None listed
Conditions
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.
Interventions
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 fu
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.
Sponsors
John Walsh Centre for Rehabilitation Research, The University of Sydney
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
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.
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.
Outcome results
None listed