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Trial registered on ANZCTR


Registration number
ACTRN12613001137785
Ethics application status
Approved
Date submitted
27/05/2013
Date registered
11/10/2013
Date last updated
30/05/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
The CIVIC pilot trial: Community-based intervention to prevent serious complications following spinal cord injury in Bangladesh
Scientific title
Pilot trial of a community-based intervention to prevent serious complications following spinal cord injury in Bangladesh
Secondary ID [1] 282527 0
nil known
Universal Trial Number (UTN)
Trial acronym
CIVIC
Linked study record

Health condition
Health condition(s) or problem(s) studied:
spinal cord injury 289191 0
Condition category
Condition code
Neurological 289517 289517 0 0
Other neurological disorders
Physical Medicine / Rehabilitation 289518 289518 0 0
Other physical medicine / rehabilitation
Injuries and Accidents 289519 289519 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. 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.
Intervention code [1] 287187 0
Rehabilitation
Intervention code [2] 287188 0
Behaviour
Intervention code [3] 287189 0
Treatment: Other
Comparator / control treatment
Usual care.

Participants allocated to the Control group will receive the level of care currently provided by the Centre for Rehabilitation of the Paralysed after discharge from hospital. That is, a healthcare worker will 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 ongoing support although they will be free to seek any support they can access.
Control group
Active

Outcomes
Primary outcome [1] 289614 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] 289614 0
2 years
Secondary outcome [1] 302859 0
Spinal Cord Injury Secondary Conditions Scale
Timepoint [1] 302859 0
2 years
Secondary outcome [2] 302862 0
Pressure Ulcer Scale for Healing (PUSH)
Timepoint [2] 302862 0
2 years
Secondary outcome [3] 302863 0
Center for Epidemiologic Studies Depression Scale
Timepoint [3] 302863 0
2 years
Secondary outcome [4] 302864 0
SF12 - Health Related Quality of Life
Timepoint [4] 302864 0
2 years
Secondary outcome [5] 302866 0
Spinal Cord Independence Measure
Timepoint [5] 302866 0
2 years
Secondary outcome [6] 302867 0
WHODAS – 2 – Participation Items
Timepoint [6] 302867 0
2 years
Secondary outcome [7] 302868 0
Out of bed measure. Participants will be asked to recall the number of days in the last week in which they have got out of bed.
Timepoint [7] 302868 0
2 years
Secondary outcome [8] 302869 0
Out of house measure. Participants will be asked to recall the number of days in the last week in which they have gone out of the bounds of their home.
Timepoint [8] 302869 0
2 years
Secondary outcome [9] 302870 0
Work activities. Participants will be asked to report the number of days in the preceding week in which they engaged in work activities.
Timepoint [9] 302870 0
2 years
Secondary outcome [10] 315390 0
Prevalence of pressure ulcers, assessed by physical examination (inspection of the skin).
Timepoint [10] 315390 0
2 years

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

Study design
Purpose of the study
Treatment
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 their discharge from the Centre for Rehabilitation of the Paralysed in Bangladesh.

Allocation: A secure random allocation sequence will be generated by independent researchers. 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.
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
Phase 2 / Phase 3
Type of endpoint(s)
Efficacy
Statistical methods / analysis
All analyses will be conducted on an intention-to-treat basis. Separate analyses will be conducted on each outcome. 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 equal to or less than 0.05). Between-group comparisons of secondary outcomes will be conducted using logistic regression (for dichotomous outcomes) or linear regression (for continuous outcomes). In these models the outcome will be a linear function of a dummy-coded variable representing group membership (Intervention or Control group) and a dummy-coded variable for stratum (paraplegia or tetraplegia). For all continuous outcomes, baseline scores will be included in the model to increase statistical precision and statistical power.

A sample size of 30 is sufficient to demonstrate the feasibility of the trial protocol.

Recruitment
Recruitment status
Completed
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] 5088 0
Bangladesh
State/province [1] 5088 0

Funding & Sponsors
Funding source category [1] 287307 0
University
Name [1] 287307 0
The University of Sydney
Address [1] 287307 0
PO Box 6, Ryde, NSW, Australia, 2038
Country [1] 287307 0
Australia
Primary sponsor type
Hospital
Name
Centre for Rehabilitation of the Paralysed
Address
PO CRP - Chapain
Savar, 1343
Country
Bangladesh
Secondary sponsor category [1] 286059 0
None
Name [1] 286059 0
Address [1] 286059 0
Country [1] 286059 0
Other collaborator category [1] 277411 0
University
Name [1] 277411 0
The University of Sydney
Address [1] 277411 0
University of Sydney NSW 2006
Country [1] 277411 0
Australia
Other collaborator category [2] 277412 0
Charities/Societies/Foundations
Name [2] 277412 0
Livability
Address [2] 277412 0
Creevymore, Cliffoney, Ireland (no postcode)
Country [2] 277412 0
United Kingdom
Other collaborator category [3] 277468 0
Other Collaborative groups
Name [3] 277468 0
Neuroscience Research Australia (NeuRA)
Address [3] 277468 0
Neuroscience Research Australia
PO Box 1165
Randwick NSW 2031
Country [3] 277468 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289283 0
Bangladesh Medical Research Council
Ethics committee address [1] 289283 0
Ethics committee country [1] 289283 0
Bangladesh
Date submitted for ethics approval [1] 289283 0
26/04/2013
Approval date [1] 289283 0
08/10/2013
Ethics approval number [1] 289283 0
BMRC/NREC/2010-2013/1134

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 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.
Trial website
Trial related presentations / publications
Hossain MS, Harvey LA, Rahman MA, Bowden JL, Islam MS, Taylor V, Muldoon S, Herbert RD (2016) A pilot randomised trial of community-based care following discharge from hospital with a recent spinal cord injury in Bangladesh. [Accepted, Clinical Rehabilitation, 19 May 2016].
Public notes

Contacts
Principal investigator
Name 40166 0
A/Prof Sohrab Hossain
Address 40166 0
The Centre for Rehabilitation of the Paralysed
PO CRP - Chapain
Savar, 1343
Country 40166 0
Bangladesh
Phone 40166 0
8802 7745464
Fax 40166 0
8802 7745069
Email 40166 0
sohrabphysio@gmail.com
Contact person for public queries
Name 40167 0
Prof Lisa Harvey
Address 40167 0
John Walsh Centre for Rehabilitation Research
The University of Sydney
Level 13, Kolling Institute
Royal North Shore Hospital
St Leonards, NSW, 2065
Country 40167 0
Australia
Phone 40167 0
+61 2 9926 4594
Fax 40167 0
+61 2 9926 4045
Email 40167 0
l.harvey@usyd.edu.au
Contact person for scientific queries
Name 40168 0
Prof Lisa Harvey
Address 40168 0
John Walsh Centre for Rehabilitation Research
The University of Sydney
Level 13, Kolling Institute
Royal North Shore Hospital
St Leonards, NSW, 2065
Country 40168 0
Australia
Phone 40168 0
+61 2 99264594
Fax 40168 0
+61 2 99264045
Email 40168 0
l.harvey@usyd.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary