Medication AdherencePhase 1NCT01105104
An Enhanced Medication Monitoring Program
A Phase 1 study testing MedMinder System and MedMinder System - deactivated in people with Medication Adherence and Hypertension, run by MedMinder Systems Inc. at 1 site in United States.
Trial summary
The goal of the Enhanced Medication Management Program (eMMp) being developed by MedMinder Systems, Inc. is to increase the ability of frail elders to adhere to complex medication regimens for chronic conditions. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Medication Adherence, Hypertension
- What is being tested?
- MedMinder System and MedMinder System - deactivated
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2011to Jun 2013
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- persons aged 55 years and older who are coming in for routine outpatient visits
- speaks and reads English
- history of high blood pressure
- systolic blood pressure ≥ 130 mm Hg
- using antihypertensive medication
- using 2 or more prescription medications
- plans to stay in area for the 9 months of study
Who cannot join
- receives personal help or reminders to take medication
- has moderate to severe dementia (MMSE score<18)
- has severe hearing or vision deficiency
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
VA New York Harbor Healthcare System
New York, New York, 10010
Sundar Natarajan, MD, M.Sc., 212-951-3395, sundar.natarajan@va.gov
About this study
The goal of the Enhanced Medication Management Program (eMMp) being developed by MedMinder Systems, Inc. is to increase the ability of frail elders to adhere to complex medication regimens for chronic conditions. Adherence will facilitate effective self-care and decrease personal and societal costs associated with disease progression and loss of independence. Multiple studies have shown that more frequent personal follow-up is the most effective way to maximize medication adherence, but such personal care is too costly to translate well to real life in a world of limited healthcare resources.
Currently available "smart pillboxes" are too expensive, too limited in the number and types of medications delivered, and too technically complex for the large majority of senior citizens. The eMMp is designed to deliver prompts and reminders to the user, to be remotely programmable by caregivers, to allow the option of using pre-filled medication trays, to provide electronic adherence reports to family/caregivers and to provide personalized reinforcing phone calls from professional caregivers, all at a modest cost. The in-home ReMinder will use a familiar pillbox layout (4 doses/day for 7 days) and allow easy removal of medication cups by elderly, rheumatic fingers. Installation will require only an electrical outlet (no modems or dedicated phone lines). Once plugged in, the built-in pager will continuously download remotely programmed visual and/or aural prompts and reminders from a central server (RemoteMind). It will continuously upload the date and time when each medi-cation cup is removed and when weekly refill is carried out, enabling remote adherence monitoring, alerts to caregivers, and follow-up intervention(s) from personal and/or professional caregivers as needed.
The hypothesis to be tested in this 2 year SBIR Phase I work plan is that the eMMp will significantly im-prove adherence and clinical outcome (blood pressure control) in a population of frail elderly who are hyper-tensive. SBIR Phase II will determine the minimum level of intervention needed to achieve sustained medication adherence and control of blood pressure in a larger group of hypertensive elders.
- Conditions
- Medication Adherence, Hypertension
- Being tested
- MedMinder System, MedMinder System - deactivated
- Medical subject headings
- Medication Adherence, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MedMinder SystemDevice
Participants will receive a fully activated reminder unit as well as at least one call per month from a counselor.
MedMinder System - deactivatedDevice
Participants will receive a one-way reminder unit that will remotely transit information on medication adherence
| Study group | Role | What they receive |
|---|---|---|
| MedMinder System | Other | Not described Receives: Device: MedMinder System |
| MedMinder System - deactivated | Other | Not described Receives: Device: MedMinder System - deactivated |
What is being measured
The primary outcome is the main question the study is designed to answer.
medication adherence
Measured: 6 months
change in systolic blood pressure
Measured: 6 months
Secondary outcomes (2)
change in self-efficacy about taking medication
Measured: 6 months
self-reported medication taking
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2010 (estimated)
- Study startSep 2011
- Primary completionMay 2013 (estimated)
- Study completionJun 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Medication AdherenceStudies 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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MedMinder Systems Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Narrows Institute for Biomedical Research
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01105104
- Sponsor's protocol ID
- 1R43HL097395-01A1
- Status last verified
- Nov 2011
- First submitted
- 14 Apr 2010
- Last updated
- 8 Nov 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Enhanced Medication Monitoring Program
- ClinicalTrials.gov ID
- NCT01105104
- Acronym / sponsor ID
- 1R43HL097395-01A1
- Conditions
- Medication Adherence, Hypertension
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- MedMinder Systems Inc.Industry (pharma, biotech, devices)
- Collaborators
- Narrows Institute for Biomedical Research
- Study start
- Sep 2011
- Primary completion
- May 2013 (estimated)
- Study completion
- Jun 2013 (estimated)
- First posted
- 16 Apr 2010 (estimated)
- Results
- Not posted in the source record
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 the Enhanced Medication Management Program (eMMp) being developed by MedMinder Systems, Inc. is to increase the ability of frail elders to adhere to complex medication regimens for chronic conditions. Adherence will facilitate effective self-care and decrease personal and societal costs associated with disease progression and loss of independence. Multiple studies have shown that more frequent personal follow-up is the most effective way to maximize medication adherence, but such personal care is too costly to translate well to real life in a world of limited healthcare resources.
Currently available "smart pillboxes" are too expensive, too limited in the number and types of medications delivered, and too technically complex for the large majority of senior citizens. The eMMp is designed to deliver prompts and reminders to the user, to be remotely programmable by caregivers, to allow the option of using pre-filled medication trays, to provide electronic adherence reports to family/caregivers and to provide personalized reinforcing phone calls from professional caregivers, all at a modest cost. The in-home ReMinder will use a familiar pillbox layout (4 doses/day for 7 days) and allow easy removal of medication cups by elderly, rheumatic fingers. Installation will require only an electrical outlet (no modems or dedicated phone lines). Once plugged in, the built-in pager will continuously download remotely programmed visual and/or aural prompts and reminders from a central server (RemoteMind). It will continuously upload the date and time when each medi-cation cup is removed and when weekly refill is carried out, enabling remote adherence monitoring, alerts to caregivers, and follow-up intervention(s) from personal and/or professional caregivers as needed.
The hypothesis to be tested in this 2 year SBIR Phase I work plan is that the eMMp will significantly im-prove adherence and clinical outcome (blood pressure control) in a population of frail elderly who are hyper-tensive. SBIR Phase II will determine the minimum level of intervention needed to achieve sustained medication adherence and control of blood pressure in a larger group of hypertensive elders.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MedMinder System | Other | Device: MedMinder System |
| MedMinder System - deactivated | Other | Device: MedMinder System - deactivated |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- persons aged 55 years and older who are coming in for routine outpatient visits
- speaks and reads English
- history of high blood pressure
- systolic blood pressure ≥ 130 mm Hg
- using antihypertensive medication
Key exclusion criteria (3 listed)
- receives personal help or reminders to take medication
- has moderate to severe dementia (MMSE score<18)
- has severe hearing or vision deficiency
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 |
|---|---|---|
| MedMinder SystemParticipants will receive a fully activated reminder unit as well as at least one call per month from a counselor. | Device | MedMinder System |
| MedMinder System - deactivatedParticipants will receive a one-way reminder unit that will remotely transit information on medication adherence | Device | MedMinder System - deactivated |
Primary outcome
medication adherence
Time frame: 6 months
change in systolic blood pressure
Time frame: 6 months
2 secondary outcomes
change in self-efficacy about taking medication
Time frame: 6 months
self-reported medication taking
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2011.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MedMinder System and MedMinder System - deactivated in people with Medication Adherence and Hypertension, run by MedMinder Systems Inc. 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 7 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 8 Nov 2011. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sundar Natarajan, MD, M.Sc (212-951-3395, sundar.natarajan@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
medication adherence (time frame: 6 months). 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 8 Nov 2011.