Medication AdherenceNCT02018809
Social Forces to Improve Statin Adherence (Study A)
A study testing Medication Adherence Partner and Electronic pill bottle in people with Medication Adherence and High Blood Pressure, run by University of Pennsylvania at 1 site in United States.
Trial summary
To assess the effectiveness of reporting statin adherence patterns to a Medication Adherence Partner (MAP) in improving the outcome of statin adherence versus usual care as measured by an electronic pill bottle. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Medication Adherence, High Blood Pressure, Diabetes
- What is being tested?
- Medication Adherence Partner and Electronic pill bottle
- Type of treatment
- Pill or oral medicine, Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2014to Jan 2015
- 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
- The subject is Humana insured
- The subject is an English speaking adult
- Age range ≥18 years
- The subject has diagnosis with diabetes for ≥12 months
- The subject has an MPR <70% to a statin medication
- Subject denies side-effects to their statin medication
- The subject identified a person who agreed to serve as their MAP
Who cannot join
- The subject is <18 years old
- The subject is considered part of a vulnerable population (is a prisoner, a cognitively impaired person, or a pregnant woman)
- On statin combination medication
- The subject does not identify an individual who agrees to serve as their MAP
- The subject reports a clinically important side effect to the statin medication or active liver disease:
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania Perelman School of Medicine
Philadelphia, Pennsylvania, 19104
About this study
Official title: Using Social Support To Improve Medication Adherence In Statin Users With Diabetes
To assess the effectiveness of reporting statin adherence patterns to a Medication Adherence Partner (MAP) in improving the outcome of statin adherence versus usual care as measured by an electronic pill bottle.
Hypothesis: Subjects with a MAP receiving daily adherence feedback will have the highest statin adherence of any arm, as measured by pill bottle data.
Read the detailed description
We propose to complete a randomized controlled trial (RCT) of 200 subjects with medication treated diabetes and evidence of poor adherence to a statin medication (<70% medication possession ratio determined through pharmacy records; no combination meds). Study subjects will use an electronic pill bottle (GlowCap) to store their statin medication. Study subjects will identify potential Medication Adherence Partners (MAPs) who can receive information about their adherence patterns at enrollment. For the 90-day trial, subjects will be randomized to: 1) the subject's MAP receives daily notification about whether subject took statin; 2) the subject's MAP receives weekly about how often the subject took statin during previous week; 3) the subject's MAP receives notification if the subject missed >2 consecutive daily doses of statin; and 4) usual care (GlowCaps without any notifications). The primary outcome will be the percent of statin doses taken during the study as measured by the GlowCaps. The secondary outcome will be subjects' statin medication possession ratio (MPR) during the study.
- Conditions
- Medication Adherence, High Blood Pressure, Diabetes
- Being tested
- Medication Adherence Partner, Electronic pill bottle
- Keywords
- Medication Adherence, High Blood Pressure, Diabetes, Statins
- Medical subject headings
- Medication Adherence, Hypertension, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medication Adherence PartnerBehavioural
Electronic pill bottleDevice
Also called Vitality GlowCap
This device can remotely track medication taking and will be used by subjects to store once-a-day statin medication already prescribed pre-trial.
| Study group | Role | What they receive |
|---|---|---|
| MAP Daily Notification | Experimental | The subject's MAP receives daily notification about whether subject took statin. Receives: Behavioral: Medication Adherence Partner; Device: Electronic pill bottle |
| MAP Weekly Notification | Experimental | The subject's MAP receives weekly about how often the subject took statin during previous week. Receives: Behavioral: Medication Adherence Partner; Device: Electronic pill bottle |
| MAP Missed Doses | Experimental | The subject's MAP receives notification if the subject missed >2 consecutive daily doses of statin. Receives: Behavioral: Medication Adherence Partner; Device: Electronic pill bottle |
| Usual Care | Other | Usual care with GlowCap. Receives: Device: Electronic pill bottle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Statin Adherence
The primary outcome will be the percent of statin doses taken during the study as measured by the GlowCaps.
Measured: 90 days
Secondary outcomes (1)
Morisky Medication Adherence Scale (MMAS)
The secondary outcome will be subjects' self-reports medication adherence. Morisky et al. developed this 8-item MMAS (MMAS-8) in 2008. The first seven items are Yes/No responses while the last item is a 5-point Likert response. The scoring scheme is: "Yes" = 0 and "No" = 1 (and "0" = 0 and "1-4" = 1 for Likert question). The items are summed to give a range of scores from 0 to 8. Respondents' summed score get grouped as follows: "0" = High Adherence; "1-2" = Medium Adherence; "3-8" = Low Adherence.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2013 (estimated)
- Study startJan 2014
- Primary completionOct 2014
- Study completionJan 2015
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 Medication AdherenceStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
- Investigators
- Peter P Reese, MD, MSCE, Principal investigator, UPenn PSOMJudd B Kessler, PhD, Principal investigator, UPenn, WhartonKevin Volpp, MD, PhD, Principal investigator, UPenn, PSOM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02018809
- Sponsor's protocol ID
- 819129-A
- Status last verified
- Aug 2017
- First submitted
- 17 Dec 2013
- Last updated
- 14 Sep 2017
- 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 14 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Social Support To Improve Medication Adherence In Statin Users With Diabetes
- ClinicalTrials.gov ID
- NCT02018809
- Acronym / sponsor ID
- 819129-A
- Conditions
- Medication Adherence, High Blood Pressure, Diabetes
- Keywords
- Medication Adherence, High Blood Pressure, Diabetes, Statins
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- Jan 2014
- Primary completion
- Oct 2014 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 23 Dec 2013 (estimated)
- Results
- Posted 23 May 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To assess the effectiveness of reporting statin adherence patterns to a Medication Adherence Partner (MAP) in improving the outcome of statin adherence versus usual care as measured by an electronic pill bottle.
Hypothesis: Subjects with a MAP receiving daily adherence feedback will have the highest statin adherence of any arm, as measured by pill bottle data.
Detailed description
We propose to complete a randomized controlled trial (RCT) of 200 subjects with medication treated diabetes and evidence of poor adherence to a statin medication (<70% medication possession ratio determined through pharmacy records; no combination meds). Study subjects will use an electronic pill bottle (GlowCap) to store their statin medication. Study subjects will identify potential Medication Adherence Partners (MAPs) who can receive information about their adherence patterns at enrollment. For the 90-day trial, subjects will be randomized to: 1) the subject's MAP receives daily notification about whether subject took statin; 2) the subject's MAP receives weekly about how often the subject took statin during previous week; 3) the subject's MAP receives notification if the subject missed >2 consecutive daily doses of statin; and 4) usual care (GlowCaps without any notifications). The primary outcome will be the percent of statin doses taken during the study as measured by the GlowCaps. The secondary outcome will be subjects' statin medication possession ratio (MPR) during the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| MAP Daily Notification | Experimental | Behavioral: Medication Adherence Partner, Device: Electronic pill bottleThe subject's MAP receives daily notification about whether subject took statin. |
| MAP Weekly Notification | Experimental | Behavioral: Medication Adherence Partner, Device: Electronic pill bottleThe subject's MAP receives weekly about how often the subject took statin during previous week. |
| MAP Missed Doses | Experimental | Behavioral: Medication Adherence Partner, Device: Electronic pill bottleThe subject's MAP receives notification if the subject missed >2 consecutive daily doses of statin. |
| Usual Care | Other | Device: Electronic pill bottleUsual care with GlowCap. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- The subject is Humana insured
- The subject is an English speaking adult
- Age range ≥18 years
- The subject has diagnosis with diabetes for ≥12 months
- The subject has an MPR <70% to a statin medication
Key exclusion criteria (5 listed)
- The subject is <18 years old
- The subject is considered part of a vulnerable population (is a prisoner, a cognitively impaired person, or a pregnant woman)
- On statin combination medication
- The subject does not identify an individual who agrees to serve as their MAP
- The subject reports a clinically important side effect to the statin medication or active liver disease:
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 |
|---|---|---|
| Medication Adherence Partner | Behavioural | MAP Daily Notification, MAP Missed Doses, MAP Weekly Notification |
| Electronic pill bottleAlso: Vitality GlowCapThis device can remotely track medication taking and will be used by subjects to store once-a-day statin medication already prescribed pre-trial. | Device | MAP Daily Notification, MAP Missed Doses, MAP Weekly Notification, Usual Care |
Primary outcome
Statin Adherence
Time frame: 90 days
The primary outcome will be the percent of statin doses taken during the study as measured by the GlowCaps.
1 secondary outcome
Morisky Medication Adherence Scale (MMAS)
Time frame: 90 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2017.
- 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.
Peter P Reese, MD, MSCE principal investigator
UPenn PSOM
Judd B Kessler, PhD principal investigator
UPenn, Wharton
Kevin Volpp, MD, PhD principal investigator
UPenn, PSOM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medication Adherence Partner and Electronic pill bottle in people with Medication Adherence and High Blood Pressure, 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?
The sponsor lists 7 inclusion and 5 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 14 Sep 2017. 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 23 May 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?
Statin Adherence (time frame: 90 days). 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 14 Sep 2017.