Please be advised that due to the high volume of submissions, the ANZCTR is currently experiencing delays in processing submissions from those outside of Australia and New Zealand. As the ANZCTR is funded by Australia and New Zealand, we must prioritise submissions from these countries first, therefore international submissions should allow additional time for registration or updates to registration records. Apologies for any inconvenience caused.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12615000630516
Ethics application status
Approved
Date submitted
15/06/2015
Date registered
17/06/2015
Date last updated
28/05/2019
Date data sharing statement initially provided
28/05/2019
Date results information initially provided
28/05/2019
Type of registration
Prospectively registered

Titles & IDs
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
Secondary ID [1] 286906 0
Nil known
Universal Trial Number (UTN)
U1111-1171-1876
Trial acronym
CIVIC
Linked study record

Health condition
Health condition(s) or problem(s) studied:
spinal cord injury 295322 0
Condition category
Condition code
Neurological 295592 295592 0 0
Other neurological disorders
Physical Medicine / Rehabilitation 295593 295593 0 0
Other physical medicine / rehabilitation
Injuries and Accidents 295594 295594 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 292093 0
Treatment: Other
Comparator / control treatment
Usual care.
After discharge from hospital, participants allocated to the Control group will receive the level of care currently provided by the Centre for Rehabilitation of the Paralysed. That is, a healthcare worker may telephone Control group participants in the first month after discharge. On this one occasion only, the healthcare worker will provide the same advice to Control group participants as is provided to Intervention group participants on the first telephone contact with participants. Control group participants will not receive routine ongoing support from the Centre for Rehabilitation of the Paralysed although they will be free to seek any support they can access.
Control group
Active

Outcomes
Primary outcome [1] 295305 0
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.
Timepoint [1] 295305 0
2 years
Secondary outcome [1] 315306 0
Spinal Cord Injury Secondary Conditions Scale
Timepoint [1] 315306 0
2 years
Secondary outcome [2] 315307 0
Prevalence of pressure ulcers, assessed by a physical examination.
Timepoint [2] 315307 0
2 years
Secondary outcome [3] 315308 0
Pressure Ulcer Scale for Healing (PUSH)
Timepoint [3] 315308 0
2 years
Secondary outcome [4] 315309 0
Center for Epidemiologic Studies Depression Scale
Timepoint [4] 315309 0
2 years
Secondary outcome [5] 315310 0
SF12 - Health Related Quality of Life
Timepoint [5] 315310 0
2 years
Secondary outcome [6] 315311 0
Spinal Cord Independence Measure
Timepoint [6] 315311 0
2 years
Secondary outcome [7] 315312 0
WHODAS – 2 – Participation Items
Timepoint [7] 315312 0
2 years
Secondary outcome [8] 315313 0
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.
Timepoint [8] 315313 0
2 years
Secondary outcome [9] 315314 0
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.
Timepoint [9] 315314 0
2 years
Secondary outcome [10] 315315 0
Work activities. Participants will be asked to report the number of days in the preceding week on which they engaged in work activities.
Timepoint [10] 315315 0
2 years

Eligibility
Key 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.
Minimum age
15 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Moving to another country following discharge from the Centre for Rehabilitation of the Paralysed, Bangladesh.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Enrolment: People with recent spinal cord injury will be screened for inclusion by research staff prior to discharge from the Centre for Rehabilitation of the Paralysed in Bangladesh.
Allocation: A secure random allocation sequence will be generated by an independent researcher. Allocation will be stratified by level of injury (paraplegia or tetraplegia). The allocation schedule will be concealed from investigators, potential participants, and clinical and research staff in Bangladesh. A participant’s allocation will only be revealed to the clinical staff administering the intervention. Randomisation will occur at
the time of discharge from hospital and will involve contacting the holder of the allocation schedule who is "off-site".
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The random allocation sequence will be computer generated by an independent researcher.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
All analyses will be conducted on an intention-to-treat basis, with the exception of secondary analyses which will estimate local average treatment effects (complier average causal effects and survivor average causal effects). Separate analyses will be conducted on each outcome. The analysis will follow a detailed statistical plan developed prior to inspection of the data.
The primary effectiveness analysis will compare the rates of all-cause mortality in the Intervention and Control Groups using the log-rank test (two-tailed alpha = 0.05).
Between-group comparisons of secondary outcomes will be conducted using logistic regression for binary outcomes or linear regression for other outcomes.
The cost-effectiveness analysis will involve a trial-based economic evaluation based on differences in overall survival and quality-adjusted survival at two years. In addition, a model-based evaluation will be conducted through a state-transition model which extrapolates long term costs and outcomes (survival and quality of life).
A sample size of 410 gives a better than 80% probability of detecting an increase in survival from 83% to 93% at two years with a two-sided log-rank test, uniform follow-up time of two years, loss to follow-up in both groups of 15% at two years, and alpha of 0.05.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 6976 0
Bangladesh
State/province [1] 6976 0

Funding & Sponsors
Funding source category [1] 291464 0
Government body
Name [1] 291464 0
National Health and Medical Research Council of Australia
Address [1] 291464 0
Level 1
16 Marcus Clarke Street
Canberra ACT 2601
Country [1] 291464 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
University of Sydney NSW 2006
Country
Australia
Secondary sponsor category [1] 290144 0
None
Name [1] 290144 0
Address [1] 290144 0
Country [1] 290144 0
Other collaborator category [1] 278497 0
Hospital
Name [1] 278497 0
Centre for Rehabilitation of the Paralysed
Address [1] 278497 0
PO CRP - Chapain
Savar, 1343
Country [1] 278497 0
Bangladesh
Other collaborator category [2] 278498 0
Other Collaborative groups
Name [2] 278498 0
Neuroscience Research Australia (NeuRA)
Address [2] 278498 0
Barker St
Randwick NSW 2031
Country [2] 278498 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293013 0
The University of Sydney Human Research Ethics Committee
Ethics committee address [1] 293013 0
University of Sydney NSW 2006
Ethics committee country [1] 293013 0
Australia
Date submitted for ethics approval [1] 293013 0
06/01/2015
Approval date [1] 293013 0
05/02/2015
Ethics approval number [1] 293013 0
2015/041

Summary
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
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 58082 0
A/Prof Sohrab Hossain
Address 58082 0
The Centre for Rehabilitation of the Paralysed
PO CRP - Chapain
Savar 1343
Country 58082 0
Bangladesh
Phone 58082 0
+88 02 7745464
Fax 58082 0
Email 58082 0
sohrabphysio@gmail.com
Contact person for public queries
Name 58083 0
Prof Lisa Harvey
Address 58083 0
John Walsh Centre for Rehabilitation Research
Kolling Institute
University of Sydney
c/- Royal North Shore Hospital
St Leonards NSW 2065
Country 58083 0
Australia
Phone 58083 0
+61 02 99264594
Fax 58083 0
Email 58083 0
l.harvey@usyd.edu.au
Contact person for scientific queries
Name 58084 0
Prof Lisa Harvey
Address 58084 0
John Walsh Centre for Rehabilitation Research
Kolling Institute
University of Sydney
c/- Royal North Shore Hospital
St Leonards NSW 2065
Country 58084 0
Australia
Phone 58084 0
+61 02 99264594
Fax 58084 0
Email 58084 0
l.harvey@usyd.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All individual data for the primary and secondary outcomes
When will data be available (start and end dates)?
The data will be made available one year after publication of the primary paper (or earlier) and will be available thereafter with no end date.
Available to whom?
All
Available for what types of analyses?
Any analyses
How or where can data be obtained?
The data will be provided to the publisher of the primary paper as a Supplementary File.
What supporting documents are/will be available?
Study protocol
Statistical analysis plan
How or where can supporting documents be obtained?
Type [1] 2141 0
Study protocol
Citation [1] 2141 0
Link [1] 2141 0
Email [1] 2141 0
Other [1] 2141 0
Type [2] 2142 0
Statistical analysis plan
Citation [2] 2142 0
Link [2] 2142 0
Email [2] 2142 0
Other [2] 2142 0
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
No
Results – basic reporting
Results – plain English summary