Are self-care interventions effective for the management of skin neglected tropical diseases in Anambra State, Nigeria?
| ISRCTN | ISRCTN20317241 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN20317241 |
| Secondary identifying numbers | GLRA001 |
- Submission date
- 13/08/2021
- Registration date
- 27/08/2021
- Last edited
- 27/09/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Skin and Connective Tissue Diseases
Plain English Summary
Background and study aims
Lymphatic filariasis (LF), Buruli ulcer (BU), and leprosy are neglected tropical diseases (NTDs) of the skin. These diseases often occur together in the same communities. The cutaneous manifestations of these diseases may include physical changes and losses to body structures causing permanent impairments and disability. Due to the frequent co-existence of these NTDs and the similarity in their management and control the World Health Organization (WHO) has called for their integrated management and care. However, not enough is known about the impact of integrated morbidity management and disability prevention in people with these conditions. The authors assessed the effectiveness of an integrated self-care intervention for people with these skin NTDs in two communities in terms of the effectiveness of self-care interventions on participants' costs of care for the impairment, disability status, and health-related quality of life.
Who can participate?
Individuals diagnosed with LF, BU, or leprosy who had completed specific treatment for their condition but who still had morbidities (like impairments, ulcers, etc) requiring additional care.
What does the study involve?
Individuals diagnosed with LF, BU, or leprosy who had completed specific treatment for their condition but who still had morbidities (like impairments, ulcers, etc) requiring additional care were trained to offer themselves self-care for their impairment and lesion. For each patient, the self-care skills and training were tailored to their need. Participants were instructed to visit a selected nearby health facility where a healthcare worker reinforces the taught self-care skills and interact with other patients.
Of the 48 participants recruited from December 2017 to March 2018, 30 of them reached the the last follow-up by June 2018
What are the possible benefits and risks of participating?
Improvement in the well-being, quality of life and reduction in the disability status of participants including their costs of managing the impairment
Where is the study run from?
DAHW German Leprosy and TB Relief Association (GLRA) Nigeria
When is the study starting and how long is it expected to run for?
September 2017 to June 2018
Who is funding the study?
The study was funded by the American Leprosy Mission, USA. The funders provided technical assistance in the training of field healthcare workers as well as technical support during the project. The funders had no role in study design, data collection and analysis, preparation of the manuscript or the decision to publish the manuscript.
Who is the main contact?
Ms Chinwe Eze, chinwe.eze@dahw.org
Contact information
Scientific
Department of Medicine
Alex Ekwueme Federal University Teaching Hospital
FMC Rd
Abakaliki
23433
Nigeria
 ORCID ID |
0000-0002-1974-8735 |
|---|---|
| Phone | +234 8036243196 |
| ukwajakingsley@yahoo.co.uk |
Public
Medical Department
German Leprosy and TB Relief Association
Enugu
234
Nigeria
| ORCID ID |
0000-0002-2704-6952 |
|---|---|
| Phone | +234 9032716409 |
| chinwe.eze@dahw.org |
Study information
| Study design | Quasi-experimental pre-test/post-test design |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Community |
| Study type | Quality of life |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet. |
| Scientific title | Effectiveness of self-care interventions for integrated morbidity management of skin neglected tropical diseases in Anambra State, Nigeria |
| Study hypothesis | The objective of the study was to assess the effectiveness of self-care interventions on participants costs of care, disability status and health-related quality of life |
| Ethics approval(s) | Approved 30/09/2017, Health Research Ethics Committee of the Anambra State Ministry of Health (Okechukwu Chidi, Jerome Udoji Secretariat Complex, Ministry of Health, PMB 6002, Awka, Anambra State, Nigeria; no telephone number provided; no email provided), ref: MH/AWK/M:321/383 |
| Condition | Skin neglected tropical diseases: Leprosy, Buruli Ulcer (BU), or Lymphatic Filariasis (LF) and non-neglected tropical diseases skin lesions (such as diabetic ulcers, sickle cell disease and trauma) |
| Intervention | In the study setting, the cadre of healthcare workers involved in the project are community health extension workers and community health officers. The self-care intervention for integrated morbidity management of skin NTDs had the following components: a) Improvement of healthcare workers’ (HCWs) knowledge and skills to identify and manage NTD impairments and complications locally or refer participants to other individuals or organizations that could help. This involved a 5-day non-residential training of HCWs in integrated management of NTD impairments using the American Leprosy Mission’s monograph, “Ten steps: A guide for health promotion and empowerment of people affected by NTDs” . The training involved the identification and management of common impairments and teaching self-care to affected participants. In addition, HCWs received guidance on measuring and recording impairments (for example, ulcer size, size of swelling, and limitations of movement) during participants’ baseline and follow-up visits at the health service. Six HCWs (who were community health extension workers and community health officers) from four primary health centres in the study sites were trained in integrated morbidity management and disability prevention for skin NTDs. b) HCWs’ provision of health education about NTDs and teaching participants with NTD self-care skills on how to manage their own impairments at home. This involved HCWs working with each participant to identify and care for his/her impairments so that they could manage their own care. The skills taught to participants during monthly visits with HCWs included skin and scar care, wound dressing, guidance on sterilisation of bandages, management of swelling and prevention and management of movement limitations. Monthly visits were not feasible for participants who lived too far away, but every participant had at least two visits. During these visits, the HCWs evaluated the participants’ impairments, addressed concerns or challenges faced by the participant when implementing self-care at home, and recorded changes in participants’ impairments. c) Improvement in self-care practices among participants with skin NTDs. All participants in the study had BU, leprosy or LF with impairments and movement limitations or had similar impairments not related to NTDs (such as diabetic ulcers, sickle cell disease and trauma). Welcoming participants without NTDs was important to increase uptake and reduce resentment among those who otherwise would have been turned away. All of those who wanted to participate were trained at the health facility on self-care specific to their needs using the “10-steps” monograph. Enrolled patients were expected to report to participating health facilities at least once every month for reassessment of impairment, reinforcement of self-care teaching and refill of self-care materials where necessary. In order to evaluate the success of the project, participants were asked to report monthly costs of their impairment care, disability status and Quality of Life (QoL) at baseline and follow-up after the intervention. |
| Intervention type | Behavioural |
| Primary outcome measure | 1. Self-reported economic costs of managing the impairment or lesion before (December 2017) and after (May/June 2018) the intervention period assessed with a costing tool 2. Disability status due to the impairment or lesion before (December 2017) and after (May/June 2018) the intervention period assessed using the World Health Organization Disability Scale-2 (WHODAS-2.0) 3. Quality of life due to the impairment or lesion before (December 2017) and after (May/June 2018) the intervention period assessed using the World Health Organization Quality of Life-BREF (WHOQOL-BREF) tool |
| Secondary outcome measures | 1. Self-reported economic costs of managing the impairment or lesion assessed with a costing tool by patients who provided baseline data but did not complete follow-up compared to those who completed follow-up. 2. Disability status due to the impairment or lesion assessed using the World Health Organization Disability Scale-2 (WHODAS-2.0) by patients who provided baseline data but did not complete follow-up compared to those who completed follow-up. 3. Quality of life due to the impairment or lesion assessed using the World Health Organization Quality of Life-BREF (WHOQOL-BREF) tool by patients who provided baseline data but did not complete follow-up compared to those who completed follow-up. |
| Overall study start date | 01/09/2017 |
| Overall study end date | 30/06/2018 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 48 |
| Total final enrolment | 48 |
| Participant inclusion criteria | 1. Diagnosed with LF, BU or leprosy 2. Completed specific treatment for their condition but still had morbidities requiring additional care |
| Participant exclusion criteria | Participants who had no impairment due to neglected tropical diseases or related conditions with similar impairment |
| Recruitment start date | 01/12/2017 |
| Recruitment end date | 31/03/2018 |
Locations
Countries of recruitment
- Nigeria
Study participating centre
Anambra
431108
Nigeria
Sponsor information
Charity
56 Nza S
Independence Layout
Enugu
400001
Nigeria
| Phone | +234 (0)803 668 0252 |
|---|---|
| glra.medical@dahw.org | |
| Website | https://whttp://glra.org.ng/ |
Funders
Funder type
Charity
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- ALM
- Location
- United States of America
Results and Publications
| Intention to publish date | 30/12/2021 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high impact journal. Accepted pending minor revision in BMC Public Health. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request. The Medical Department of German Leprosy and TB Relief Association, contact Ms Chinwe Eze, chinwe.eze@dahw.org, deanonymized data will be made available upon reasonable request for research and educational purposes. Access to the data will be given by email and any further research based on the dataset must be by collaboration with the study authors |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | 25/08/2021 | No | No | ||
| Results article | 25/09/2021 | 27/09/2021 | Yes | No |
Additional files
Editorial Notes
27/09/2021: Publication reference added.
25/08/2021: Trial's existence confirmed by American Leprosy Missions.
