Heart Failure
Conditions
Keywords
Heart Failure
Brief summary
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.
Detailed description
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.
Interventions
DEVICEiPhone or pillbox
People will be reminded to take their medications by a device that alerts the patient to the need to take a medication.
BEHAVIORALNon-reminding
As a comparison, the devices will collect medication taking information without providing reminders.
Sponsors
Summa Health System
Kent State University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
45 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* 45-90 years of age * documented systolic or diastolic heart failure
Exclusion criteria
* History of neurological disorder * moderate or severe head injury with greater than 10 min loss of consciousness * Past or current history of severe psychiatric illness. Specifically, psychotic disorders (e.g. schizophrenia) and bipolar disorder. Potential study participants will not be excluded on the basis of managed depressive or anxiety disorder. These conditions are common in HF patients and their exclusion may limit generalizability of findings. * 5 year past or current history of alcohol or drug abuse (defined by DSM-IV criteria) * History of learning disorder or developmental disability (defined by DSM-IV criteria) * Renal failure requiring dialysis * Current home telemonitoring program to assist with HF self-management * They do not have a land-line telephone * Cardiac surgery \< 3 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Acceptance | 28 days | 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. |
| Medication Adherence | 28 days | The percentage of prescribed medications recorded as taken by the medication reminding device. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 14 |
| 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. | 15 |
| 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. | 13 |
| 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. | 13 |
| Total | 55 |
Baseline characteristics
| Characteristic | Total | Device 2 Passive | Device 2 Active | Device 1 Active | Device 1 Passive |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 34 Participants | 9 Participants | 9 Participants | 8 Participants | 8 Participants |
| Age, Categorical Between 18 and 65 years | 21 Participants | 5 Participants | 6 Participants | 5 Participants | 5 Participants |
| Age, Continuous | 69.3 years STANDARD_DEVIATION 10.9 | 69 years STANDARD_DEVIATION 10.6 | 69 years STANDARD_DEVIATION 10.6 | 69.6 years STANDARD_DEVIATION 11.3 | 69.6 years STANDARD_DEVIATION 11.3 |
| Education | 55 participants | 14 participants | 15 participants | 13 participants | 13 participants |
| Region of Enrollment United States | 55 Participants | 14 Participants | 15 Participants | 13 Participants | 13 Participants |
| Sex: Female, Male Female | 11 Participants | 3 Participants | 3 Participants | 3 Participants | 2 Participants |
| Sex: Female, Male Male | 44 Participants | 11 Participants | 12 Participants | 10 Participants | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 14 | 0 / 15 | 0 / 13 | 0 / 13 |
| serious Total, serious adverse events | 0 / 14 | 0 / 15 | 0 / 13 | 0 / 13 |
Outcome results
Primary
Medication Adherence
The percentage of prescribed medications recorded as taken by the medication reminding device.
Time frame: 28 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Device 2 Passive | Medication Adherence | 76 percentage of medication taken | Standard Deviation 33 |
| Device 2 Active | Medication Adherence | 84 percentage of medication taken | Standard Deviation 32 |
| Device 1 Active | Medication Adherence | 73 percentage of medication taken | Standard Deviation 39 |
| Device 1 Passive | Medication Adherence | 79 percentage of medication taken | Standard Deviation 33 |
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.
Time frame: 28 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Device 2 Passive | Patient Acceptance | 33.4 units on a scale | Standard Deviation 11 |
| Device 2 Active | Patient Acceptance | 33.4 units on a scale | Standard Deviation 12 |
| Device 1 Active | Patient Acceptance | 48.7 units on a scale | Standard Deviation 11 |
| Device 1 Passive | Patient Acceptance | 48.7 units on a scale | Standard Deviation 12 |