impact of COMPANION on fcSCI's psychological well-being. RESULTS: As of June 2024, recruitment has begun and is ongoing. Data collection has begun and will conclude in 2025. The fcSCI randomized into the intervention group have been given access to COMPANION after randomization. Data collection for both participant groups (COMPANION and control) is collected after randomization, and again after three months (T2) and six months (T3) to capture the impact of COMPANION on fcSCI's psychological wellbeing. CONCLUSIONS: Study results will evaluate whether the full study can and should be conducted and will lead to the refinement of COMPANION. TRIAL REGISTRATION: ClinicalTrials.gov NCT06364813; https://clinicaltrials.gov/study/NCT06364813. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/67709.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.034 | 0.030 |
| Meta-epidemiology (narrow) | 0.005 | 0.003 |
| Meta-epidemiology (broad) | 0.008 | 0.004 |
| Bibliometrics | 0.003 | 0.003 |
| Science and technology studies | 0.004 | 0.003 |
| Scholarly communication | 0.005 | 0.004 |
| Open science | 0.004 | 0.003 |
| Research integrity | 0.007 | 0.008 |
| Insufficient payload (model declined to judge) | 0.067 | 0.011 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".