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Disability and Quality of Life in Patients With Lymphatic Filariasis in Rural Southern India

Completed
Conditions
Lymphatic Filariasis
Registration Number
NCT01629771
Lead Sponsor
Northwestern University
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
72
Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Dermatology Life Quality Index (DLQI) Domain ScoresAssessed after enrollment

The DLQI is a 10-item questionnaire measuring skin-specific quality of life through six domains: Symptoms \& Feelings, Daily Activities, Leisure, Work \& School, Personal Relationships, and Treatment. Symptoms \& Feelings, Daily Activities, Leisure, and Personal Relationships are each scored from 0 to 3, where 0 is associated with no effect on a patient's life, and 3 is associated with a large effect on a patient's life. Work \& School and Treatment are each scored from 0 to 3, where 0 is associated with no effect on a patient's life, and 6 is associated with a large effect on a patient's life.

Lymphatic Filariasis-Specific Quality of Life (LFSQQ) Domain ScoresAssessed after enrollment

The LFSQQ was developed to assess quality of life in subjects with lymphatic filariasis through seven domains: Mobility, Self-Care, Usual Activities, Disease Burden, Pain/Discomfort, Psychological Health, and Social Participation. Items are scored on a 5-point scale (no problem, mild, moderate, severe, most severe), and scores for each domain are calculated based on the number of questions answered and the raw scores. Scores for each domain range from 0 to 100, where 0 is associated with a worse quality of life and 100 is associated with a better quality of life.

World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0) Domain ScoresAssessed after enrollment

The WHODAS 2.0 is a generic health and disability assessment tool that describes effects of disease on six domains: Cognition, Mobility, Self-Care, Getting Along, Life Activities, and Participation in Society. Responses are measured on a 5-point scale from 1 (no difficulty) to 5 (extreme difficulty or cannot do). Scores are calculated using a WHO SPSS 36 version syntax for employed subjects and a WHO SPSS 32 version syntax for unemployed subjects. Scores for each domain range from 0 to 100, where 0 is associated with no impairment of health status, and 100 is associated with a greater impairment of health status.

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (2)

Northwestern University Department of Dermatology

🇺🇸

Chicago, Illinois, United States

Institute of Applied Dermatology

🇮🇳

Kasaragod district, Kerala, India

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