Clinical trial NCT01629771: Disability and Quality of Life in Patients With Lymphatic Filariasis in Rural Southern India
Official title: Disability and Quality of Life in Patients With Lymphatic Filariasis in Rural Southern India
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lymphatic Filariasis
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2012-06-28
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: This study will be conducted in the Kasaragod district of Kerala, India. Subjects with a clinical diagnosis of lymphatic filariasis of a single body part or more will be recruited from the Institute of Applied Dermatology, and age-matched controls

Brief 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

Primary outcomes:
measure: Dermatology Life Quality Index (DLQI) Domain Scores
timeFrame: Assessed after enrollment
measure: Lymphatic Filariasis-Specific Quality of Life (LFSQQ) Domain Scores
timeFrame: Assessed after enrollment
measure: World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0) Domain Scores
timeFrame: Assessed after enrollment
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University Department of Dermatology
state: Illinois
city: Kasaragod district
country: India
facility: Institute of Applied Dermatology
state: Kerala
Study officials:
affiliation: Northwestern University
name: Roopal Kundu, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Raju K, Jambulingam P, Sabesan S, Vanamail P. Lymphatic filariasis in India: epidemiology and control measures. J Postgrad Med. 2010 Jul-Sep;56(3):232-8. doi: 10.4103/0022-3859.68650.
citation: Narahari SR, Aggithaya MG, Prasanna KS, Bose KS. An integrative treatment for lower limb lymphedema (elephantiasis). J Altern Complement Med. 2010 Feb;16(2):145-9. doi: 10.1089/acm.2008.0546. No abstract available.
citation: Finlay AY, Khan GK. Dermatology Life Quality Index (DLQI)--a simple practical measure for routine clinical use. Clin Exp Dermatol. 1994 May;19(3):210-6. doi: 10.1111/j.1365-2230.1994.tb01167.x.
citation: International Society of Lymphology. The diagnosis and treatment of peripheral lymphedema. 2009 Concensus Document of the International Society of Lymphology. Lymphology. 2009 Jun;42(2):51-60. No abstract available.