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The CIVIC pilot trial: Community-based intervention to prevent serious complications following spinal cord injury in Bangladesh

Pilot trial of a community-based intervention to prevent serious complications following spinal cord injury in Bangladesh

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12613001137785
Acronym
CIVIC
Enrollment
30
Registered
2013-10-11
Start date
2013-11-28
Completion date
2014-03-03
Last updated
2020-01-13

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 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 to compare a model of community-based care with usual care for people discharged home following recent spinal cord injury in Bangladesh. The primary aim is to determine whether a low-cost community-based model of care reduces all-cause mortality of people with spinal cord injury in Bangladesh. The secondary aims are to determine whether this model of care reduces the incidence of complications, enhances quality of life and independence, 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. It is conservatively estimated that 20% of participants will not be contactable by telephone. These particip

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. It is conservatively estimated that 20% of participants will not be contactable by telephone. These participants will be monitored with more frequent home visits. Each time the healthcare workers speak to participants, they will screen the participants for complications using purpose-designed interview scripts. Specifically, the healthcare workers will screen participants for the first indication of pressure ulcers, urinary tract infection, bowel impaction, bladder infection, depression, autonomic dysreflexia or respiratory complications. At the first indication of any of these complications, the healthcare workers will provide advice to participants and their families about management and then closely monitor them 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. Participants who cannot be contacted by telephone will be visited more frequently: three times in the first year and twice in the second year. At each home visit, the healthcare worker will assess the participant’s home situation and provide advice as needed.

Sponsors

Centre for Rehabilitation of the Paralysed
Lead SponsorHospital

Study design

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

Eligibility

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

Inclusion criteria

1. inpatient at the Centre for Rehabilitation of the Paralysed, Bangladesh about to be discharged. 2. sustained a traumatic or non-traumatic Spinal Cord Injury within the last 2 years. 3. aged 18 years or over at the time of consent. 4. requires a wheelchair for mobility on a daily basis

Exclusion criteria

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

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026