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

• Register: ANZCTR
• Last refreshed on: 29 March 2021
• Main ID: ACTRN12615000630516
• Date of registration: 17/06/2015
• Prospective Registration: Yes
• Primary sponsor: The University of Sydney
• Public title: The CIVIC TRIAL: a randomised trial of a community-based intervention to prevent serious complications following spinal cord injury in Bangladesh
• Scientific title: A randomised trial of community-based intervention compared to standard care to prevent serious complications following spinal cord injury in Bangladesh
• Date of first enrolment: 12/07/2015
• Target sample size: 410
• Recruitment status: Completed
• URL: https://anzctr.org.au/ACTRN12615000630516.aspx
• Study type: Interventional
• Study design: Purpose: Prevention; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Efficacy;
• Phase: Not Applicable

Countries of recruitment

Bangladesh

Contacts

• Name: Prof Lisa Harvey

• Name: Prof Lisa Harvey

Key inclusion & exclusion criteria

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.

Age minimum: 15 Years
Age maximum: No limit
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Injuries and Accidents - Other injuries and accidents

spinal cord injury;
spinal cord injury

Neurological - Other neurological disorders

Physical Medicine / Rehabilitation - Other physical medicine / rehabilitation

Intervention(s)

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.

Primary Outcome(s)

All-cause mortality.
The date of death will be confirmed by interviewing next of kin
(Bangladesh does not have a death registry). Wherever possible
independent corroboration of the date of death will be obtained, for
example from local community leaders.[2 years]

Secondary Outcome(s)

Center for Epidemiologic Studies Depression Scale[2 years]

Out of house measure. Participants will be asked to report the number of days in the preceding week on which they left the bounds of their home.[2 years]

Pressure Ulcer Scale for Healing (PUSH)[2 years]

Spinal Cord Injury Secondary Conditions Scale[2 years]

WHODAS – 2 – Participation Items[2 years]

Spinal Cord Independence Measure[2 years]

Out of bed measure. Participants will be asked to report the number of days in the preceding week on which they got out of bed.[2 years]

Prevalence of pressure ulcers, assessed by a physical examination.[2 years]

SF12 - Health Related Quality of Life[2 years]

Work activities. Participants will be asked to report the number of days in the preceding week on which they engaged in work activities.[2 years]

Secondary ID(s)

Nil known

Source(s) of Monetary Support

National Health and Medical Research Council of Australia

Ethics review

Status: Approved
Approval date: 05/02/2015
Contact:

The University of Sydney Human Research Ethics Committee

Results

• Results available: Yes
• Date Posted: 28/05/2019
• Date Completed: 15/02/2020