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

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.

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Key information

Conditions

Lymphatic Filariasis Elephantiasis, Filarial Filariasis Helminthiasis Hemic and Lymphatic Diseases Infections Lymphatic Diseases Lymphedema Mosquito-Borne Diseases Nematode Infections Parasitic Diseases Secernentea Infections Spirurida Infections Vector Borne Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Institute of Applied Dermatology, Kasaragod District, Kerala, India

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Dermatology Life Quality Index (DLQI) Domain Scores

Time frame: Assessed 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 Scores

Time frame: Assessed 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 Scores

Time frame: Assessed 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.

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Registry information

Important dates

Study start: 2012
Primary completion: 2012
Study completion: 2012
First posted: Jun 28, 2012
Registry last updated: Mar 20, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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