HMB- Data Collection Methods
Primary Purpose
Heavy Menstrual Bleeding
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Web-based data collection
Paper-based data collection
Sponsored by
About this trial
This is an interventional other trial for Heavy Menstrual Bleeding focused on measuring quality of life, heavy menstrual bleeding, electronic data collection
Eligibility Criteria
Inclusion Criteria:
Patients who are presenting for gynecologic visits or well-woman examinations who still have an intact uterus and are between the ages of 18 and 51 years, have abnormal uterine bleeding, and can read and write in English.
Exclusion Criteria:
- Women who are presently on a treatment for abnormal uterine bleeding.
Sites / Locations
- Women & Infants Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Paper-based data collection
Web-based data collection
Arm Description
Paper-based data collection
Web-based data collection
Outcomes
Primary Outcome Measures
Menstrual bleeding questionnaire score
Condition-specific quality of life measurement tool for heavy menstrual bleeding compare change in quality of life over time between women receiving different treatments for heavy menstrual bleeding
Secondary Outcome Measures
Quality of data collected
Compare between the two modes of data collection(paper and electronic):
number of "unusable" answers correlation of item responses to domain scores
Full Information
NCT ID
NCT02001324
First Posted
November 27, 2013
Last Updated
August 23, 2021
Sponsor
Women and Infants Hospital of Rhode Island
1. Study Identification
Unique Protocol Identification Number
NCT02001324
Brief Title
HMB- Data Collection Methods
Official Title
Patient-based Outcomes for Heavy Menstrual Bleeding: Comparisons of Treatments and Methods of Data Collection
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Terminated
Why Stopped
this pilot project is no longer funded
Study Start Date
March 2013 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
December 31, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Women and Infants Hospital of Rhode Island
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is an observational study to determine the effect of various treatments prescribed by healthcare providers for heavy menstrual bleeding on bleeding related quality of life (as measured by the Menstrual Bleeding Questionnaire) and to compare electronic and paper-based modes of data collection.
Detailed Description
Approximately 10% of women of reproductive age seek medical care each year for evaluation and treatment of heavy menstrual bleeding. Women with heavy menstrual bleeding suffer diminished quality of life, [1-2] lose work productivity,[3] and utilize expensive medical resources.[4] Although hysterectomy is considered the "definitive" treatment for heavy menstrual bleeding, many other options are available including endometrial ablation, the levonorgestrel intrauterine system (LNG-IUS), combined oral contraceptives (COCs), oral progestin, NSAIDs, and tranexamic acid. Better characterization of the relative efficacy of commonly used therapies for abnormal uterine bleeding will improve patient counseling, facilitate informed decision-making, and reduce the burden of unnecessary procedures on both the patient and the health care system. The data comparing these treatments in terms of patient-based outcome measures and bleeding-related quality of life are quite limited. We plan to prospectively compare bleeding-related quality of life between treatment methods within a cohort of patients receiving clinical care for heavy menstrual bleeding.
This study is being performed to determine the effect of various treatments prescribed by healthcare providers for heavy menstrual bleeding on bleeding related quality of life (as measured by the MBQ) and to compare electronic and paper-based modes of data collection. Eligible and consenting participants will be randomized to complete the study questionnaires electronically on IPad devices or on paper. At enrollment, participants will complete a background questionnaire and the MBQ. The background questionnaire will include information on age, race-ethnicity, primary language, income, education, and other medical issues. (Background Information Form) This will allow us to evaluate the effect of important demographic characteristics and concomitant medical problems on the effectiveness of prescribed treatments for heavy menstrual bleeding. We will also perform a chart review to validate the patient-reported medical information.
This study includes both prospective data collection with randomization of participants to mode of data collection. Studies will be conducted at Women and Infants Hospital in the Women's Primary Care Center. Approximately 13,000 women are seen for care that is not related to pregnancy. If only 10% of these women report heavy menstrual bleeding (which has a prevalence of 10-30%), 1300 patients in the WPCC could be eligible for these studies annually. Patient charts will be reviewed for potential eligibility in the WPCC in the evening and the morning. We plan to approach patients for screening who are presenting for gynecologic visits or well-woman examinations who still have an intact uterus and are between the ages of 18 and 51 years. The research assistant will make a list of names and appointment times to plan recruitment and will place a note on the front of the chart to page her when the patient is placed in a room. Lists of names will be destroyed each day. The research assistant or principal investigator will approach patients and screen them for eligibility. (Screening Form) The study will be described to eligible participants and informed consent obtained.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heavy Menstrual Bleeding
Keywords
quality of life, heavy menstrual bleeding, electronic data collection
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
42 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Paper-based data collection
Arm Type
Active Comparator
Arm Description
Paper-based data collection
Arm Title
Web-based data collection
Arm Type
Active Comparator
Arm Description
Web-based data collection
Intervention Type
Other
Intervention Name(s)
Web-based data collection
Intervention Type
Other
Intervention Name(s)
Paper-based data collection
Primary Outcome Measure Information:
Title
Menstrual bleeding questionnaire score
Description
Condition-specific quality of life measurement tool for heavy menstrual bleeding compare change in quality of life over time between women receiving different treatments for heavy menstrual bleeding
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Quality of data collected
Description
Compare between the two modes of data collection(paper and electronic):
number of "unusable" answers correlation of item responses to domain scores
Time Frame
6 Months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
51 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patients who are presenting for gynecologic visits or well-woman examinations who still have an intact uterus and are between the ages of 18 and 51 years, have abnormal uterine bleeding, and can read and write in English.
Exclusion Criteria:
Women who are presently on a treatment for abnormal uterine bleeding.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kristen Matteson, MD, MPH
Organizational Affiliation
Women & Infants Hospital, Brown University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Women & Infants Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02905
Country
United States
12. IPD Sharing Statement
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HMB- Data Collection Methods
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