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Clinical Trials/ISRCTN16764792
ISRCTN16764792
Completed
未知

Enhanced self-care protocol for severe case management of lymphoedema

iverpool School of Tropical Medicine0 sites618 target enrollmentApril 4, 2018

Overview

Phase
未知
Intervention
Not specified
Conditions
ower limb lymphoedema caused by either
Sponsor
iverpool School of Tropical Medicine
Enrollment
618
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

  1. 2019 protocol in https://pubmed.ncbi.nlm.nih.gov/31487887 (added 08/05/2020) 2. 2019 Indurometer reliability and agreement evaluation in https://pubmed.ncbi.nlm.nih.gov/31859599 (added 08/05/2020) 3. 2020 results in https://pubmed.ncbi.nlm.nih.gov/32751676/ (added 07/08/2020)
Registry
who.int
Start Date
April 4, 2018
End Date
May 10, 2019
Last Updated
5 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
iverpool School of Tropical Medicine

Eligibility Criteria

Inclusion Criteria

  • Patients lymphoedema, their carers and community health workers who:
  • 1\. Reside within a 10 km radius of the selected health facilities
  • 2\. Are 18 years of age or older
  • 3\. Patients must have moderate to severe leg lymphoedema as defined as stage 3 or above according to the Dreyer staging system for filarial lymphoedema
  • 4\. Patients must be able to perform the daily self\-care protocol either independently or with the aid of a carer.
  • 5\. Carers must be available on a daily basis to assist the patient with lymphoedema\-care activities as needed
  • 6\. All participants must be able to provide informed consent

Exclusion Criteria

  • Patients lymphoedema, their carers and community health workers who:
  • 1\. Are under 18 years of age
  • 2\. Decline to be involved in the study
  • 3\. Are unable to give informed consent
  • 4\. Are too unwell to participate
  • 5\. Lymphoedema patients who have mild leg lymphoedema as defined as stage 2 or below according to the Dreyer staging system for filarial lymphoedema
  • 6\. Patients with any medical condition eg heart, kidney, lung disease
  • 7\. Patients with severe arthritis
  • 8\. Patients with traumatic injury or surgery on the lymphoedema limb
  • 9\. Patients or carers who are unable or unwilling to perform daily lymphoedema\-care activities

Outcomes

Primary Outcomes

Not specified

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