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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Roopal Kundu, Northwestern University
ClinicalTrials.gov Identifier:
NCT01629771
First received: June 26, 2012
Last updated: February 24, 2014
Last verified: February 2014
  Purpose

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.


Condition
Lymphatic Filariasis

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Disability and Quality of Life in Patients With Lymphatic Filariasis in Rural Southern India

Resource links provided by NLM:


Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • Dermatology Life Quality Index (DLQI) Domain Scores [ Time Frame: Assessed after enrollment ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Enrollment: 72
Study Start Date: May 2012
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Lymphatic Filariasis
Patients without Lymphatic Filariasis

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01629771

Locations
United States, Illinois
Northwestern University Department of Dermatology
Chicago, Illinois, United States, 60611
India
Institute of Applied Dermatology
Kasaragod district, Kerala, India
Sponsors and Collaborators
Northwestern University
Investigators
Principal Investigator: Roopal Kundu, MD Northwestern University
  More Information

Additional Information:
Publications:
Responsible Party: Roopal Kundu, Assistant Professor of Dermatology, Northwestern University
ClinicalTrials.gov Identifier: NCT01629771     History of Changes
Other Study ID Numbers: STU63944
Study First Received: June 26, 2012
Results First Received: June 3, 2013
Last Updated: February 24, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Filariasis
Elephantiasis
Elephantiasis, Filarial
Spirurida Infections
Secernentea Infections
Nematode Infections
Helminthiasis
Parasitic Diseases
Lymphedema
Lymphatic Diseases

ClinicalTrials.gov processed this record on September 29, 2014