Community-based interventions to prevent serious complications following spinal cord injury in Bangladesh: the CIVIC trial statistical analysis plan

Trials, 2019 · DOI: https://doi.org/10.1186/s13063-019-3181-2 · Published: April 23, 2019

Spinal Cord Injury Rehabilitation Research Methodology & Design

Simple Explanation

This study aims to evaluate a community-based care model for individuals with spinal cord injuries in Bangladesh, focusing on reducing mortality and complications after hospital discharge. The intervention involves case managers providing telephone support and home visits over two years, with a focus on preventing and treating pressure ulcers. The study will compare mortality rates and other outcomes between the intervention group and a control group receiving standard care.

Study Duration

2 years

Participants

410 people with recent spinal cord injury who are wheelchair dependent

Evidence Level

Level 1, Randomized Controlled Trial

Key Findings

1
The primary outcome is all-cause mortality at 2 years, determined by a blinded assessor due to the absence of a death registry in Bangladesh.
2
Secondary outcomes include the burden of complications, prevalence and severity of pressure ulcers, depression, quality of life, independence, and participation.
3
The statistical analysis plan includes intention-to-treat analysis and sensitivity analyses to address missing data and potential confounders.

Research Summary

The CIVIC trial is designed to assess the effectiveness of a community-based care model in reducing mortality and complications among individuals with spinal cord injuries in Bangladesh. The intervention involves ongoing support from case managers through phone calls and home visits, focusing on preventing pressure ulcers and other complications. The study employs a randomized controlled trial design with blinded assessment of outcomes and a detailed statistical analysis plan to ensure unbiased and precise results.

Practical Implications

Healthcare Policy

The trial results will inform the development and implementation of community-based care models for people with spinal cord injuries in low- and middle-income countries.

Clinical Practice

The findings will guide healthcare providers in managing and supporting individuals with spinal cord injuries after hospital discharge.

Further Research

The study will contribute to the limited data on mortality rates and effective interventions for spinal cord injuries in resource-constrained settings.

Study Limitations

1
Potential for ascertainment bias in safety data due to closer monitoring of the intervention group.
2
Incomplete safety data from the control group due to limited contact during the trial.
3
Reliance on next of kin or carers for mortality data due to the absence of a death registry in Bangladesh.

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