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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/17/2021.
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/17/2021.

Utilization of the TAD Device for Dispensing Pain Medications in Hospice Patients

Clinicaltrials.gov identifier NCT03940534

Recruitment Status Completed

First Posted May 7, 2019

Last update posted May 8, 2019

Study Description

Brief summary:

A novel device, TAD, has been developed to aid adherence to prescribed regimens and may have a roll in hospice pain management. This study aims to assess medication adherence relating to missed doses or improperly timed doses with and without the aid of a mobile device as a primary endpoint. Secondary endpoints will be patient, nursing, and provider satisfaction.

  • Condition or Disease:Medication Adherence
    Satisfaction, Personal
  • Intervention/Treatment: Device: TAD
  • Phase: N/A
Detailed Description

This study is a randomized crossover study in which patients will be randomized to start with or without a mobile device assisting the patient or caregiver in using the device. The investigators aim to enroll 20 patients across 3 sites. Each patient is expected to participate in the study for 12 weeks. After the first 2 weeks of participation, the patient will either begin using the mobile device to assist or will stop using the mobile device for the next 2 weeks. after the initial 4 weeks, the patient will choose to continue with or without using the mobile device.

Study Design
  • Study Type: Interventional
  • Actual Enrollment: 8 participants
  • Allocation: Randomized
  • Intervention Model: Crossover Assignment
  • Intervention Model Description: This study is a randomized crossover design.
  • Masking: None (Open Label) ()
  • Primary Purpose: Other
  • Official Title: Utilization of the TAD Device for Dispensing Pain Medications in Hospice Patients
  • Actual Study Start Date: March 2018
  • Actual Primary Completion Date: February 2019
  • Actual Study Completion Date: February 2019
Arms and interventions
Arm Intervention/treatment
Active Comparator: Start with Mobile Device
Device: TAD
TAD is a device used to aid medication adherence.
Active Comparator: Start without Mobile Device
Device: TAD
TAD is a device used to aid medication adherence.
Outcome Measures
  • Primary Outcome Measures: 1. Difference from Scheduled Dosing Time [ Time Frame: through study completion, up to 1 year ]
    The time difference between when the patient took the dose and the scheduled time of administration.
  • 2. Missed Doses [ Time Frame: through study completion, up to 1 year ]
    The number of missed doses that occurred during the study.
  • Secondary Outcome Measures: 1. Patient Satisfaction: scale of 1 to 5 [ Time Frame: through study completion, up to 1 year ]
    The patient's satisfaction will be measured on a scale of 1 to 5 (from 1 being extremely dissatisfied to 5 being extremely satisfied). Satisfaction will be assessed with the follow questions: Using the mail order pharmacy to receive your pain medication? Ease of using the TAD device to dispense your pain medication? Ease of using the mobile device application with the TAD device? (ONLY when using the mobile application) The ability of the device to provide you the dose of pain medication at the correct time? The overall experience of using the TAD device?
  • 2. Nurse Satisfaction: scale of 1 to 5 [ Time Frame: through study completion, up to 1 year ]
    The nurse's satisfaction will be measured on a scale of 1 to 5 (from 1 being extremely dissatisfied to 5 being extremely satisfied). Satisfaction will be assessed with the follow questions: Using the mail order pharmacy get your patient their pain medication? Your patient's ability to use the TAD device to dispense their pain medication? Your patient's ability to use the mobile device application with the TAD device? (ONLY when using the mobile application) The ability of the device to increase compliance of the pain medication? The overall experience of using the TAD device?
  • 3. Physician Satisfaction: scale of 1 to 5 [ Time Frame: through study completion, up to 1 year ]
    The physician's satisfaction will be measured on a scale of 1 to 5 (from 1 being extremely dissatisfied to 5 being extremely satisfied). Satisfaction will be assessed with the follow questions: Using the mail order pharmacy get your patient their pain medication? Your patient's ability to use the TAD device to dispense their pain medication? Your patient's ability to use the mobile device application with the TAD device? (ONLY when using the mobile application) The ability of the device to increase compliance of the pain medication? The overall experience of using the TAD device?satisfaction will be measured on a scale of 1 to 5 for satisfaction of using the mail order pharmacy, ease of using the device, ease of using the mobile device, the ability of the device to accurately provide the dose, and overall experience with the device.
Eligibility Criteria
  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
Criteria

Inclusion Criteria:

- any patient taking morphine ER or Oxycontin on one of three hospice home teams

Exclusion Criteria:

- pregnancy

- inability to demonstrate competent use of the device

- age less than 18

Contacts and Locations
Contacts
Locations

United States, Florida
Haven: Advanced Illness Care
Gainesville

United States, Florida
Haven: Advanced Illness Care
Lake City

United States, Florida
Haven: Advanced Illness Care
Palatka

Sponsors and Collaborators

Intent Solutions, Inc.

Investigators

Principal Investigator: Christopher E Richter, PharmD Clinical Pharmacist

Study Director: Ellen Talos, MD Medical Director

More Information
  • Responsible Party: Intent Solutions, Inc.
  • ClinicalTrials.gov Identifier: NCT03940534 History of Changes
  • Other Study ID Numbers: 6195-001
  • First Posted: May 7, 2019 Key Record Dates
  • Last Update Posted: May 8, 2019
  • Last Verified: May 2019
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: Undecided
  • Plan Description: Other study staff may apply to access the data through an appropriate IRB in the future, but this is not known at this time.
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: Yes
  • Product Manufactured in and Exported from the U.S.: Yes