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

May 6, 2019 updated by: Intent Solutions, Inc.
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.

Study Overview

Status

Completed

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

8

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Florida
      • Gainesville, Florida, United States, 32606
        • Haven: Advanced Illness Care
      • Lake City, Florida, United States, 32055
        • Haven: Advanced Illness Care
      • Palatka, Florida, United States, 32177
        • Haven: Advanced Illness Care

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Start with Mobile Device
TAD is a device used to aid medication adherence.
Active Comparator: Start without Mobile Device
TAD is a device used to aid medication adherence.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
through study completion, up to 1 year
Missed Doses
Time Frame: through study completion, up to 1 year
The number of missed doses that occurred during the study.
through study completion, up to 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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:

  1. Using the mail order pharmacy to receive your pain medication?
  2. Ease of using the TAD device to dispense your pain medication?
  3. Ease of using the mobile device application with the TAD device? (ONLY when using the mobile application)
  4. The ability of the device to provide you the dose of pain medication at the correct time?
  5. The overall experience of using the TAD device?
through study completion, up to 1 year
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:

  1. Using the mail order pharmacy get your patient their pain medication?
  2. Your patient's ability to use the TAD device to dispense their pain medication?
  3. Your patient's ability to use the mobile device application with the TAD device? (ONLY when using the mobile application)
  4. The ability of the device to increase compliance of the pain medication?
  5. The overall experience of using the TAD device?
through study completion, up to 1 year
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:

  1. Using the mail order pharmacy get your patient their pain medication?
  2. Your patient's ability to use the TAD device to dispense their pain medication?
  3. Your patient's ability to use the mobile device application with the TAD device? (ONLY when using the mobile application)
  4. The ability of the device to increase compliance of the pain medication?
  5. 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.
through study completion, up to 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Christopher E Richter, PharmD, Clinical Pharmacist
  • Study Director: Ellen Talos, MD, Medical Director

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 9, 2018

Primary Completion (Actual)

February 26, 2019

Study Completion (Actual)

February 26, 2019

Study Registration Dates

First Submitted

April 29, 2019

First Submitted That Met QC Criteria

May 6, 2019

First Posted (Actual)

May 7, 2019

Study Record Updates

Last Update Posted (Actual)

May 8, 2019

Last Update Submitted That Met QC Criteria

May 6, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • 6195-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD 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.

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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