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

Medication Adherence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03940534
• Other study ID #: 6195-001
• Status: Completed
• Phase: N/A
• Start date: March 9, 2018
• Est. completion date: February 26, 2019

Study information

• Verified date: May 2019
• Source: Intent Solutions, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: February 26, 2019
• Est. primary completion date: February 26, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Medication Adherence
• Satisfaction, Personal

Intervention

Device:
• TAD
TAD is a device used to aid medication adherence.

Locations

Country	Name	City	State
United States	Haven: Advanced Illness Care	Gainesville	Florida
United States	Haven: Advanced Illness Care	Lake City	Florida
United States	Haven: Advanced Illness Care	Palatka	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Intent Solutions, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference from Scheduled Dosing Time	The time difference between when the patient took the dose and the scheduled time of administration.	through study completion, up to 1 year
Primary	Missed Doses	The number of missed doses that occurred during the study.	through study completion, up to 1 year
Secondary	Patient Satisfaction: scale of 1 to 5	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?	through study completion, up to 1 year
Secondary	Nurse Satisfaction: scale of 1 to 5	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?	through study completion, up to 1 year
Secondary	Physician Satisfaction: scale of 1 to 5	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.	through study completion, up to 1 year