NCT01200199CompletedNot Applicable
Performance of Daily Electronic Diary to Capture Venous Symptoms Before and After Intervention for Great Saphenous Vein Incompetence
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 45
- Primary Endpoint
- To assess the feasibility, variability, validity and sensitivity of patient's varicose vein symptoms using a disease-specific symptom questionnaire, administered as a daily electronic diary in patients undergoing treatment for varicose veins
Study Overview
Brief Summary
The purpose of this study is to contribute to the validation of an electronic daily diary to assess symptoms in patients with varicose veins.
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Sign informed consent and complete study assessments in written English
- •Male or female age 18 to 75
- •Patients having Saphenofemoral Junction (SFJ) incompetence and scheduled to receive foam sclerotherapy treatment for varicose veins in one leg
- •Screening Symptom score of 7 points or more as measured by Question 1 on the modified VEINES-QOL/Sym questionnaire
Exclusion Criteria
- •Unable to comply with completing a daily diary for a total of 24 days
- •Participation in any other investigational pharmaceutical product, or device study within the 3 months prior to Visit 1
- •Current venous leg ulcer in either leg
Outcomes
Primary Outcomes
To assess the feasibility, variability, validity and sensitivity of patient's varicose vein symptoms using a disease-specific symptom questionnaire, administered as a daily electronic diary in patients undergoing treatment for varicose veins
Time Frame: 8 weeks
Secondary Outcomes
- To establish the treatment effect size of foam sclerotherapy treatment(8 weeks)
Investigators
Similar Trials
Unknown
Not Applicable
Electronic Mobile Phone App Stool DiaryIncontinence BowelConstipationNCT04644133Augusta University135
Completed
Not Applicable
The Feasibility Of a Daily Diary Methodology With a Pediatric Cancer PopulationCancerNCT01477255St. Jude Children's Research Hospital154
Completed
Not Applicable
The Ability of Electronic Patient Symptom Reporting to Reduce Symptom Burden During Hospitalization for ChemotherapyStem Cell Transplantation, HematopoieticNCT02574897UNC Lineberger Comprehensive Cancer Center76
Recruiting
Not Applicable
Use of a Diary to Assess and Monitor Behavioral and Psychological Symptoms of Dementia ( BPSDiary )Behavioral and Psychiatric Symptoms of DementiaNCT05977855Fondazione IRCCS San Gerardo dei Tintori300
Completed
Not Applicable
Assessing the Impact of Electronic Capture of Patient Reported Outcomes in Radiation OncologyPatients With Lung, Breast, Head and Neck, or Pelvic MalignanciesNCT02756767Abramson Cancer Center at Penn Medicine75