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

NCT01629771 | Completed Results DMC

• 1 other identifier: STU63944
• Study Type: observational
• Target: 72
• Locations: 2 countries
• Sites: 2

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.

Conditions

Lymphatic Filariasis

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Study Arms (2)

Lymphatic Filariasis

Patients without Lymphatic Filariasis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• Subjects with a clinical diagnosis of lymphatic filariasis
• Subjects over the age of 18 and able to give consent

You may not qualify if:

• Subjects on active treatment for lymphatic filariasis
• Subjects who are under the age of 18 or unable to give informed consent
• Subjects without a clinical diagnosis of lymphatic filariasis
• Subjects over the age of 18 and able to give consent
• Subjects without a clinical diagnosis of lymphatic filariasis
• Subjects who are under the age of 18 or unable to give informed consent

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (2)

Northwestern University Department of Dermatology

Chicago, Illinois, 60611, United States

Location

Institute of Applied Dermatology

Kasaragod District, Kerala, India

Location

Related Publications (8)

• Michael E, Bundy DA, Grenfell BT. Re-assessing the global prevalence and distribution of lymphatic filariasis. Parasitology. 1996 Apr;112 ( Pt 4):409-28. doi: 10.1017/s0031182000066646.

  PMID: 8935952 BACKGROUND

• 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. doi: 10.1046/j.1365-3156.1998.00238.x.

  PMID: 9657509 BACKGROUND

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

  PMID: 8145708 BACKGROUND

• Dreyer G, Noroes 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. doi: 10.1016/s0035-9203(00)90200-1. No abstract available.

  PMID: 11198637 BACKGROUND

• 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.

  PMID: 20739779 BACKGROUND

• 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. No abstract available.

  PMID: 20180687 BACKGROUND

• 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. doi: 10.1111/j.1365-2230.1994.tb01167.x.

  PMID: 8033378 BACKGROUND

• 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. No abstract available.

  PMID: 19725269 BACKGROUND

Related Links

• Northwestern University Department of Dermatology Actively Enrolling Research Trials

MeSH Terms

Conditions

Elephantiasis, Filarial

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Clinical Trials Unit Coordinator
• Organization: Northwestern University

j-bae@northwestern.edu

312-695-6829

Study Officials

• Roopal Kundu, MD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Dermatology

Study Record Dates

• First Submitted: June 26, 2012
• First Posted: June 28, 2012
• Study Start: May 1, 2012
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: March 20, 2014
• Results First Posted: August 2, 2013

Record last verified: 2014-02

Locations

US (1); IN (1)