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

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

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

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 Summary:
Sponsor: Northwestern University

Current Primary Outcome:

  • 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:

    Original Primary Outcome: disability and patient quality of life [ Time Frame: 0 hours ]

    How does lymphatic filariasis impact patients' disability and health-related quality of life?


    Current Secondary Outcome:

    Original Secondary Outcome:

    • Disability Severity [ Time Frame: 0 Hours ]
      What is the effect of disability severity on health-related quality of life in lymphatic filariasis subjects?
    • Health Related Quality of Life [ Time Frame: 0 hours ]
      How does the HRQoL instrument created by IAD compare to the DLQI in determining HRQoL in patients?
    • Demographic Factors [ Time Frame: 0 hours ]
      What are demographic and disease-specific factors associated with HRQoL and disability in lymphatic filariasis subjects?


    Information By: Northwestern University

    Dates:
    Date Received: June 26, 2012
    Date Started: May 2012
    Date Completion:
    Last Updated: February 24, 2014
    Last Verified: February 2014