Lymphatic Filariasis
Conditions
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.
Interventions
None listed
Sponsors
Northwestern University
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dermatology Life Quality Index (DLQI) Domain Scores | Assessed after enrollment | 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. |
| Lymphatic Filariasis-Specific Quality of Life (LFSQQ) Domain Scores | Assessed after enrollment | 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. |
| World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0) Domain Scores | Assessed after enrollment | 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. |
Countries
India, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Subjects With Lymphatic Filariasis Subjects with lymphatic filariasis completed health-related quality of life questionnaires. | 36 |
| Control Subjects Age- and gender-matched control subjects completed health-related quality of life questionnaires. | 36 |
| Total | 72 |
Baseline characteristics
| Characteristic | Subjects With Lymphatic Filariasis | Control Subjects | Total |
|---|---|---|---|
| Age, Continuous | 51.7 years STANDARD_DEVIATION 16.2 | 52.3 years STANDARD_DEVIATION 16.1 | 52.0 years STANDARD_DEVIATION 16 |
| Region of Enrollment India | 36 participants | 36 participants | 72 participants |
| Sex: Female, Male Female | 28 Participants | 28 Participants | 56 Participants |
| Sex: Female, Male Male | 8 Participants | 8 Participants | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
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.
Time frame: Assessed after enrollment
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Subjects With Lymphatic Filariasis | Dermatology Life Quality Index (DLQI) Domain Scores | Symptoms & Feelings | 3 units on a scale |
| Subjects With Lymphatic Filariasis | Dermatology Life Quality Index (DLQI) Domain Scores | Daily Activities | 1 units on a scale |
| Subjects With Lymphatic Filariasis | Dermatology Life Quality Index (DLQI) Domain Scores | Leisure | 1 units on a scale |
| Subjects With Lymphatic Filariasis | Dermatology Life Quality Index (DLQI) Domain Scores | Work & School | 0 units on a scale |
| Subjects With Lymphatic Filariasis | Dermatology Life Quality Index (DLQI) Domain Scores | Personal Relationships | 0 units on a scale |
| Subjects With Lymphatic Filariasis | Dermatology Life Quality Index (DLQI) Domain Scores | Treatment | 0 units on a scale |
| Control Subjects | Dermatology Life Quality Index (DLQI) Domain Scores | Personal Relationships | 0 units on a scale |
| Control Subjects | Dermatology Life Quality Index (DLQI) Domain Scores | Symptoms & Feelings | 0 units on a scale |
| Control Subjects | Dermatology Life Quality Index (DLQI) Domain Scores | Work & School | 0 units on a scale |
| Control Subjects | Dermatology Life Quality Index (DLQI) Domain Scores | Daily Activities | 0 units on a scale |
| Control Subjects | Dermatology Life Quality Index (DLQI) Domain Scores | Treatment | 0 units on a scale |
| Control Subjects | Dermatology Life Quality Index (DLQI) Domain Scores | Leisure | 0 units on a scale |
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.
Time frame: Assessed after enrollment
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Subjects With Lymphatic Filariasis | Lymphatic Filariasis-Specific Quality of Life (LFSQQ) Domain Scores | Usual Activities | 92 units on a scale |
| Subjects With Lymphatic Filariasis | Lymphatic Filariasis-Specific Quality of Life (LFSQQ) Domain Scores | Pain/Discomfort | 90 units on a scale |
| Subjects With Lymphatic Filariasis | Lymphatic Filariasis-Specific Quality of Life (LFSQQ) Domain Scores | Self-Care | 100 units on a scale |
| Subjects With Lymphatic Filariasis | Lymphatic Filariasis-Specific Quality of Life (LFSQQ) Domain Scores | Psychological Health | 75 units on a scale |
| Subjects With Lymphatic Filariasis | Lymphatic Filariasis-Specific Quality of Life (LFSQQ) Domain Scores | Disease Burden | 63 units on a scale |
| Subjects With Lymphatic Filariasis | Lymphatic Filariasis-Specific Quality of Life (LFSQQ) Domain Scores | Social Participation | 67 units on a scale |
| Subjects With Lymphatic Filariasis | Lymphatic Filariasis-Specific Quality of Life (LFSQQ) Domain Scores | Mobility | 67 units on a scale |
| Control Subjects | Lymphatic Filariasis-Specific Quality of Life (LFSQQ) Domain Scores | Social Participation | 100 units on a scale |
| Control Subjects | Lymphatic Filariasis-Specific Quality of Life (LFSQQ) Domain Scores | Mobility | 100 units on a scale |
| Control Subjects | Lymphatic Filariasis-Specific Quality of Life (LFSQQ) Domain Scores | Self-Care | 100 units on a scale |
| Control Subjects | Lymphatic Filariasis-Specific Quality of Life (LFSQQ) Domain Scores | Usual Activities | 100 units on a scale |
| Control Subjects | Lymphatic Filariasis-Specific Quality of Life (LFSQQ) Domain Scores | Disease Burden | 100 units on a scale |
| Control Subjects | Lymphatic Filariasis-Specific Quality of Life (LFSQQ) Domain Scores | Pain/Discomfort | 100 units on a scale |
| Control Subjects | Lymphatic Filariasis-Specific Quality of Life (LFSQQ) Domain Scores | Psychological Health | 100 units on a scale |
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.
Time frame: Assessed after enrollment
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Subjects With Lymphatic Filariasis | World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0) Domain Scores | Cognition | 15 units on a scale |
| Subjects With Lymphatic Filariasis | World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0) Domain Scores | Mobility | 50 units on a scale |
| Subjects With Lymphatic Filariasis | World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0) Domain Scores | Self-Care | 5 units on a scale |
| Subjects With Lymphatic Filariasis | World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0) Domain Scores | Getting Along | 25 units on a scale |
| Subjects With Lymphatic Filariasis | World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0) Domain Scores | Life Activities | 20 units on a scale |
| Subjects With Lymphatic Filariasis | World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0) Domain Scores | Participation in Society | 25 units on a scale |
| Control Subjects | World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0) Domain Scores | Life Activities | 0 units on a scale |
| Control Subjects | World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0) Domain Scores | Cognition | 0 units on a scale |
| Control Subjects | World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0) Domain Scores | Getting Along | 0 units on a scale |
| Control Subjects | World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0) Domain Scores | Mobility | 0 units on a scale |
| Control Subjects | World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0) Domain Scores | Participation in Society | 0 units on a scale |
| Control Subjects | World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0) Domain Scores | Self-Care | 0 units on a scale |