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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lymphatic Filariasis | |||
| Patients without Lymphatic Filariasis |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Case Inclusion Criteria
Case Exclusion Criteria
Control Inclusion Criteria
Control Exclusion Criteria
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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
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| Name | Affiliation | Role |
|---|---|---|
| Roopal Kundu, MD | Northwestern University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern University Department of Dermatology | Chicago | Illinois | 60611 | United States | ||
| Institute of Applied Dermatology |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 8935952 | Background | 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. | |
| 9657509 | 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. |
| Label | URL |
|---|---|
| Northwestern University Department of Dermatology Actively Enrolling Research Trials | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Subjects With Lymphatic Filariasis | Subjects with lymphatic filariasis completed health-related quality of life questionnaires. |
| FG001 | Control Subjects | Age- and gender-matched control subjects completed health-related quality of life questionnaires. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Subjects With Lymphatic Filariasis | Subjects with lymphatic filariasis completed health-related quality of life questionnaires. |
| BG001 | Control Subjects | Age- and gender-matched control subjects completed health-related quality of life questionnaires. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Median | Inter-Quartile Range | units on a scale | Assessed after enrollment |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Subjects With Lymphatic Filariasis | Subjects with lymphatic filariasis completed health-related quality of life questionnaires. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trials Unit Coordinator | Northwestern University | 312-695-6829 | j-bae@northwestern.edu |
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| ID | Term |
|---|---|
| D004605 | Elephantiasis, Filarial |
| ID | Term |
|---|---|
| D005368 | Filariasis |
| D017205 | Spirurida Infections |
| D017190 | Secernentea Infections |
| D009349 | Nematode Infections |
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| Kasaragod District |
| Kerala |
| India |
| 8145708 | Background | Recommendations of the International Task Force for Disease Eradication. MMWR Recomm Rep. 1993 Dec 31;42(RR-16):1-38. |
| 11198637 | 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. |
| 20739779 | 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. |
| 20180687 | 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. |
| 8033378 | 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. |
| 19725269 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 |
| Control Subjects |
Age- and gender-matched control subjects completed health-related quality of life questionnaires. |
|
|
| 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. | Posted | Median | Inter-Quartile Range | units on a scale | Assessed after enrollment |
|
|
|
| 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. | Posted | Median | Inter-Quartile Range | units on a scale | Assessed after enrollment |
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Control Subjects | Age- and gender-matched control subjects completed health-related quality of life questionnaires. | 0 | 0 | 0 | 0 |
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| D006373 |
| Helminthiasis |
| D010272 | Parasitic Diseases |
| D007239 | Infections |
| D000096724 | Mosquito-Borne Diseases |
| D000079426 | Vector Borne Diseases |
| D008209 | Lymphedema |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| Usual Activities |
|
| Disease Burden |
|
| Pain/Discomfort |
|
| Psychological Health |
|
| Social Participation |
|
| Self-Care |
|
| Getting Along |
|
| Life Activities |
|
| Participation in Society |
|