Enhanced self-care for advanced lymphoedema

• Register: ISRCTN
• Last refreshed on: 17 August 2020
• Main ID: ISRCTN16764792
• Date of registration: 04/04/2018
• Prospective Registration: Yes
• Primary sponsor: Liverpool School of Tropical Medicine
• Public title: Enhanced self-care for advanced lymphoedema
• Scientific title: Enhanced self-care protocol for severe case management of lymphoedema
• Date of first enrolment: 08/10/2018
• Target sample size: 640
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN16764792
• Study type: Interventional
• Study design: Multicentre comparative cohort six-month study (Treatment)
• Phase: Not Applicable

Countries of recruitment

Bangladesh, Ethiopia

Contacts

• Name: Janet Douglass

Key inclusion & exclusion 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


Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

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

Intervention(s)

19 districts in Bangladesh and 20 districts in Ethiopia have information on burden of disease. In each country, 20 health facility catchments are randomly selected using a random number generator. Of these 20 health facility catchments, 10 are allocated to Group A and 10 are allocated to Group B using a random number generator. However, to ensure the groups are located far enough away from each other to reduce any likelihood of discussions between groups allocated to different protocols, purposeful sampling may be used. Within each health facility catchment, community health workers (CHW) invites all known moderate and severe lymphoedema patients, over the age of 18 years to be involved in the study. participants will be allocated to group A or group B depending on their health facility allocation. CHW, patients and their carers are trained in the daily lymphoedema care protocol according to their group allocation. Upon completion of the study all participants will be trained in the enhanced care protocol.

Control Group A: Participants in this group receive the standard lymphoedema self-care (WHO guidelines) including;
1. Daily washing and drying of the limbs
2. Attending to entry lesions to prevent secondary bacterial infections
3. Daily elevation and simple exercises

Intervention Group B: Participants in this group receive the enhanced lymphoedema self-care including
1. All standard-care activities as described above
2. Daily deep breathing exercises
3. Additional exercises and walking
4. Daily lymphatic massage
5. Daily consumption of fresh fruits and vegetable
6. Daily cons

Primary Outcome(s)

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:
1. Lymphoedema stage according to the Dreyer 7 stage system
2. Limb circumference at mid-calf using a tape measure
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)

Secondary Outcome(s)

1. Adherence to the self-care protocol 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:
1.1. Daily journal kept by the participant and collected at each follow-up measure
1.2. Knowledge, attitudes and practices (KAP) questionnaire administered at baseline and after 24 weeks
2. Self-reported symptoms 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:
2.1. Pain
2.2. Perceived level of functional disability
2.3. Frequency and duration of acute attacks (secondary bacterial infections)
2.4. Days of work lost due to the disease
3. Quality of life measured using visual analogue scale at baseline prior to participants receiving the training in lymphoedema care, and after 4, 12 and 24 weeks of performing the daily protocol

Secondary ID(s)

GSK obj 5

Source(s) of Monetary Support

GlaxoSmithKline, Department for International Development

Ethics review

Status:
Approval date:
Contact:

Ethics approval as of 29/11/2018: Liverpool School of Tropical Medicine Research Ethics Committee (approval number 18-012): 05/10/2018 Bangladesh Medical Research Council (approval number 120 12 06 2018): 07/08/2018 Amhara Public Health Institute Research Ethics review Committee (approval number RTT03/15/2018): 31/10/2018. Previous ethics approval: Liverpool School of Tropic

Results

• Results available: Yes
• Date Completed: 10/05/2019