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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Start with Mobile Device | Active Comparator |
| |
| Start without Mobile Device | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TAD | Device | TAD is a device used to aid medication adherence. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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:
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christopher E Richter, PharmD | Clinical Pharmacist | Principal Investigator |
| Ellen Talos, MD | Medical Director | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Haven: Advanced Illness Care | Gainesville | Florida | 32606 | United States | ||
| Haven: Advanced Illness Care |
Other study staff may apply to access the data through an appropriate IRB in the future, but this is not known at this time.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 9, 2018 | May 3, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D055118 | Medication Adherence |
| D010549 | Personal Satisfaction |
| ID | Term |
|---|---|
| D010349 | Patient Compliance |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
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This study is a randomized crossover design.
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No masking is to be used in this study.
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| through study completion, up to 1 year |
| 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:
| through study completion, up to 1 year |
| 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:
| through study completion, up to 1 year |
| Lake City |
| Florida |
| 32055 |
| United States |
| Haven: Advanced Illness Care | Palatka | Florida | 32177 | United States |
| D001519 | Behavior |