Chronic Venous Insufficiency; Impact of Compression Stockings on Quality of Life
NCT ID: NCT02050061
Last Updated: 2014-01-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
100 participants
INTERVENTIONAL
2011-11-30
2012-10-31
Brief Summary
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Detailed Description
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Study site and population:
The study was conducted within multiple Primary Health Care (PHC) centers in Buraidah and Unaizah, the largest two cities in Qassim region, estimated population 800,000. We recruited all consecutive patients visited the primary health care center for various reasons until we have reached 100 participants clinically diagnosed with CVI. Informed consent was obtained from all screened participants.
Exclusion criteria: Pregnant women and those patients who refused or unable to obtain an informed consent.
Phase 1: We conducted a cross sectional study among patients attending PHC Centers of Qassim region. The duration of study was six months, from October 2011 to March 2012. Patients are consecutively interviewed and a dedicated questionnaire designed for this study applied to them. They were assessed using the most recent scale for CVI assessment, which is the clinical severity, etiology or cause, anatomy, pathophysiology (CEAP) scale. The study continued until we have achieved 100 patients with clinical diagnosis of CVI as per CEAP classification.
Phase 2: this phase immediately started after completion of the first phase. We randomize the patients regardless of their CEAP class to receive either compression stocking (SIGVARISTM) or standard medical therapy, fifty patients in each group. The compression-stocking group needs to pick up the stocking from a specific store free of charge located in Buraidah city. The standard therapy includes encouragement of exercise avoid prolonged standing still.
The questionnaire includes questions about basic demographic data, symptoms and signs of CVI, and presence of chronic disease such as diabetes, hypertension and heart disease. Focused physical examination of the lower limb for signs of CVI. CEAP class, score, venous severity score were also calculated for all CVI patients to assess the severity of CVI. All CVI patients were instructed about the estimated prevalence of CVI, risk factors, symptoms, grades and approach to management. About 30 participants from the overall 100 participants are exposed to SF36 quality of life questionnaire.
Follow Up:
Trans telephonic follow up for all the 100 CVI participants in whom the evaluator was blinded about the participant's prior answers and group allocation. Toward the end of the follow up questionnaire, a question of compliance to and practicality of compression stockings was assessed, if applicable. The compliance assessment was done by asking whether the participant picked up the compression stockings from the store, used regularly and the effect of the stockings i.e good or not comfortable or neutral). Last question was whether the participant would recommend compression stockings to others with the same problem.
The study protocol was reviewed and approved by the Research Committee of Qassim University and Medical education and research center in Qassim region, Ministry of health.
Statistical Analysis:
Statistical Package Social Science; SPSS version 17 software (SPSS Inc. Chicago, Illinois, USA) was used for data entry and processing. We used chi-square test, ANOVA and linear regression to assess the impact of compression stockings on the clinical and venous scores of CVI before and after the intervention.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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compression stocking
compression stocking (SIGVARISTM), daily for 3 months
compression stocking
study the impact of compression stocking
standard medical therapy
Usual care
No interventions assigned to this group
Interventions
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compression stocking
study the impact of compression stocking
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
70 Years
ALL
No
Sponsors
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Qassim University
OTHER
Responsible Party
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Abdulrahman Al-Mohaimeed
Doctor
Locations
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Primary care centers
Buraidah, Al-Qassim Region, Saudi Arabia
Countries
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References
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Al Shammeri O, AlHamdan N, Al-Hothaly B, Midhet F, Hussain M, Al-Mohaimeed A. Chronic Venous Insufficiency: prevalence and effect of compression stockings. Int J Health Sci (Qassim). 2014 Jul;8(3):231-6. doi: 10.12816/0023975.
Other Identifiers
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srd-873
Identifier Type: -
Identifier Source: org_study_id