Diabetes Mellitus(TVHST2DM)NCT02593032
Effects of Use of a Connected Pillbox On Medication Adherence
A study testing Pre-filled trays in people with Diabetes Mellitus and Hypertension, run by University of Pennsylvania at 1 site in United States.
Trial summary
Medication adherence is defined as the extent to which a patient takes his or her medication as prescribed by their healthcare provider. One third to one half of all patients in the United States do not take their medication as directed, resulting in nearly $100B in avoidable hospital costs per year. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Hypertension, Hyperlipidemia
- What is being tested?
- Pre-filled trays
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2015to 21 Sep 2017
- 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
Inclusion Criteria:• Insurance and pharmacy coverage with Independence Blue Cross (IBC); 18 years or older; Current diagnosis of Type II Diabetes Mellitus, Hypertension or Hyperlipidemia and taking 5 or more medications; Less than 80% medication adherence; Able to communicate in English; Willing to give informed consent, receive recruitment (invitation)letter from IBC
Exclusion Criteria: Known alcohol or illicit drug abuse; Significant cognitive impairment at baseline as defined by the Animal Naming Screening Tool; Residence in a care facility that provides medication on schedule; Unwilling to use TowerView Health's connected pillbox and accompanying medication trays; Any active medical or psychiatric diagnosis that, based on the clinical assessment of the research team, would prevent the study participant from completing the trial such as: markedly shortened life expectancy (e.g. diagnosis of metastatic cancer, end stage renal disease on dialysis, New York Heart Association (NYHA) Class III or IV heart failure, active psychosis or suicidal ideation, etc.) or dexterity/motor impairments (e.g. severe arthritis, neuromuscular disorders, etc); and Lack a mobile or land line phone.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: Study On The Effect of Combined Use of a Connected Pillbox, Pre-filled Medication Trays, Automated Text Message/Phone Call Reminds, On Medication Adherence in Patients With Type II Diabetes Mellitus, Hypertension or Hyperlipidemia
Medication adherence is defined as the extent to which a patient takes his or her medication as prescribed by their healthcare provider. One third to one half of all patients in the United States do not take their medication as directed, resulting in nearly $100B in avoidable hospital costs per year. Recent efforts to improve medication adherence in patients with multiple comorbidities have turned to case management and disease management programs. Connected monitoring devices offer an alternative- or supplement- to frequent nurse visits and outreach. These devices enable frequent monitoring and intervention but can also generate large volumes of data that can be difficult for care teams to manage. The present study explores the use of one such device- a technology-enabled, connected pillbox. Given the continued emphasis on bending the cost curve in US healthcare, clinical validation of tools that may improve the management of costly chronic diseases, such as diabetes, is essential.
Read the detailed description
Randomized Control Trial Patients in the research treatment group receive pre-filled, 3x7 disposable trays that separate their medication by dose and time (e.g. morning, afternoon, evening). These pre-filled trays are inserted into a connected, weekly pillbox that detects when pills are removed from its wells. Using this information, TowerView Health system is able to send automated text messages or phone reminders to patients to take forgotten or ignored medication doses. Medication adherence data from deployed pillboxes populates a software platform, which a research coordinator can access.
Patients who miss 3 consecutive doses or 5 doses out of 12 over a 4-day period trigger an alert for the study research coordinator who can contact the patient via phone call. The research coordinator follows a scripted motivational interview in his or her outreach to determine the etiology of non-adherence. Patients reporting worrisome symptoms will be instructed to contact their provider directly and/or go to the emergency room for immediate attention. The investigator acknowledges that the current study actually involves multiple interventions: 1. The pre-filled medication trays are provided by a pharmacist, which overcomes medication access issues as well as the inconvenience of manually organizing medications. 2. The electronic pillbox, which monitors adherence that triggers text message or phone reminders in instances where patients forget or ignore medication doses 3. Research coordinator alerts, which trigger outreach events that employ a motivational interview in order to improve patient adherence.
- Conditions
- Diabetes Mellitus, Hypertension, Hyperlipidemia
- Being tested
- Pre-filled trays
- Keywords
- hemoglobin A1c protein, human > 7.5
- Medical subject headings
- Diabetes Mellitus, Hypertension, Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pre-filled traysDevice
Randomized Control Trial Patients in the research treatment group receive pre-filled, 3x7 disposable trays that separate their medication by dose and time (e.g. morning, afternoon, evening). These pre-filled trays are inserted into a connected, weekly pillbox that detects when pills are removed from its wells.
| Study group | Role | What they receive |
|---|---|---|
| Randomized Treatment | Experimental | Patients in the treatment group will begin receiving their medications in pre-filled trays from Friendship Pharmacy. Patients will receive 5 trays on a monthly basis in order to accommodate a 30-day, insurance-reimbursed fill schedule. Receives: Device: Pre-filled trays |
| Control Arm | No intervention | Patients in the control arm will receive usual care and can continue using their existing pharmacy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of Participants With Adherence at Month 6
The primary outcome of interest in the present study is improvement in adherence. We will determine if a multi-modal intervention focused on improving medication adherence among adults who were previously non-adherent results in improved medication adherence over a 6-month interval averaged across months 1 to 6. This will be reported as the percent persistent on therapy at 6 months across the three conditions (diabetes, HTN, hyperlipidemia)
Measured: 6-month interval
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2015 (estimated)
- Study startFeb 2015
- Primary completionApr 2017
- Study completion21 Sep 2017
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 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe 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
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- TowerView Health
- Responsible party
- Sponsor
- Investigators
- Nalaka S Gooneratne, MD, Principal investigator, University of Pennsylvannia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02593032
- Sponsor's protocol ID
- 821737
- Acronym
- (TVHST2DM)
- Status last verified
- Aug 2026
- First submitted
- 19 Oct 2015
- Last updated
- 15 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study On The Effect of Combined Use of a Connected Pillbox, Pre-filled Medication Trays, Automated Text Message/Phone Call Reminds, On Medication Adherence in Patients With Type II Diabetes Mellitus, Hypertension or Hyperlipidemia
- ClinicalTrials.gov ID
- NCT02593032
- Acronym / sponsor ID
- (TVHST2DM) / 821737
- Conditions
- Diabetes Mellitus, Hypertension, Hyperlipidemia
- Keywords
- hemoglobin A1c protein, human > 7.5
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- TowerView Health
- Study start
- Feb 2015
- Primary completion
- Apr 2017 (actual)
- Study completion
- 21 Sep 2017 (actual)
- First posted
- 30 Oct 2015 (estimated)
- Results
- Posted 4 Aug 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Medication adherence is defined as the extent to which a patient takes his or her medication as prescribed by their healthcare provider. One third to one half of all patients in the United States do not take their medication as directed, resulting in nearly $100B in avoidable hospital costs per year. Recent efforts to improve medication adherence in patients with multiple comorbidities have turned to case management and disease management programs. Connected monitoring devices offer an alternative- or supplement- to frequent nurse visits and outreach. These devices enable frequent monitoring and intervention but can also generate large volumes of data that can be difficult for care teams to manage. The present study explores the use of one such device- a technology-enabled, connected pillbox. Given the continued emphasis on bending the cost curve in US healthcare, clinical validation of tools that may improve the management of costly chronic diseases, such as diabetes, is essential.
Detailed description
Randomized Control Trial Patients in the research treatment group receive pre-filled, 3x7 disposable trays that separate their medication by dose and time (e.g. morning, afternoon, evening). These pre-filled trays are inserted into a connected, weekly pillbox that detects when pills are removed from its wells. Using this information, TowerView Health system is able to send automated text messages or phone reminders to patients to take forgotten or ignored medication doses. Medication adherence data from deployed pillboxes populates a software platform, which a research coordinator can access.
Patients who miss 3 consecutive doses or 5 doses out of 12 over a 4-day period trigger an alert for the study research coordinator who can contact the patient via phone call. The research coordinator follows a scripted motivational interview in his or her outreach to determine the etiology of non-adherence. Patients reporting worrisome symptoms will be instructed to contact their provider directly and/or go to the emergency room for immediate attention. The investigator acknowledges that the current study actually involves multiple interventions: 1. The pre-filled medication trays are provided by a pharmacist, which overcomes medication access issues as well as the inconvenience of manually organizing medications. 2. The electronic pillbox, which monitors adherence that triggers text message or phone reminders in instances where patients forget or ignore medication doses 3. Research coordinator alerts, which trigger outreach events that employ a motivational interview in order to improve patient adherence.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Randomized Treatment | Experimental | Device: Pre-filled traysPatients in the treatment group will begin receiving their medications in pre-filled trays from Friendship Pharmacy. Patients will receive 5 trays on a monthly basis in order to accommodate a 30-day, insurance-reimbursed fill schedule. |
| Control Arm | No intervention | –Patients in the control arm will receive usual care and can continue using their existing pharmacy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Pre-filled traysRandomized Control Trial Patients in the research treatment group receive pre-filled, 3x7 disposable trays that separate their medication by dose and time (e.g. morning, afternoon, evening). These pre-filled trays are inserted into a connected, weekly pillbox that detects when pills are removed from its wells. | Device | Randomized Treatment |
Primary outcome
Percent of Participants With Adherence at Month 6
Time frame: 6-month interval
The primary outcome of interest in the present study is improvement in adherence. We will determine if a multi-modal intervention focused on improving medication adherence among adults who were previously non-adherent results in improved medication adherence over a 6-month interval averaged across months 1 to 6. This will be reported as the percent persistent on therapy at 6 months across the three conditions (diabetes, HTN, hyperlipidemia)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Nalaka S Gooneratne, MD principal investigator
University of Pennsylvannia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pre-filled trays in people with Diabetes Mellitus and Hypertension, run by University of Pennsylvania 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?
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 15 Sep 2026. 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 4 Aug 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?
Percent of Participants With Adherence at Month 6 (time frame: 6-month interval). 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 15 Sep 2026.