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

Lymphatic Filariasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01629771
• Other study ID #: STU63944
• Status: Completed
• Phase: N/A
• First received: June 26, 2012
• Last updated: February 24, 2014
• Start date: May 2012
• Est. completion date: June 2012

Study information

• Verified date: February 2014
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Filariasis
• Lymphatic Filariasis

Locations

Country	Name	City	State
India	Institute of Applied Dermatology	Kasaragod district	Kerala
United States	Northwestern University Department of Dermatology	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Northwestern University

Countries where clinical trial is conducted

United States,  India, 

References & Publications (8)

Coreil J, Mayard G, Louis-Charles J, Addiss D. Filarial elephantiasis among Haitian women: social context and behavioural factors in treatment. Trop Med Int Health. 1998 Jun;3(6):467-73. — View Citation

Dreyer G, Norões J, Figueredo-Silva J. New insights into the natural history and pathology of bancroftian filariasis: implications for clinical management and filariasis control programmes. Trans R Soc Trop Med Hyg. 2000 Nov-Dec;94(6):594-6. Review. — View 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. — View 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. — View Citation

Michael E, Bundy DA, Grenfell BT. Re-assessing the global prevalence and distribution of lymphatic filariasis. Parasitology. 1996 Apr;112 ( Pt 4):409-28. Review. — View 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. — View 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. Review. — View Citation

Recommendations of the International Task Force for Disease Eradication. MMWR Recomm Rep. 1993 Dec 31;42(RR-16):1-38. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dermatology Life Quality Index (DLQI) Domain Scores	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.	Assessed after enrollment	No
Primary	Lymphatic Filariasis-Specific Quality of Life (LFSQQ) Domain Scores	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.	Assessed after enrollment	No
Primary	World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0) Domain Scores	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.	Assessed after enrollment	No

External Links

•   Northwestern University Department of Dermatology Actively Enrolling Research Trials