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  4. 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

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 · DOI: 10.1136/bmjopen-2015-008369 · Published: July 8, 2015

Spinal Cord InjuryTelehealth & Digital HealthDermatology

Simple Explanation

This study aims to see if phone support can help people with spinal cord injuries manage pressure ulcers at home, especially in poorer countries where such injuries are a big problem. It will compare the results of those receiving phone support with those receiving standard care. The trial involves 120 people who have pressure ulcers because of their spinal cord injury. Some will get the usual care, while others will also receive weekly phone calls offering advice and support for 12 weeks. Researchers will measure the size of the ulcers after 12 weeks to see if the phone support made a difference. They will also look at other things like quality of life, depression, and how happy people are with their healthcare.

Study Duration
12 weeks
Participants
120 participants with pressure ulcers
Evidence Level
Randomised controlled trial

Key Findings

  • 1
    The primary outcome will be the size of the pressure ulcer at 12 weeks, assessed using commercially available grid paper to measure length and width.
  • 2
    Secondary outcomes include the severity of the pressure ulcer, undermining distance, depth, and pressure ulcer risk factors, assessed using various scales and measurements.
  • 3
    The study will also assess health-related quality of life, depression, participation, and satisfaction with healthcare provision, using validated questionnaires.

Research Summary

This study is designed to evaluate the effectiveness and cost-effectiveness of telephone-based support for managing pressure ulcers in individuals with spinal cord injuries in low- and middle-income countries. The research employs a multicentre, assessor-blinded, randomised controlled trial design, comparing usual community care with usual care plus weekly telephone support over a 12-week period. Outcomes measured include pressure ulcer size, severity, and various patient-reported measures such as quality of life, depression, and satisfaction with healthcare.

Practical Implications

Inexpensive intervention

Telephone-based support may provide a low cost way of helping people with SCI manage pressure ulcers at home in LMIC.

Improve self-management

With early advice, most people can be taught self-help strategies to manage less severe pressure ulcers at home.

Reduce hospitalization

By managing pressure ulcers at home, costly hospitalization and surgery can potentially be avoided.

Study Limitations

  • 1
    Assessors will be blinded, but it is not possible to blind participants or the clinicians.
  • 2
    The study is limited to individuals with spinal cord injuries and pressure ulcers on specific locations.
  • 3
    The intervention's effectiveness may be influenced by the participants' access to healthcare resources.

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