Utilization of the TAD Device for Dispensing Pain Medications in Hospice Patients
1 other identifier
interventional
8
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2018
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 9, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 26, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
February 26, 2019
CompletedFirst Submitted
Initial submission to the registry
April 29, 2019
CompletedFirst Posted
Study publicly available on registry
May 7, 2019
CompletedMay 8, 2019
May 1, 2019
12 months
April 29, 2019
May 6, 2019
Conditions
Outcome Measures
Primary Outcomes (2)
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
Missed Doses
The number of missed doses that occurred during the study.
through study completion, up to 1 year
Secondary Outcomes (3)
Patient Satisfaction: scale of 1 to 5
through study completion, up to 1 year
Nurse Satisfaction: scale of 1 to 5
through study completion, up to 1 year
Physician Satisfaction: scale of 1 to 5
through study completion, up to 1 year
Study Arms (2)
Start with Mobile Device
ACTIVE COMPARATORStart without Mobile Device
ACTIVE COMPARATORInterventions
TAD is a device used to aid medication adherence.
Eligibility Criteria
You may qualify if:
- any patient taking morphine ER or Oxycontin on one of three hospice home teams
You may not qualify if:
- pregnancy
- inability to demonstrate competent use of the device
- age less than 18
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Haven: Advanced Illness Care
Gainesville, Florida, 32606, United States
Haven: Advanced Illness Care
Lake City, Florida, 32055, United States
Haven: Advanced Illness Care
Palatka, Florida, 32177, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Christopher E Richter, PharmD
Clinical Pharmacist
- STUDY DIRECTOR
Ellen Talos, MD
Medical Director
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Masking Details
- No masking is to be used in this study.
- Purpose
- OTHER
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 29, 2019
First Posted
May 7, 2019
Study Start
March 9, 2018
Primary Completion
February 26, 2019
Study Completion
February 26, 2019
Last Updated
May 8, 2019
Record last verified: 2019-05