Venous Thrombosis Prevention and Sleep Quality: A Comparison of the Kendall and the Recovery Health MAC Systems
Condition: Deep Venous Thrombosis of Deep Femoral Vein
MeSH terms: Thrombosis; Venous Thrombosis
Study type: Interventional

Summary: 
      Venous thromboembolism is prevalent, associated with a high degree of morbidity and
      mortality, and largely preventable. External mechanical compression is a standard of care for
      prevention, but compliance with traditional external mechanical compression devices is low
      due to patient reported issues with comfort, mobility, usability, noise, and sleep
      disturbances. The purpose of this study was to compare user-rated comfort, mobility,
      usability, noise, perceived sleep disturbance, and objective sleep disturbance for a novel
      external lower limb mechanical compression device as compared to a standard sequential
      compression device.

      Using a 2-day counterbalanced, within-subject repeated-measures design, 16 participants wore
      two mechanical compression devices, the commonly-used Kendall sequential compression device
      Express 9525 and the novel Recovery Force Movement and Compressions Device for 1 night each
      in their home while sleep was recorded with polysomnography. For each device, participants
      also completed questionnaires to assess usability, mobility, perceived noise disturbance, and
      perceived sleep disturbance.
    

Detailed description: 
      Recruitment

        1. Respondents are solicited via social media/local flyer campaigns (see attached flyers),
           or word of mouth (see Recruitment via Word of Mouth) to complete a brief, electronic
           pre-screening survey powered by REDCap software, or to set up a phone call to review
           study eligibility if preferred.

        2. Recruiter responds to eligible or interested Respondents as described in Recruitment
           Attachments (i.e., Recruitment Email Script).

        3. Recruiter coordinates a phone interview with interested and eligible Respondents to
           confirm eligibility criteria and review the Informed Consent Form with the Respondent in
           real time over the phone, while the Respondent follows along with a secure REDCap
           Informed Consent survey to capture an electronic signature.

        4. Consenting Participants will submit the Informed Consent form electronically, receive a
           .pdf copy of their completed (signed) Informed Consent form, and be prompted to complete
           a subsequent electronic Contact Information Questionnaire, which will only be accessible
           within the REDCap server by authorized study personnel, e.g. PI and Recruitment
           Coordinator. A electronic COVID-19 Vaccination Status Confirmation Form will also be
           completed at this time, including a single upload field for a digital image of the
           participant's vaccination card. This image will be visually inspected by the Recruiter
           and immediately deleted from the REDCap server.

        5. The Recruiter will manually assign the Participant a coded record ID and follow-up with
           the Participant via phone or email for tentative scheduling of equipment delivery and
           data collection through the full protocol. Scheduling will be confirmed with
           Participants in the week leading up to each transport event.

        6. Prior to scheduled data collection, all consenting participants will be screened in
           their homes for undetected deep vein thrombosis using mobile doppler ultrasound while
           following all COVID-19 guidelines. Any participant who screens in positive for deep vein
           thrombosis will be withdrawn from the study.

      Study Procedures

        1. Once interested respondents have completed all pre-screening, informed consent process
           will be completed. The voluntary nature of the research will be stressed, participants
           will have the opportunity to have all of their questions answered, and they will be
           reminded that they can withdraw their consent at any time.

        2. Once consent has been executed and subsequent enrollment forms completed, participants
           will be scheduled for their deep vein thrombosis screening, their sleep monitoring data
           collection nights, and their equipment delivery.

        3. Participants will then be randomized to receive either the Kendall® or RF Health System
           on data collection night 1

        4. Due to the COVID-19 outbreak, UMass researchers will transport the all study equipment
           to and from the participants residences using all COVID-19 guidelines and will disinfect
           all materials at the UMass Sleep Monitoring Laboratory between uses.

        5. To ensure high-quality data acquisition, researchers will video conference with
           participants at prescheduled times, approximately 1-hour prior to participants typical
           bedtime to provide real-time, remote guidance for proper self-application of the Sleep
           Profiler headset, Kendall and RF Health System. The first of these sessions will take
           place shortly after the scheduled deep vein thrombosis screening session. The
           teleconferencing will take not more of the participant's time than a typical, in-person
           application.

        6. At the conclusion of their first overnight sleep profiler data collection (via Sleep
           Profiler headset, see attached Technical Manual) while using one of the leg compression
           devices, participants will be asked to complete their self-report measures in the
           following order: PROMIS Sleep Disturbance Form 6a, Comfort Rating Scale, Environmental
           Comfort Scale, System Usability Scale, and Task Load Index.

        7. There will be at least one night without any devices between data collection nights 1 &
           2.

        8. All study procedures will be repeated on data collection overnight 2 using the other
           external compression device.

        9. Once data collection for night 2 has been completed, all participants will be asked if
           they have any further questions and all questions will be addressed.
    

Intervention name(s): RF Health MAC Device
Intervention type(s): Device
Intervention description(s): Using a 2-day counterbalanced, within-subject repeated-measures design, 16 participants wore two mechanical compression devices, the commonly-used Kendall SCD Express 9525 (SCD) and the novel Recovery Force Movement and Compressions Device (RF-MAC) for 1 night each in their home while sleep was recorded with polysomnography. For each device, participants also completed questionnaires to assess usability, mobility, perceived noise disturbance, and perceived sleep disturbance.
Intervention model: Single Group Assignment
Intervention model description: Repeated measures study design where each participant gets both devices on different nights in random order
Masking: None (Open Label)
Primary purpose: Health Services Research