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

• Sponsor: Northwestern University (Other)
• Overall Status: Completed
• CT.gov ID: NCT01629771
• Collaborator: (none)
• Enrollment: 72
• Locations: 2
• Duration (Months): 1
• Patients Per Site: 36
• Patients Per Site Per Month: 35.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Lymphatic Filariasis

Study Design

• Study Type: Observational
• Actual Enrollment: 72 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: Disability and Quality of Life in Patients With Lymphatic Filariasis in Rural Southern India
• Study Start Date: May 1, 2012
• Actual Primary Completion Date: Jun 1, 2012
• Actual Study Completion Date: Jun 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Lymphatic Filariasis
Patients without Lymphatic Filariasis

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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.

3. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Northwestern University Department of Dermatology	Chicago	Illinois	United States	60611
2	Institute of Applied Dermatology	Kasaragod district	Kerala	India

Sponsors and Collaborators

• Northwestern University

Investigators

• Principal Investigator: Roopal Kundu, MD, Northwestern University

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Northwestern University Department of Dermatology Actively Enrolling Research Trials

Publications

• 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.
• Dreyer G, Norões 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. Review.
• 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.
• 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.
• Michael E, Bundy DA, Grenfell BT. Re-assessing the global prevalence and distribution of lymphatic filariasis. Parasitology. 1996 Apr;112 ( Pt 4):409-28. Review.
• 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.
• 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. Review.
• Recommendations of the International Task Force for Disease Eradication. MMWR Recomm Rep. 1993 Dec 31;42(RR-16):1-38.

• Responsible Party: Roopal Kundu, Assistant Professor of Dermatology, Northwestern University
• ClinicalTrials.gov Identifier: NCT01629771
• Other Study ID Numbers: STU63944
• First Posted: Jun 28, 2012
• Last Update Posted: Mar 20, 2014
• Last Verified: Feb 1, 2014

• Additional relevant MeSH terms: Filariasis; Elephantiasis, Filarial; Elephantiasis

Study Results

Participant Flow

Arm/Group Title	Subjects With Lymphatic Filariasis	Control Subjects
Arm/Group Description	Subjects with lymphatic filariasis completed health-related quality of life questionnaires.	Age- and gender-matched control subjects completed health-related quality of life questionnaires.
Period Title: Overall Study
STARTED	36	36
COMPLETED	36	36
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Subjects With Lymphatic Filariasis	Control Subjects	Total
Arm/Group Description	Subjects with lymphatic filariasis completed health-related quality of life questionnaires.	Age- and gender-matched control subjects completed health-related quality of life questionnaires.	Total of all reporting groups
Overall Participants	36	36	72
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	51.7 (16.2)	52.3 (16.1)	52.0 (16.0)
Sex: Female, Male (Count of Participants)
Female	28 77.8%	28 77.8%	56 77.8%
Male	8 22.2%	8 22.2%	16 22.2%
Region of Enrollment (participants) [Number]
India	36 100%	36 100%	72 100%

Outcome Measures

1. Primary Outcome

Title	Dermatology Life Quality Index (DLQI) Domain Scores
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Subjects With Lymphatic Filariasis	Control Subjects
Arm/Group Description	Subjects with lymphatic filariasis completed health-related quality of life questionnaires.	Age- and gender-matched control subjects completed health-related quality of life questionnaires.
Measure Participants	36	36
Symptoms & Feelings	3	0
Daily Activities	1	0
Leisure	1	0
Work & School	0	0
Personal Relationships	0	0
Treatment	0	0

2. Primary Outcome

Title	Lymphatic Filariasis-Specific Quality of Life (LFSQQ) Domain Scores
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Subjects With Lymphatic Filariasis	Control Subjects
Arm/Group Description	Subjects with lymphatic filariasis completed health-related quality of life questionnaires.	Age- and gender-matched control subjects completed health-related quality of life questionnaires.
Measure Participants	36	36
Mobility	67	100
Self-Care	100	100
Usual Activities	92	100
Disease Burden	63	100
Pain/Discomfort	90	100
Psychological Health	75	100
Social Participation	67	100

3. Primary Outcome

Title	World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0) Domain Scores
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Subjects With Lymphatic Filariasis	Control Subjects
Arm/Group Description	Subjects with lymphatic filariasis completed health-related quality of life questionnaires.	Age- and gender-matched control subjects completed health-related quality of life questionnaires.
Measure Participants	36	36
Cognition	15	0
Mobility	50	0
Self-Care	5	0
Getting Along	25	0
Life Activities	20	0
Participation in Society	25	0

Adverse Events

Arm/Group Title	Subjects With Lymphatic Filariasis		Control Subjects
Arm/Group Description	Subjects with lymphatic filariasis completed health-related quality of life questionnaires.		Age- and gender-matched control subjects completed health-related quality of life questionnaires.
All Cause Mortality
	Subjects With Lymphatic Filariasis		Control Subjects
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Subjects With Lymphatic Filariasis		Control Subjects
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)
Other (Not Including Serious) Adverse Events
	Subjects With Lymphatic Filariasis		Control Subjects
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.