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The CIVIC TRIAL: a randomised trial of a community-based intervention to prevent serious complications following spinal cord injury in Bangladesh

A randomised trial of community-based intervention compared to standard care to prevent serious complications following spinal cord injury in Bangladesh

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12615000630516
Acronym
CIVIC
Enrollment
410
Registered
2015-06-17
Start date
2015-07-12
Completion date
2018-03-19
Last updated
2021-03-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Spinal cord injuries are four times more common in low income countries than in high income countries. In most low income countries, people who sustain a spinal cord injury are discharged home with very little access to support services. They often then develop life-threatening complications, and many die within years of discharge. It is not clear if a low-cost and sustainable community-based model of care for people who have returned home after spinal cord injury can prevent complications following spinal cord injury. We will investigate the effectiveness of a sustainable model of care which involves regular monitoring and provision of ongoing education and advice by telephone, together with a limited number of home visits, for patients and their families and carers. The service will be provided in the first 2 years following discharge when patients are most vulnerable to complications. A pragmatic randomised controlled trial will be undertaken. The primary aim is to determine whether this low-cost community-based model of care reduces all-cause mortality of people with spinal cord injury in Bangladesh. Secondary aims are to determine whether this model of care - reduces the burden of complications - reduces the prevalence and severity of pressure ulcers - reduces depression - enhances quality of life, independence and participation, and - is cost-effective

Interventions

Community-based care. Participants allocated to the Intervention group will be followed-up by telephone for two years after discharge. Community-based healthcare workers will telephone participants each fortnight in the first year and each month in the second year. They will encourage participants to contact healthcare workers at the first signs of complications or as needed for support. Each time the healthcare workers speak to a participant, the healthcare worker will screen the participant f

Community-based care. Participants allocated to the Intervention group will be followed-up by telephone for two years after discharge. Community-based healthcare workers will telephone participants each fortnight in the first year and each month in the second year. They will encourage participants to contact healthcare workers at the first signs of complications or as needed for support. Each time the healthcare workers speak to a participant, the healthcare worker will screen the participant for complications using purpose-designed interview scripts. Specifically, the healthcare worker will screen for the first indication of a pressure ulcer, urinary tract infection, bowel impaction, bladder infection, depression, autonomic dysreflexia or respiratory complications. At the first indication of any of these complications, the healthcare worker will provide advice to participants and their families about management and then closely monitor the participant over the next few days or weeks until the complication is resolved. The healthcare workers will also visit participants and their families in their homes. There will be two home visits in the first year and one in the second year. At each home visit, the healthcare worker will assess the participant’s home situation and provide advice as needed.

Sponsors

The University of Sydney
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
15 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. inpatient at the Centre for Rehabilitation of the Paralysed, Bangladesh, soon to be discharged. 2. sustained a traumatic or non-traumatic spinal cord injury in the last 2 years. 3. aged 15 years or over at the time of consent. 4. requires a wheelchair for mobility on a daily basis.

Exclusion criteria

Moving to another country following discharge from the Centre for Rehabilitation of the Paralysed, Bangladesh.

Outcome results

None listed

Source: ANZCTR · Data processed: Mar 3, 2026