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| Name | Class |
|---|---|
| Summa Health System | OTHER |
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This study is being done to look at how people manage their heart failure. The investigators are testing two medication reminder systems and the investigators want to know which one people like better. The investigators also want to see if they have any effect on ease of managing medication in individuals with heart failure.
A pilot and feasibility randomized trial of two medication reminder systems for patients with heart failure (HF). The investigators believe that medication reminder systems will improve adherence and will reduce the effects of cognitive impairment on medication adherence. The investigators believe that patients will accept and use a medication reminder system, but the investigators cannot specify which system will be preferred. Each has different features which may be perceived as more or less desirable.
The investigators will enroll 60 patients with HF and randomize them to four conditions in a 2 (device 1 versus device 2) by 2 (Active versus Passive) design. After enrollment in the trial, patients will be consented and will complete pretesting at Summa Health System in the Center for Clinical Trials. They will primarily undergo brief computerized cognitive testing, complete self-report measures (e.g., quality of life, depression, self-management related social support), and will give consent for medical information to be collected from their electronic medical record. They will then be randomized to condition. In-home training will be provided regarding how to use the equipment. Medication adherence will be monitored for 28 days, followed by an in-home post-test (all pre-test measures) during which the equipment is returned.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Device 2 passive | Active Comparator | Device 2 will NOT remind patients to take medications |
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| Device 2 active | Active Comparator | Device 2 will remind patients to take medications |
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| Device 1 active | Active Comparator | Device 1 will remind patients to take their medications |
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| Device 1 Passive | Placebo Comparator | Device 1 will NOT remind patients to take medications. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| iPhone or pillbox | Device | People will be reminded to take their medications by a device that alerts the patient to the need to take a medication. |
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| Measure | Description | Time Frame |
|---|---|---|
| Patient Acceptance | Patient ratings of their satisfaction with the device, ease of use, and other impressions. A survey was created for this study to assess individuals' evaluations of the device to which they were randomized (see Appendix 1). At the final study session, participants completed the questionnaire about their preference for the device they were assigned. The 14 items were summed into a total score reflecting their ultimate appraisal for the device. The range of possible scores was 14-70. A higher score is greater patient acceptance. Participants rated how much they agreed to each statement from strongly disagree to strongly agree. The statements assess factors such as helpfulness, improving quality of life, and satisfaction. | 28 days |
| Medication Adherence | The percentage of prescribed medications recorded as taken by the medication reminding device. | 28 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joel W Hughes, PhD | Kent State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Akron City Hospital | Akron | Ohio | 44304 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Device 2 Passive | Device 2 will NOT remind patients to take medications Non-reminding: As a comparison, the devices will collect medication taking information without providing reminders. |
| FG001 | Device 2 Active | Device 2 will remind patients to take medications iPhone or pillbox: People will be reminded to take their medications by a device that alerts the patient to the need to take a medication. |
| FG002 | Device 1 Active | Device 1 will remind patients to take their medications iPhone or pillbox: People will be reminded to take their medications by a device that alerts the patient to the need to take a medication. |
| FG003 | Device 1 Passive | Device 1 will NOT remind patients to take medications. Non-reminding: As a comparison, the devices will collect medication taking information without providing reminders. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Device 2 Passive | Device 2 will NOT remind patients to take medications Non-reminding: As a comparison, the devices will collect medication taking information without providing reminders. |
| BG001 | Device 2 Active |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Patient Acceptance | Patient ratings of their satisfaction with the device, ease of use, and other impressions. A survey was created for this study to assess individuals' evaluations of the device to which they were randomized (see Appendix 1). At the final study session, participants completed the questionnaire about their preference for the device they were assigned. The 14 items were summed into a total score reflecting their ultimate appraisal for the device. The range of possible scores was 14-70. A higher score is greater patient acceptance. Participants rated how much they agreed to each statement from strongly disagree to strongly agree. The statements assess factors such as helpfulness, improving quality of life, and satisfaction. | Posted | Mean | Standard Deviation | units on a scale | 28 days |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Device 2 Passive | Device 2 will NOT remind patients to take medications Non-reminding: As a comparison, the devices will collect medication taking information without providing reminders. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Joel Hughes | Kent State University | 3306727721 | jhughes1@kent.edu |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Non-reminding | Behavioral | As a comparison, the devices will collect medication taking information without providing reminders. |
|
Device 2 will remind patients to take medications
iPhone or pillbox: People will be reminded to take their medications by a device that alerts the patient to the need to take a medication.
| BG002 | Device 1 Active | Device 1 will remind patients to take their medications iPhone or pillbox: People will be reminded to take their medications by a device that alerts the patient to the need to take a medication. |
| BG003 | Device 1 Passive | Device 1 will NOT remind patients to take medications. Non-reminding: As a comparison, the devices will collect medication taking information without providing reminders. |
| BG004 | Total | Total of all reporting groups |
| Participants |
| No |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Education | Number | participants |
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| OG001 | Device 2 Active | Device 2 will remind patients to take medications iPhone or pillbox: People will be reminded to take their medications by a device that alerts the patient to the need to take a medication. |
| OG002 | Device 1 Active | Device 1 will remind patients to take their medications iPhone or pillbox: People will be reminded to take their medications by a device that alerts the patient to the need to take a medication. |
| OG003 | Device 1 Passive | Device 1 will NOT remind patients to take medications. Non-reminding: As a comparison, the devices will collect medication taking information without providing reminders. |
|
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| Primary | Medication Adherence | The percentage of prescribed medications recorded as taken by the medication reminding device. | Posted | Mean | Standard Deviation | percentage of medication taken | 28 days |
|
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| 0 |
| 14 |
| 0 |
| 14 |
| EG001 | Device 2 Active | Device 2 will remind patients to take medications iPhone or pillbox: People will be reminded to take their medications by a device that alerts the patient to the need to take a medication. | 0 | 15 | 0 | 15 |
| EG002 | Device 1 Active | Device 1 will remind patients to take their medications iPhone or pillbox: People will be reminded to take their medications by a device that alerts the patient to the need to take a medication. | 0 | 13 | 0 | 13 |
| EG003 | Device 1 Passive | Device 1 will NOT remind patients to take medications. Non-reminding: As a comparison, the devices will collect medication taking information without providing reminders. | 0 | 13 | 0 | 13 |
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