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

NCT ID: NCT03940534

Last Updated: 2019-05-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-09

Study Completion Date

2019-02-26

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Medication Adherence Satisfaction, Personal

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

This study is a randomized crossover design.
Primary Study Purpose

OTHER

Blinding Strategy

NONE

No masking is to be used in this study.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Start with Mobile Device

Group Type ACTIVE_COMPARATOR

TAD

Intervention Type DEVICE

TAD is a device used to aid medication adherence.

Start without Mobile Device

Group Type ACTIVE_COMPARATOR

TAD

Intervention Type DEVICE

TAD is a device used to aid medication adherence.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

TAD

TAD is a device used to aid medication adherence.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Intent Solutions, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Christopher E Richter, PharmD

Role: PRINCIPAL_INVESTIGATOR

Clinical Pharmacist

Ellen Talos, MD

Role: STUDY_DIRECTOR

Medical Director

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Haven: Advanced Illness Care

Gainesville, Florida, United States

Site Status

Haven: Advanced Illness Care

Lake City, Florida, United States

Site Status

Haven: Advanced Illness Care

Palatka, Florida, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

6195-001

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Effect of Reminders on Adherence
NCT02411006 COMPLETED NA
Medication Adherence Program
NCT05183763 RECRUITING NA