Lymphatic FilariasisNCT01629771
Disability and Quality of Life in Patients With Lymphatic Filariasis in Rural Southern India
An observational study of Lymphatic Filariasis, run by Northwestern University at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Lymphatic Filariasis
- How many people
- 72 participants
- Where
- 2 sitesin 2 countries
- Study dates
- May 2012to Jun 2012
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
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 Exclusion Criteria
- Subjects without a clinical diagnosis of lymphatic filariasis
- Subjects who are under the age of 18 or unable to give informed consent
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
Northwestern University Department of Dermatology
Chicago, Illinois, 60611
About this study
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
- Medical subject headings
- Elephantiasis, Filarial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Lymphatic Filariasis | Not described | |
| Patients without Lymphatic Filariasis | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Assessed after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2012 (estimated)
- Study startMay 2012
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Lymphatic FilariasisStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roopal Kundu, Northwestern University
- Investigators
- Roopal Kundu, MD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01629771
- Sponsor's protocol ID
- STU63944
- Status last verified
- Feb 2014
- First submitted
- 26 Jun 2012
- Last updated
- 20 Mar 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 8935952Coreil 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.
PubMed 9657509Recommendations of the International Task Force for Disease Eradication. MMWR Recomm Rep. 1993 Dec 31;42(RR-16):1-38.
PubMed 8145708Dreyer 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.
PubMed 11198637Raju 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.
PubMed 20739779Narahari 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.
PubMed 20180687Finlay 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.
PubMed 8033378International 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.
PubMed 19725269
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Disability and Quality of Life in Patients With Lymphatic Filariasis in Rural Southern India
- ClinicalTrials.gov ID
- NCT01629771
- Acronym / sponsor ID
- STU63944
- Conditions
- Lymphatic Filariasis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 28 Jun 2012 (estimated)
- Results
- Posted 2 Aug 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lymphatic Filariasis | – | – |
| Patients without Lymphatic Filariasis | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Dermatology Life Quality Index (DLQI) Domain Scores
Time frame: 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
Time frame: 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
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 8935952Michael 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.
- Background: PubMed 9657509Coreil 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.
- Background: PubMed 8145708Recommendations of the International Task Force for Disease Eradication. MMWR Recomm Rep. 1993 Dec 31;42(RR-16):1-38.
- Background: PubMed 11198637Dreyer 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.
- Background: PubMed 20739779Raju 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.
- Background: PubMed 20180687Narahari 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.
- Background: PubMed 8033378Finlay 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.
- Background: PubMed 19725269International 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.
- Northwestern University Department of Dermatology Actively Enrolling Research TrialsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roopal Kundu, MD principal investigator
Northwestern University
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lymphatic Filariasis, run by Northwestern University at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Aug 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dermatology Life Quality Index (DLQI) Domain Scores (time frame: Assessed after enrollment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01629771, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2014.