Enhanced self-care for advanced lymphoedema

Not Applicable

Completed

• Conditions: infection with lymphatic filariasis or podoconiosis; Lower limb lymphoedema caused by either; ower limb lymphoedema caused by either; Infections and Infestations

• Registration Number: ISRCTN16764792
• Lead Sponsor: iverpool School of Tropical Medicine

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)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-04-04
• Study Completion: 2019-05-10
• Last Update Posted: 17 August 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 618

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> Lymphoedema status is measured at baseline prior to participants receiving the training in lymphoedema care, and after 4, 12 and 24 weeks of performing the daily protocol using:<br> 1. Lymphoedema stage according to the Dreyer 7 stage system<br> 2. Limb circumference at mid-calf using a tape measure<br> 3. Subcutaneous tissue compressibility at mid-calf using an indurometer (the Indurometer is a small hand held device which non-invasively measures the degree of tissue compressibility in the skin and subcutaneous compartment. This device is previously validated in women with breast cancer-related arm lymphoedema and young, asymptomatic people residing in an LF endemic region in Myanmar)<br>