Trial Outcomes & Findings for Disability and Quality of Life in Patients With Lymphatic Filariasis in Rural Southern India (NCT NCT01629771)

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

72 participants

Primary outcome timeframe

Assessed after enrollment

Results posted on

2014-03-20

Participant Flow

Participant milestones

Participant milestones
Measure	Subjects With Lymphatic Filariasis Subjects with lymphatic filariasis completed health-related quality of life questionnaires.	Control Subjects Age- and gender-matched control subjects completed health-related quality of life questionnaires.
Overall Study STARTED	36	36
Overall Study COMPLETED	36	36
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Subjects With Lymphatic Filariasis n=36 Participants Subjects with lymphatic filariasis completed health-related quality of life questionnaires.	Control Subjects n=36 Participants Age- and gender-matched control subjects completed health-related quality of life questionnaires.	Total n=72 Participants Total of all reporting groups
Age, Continuous	51.7 years STANDARD_DEVIATION 16.2 • n=5 Participants	52.3 years STANDARD_DEVIATION 16.1 • n=7 Participants	52.0 years STANDARD_DEVIATION 16.0 • n=5 Participants
Sex: Female, Male Female	28 Participants n=5 Participants	28 Participants n=7 Participants	56 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	8 Participants n=7 Participants	16 Participants n=5 Participants
Region of Enrollment India	36 participants n=5 Participants	36 participants n=7 Participants	72 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Subjects With Lymphatic Filariasis n=36 Participants Subjects with lymphatic filariasis completed health-related quality of life questionnaires.	Control Subjects n=36 Participants Age- and gender-matched control subjects completed health-related quality of life questionnaires.
Dermatology Life Quality Index (DLQI) Domain Scores Symptoms & Feelings	3 units on a scale Interval 2.0 to 4.0	0 units on a scale Interval 0.0 to 0.0
Dermatology Life Quality Index (DLQI) Domain Scores Daily Activities	1 units on a scale Interval 0.0 to 2.0	0 units on a scale Interval 0.0 to 0.0
Dermatology Life Quality Index (DLQI) Domain Scores Leisure	1 units on a scale Interval 1.0 to 3.0	0 units on a scale Interval 0.0 to 0.0
Dermatology Life Quality Index (DLQI) Domain Scores Work & School	0 units on a scale Interval 0.0 to 1.0	0 units on a scale Interval 0.0 to 0.0
Dermatology Life Quality Index (DLQI) Domain Scores Personal Relationships	0 units on a scale Interval 0.0 to 1.0	0 units on a scale Interval 0.0 to 0.0
Dermatology Life Quality Index (DLQI) Domain Scores Treatment	0 units on a scale Interval 0.0 to 1.0	0 units on a scale Interval 0.0 to 0.0

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Subjects With Lymphatic Filariasis n=36 Participants Subjects with lymphatic filariasis completed health-related quality of life questionnaires.	Control Subjects n=36 Participants Age- and gender-matched control subjects completed health-related quality of life questionnaires.
Lymphatic Filariasis-Specific Quality of Life (LFSQQ) Domain Scores Social Participation	67 units on a scale Interval 50.0 to 85.0	100 units on a scale Interval 100.0 to 100.0
Lymphatic Filariasis-Specific Quality of Life (LFSQQ) Domain Scores Mobility	67 units on a scale Interval 58.0 to 80.0	100 units on a scale Interval 88.0 to 100.0
Lymphatic Filariasis-Specific Quality of Life (LFSQQ) Domain Scores Self-Care	100 units on a scale Interval 82.0 to 100.0	100 units on a scale Interval 100.0 to 100.0
Lymphatic Filariasis-Specific Quality of Life (LFSQQ) Domain Scores Usual Activities	92 units on a scale Interval 75.0 to 100.0	100 units on a scale Interval 100.0 to 100.0
Lymphatic Filariasis-Specific Quality of Life (LFSQQ) Domain Scores Disease Burden	63 units on a scale Interval 60.0 to 75.0	100 units on a scale Interval 100.0 to 100.0
Lymphatic Filariasis-Specific Quality of Life (LFSQQ) Domain Scores Pain/Discomfort	90 units on a scale Interval 83.0 to 96.0	100 units on a scale Interval 98.0 to 100.0
Lymphatic Filariasis-Specific Quality of Life (LFSQQ) Domain Scores Psychological Health	75 units on a scale Interval 64.0 to 86.0	100 units on a scale Interval 95.0 to 100.0

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Subjects With Lymphatic Filariasis n=36 Participants Subjects with lymphatic filariasis completed health-related quality of life questionnaires.	Control Subjects n=36 Participants Age- and gender-matched control subjects completed health-related quality of life questionnaires.
World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0) Domain Scores Self-Care	5 units on a scale Interval 0.0 to 10.0	0 units on a scale Interval 0.0 to 0.0
World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0) Domain Scores Getting Along	25 units on a scale Interval 0.0 to 33.0	0 units on a scale Interval 0.0 to 0.0
World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0) Domain Scores Life Activities	20 units on a scale Interval 0.0 to 40.0	0 units on a scale Interval 0.0 to 5.0
World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0) Domain Scores Participation in Society	25 units on a scale Interval 17.0 to 38.0	0 units on a scale Interval 0.0 to 8.0
World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0) Domain Scores Cognition	15 units on a scale Interval 3.0 to 20.0	0 units on a scale Interval 0.0 to 3.0
World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0) Domain Scores Mobility	50 units on a scale Interval 19.0 to 69.0	0 units on a scale Interval 0.0 to 13.0

Adverse Events

Subjects With Lymphatic Filariasis

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control Subjects

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Clinical Trials Unit Coordinator

Northwestern University

Phone: 312-695-6829

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place