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Trial registered on ANZCTR


Registration number
ACTRN12613001225707
Ethics application status
Approved
Date submitted
10/10/2013
Date registered
7/11/2013
Date last updated
11/11/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Telerehabilitation for people with pressure ulcers secondary to spinal cord injury in India
Scientific title
Telerehabilitation versus standard care for management of pressure ulcers in people with spinal cord injury in India- a 12-week TREPUS randomized controlled trial.
Secondary ID [1] 283242 0
Nil
Universal Trial Number (UTN)
Trial acronym
TREPUS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pressure ulcers in people with spinal cord injury. 290113 0
Condition category
Condition code
Neurological 290492 290492 0 0
Other neurological disorders
Skin 290685 290685 0 0
Dermatological conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Telerehabilitation- Participants allocated to the intervention group will receive telephone support once a week for 12 weeks. Telephone support will be 15-25 minutes in duration and will be focused on pressure ulcer management. Specifically, participants will receive education and advice about seating, pressure-relief, support surfaces, nutrition, wound dressing, self-care activities and other issues related to their pressure ulcer. The participants will also receive advice about when to seek further nursing or medical attention.

Participants allocated to the intervention group will continue with their usual care and receive a pamphlet containing information about pressure ulcer management.
Intervention code [1] 287969 0
Rehabilitation
Comparator / control treatment
Participants allocated to the control group will receive usual care. This typically involves care provided by the family. They will also receive a pamphlet containing information about pressure ulcer management.

Participants allocated to the control group will be free to seek any other type of help or medical assistance they deem appropriate or have access to.
Control group
Active

Outcomes
Primary outcome [1] 290513 0
Size of pressure ulcers measured using grid paper.
Timepoint [1] 290513 0
At baseline and at 12 weeks post randomization.
Secondary outcome [1] 304684 0
Severity of pressure ulcer using the Pressure Ulcer Scale for Healing (PUSH).
Timepoint [1] 304684 0
At baseline and at 12 weeks post randomization.
Secondary outcome [2] 304685 0
Risk of developing a pressure ulcer using the Braden Scale.
Timepoint [2] 304685 0
At baseline and at 12 weeks post randomization.
Secondary outcome [3] 304686 0
Undermining distance of the pressure ulcer using a sterile scaled probe.
Timepoint [3] 304686 0
At baseline and at 12 weeks post randomization.
Secondary outcome [4] 304687 0
Depth of pressure ulcer using a sterile scaled probe.
Timepoint [4] 304687 0
At baseline and at 12 weeks post randomization.
Secondary outcome [5] 304688 0
Quality of life using the EuroQoL-5D questionnaire.
Timepoint [5] 304688 0
At baseline and at 12 weeks post randomization.
Secondary outcome [6] 304689 0
Depression using the Hospital and Anxiety Scale (HADS).
Timepoint [6] 304689 0
At baseline and at 12 weeks post randomization.
Secondary outcome [7] 304690 0
Participation using the Participation items of World Health Organization Disability Assessment Scale Schedule 2.0.
Timepoint [7] 304690 0
At baseline and at 12 weeks post randomization.
Secondary outcome [8] 304691 0
Participants’ self-report on time to pressure ulcer resolution.
Timepoint [8] 304691 0
At baseline and weekly post randomization for 12 weeks.
Secondary outcome [9] 304694 0
Participants' impression of pressure ulcer status measured using a 11-point scale (0=extremely poor, 10=extremely good).
Timepoint [9] 304694 0
At baseline and at 12 weeks post randomization.
Secondary outcome [10] 304695 0
Clinicians’ impression of pressure ulcer status measured using an 11-point scale (0=extremely poor, 10=extremely good).
Timepoint [10] 304695 0
At baseline and at 12 weeks post randomization.
Secondary outcome [11] 304696 0
Participants’ satisfaction with the service they have received for their pressure ulcers over the last 12 weeks measured using an 11-point scale (0=very unsatisfied, 10=very satisfied).
Timepoint [11] 304696 0
At 12 weeks post randomization.
Secondary outcome [12] 304697 0
Participants’ confidence to manage the pressure ulcer measured using an 11-point scale (0=not very confident, 10=very confident).
Timepoint [12] 304697 0
At baseline and at 12 weeks post randomization.
Secondary outcome [13] 304698 0
Economic evaluation- Both a cost-effectiveness analysis in which outcomes are measured in natural units, and a cost-utility analysis in which outcomes are measured in incremental quality adjusted life years (QALYs) will be conducted. Participant will be given weekly diaries to capture the cost.
Timepoint [13] 304698 0
At baseline and weekly post randomization for 12 weeks.

Eligibility
Key inclusion criteria
Participants will be included if they:
i. are 18 years of age or over, and willing to provide signed informed consent.
ii. have a documented diagnosis of complete or incomplete spinal cord injury:
iia. due to traumatic or non-traumatic cause.
iib. of more than 6 months duration.
iii. have at least one pressure ulcer secondary to SCI on sacrum, ischial tuberosity or trochanter.
iv. are living in the National Capital Region or are able to return to the Indian Spinal Injuries Centre for assessment.
v. are able to speak sufficient Hindi to allow them to participate in the study without the assistance of a translator.
vi. have access to a mobile phone and will be able to comply with regular phone interviews as specified by the protocol.
vii. are likely to comply with the study schedule and assessments as specified by the protocol.
viii. have the potential to benefit from telerehabilitation.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants will be excluded if they:
i. have been advised of the possibility of requiring surgery within the next 12 weeks.
ii. are not willing or able to be contacted on a mobile phone.
iii. have any cognitive or verbal impairment.
iv. have a clinically significant or unstable medical condition including psychiatric, behavioural or terminal illness that would compromise participation in the study.

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)
Potential and interested participants will be informed about the trial both verbally and in writing using a participant information sheet (PIS) as per the Good Clinical Practices guidelines. Participants will be given the opportunity to ask any question and discuss their participation with their doctor and family. A signed and dated copy of the PIS and informed consent form (ICF) will be given to participants for their records. Participants will be given an English or Hindi version of the PIS and ICF as appropriate. Participants will be randomly allocated to one of the two groups using the principle of concealed allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A blocked randomisation schedule will be used. This will be computer-generated prior to commencement of the study by an independent person located off the study site. Concealment will be ensured by placing each participant’s allocation into a sealed, opaque and sequentially numbered envelope. The envelopes will be kept off site by an independent person. Once a participant has completed the baseline assessment and his/her details are lodged, the researcher will contact the independent person to open an envelope and attain the participant’s allocation. The participant will be considered to have entered the trial at this point.
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 statistical analyses will be performed using the principles of ‘intention to treat’. The purpose of all analyses will be to provide point estimates of the size of treatment effects. Separate analyses will be conducted on each outcome. The economic evaluation will be conducted from a societal perspective and will include costs incurred by the individual and healthcare providers.

A sample size of 120 will be used. This assumes a SD of 30 cm2, loss to follow-up of 15% and an alpha of 0.05. The minimally worthwhile treatment effect will be set as 10% of mean initial size of pressure ulcers of all participants.

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] 5429 0
India
State/province [1] 5429 0
New Delhi

Funding & Sponsors
Funding source category [1] 287998 0
Self funded/Unfunded
Name [1] 287998 0
Unfunded
Address [1] 287998 0
NA
Country [1] 287998 0
Primary sponsor type
University
Name
John Walsh Centre for Rehabilitation Research, The University of Sydney
Address
John Walsh Centre for Rehabilitation Research
Kolling Building Level 13, Royal North Shore Hospital
Sydney Medical School- Northern
THE UNIVERSITY OF SYDNEY
St. Leonards NSW 2065
Country
Australia
Secondary sponsor category [1] 286717 0
Hospital
Name [1] 286717 0
Indian Spinal Injuries Centre
Address [1] 286717 0
Indian Spinal Injuries Centre
Sector-C Vasant Kunj
Opposite Vasant Valley School
New Delhi-110070
Country [1] 286717 0
India

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289923 0
Institutional Ethics Committee- Indian Spinal Injuries Centre
Ethics committee address [1] 289923 0
Indian Spinal Injuries Centre
Sector-C Vasant Kunj
Opposite Vasant Valley School
New Delhi-110070
Ethics committee country [1] 289923 0
India
Date submitted for ethics approval [1] 289923 0
Approval date [1] 289923 0
01/10/2013
Ethics approval number [1] 289923 0
Ethics committee name [2] 292640 0
Ethics Review Committee
Ethics committee address [2] 292640 0
Ethics Review Committee
Centre for the Rehabilitation of the Paralysed (CRP)
Savar, Dhaka-1344
Ethics committee country [2] 292640 0
Bangladesh
Date submitted for ethics approval [2] 292640 0
17/09/2014
Approval date [2] 292640 0
20/10/2014
Ethics approval number [2] 292640 0
CRP/RE/0401/110
Ethics committee name [3] 292641 0
Institutional Ethics Committee
Ethics committee address [3] 292641 0
Punjabi University
Patiala, Punjab
Ethics committee country [3] 292641 0
India
Date submitted for ethics approval [3] 292641 0
11/08/2014
Approval date [3] 292641 0
04/12/2014
Ethics approval number [3] 292641 0
254/DLS/HG

Summary
Brief summary
Pressure ulcers are common and severe complications after SCI. They hinder rehabilitation and have many deleterious consequences like contractures, permanent scarring, deformities, osteomyelitis, loss of limb, and sepsis often requiring hospital admissions. In addition, they affect a person’s family and social life, and are costly and difficult to manage. Pressure ulcers can also lead to death. It is estimated that they are responsible for 7 to 8 per cent of deaths in persons with SCI in developed countries. This figure is probably much higher in low and middle-income countries although accurate data about the extent of the problem is not currently available. So while the exact extent of the problem in low- and middle-income countries is not known, there is general consensus that pressure ulcers are a major and life-threatening problem. On the other hand, the main strategy for the treatment and prevention of pressure ulcers is education. In the community, pressure ulcer management requires weekly assessment in persons with SCI. In vast geographic and low resourced countries like India, it is difficult to follow patients up on a weekly basis. Hence, pressure ulcers are commonly neglected leading to widespread misery. Telerehabilitation is the delivery of rehabilitation services using communication and information technologies. It increases accessibility and enhances continuity of care for people with disabilities.
Telerehabilitation is increasingly available in India with the popular use of mobile phones. This might provide an inexpensive way of managing pressure ulcers from a distance through reinforcing measures for prevention & management. The trial will be called - the TeleREhabilitation program for managing Pressure Ulcers in persons with SCI (TREPUS) trial.

It will be the first, large, prospective, randomised, single blinded trial to investigate this question. There will be two groups; Intervention and Control. Participants in the Intervention group will receive telephone support on a weekly basis for 12 weeks and participants in the Control group will receive usual care alone. The purpose of the trial will be to provide precise estimates of the effect of the Intervention on the size of pressure ulcers compared to the Control group.
Trial website
Trial related presentations / publications
Arora M, Harvey LA, Hayes AJ, et al. Effectiveness and cost-effectiveness of telephone-based support versus usual care for treatment of pressure ulcers in people with spinal cord injury in low-income and middle-income countries: study protocol for a 12-week randomised controlled trial. BMJ Open 2015;5:e008369. doi:10.1136/bmjopen-2015-008369
Public notes

Contacts
Principal investigator
Name 43042 0
A/Prof Lisa Harvey
Address 43042 0
John Walsh Centre for Rehabilitation Research
Kolling Building Level 13, Royal North Shore Hospital
Sydney Medical School- Northern
THE UNIVERSITY OF SYDNEY
St. Leonards NSW 2065
Country 43042 0
Australia
Phone 43042 0
+61 2 9926 4594
Fax 43042 0
+61 2 9926 4045
Email 43042 0
lisa.harvey@sydney.edu.au
Contact person for public queries
Name 43043 0
Mr Mohit Arora
Address 43043 0
John Walsh Centre for Rehabilitation Research
Kolling Building Level 13, Royal North Shore Hospital
Sydney Medical School- Northern
THE UNIVERSITY OF SYDNEY
St. Leonards NSW 2065
Country 43043 0
Australia
Phone 43043 0
+61 2 9926 4697
Fax 43043 0
+61 2 9926 4045
Email 43043 0
mohit.arora@sydney.edu.au
Contact person for scientific queries
Name 43044 0
A/Prof Lisa A Harvey
Address 43044 0
John Walsh Centre for Rehabilitation Research
Kolling Building Level 13, Royal North Shore Hospital
Sydney Medical School- Northern
THE UNIVERSITY OF SYDNEY
St. Leonards NSW 2065
Country 43044 0
Australia
Phone 43044 0
+61 2 9926 4697
Fax 43044 0
+61 2 9926 4045
Email 43044 0
mohit.arora@sydney.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