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Completed

NCT Number: NCT03940534

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

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.

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Key information

Conditions

Medication Adherence Behavior Health Behavior Patient Acceptance of Health Care Patient Compliance Personal Satisfaction Satisfaction, Personal Treatment Adherence and Compliance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Haven: Advanced Illness Care, Gainesville, Florida, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TAD

Device

TAD is a device used to aid medication adherence.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Intent Solutions, Inc.

Industry

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
May 7, 2019
Registry last updated
May 8, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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