Heart FailureHeart iRxNCT01463267
Study of Reminding to Improve Medication Adherence in Heart Failure
A study testing iPhone or pillbox and Non-reminding in people with Heart Failure, run by Kent State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 90 years
- Conditions the study is for
- Heart Failure
- What is being tested?
- iPhone or pillbox and Non-reminding
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2010to Sep 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 45-90 years of age
- documented systolic or diastolic heart failure
Who cannot join
- 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
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- Current home telemonitoring program to assist with HF self-management
- They do not have a land-line telephone
- Cardiac surgery < 3 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Heart iRx This Short Non-descriptive Title is the Real Title
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.
Read the 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.
- Conditions
- Heart Failure
- Being tested
- iPhone or pillbox, Non-reminding
- Keywords
- Heart Failure
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iPhone or pillboxDevice
People will be reminded to take their medications by a device that alerts the patient to the need to take a medication.
Non-remindingBehavioural
As a comparison, the devices will collect medication taking information without providing reminders.
| Study group | Role | What they receive |
|---|---|---|
| Device 2 passive | Active comparator | Device 2 will NOT remind patients to take medications Receives: Behavioral: Non-reminding |
| Device 2 active | Active comparator | Device 2 will remind patients to take medications Receives: Device: iPhone or pillbox |
| Device 1 active | Active comparator | Device 1 will remind patients to take their medications Receives: Device: iPhone or pillbox |
| Device 1 Passive | Placebo comparator | Device 1 will NOT remind patients to take medications. Receives: Behavioral: Non-reminding |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 28 days
Medication Adherence
The percentage of prescribed medications recorded as taken by the medication reminding device.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2011 (estimated)
- Study startNov 2010
- Primary completionSep 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kent State University
- Sponsor type
- University, hospital or other
- Collaborators
- Summa Health System
- Responsible party
- Principal investigator, Joel Hughes, Kent State University
- Investigators
- Joel W Hughes, PhD, Principal investigator, Kent State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01463267
- Sponsor's protocol ID
- 194822-4
- Acronym
- Heart iRx
- Status last verified
- Nov 2020
- First submitted
- 27 Sep 2011
- Last updated
- 27 Nov 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Heart iRx This Short Non-descriptive Title is the Real Title
- ClinicalTrials.gov ID
- NCT01463267
- Acronym / sponsor ID
- Heart iRx / 194822-4
- Conditions
- Heart Failure
- Keywords
- Heart Failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Kent State UniversityUniversity, hospital or other
- Collaborators
- Summa Health System
- Study start
- Nov 2010
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 1 Nov 2011 (estimated)
- Results
- Posted 27 Nov 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Device 2 passive | Active comparator | Behavioral: Non-remindingDevice 2 will NOT remind patients to take medications |
| Device 2 active | Active comparator | Device: iPhone or pillboxDevice 2 will remind patients to take medications |
| Device 1 active | Active comparator | Device: iPhone or pillboxDevice 1 will remind patients to take their medications |
| Device 1 Passive | Placebo comparator | Behavioral: Non-remindingDevice 1 will NOT remind patients to take medications. |
Who may qualify
- Ages
- 45 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 45-90 years of age
- documented systolic or diastolic heart failure
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| iPhone or pillboxPeople will be reminded to take their medications by a device that alerts the patient to the need to take a medication. | Device | Device 1 active, Device 2 active |
| Non-remindingAs a comparison, the devices will collect medication taking information without providing reminders. | Behavioural | Device 1 Passive, Device 2 passive |
Primary outcome
Patient Acceptance
Time frame: 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
Time frame: 28 days
The percentage of prescribed medications recorded as taken by the medication reminding device.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joel W Hughes, PhD principal investigator
Kent State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing iPhone or pillbox and Non-reminding in people with Heart Failure, run by Kent State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Nov 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Acceptance (time frame: 28 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2020.