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

NCT ID: NCT01629771

Last Updated: 2014-03-20

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

72 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-05-31

Study Completion Date

2012-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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 Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Lymphatic Filariasis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Lymphatic Filariasis

No interventions assigned to this group

Patients without Lymphatic Filariasis

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Subjects with 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 over the age of 18 and able to give consent

Exclusion Criteria

* 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 who are under the age of 18 or unable to give informed consent
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Northwestern University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Roopal Kundu

Assistant Professor of Dermatology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Roopal Kundu, MD

Role: PRINCIPAL_INVESTIGATOR

Northwestern University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Northwestern University Department of Dermatology

Chicago, Illinois, United States

Site Status

Institute of Applied Dermatology

Kasaragod District, Kerala, India

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States India

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 8935952 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9657509 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 8145708 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11198637 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20739779 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20180687 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 8033378 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19725269 (View on PubMed)

Related Links

Access external resources that provide additional context or updates about the study.

http://www.feinberg.northwestern.edu/depts/dermatology/research/clinical-trials/ctu-active%20trials.htm

Northwestern University Department of Dermatology Actively Enrolling Research Trials

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

STU63944

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.