- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03940534
Utilization of the TAD Device for Dispensing Pain Medications in Hospice Patients
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
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
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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:
|
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:
|
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:
|
through study completion, up to 1 year
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Christopher E Richter, PharmD, Clinical Pharmacist
- Study Director: Ellen Talos, MD, Medical Director
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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