An observational study in Lymphatic Filariasis, sponsored by Northwestern University. Completed at 2 sites in 2 countries. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-03-20.
Sponsored by Northwestern University · Observational
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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.
42 studies on the registry are indexed under Elephantiasis, Filarial; 5 are open to participants now.
This study's enrollment of 72 is below the median of 12,930 across 13 observational studies indexed under Elephantiasis, Filarial.
Browse Elephantiasis, Filarial studies →Northwestern University is the lead sponsor of 1,424 studies on the registry; 199 are open to participants now.
Of its 105 completed or terminated interventional studies of FDA-regulated products, 78 (74%) have results posted.
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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
Case Inclusion Criteria
Case Exclusion Criteria
Control Inclusion Criteria
Control Exclusion Criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Time frame: 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.
Time frame: 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.
Time frame: Assessed after enrollment
| Milestone | Subjects With Lymphatic Filariasis | Control Subjects |
|---|---|---|
| Started | 36 | 36 |
| Completed | 36 | 36 |
| Not completed | 0 | 0 |
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.
| units on a scale | Subjects With Lymphatic Filariasis | Control Subjects |
|---|---|---|
| Symptoms & Feelings | 3 (2 to 4) | 0 (0 to 0) |
| Daily Activities | 1 (0 to 2) | 0 (0 to 0) |
| Leisure | 1 (1 to 3) | 0 (0 to 0) |
| Work & School | 0 (0 to 1) | 0 (0 to 0) |
| Personal Relationships | 0 (0 to 1) | 0 (0 to 0) |
| Treatment | 0 (0 to 1) | 0 (0 to 0) |
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.
| units on a scale | Subjects With Lymphatic Filariasis | Control Subjects |
|---|---|---|
| Mobility | 67 (58 to 80) | 100 (88 to 100) |
| Self-Care | 100 (82 to 100) | 100 (100 to 100) |
| Usual Activities | 92 (75 to 100) | 100 (100 to 100) |
| Disease Burden | 63 (60 to 75) | 100 (100 to 100) |
| Pain/Discomfort | 90 (83 to 96) | 100 (98 to 100) |
| Psychological Health | 75 (64 to 86) | 100 (95 to 100) |
| Social Participation | 67 (50 to 85) | 100 (100 to 100) |
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.
| units on a scale | Subjects With Lymphatic Filariasis | Control Subjects |
|---|---|---|
| Cognition | 15 (3 to 20) | 0 (0 to 3) |
| Mobility | 50 (19 to 69) | 0 (0 to 13) |
| Self-Care | 5 (0 to 10) | 0 (0 to 0) |
| Getting Along | 25 (0 to 33) | 0 (0 to 0) |
| Life Activities | 20 (0 to 40) | 0 (0 to 5) |
| Participation in Society | 25 (17 to 38) | 0 (0 to 8) |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Subjects With Lymphatic Filariasis | — | — | — |
| Control Subjects | — | — | — |
| Age, Continuous(years) | Subjects With Lymphatic Filariasis | Control Subjects | Total |
|---|---|---|---|
| Mean | 51.7 ± 16.2 | 52.3 ± 16.1 | 52.0 ± 16.0 |
| Sex: Female, Male(Participants) | Subjects With Lymphatic Filariasis | Control Subjects | Total |
|---|---|---|---|
| Female | 28 | 28 | 56 |
| Male | 8 | 8 | 16 |
| Region of Enrollment(participants) | Subjects With Lymphatic Filariasis | Control Subjects | Total |
|---|---|---|---|
| India | 36 | 36 | 72 |
The record gives a start of May 2012, a primary completion of Jun 2012 and a completion of Jun 2012. It does not say whether these dates are actual or estimated.
Results were first posted in Aug 2013, 1 year 2 months after primary completion.
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This study is completed, as verified in Feb 2014. You cannot join it, but the record below documents what was studied.
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