HMB- Data Collection Methods

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Women and Infants Hospital of Rhode Island
Sponsor:
Information provided by (Responsible Party):
Kristen Matteson , M.D., Women and Infants Hospital of Rhode Island
ClinicalTrials.gov Identifier:
NCT02001324
First received: November 27, 2013
Last updated: NA
Last verified: November 2013
History: No changes posted
  Purpose

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.


Condition Intervention
Heavy Menstrual Bleeding
Other: Web-based data collection
Other: Paper-based data collection

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Patient-based Outcomes for Heavy Menstrual Bleeding: Comparisons of Treatments and Methods of Data Collection

Resource links provided by NLM:


Further study details as provided by Women and Infants Hospital of Rhode Island:

Primary Outcome Measures:
  • Quality of Life [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 6 Months ] [ Designated as safety issue: No ]

    Compare between the two modes of data collection(paper and electronic):

    number of "unusable" answers correlation of item responses to domain scores



Estimated Enrollment: 142
Study Start Date: March 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Paper-based data collection
Paper-based data collection
Other: Paper-based data collection
Active Comparator: Web-based data collection
Web-based data collection
Other: Web-based 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.

  Eligibility

Ages Eligible for Study:   18 Years to 51 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02001324

Contacts
Contact: Liliana Tavarez, BS 401-272-1122 ext 5840 ltavarez@wihri.org

Locations
United States, Rhode Island
Women & Infants Hospital Recruiting
Providence, Rhode Island, United States, 02905
Principal Investigator: Kristen Matteson, MD, MPH         
Sponsors and Collaborators
Women and Infants Hospital of Rhode Island
Investigators
Principal Investigator: Kristen Matteson, MD, MPH Women & Infants Hospital, Brown University
  More Information

No publications provided

Responsible Party: Kristen Matteson , M.D., Assistant Professor of Obstetrics and Gynecology, Women and Infants Hospital of Rhode Island
ClinicalTrials.gov Identifier: NCT02001324     History of Changes
Other Study ID Numbers: 12-0062
Study First Received: November 27, 2013
Last Updated: November 27, 2013
Health Authority: United States: Women & Infants Institutional Review Board

Keywords provided by Women and Infants Hospital of Rhode Island:
quality of life, heavy menstrual bleeding, electronic data collection

Additional relevant MeSH terms:
Hemorrhage
Menorrhagia
Pathologic Processes
Uterine Hemorrhage
Uterine Diseases
Genital Diseases, Female
Menstruation Disturbances

ClinicalTrials.gov processed this record on September 22, 2014