N/A
N=72
Disability and Quality of Life in Patients With Lymphatic Filariasis in Rural Southern India
Lymphatic Filariasis
Bottom Line
View on ClinicalTrials.gov: NCT01629771 ↗Enrolled (actual)
72
Serious AEs
—
Results posted
Aug 2013
Primary outcome: Primary: Dermatology Life Quality Index (DLQI) Domain Scores — 3; 0; 1; 0 units on a scale
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Northwestern University
- Primary completion
- Jun 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Dermatology Life Quality Index (DLQI) Domain Scores |
3; 0; 1; 0; 1; 0 | — |
| PRIMARY Lymphatic Filariasis-Specific Quality of Life (LFSQQ) Domain Scores |
67; 100; 100; 100; 92; 100 | — |
| PRIMARY World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0) Domain Scores |
15; 0; 50; 0; 5; 0 | — |
Summary
According to the World Health Organization, lymphatic filariasis, a mosquito-borne parasitic disease, is the second leading cause of disability worldwide. Across 81 countries, approximately 120 million people are infected with the disease, and of those infected, an estimated 40% reside in India alone. The most disfiguring symptoms of lymphatic filariasis, elephantiasis and lymphedema, cause long-term suffering in patients who are then often embarrassed or even rejected from their communities. Because of the disease's debilitating physical and social effects on patients, this study will explore the intersection of disability and health-related quality of life (HRQoL) in lymphatic filariasis patients in India. Specifically, HRQoL and disability in lymphatic filariasis subjects and age- and gender- matched control subjects will be compared. Two HRQoL tools , the general Dermatology Life Quality Index (DLQI) and a disease-specific instrument developed by a dermatology group in India will be used to gauge HRQol. In addition, the demographic and disease-specific factors associated with HRQoL and disability in filarial lymphedema subjects will be identified.
Eligibility Criteria
Case Inclusion Criteria
- Subjects with a clinical diagnosis of lymphatic filariasis
- Subjects over the age of 18 and able to give consent
Case Exclusion Criteria
- Subjects on active treatment for lymphatic filariasis
- Subjects who are under the age of 18 or unable to give informed consent
Control Inclusion Criteria
- Subjects without a clinical diagnosis of lymphatic filariasis
- Subjects over the age of 18 and able to give consent
Control Exclusion Criteria
- Subjects without a clinical diagnosis of lymphatic filariasis
- Subjects who are under the age of 18 or unable to give informed consent
Data sourced from ClinicalTrials.gov (NCT01629771). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.