Heart FailureNCT01814696
The Effect of the MedSentry System on Medication Adherence
A study testing MedSentry System in people with Heart Failure, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
The goal of this pilot study to evaluate the effect of the MedSentry system, a multi-faceted medication adherence device and reminder system, on medication adherence and clinical outcomes in heart-failure (HF) patients. We will also evaluate the usability and satisfaction derived from using this system. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- MedSentry System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2013to Oct 2014
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who have successfully completed the Partners Connected Cardiac Care Program (CCCP)
- Take at least 3 and no more than 10 different daily medications (including both prescription and non-prescription/over the counter medications) to treat Heart Failure (HF) and other comorbid disorders.
- Take medications no more than 4 specified times each day (i.e. morning, afternoon, early evening, bedtime).
- The patient must be able to open a pill bottle independently.
- The patient must be able to sort and manage their own medications.
- Hospitalization within the last 24 months.
Show all 11Show fewer
- Have a telephone or cell phone.
- Live in the greater Boston area.
- The patients must speak, read and write English.
- The patients must not be either vision or hearing impaired (i.e., unable to hear an alarm similar to a clock alarm or oven alarm).
- Patient must have an Massachusetts General Hospital (MGH) affiliated care provider.
Who cannot join
- Dementia or other conditions precluding the participant from providing informed consent or from learning to use the MedSentry pillbox.
- Home environment unsuitable for the MedSentry pillbox and other installed equipment.
- Awaiting revascularization, cardiac resynchronization or heart transplant.
- Patients with a coexisting terminal illness like cancer or Chronic Renal Failure (CRF) requiring dialysis.
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: The Effect of the MedSentry System on Medication Adherence for Patients With Congestive Heart Failure: A Pilot Study
The goal of this pilot study to evaluate the effect of the MedSentry system, a multi-faceted medication adherence device and reminder system, on medication adherence and clinical outcomes in heart-failure (HF) patients. We will also evaluate the usability and satisfaction derived from using this system.
We hypothesize that:
- The use of the MedSentry system will improve medication adherence in patients with a discharge diagnosis of HF.
- The improvement in adherence correlates with fewer hospitalizations and emergency department (ED) visits.
- The improvement in adherence correlates with better health-related quality of life.
- Conditions
- Heart Failure
- Being tested
- MedSentry System
- Keywords
- Heart Failure, Congestive Heart Failure, Medication Adherence, Medication Compliance, Telemedicine, Telehealth
- Medical subject headings
- Heart Failure, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MedSentry SystemDevice
Also called MedSentry pillbox, Electronic pillbox, Pillbox
Subjects will use the MedSentry System and electronic pillbox, to manage their medications.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Subjects will continue to receive usual medical care from their doctor(s). |
| MedSentry System | Experimental | Subjects will continue to receive usual medical care from their doctor(s). Subjects will use the MedSentry System and electronic pillbox, to manage their medications. Receives: Device: MedSentry System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Medical Outcomes Study (MOS) "Adhere"
Subject reported medication adherence. The Medical Outcomes Study (MOS) "Adhere" medication adherence measure consists of a single question that asks participants "How often did you take your medications as prescribed during the past 4 weeks?" Responses are recoded into a dichotomous measure of nonadherent (none, a little, some of the time) and adherent (most, all of the time).
Measured: 3 months
Secondary outcomes (6)
Number of Participants With 1 or More Emergency Department (ED) Visits.
Measured: 3 months
Number of Participants With 1 or More Hospitalizations.
Measured: 3 months
Number of Emergency Department (ED) Visits.
Measured: 3 months
Number of Hospitalization Visits.
Measured: 3 months
Hospitalization, Length of Stay (Days)
Measured: 3 months
Minnesota Living With Heart Failure Questionnaire (MLHFQ) Total Summary Score
Health-related quality of life is measured using the Minnesota Living with Heart Failure Questionnaire (MLHFQ). The questionnaire consists of 21 items that assess the impact of HF and HF treatment on key physical, emotional, and social dimensions of a patient's life during the past four weeks. Responses are coded from 0 = does not apply and 1 = very little to 5 = very much.
A higher score represents a greater negative HR-related impact on quality of life.
Measured: Baseline, end 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2013 (estimated)
- Study startMar 2013
- Primary completionMay 2014
- Study completionOct 2014
Why it stopped: Slow enrollment and reached number needed for analysis.
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joseph C. Kvedar, Massachusetts General Hospital
- Investigators
- Kamal Jethwani, MD, MPH, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01814696
- Sponsor's protocol ID
- 2012-P-002181
- Status last verified
- Aug 2020
- First submitted
- 18 Mar 2013
- Last updated
- 17 Sep 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Hale TM, Jethwani K, Kandola MS, Saldana F, Kvedar JC. A Remote Medication Monitoring System for Chronic Heart Failure Patients to Reduce Readmissions: A Two-Arm Randomized Pilot Study. J Med Internet Res. 2016 Apr 17;18(5):e91. doi: 10.2196/jmir.5256.
PubMed 27154462
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of the MedSentry System on Medication Adherence for Patients With Congestive Heart Failure: A Pilot Study
- ClinicalTrials.gov ID
- NCT01814696
- Acronym / sponsor ID
- 2012-P-002181
- Conditions
- Heart Failure
- Keywords
- Heart Failure, Congestive Heart Failure, Medication Adherence, Medication Compliance, Telemedicine, Telehealth
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow enrollment and reached number needed for analysis.
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- May 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 20 Mar 2013 (estimated)
- Results
- Posted 5 Jan 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this pilot study to evaluate the effect of the MedSentry system, a multi-faceted medication adherence device and reminder system, on medication adherence and clinical outcomes in heart-failure (HF) patients. We will also evaluate the usability and satisfaction derived from using this system.
We hypothesize that:
- The use of the MedSentry system will improve medication adherence in patients with a discharge diagnosis of HF.
- The improvement in adherence correlates with fewer hospitalizations and emergency department (ED) visits.
- The improvement in adherence correlates with better health-related quality of life.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Subjects will continue to receive usual medical care from their doctor(s). |
| MedSentry System | Experimental | Device: MedSentry SystemSubjects will continue to receive usual medical care from their doctor(s). Subjects will use the MedSentry System and electronic pillbox, to manage their medications. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Patients who have successfully completed the Partners Connected Cardiac Care Program (CCCP)
- Take at least 3 and no more than 10 different daily medications (including both prescription and non-prescription/over the counter medications) to treat Heart Failure (HF) and other comorbid disorders.
- Take medications no more than 4 specified times each day (i.e. morning, afternoon, early evening, bedtime).
- The patient must be able to open a pill bottle independently.
- The patient must be able to sort and manage their own medications.
Key exclusion criteria (4 listed)
- Dementia or other conditions precluding the participant from providing informed consent or from learning to use the MedSentry pillbox.
- Home environment unsuitable for the MedSentry pillbox and other installed equipment.
- Awaiting revascularization, cardiac resynchronization or heart transplant.
- Patients with a coexisting terminal illness like cancer or Chronic Renal Failure (CRF) requiring dialysis.
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 |
|---|---|---|
| MedSentry SystemAlso: MedSentry pillbox, Electronic pillbox, PillboxSubjects will use the MedSentry System and electronic pillbox, to manage their medications. | Device | MedSentry System |
Primary outcome
Medical Outcomes Study (MOS) "Adhere"
Time frame: 3 months
Subject reported medication adherence. The Medical Outcomes Study (MOS) "Adhere" medication adherence measure consists of a single question that asks participants "How often did you take your medications as prescribed during the past 4 weeks?" Responses are recoded into a dichotomous measure of nonadherent (none, a little, some of the time) and adherent (most, all of the time).
6 secondary outcomes
Number of Participants With 1 or More Emergency Department (ED) Visits.
Time frame: 3 months
Number of Participants With 1 or More Hospitalizations.
Time frame: 3 months
Number of Emergency Department (ED) Visits.
Time frame: 3 months
Number of Hospitalization Visits.
Time frame: 3 months
Hospitalization, Length of Stay (Days)
Time frame: 3 months
Minnesota Living With Heart Failure Questionnaire (MLHFQ) Total Summary Score
Time frame: Baseline, end 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 27154462Hale TM, Jethwani K, Kandola MS, Saldana F, Kvedar JC. A Remote Medication Monitoring System for Chronic Heart Failure Patients to Reduce Readmissions: A Two-Arm Randomized Pilot Study. J Med Internet Res. 2016 Apr 17;18(5):e91. doi: 10.2196/jmir.5256.
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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.
Kamal Jethwani, MD, MPH principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MedSentry System in people with Heart Failure, run by Massachusetts General Hospital 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 11 inclusion and 4 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: stopped early, as of the sponsor's last update on 17 Sep 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. 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 5 Jan 2017). 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?
Medical Outcomes Study (MOS) "Adhere" (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01814696, which also lists 1 linked publication.
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 17 Sep 2020.