Cardiovascular DiseaseREMINDNCT02015806
Robust Evaluation to Measure Improvements in Nonadherence From Low-cost Devices
A study testing RxTimerCap, Take-N-Slide and Pillbox in people with Cardiovascular Disease and Diabetes, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
The aim of this study is to determine whether adherence to oral maintenance medications differs for patients randomized to receive a RxTimerCap, a Take-N-Slide, a standard pillbox, or none of these devices, with the hypothesis that low-touch devices improve adherence over control and that the increase in adherence is… Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Cardiovascular Disease, Diabetes, Breast Cancer
- What is being tested?
- RxTimerCap, Take-N-Slide and Pillbox
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53,480 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2014to Feb 2015
- Phase
- Interventional
- 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 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Have 1 to 3 oral maintenance medications for chronic disease in the 12-month period prior to study eligibility evaluation
- Cardiovascular disease (defined as hypertension, hyperlipidemia, coronary artery disease, congestive heart failure, or diabetes); OR
- Another non-depression chronic condition (defined as breast cancer, benign prostatic hypertrophy, schizophrenia, bipolar disorder, anxiety, arrythmia; Parkinson's disease, seizure, and epilepsy); OR
- Depression
- Be suboptimally adherent to their qualifying medications, defined as a Medication Possession Ratio between 30% and 80% during the 12 months preceding identification of study eligibility
- Eligible for pharmacy benefits during the 12 months prior to being identified as being eligible for the study and expected to be eligible for pharmacy benefits through the end of the evaluation period.
Who cannot join
- Enrolled in Ready Fill at Mail (a pharmacy benefit program whereby members elect to have medications shipped automatically to them at the time of refill due date or prescription renewal).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessing the Impact of Low-Touch Devices on Medication Adherence
The aim of this study is to determine whether adherence to oral maintenance medications differs for patients randomized to receive a RxTimerCap, a Take-N-Slide, a standard pillbox, or none of these devices, with the hypothesis that low-touch devices improve adherence over control and that the increase in adherence is agnostic across devices.
Read the detailed description
Prior to randomization, all patients meeting the inclusion criteria stratified into two strata and two blocks within each strata. The first stratum will consist of all patients on 1 to 3 medications for cardiovascular or other non-depression chronic conditions who are suboptimally adherent to these therapies. The second stratum will include all patients whose only targeted medications are for depression and who are suboptimally adherent to this therapy. Given that the Take-N-Slide device only has a Yes/No toggle for each day of the week and can therefore only be used once per day, each stratum will be further stratified into two separate blocks based on the frequency with which the study participants' medications are (or could possibly be) taken. Patients who are on a medication that is used more than once daily will be randomized in a 2:1 ratio to receive the RxTimerCap, pillbox, or to continue with usual care. Patients for whom all medications are dosed once daily will be randomized in a 2:1 ratio to receive the Take-N-Slide, RxTimerCap, pillbox, or to continue with usual care.
- Conditions
- Cardiovascular Disease, Diabetes, Breast Cancer, Depression, Mental Health Disorder, Prostatic Hypertrophy, Benign
- Being tested
- RxTimerCap, Take-N-Slide, Pillbox
- Keywords
- Quality improvement, Randomized controlled trial, Medication adherence, RxTimer Cap, PillMinder, Take-N-Slide, Low-touch devices, Medication management
- Medical subject headings
- Cardiovascular Diseases, Diabetes Mellitus, Breast Neoplasms, Depression, Mental Disorders, Prostatic Hyperplasia, Parkinson Disease, Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RxTimerCapBehavioural
The RxTimerCap is a pill bottle cap with a digital timer that shows the time elapsed since the medication was last taken. Patients randomized to receive the RxTimerCap will receive a one-time mailing with one device for each of the maintenance medications they were using at the time of identification for study eligibility; additionally, patients will receive an information card explaining the device's use which includes a telephone number at which they can get additional information.
Take-N-SlideBehavioural
The Take-N-Slide device is a patented strip with toggles for each day of the week which are meant to be slid after taking a medication. Each Take-N-Slide can be removed and reused for the next prescription bottle. Patients randomized to receive Take-N-Slide will receive a one-time mailing with one device for each of the maintenance medications they were using at the time of identification for study eligibility; additionally, patients will receive an information card explaining the device's use which includes a telephone number at which they can get additional information.
PillboxBehavioural
The standard pillbox is a plastic organization box with one compartment for every day of the week. Patients randomized to receive a pillbox will receive a one-time mailing with one device for each of the maintenance medications they were using at the time of identification for study eligibility; additionally, patients will receive an information card explaining the device's use which includes a telephone number at which they can get additional information.
| Study group | Role | What they receive |
|---|---|---|
| All meds but depression, 1x daily use, RxTimerCap | Experimental | Individuals who are taking 1-3 cardiovascular or other non-depression chronic disease medications and who are suboptimally adherent to these therapies, whose medications are all intended for once daily use, and who are randomized to receive a RxTimerCap. Receives: Behavioral: RxTimerCap |
| All meds but depression, 1x daily use, Take-N-Slide | Experimental | Individuals who are taking 1-3 cardiovascular or other non-depression chronic disease medications and who are suboptimally adherent to these therapies, whose medications are all intended for once daily use, and who are randomized to receive a Take-N-Slide. Receives: Behavioral: Take-N-Slide |
| All meds but depression, 1x daily use, pillbox | Experimental | Individuals who are taking 1-3 cardiovascular or other non-depression chronic disease medications and who are suboptimally adherent to these therapies, whose medications are all intended for once daily use, and who are randomized to receive a standard pillbox. Receives: Behavioral: Pillbox |
| All meds but depression, 1x daily use, control | No intervention | Individuals who are taking 1-3 cardiovascular or other non-depression chronic disease medications and who are suboptimally adherent to these therapies, whose medications are all intended for once daily use, and who are randomized to continue with usual care. |
| All meds but depression, ≥1 med >1 daily use, RxTimerCap | Experimental | Individuals who are taking 1-3 cardiovascular or other non-depression chronic disease medications and who are suboptimally adherent to these therapies, who have at least one medication that is intended for use more than once daily, and who are randomized to receive a RxTimerCap. Receives: Behavioral: RxTimerCap |
| All meds but depression, ≥1 med >1 daily use, pillbox | Experimental | Individuals who are taking 1-3 cardiovascular or other non-depression chronic disease medications and who are suboptimally adherent to these therapies, who have at least one medication that is intended for use more than once daily, and who are randomized to receive a standard pillbox. Receives: Behavioral: Pillbox |
| All meds but depression, ≥1 med >1 daily use, control | No intervention | Individuals who are taking 1-3 cardiovascular or other non-depression chronic disease medications and who are suboptimally adherent to these therapies, who have at least one medication that is intended for use more than once daily, and who are randomized to continue with usual care. |
| Only depression meds, 1x daily use, RxTimerCap | Experimental | Individuals who are taking only antidepressants and who are suboptimally adherent to these therapies, whose medications are all intended for once daily use, and who are randomized to receive a RxTimerCap. Receives: Behavioral: RxTimerCap |
| Only depression meds, 1x daily use, Take-N-Slide | Experimental | Individuals who are taking only antidepressants and who are suboptimally adherent to these therapies, whose medications are all intended for once daily use, and who are randomized to receive a Take-N-Slide. Receives: Behavioral: Take-N-Slide |
| Only depression meds, 1x daily use, pillbox | Experimental | Individuals who are taking only antidepressants and who are suboptimally adherent to these therapies, whose medications are all intended for once daily use, and who are randomized to receive a standard pillbox. Receives: Behavioral: Pillbox |
| Only depression meds, 1x daily use, control | No intervention | Individuals who are taking only antidepressants and who are suboptimally adherent to these therapies, whose medications are all intended for once daily use, and who are randomized to continue with usual care. |
| Only depression meds, ≥1 med >1 daily use, RxTimerCap | Experimental | Individuals who are taking only antidepressants and who are suboptimally adherent to these therapies, who have at least one medication that is intended for use more than once daily, and who are randomized to receive a RxTimerCap. Receives: Behavioral: RxTimerCap |
| Only depression meds, ≥1 med >1 daily use, pillbox | Experimental | Individuals who are taking only antidepressants and who are suboptimally adherent to these therapies, who have at least one medication that is intended for use more than once daily, and who are randomized to receive a standard pillbox. Receives: Behavioral: Pillbox |
| Only depression meds, ≥1 med >1 daily use, control | No intervention | Individuals who are taking only antidepressants and who are suboptimally adherent to these therapies, who have at least one medication that is intended for use more than once daily, and who are randomized to continue with usual care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Optimal medication adherence to all cardiovascular or non-depression chronic disease medications
Optimal adherence to all cardiovascular or non-depression chronic disease medications, defined as a Medication Possession Ratio (MPR) equal to or greater than 80% and assessed using administrative pharmacy claims
Measured: 12 months
Secondary outcomes (3)
Optimal adherence to antidepressants
Optimal adherence to antidepressants among subjects whose only targeted therapy is an antidepressant, calculated using Medication Possession Ratios (MPR) and assessed using administrative pharmacy claims
Measured: 12 months
Optimal adherence to the targeted therapies in each randomization block independently
Optimal adherence to the targeted therapies in each of the randomization blocks independently, calculated using Medication Possession Ratios (MPR) and assessed using administrative pharmacy claims
Measured: 12 months
Optimal adherence to cardiovascular medications among subjects who are suboptimally adherent to these medications at time of randomization
Optimal adherence to cardiovascular medications among subjects who are suboptimally adherent to these medications at time of randomization, calculated using Medication Possession Ratios (MPR) and assessed using administrative pharmacy claims
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2013 (estimated)
- Study startMar 2014
- Primary completionFeb 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseaseStudies of the same condition, open and under way.
- More trials run by Brigham and Women's 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 53,480 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- CVS Caremark
- Responsible party
- Principal investigator, Niteesh K. Choudhry, MD, PhD, Brigham and Women's Hospital
- Investigators
- Niteesh K Choudhry, MD, PhD, Principal investigator, Brigham and Women's Hospital/Harvard Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02015806
- Sponsor's protocol ID
- 2013-P-00009085
- Acronym
- REMIND
- Status last verified
- Jan 2016
- First submitted
- 13 Dec 2013
- Last updated
- 11 Jan 2016
- Results posted
- No
Publications
Al-Aqeel S, Gershuni O, Al-Sabhan J, Hiligsmann M. Strategies for improving adherence to antiepileptic drug treatment in people with epilepsy. Cochrane Database Syst Rev. 2020 Oct 22;10(10):CD008312. doi: 10.1002/14651858.CD008312.pub4.
PubMed 33089492Choudhry NK, Krumme AA, Ercole PM, Girdish C, Tong AY, Khan NF, Brennan TA, Matlin OS, Shrank WH, Franklin JM. Effect of Reminder Devices on Medication Adherence: The REMIND Randomized Clinical Trial. JAMA Intern Med. 2017 May 1;177(5):624-631. doi: 10.1001/jamainternmed.2016.9627.
PubMed 28241271
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Impact of Low-Touch Devices on Medication Adherence
- ClinicalTrials.gov ID
- NCT02015806
- Acronym / sponsor ID
- REMIND / 2013-P-00009085
- Conditions
- Cardiovascular Disease, Diabetes, Breast Cancer, Depression, Mental Health Disorder, Prostatic Hypertrophy, Benign
- Keywords
- Quality improvement, Randomized controlled trial, Medication adherence, RxTimer Cap, PillMinder, Take-N-Slide, Low-touch devices, Medication management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53,480 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- CVS Caremark
- Study start
- Mar 2014
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 19 Dec 2013 (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 aim of this study is to determine whether adherence to oral maintenance medications differs for patients randomized to receive a RxTimerCap, a Take-N-Slide, a standard pillbox, or none of these devices, with the hypothesis that low-touch devices improve adherence over control and that the increase in adherence is agnostic across devices.
Detailed description
Prior to randomization, all patients meeting the inclusion criteria stratified into two strata and two blocks within each strata. The first stratum will consist of all patients on 1 to 3 medications for cardiovascular or other non-depression chronic conditions who are suboptimally adherent to these therapies. The second stratum will include all patients whose only targeted medications are for depression and who are suboptimally adherent to this therapy. Given that the Take-N-Slide device only has a Yes/No toggle for each day of the week and can therefore only be used once per day, each stratum will be further stratified into two separate blocks based on the frequency with which the study participants' medications are (or could possibly be) taken. Patients who are on a medication that is used more than once daily will be randomized in a 2:1 ratio to receive the RxTimerCap, pillbox, or to continue with usual care. Patients for whom all medications are dosed once daily will be randomized in a 2:1 ratio to receive the Take-N-Slide, RxTimerCap, pillbox, or to continue with usual care.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 14
| Arm | Type | Receives |
|---|---|---|
| All meds but depression, 1x daily use, RxTimerCap | Experimental | Behavioral: RxTimerCapIndividuals who are taking 1-3 cardiovascular or other non-depression chronic disease medications and who are suboptimally adherent to these therapies, whose medications are all intended for once daily use, and who are randomized to receive a RxTimerCap. |
| All meds but depression, 1x daily use, Take-N-Slide | Experimental | Behavioral: Take-N-SlideIndividuals who are taking 1-3 cardiovascular or other non-depression chronic disease medications and who are suboptimally adherent to these therapies, whose medications are all intended for once daily use, and who are randomized to receive a Take-N-Slide. |
| All meds but depression, 1x daily use, pillbox | Experimental | Behavioral: PillboxIndividuals who are taking 1-3 cardiovascular or other non-depression chronic disease medications and who are suboptimally adherent to these therapies, whose medications are all intended for once daily use, and who are randomized to receive a standard pillbox. |
| All meds but depression, 1x daily use, control | No intervention | –Individuals who are taking 1-3 cardiovascular or other non-depression chronic disease medications and who are suboptimally adherent to these therapies, whose medications are all intended for once daily use, and who are randomized to continue with usual care. |
| All meds but depression, ≥1 med >1 daily use, RxTimerCap | Experimental | Behavioral: RxTimerCapIndividuals who are taking 1-3 cardiovascular or other non-depression chronic disease medications and who are suboptimally adherent to these therapies, who have at least one medication that is intended for use more than once daily, and who are randomized to receive a RxTimerCap. |
| All meds but depression, ≥1 med >1 daily use, pillbox | Experimental | Behavioral: PillboxIndividuals who are taking 1-3 cardiovascular or other non-depression chronic disease medications and who are suboptimally adherent to these therapies, who have at least one medication that is intended for use more than once daily, and who are randomized to receive a standard pillbox. |
| All meds but depression, ≥1 med >1 daily use, control | No intervention | –Individuals who are taking 1-3 cardiovascular or other non-depression chronic disease medications and who are suboptimally adherent to these therapies, who have at least one medication that is intended for use more than once daily, and who are randomized to continue with usual care. |
| Only depression meds, 1x daily use, RxTimerCap | Experimental | Behavioral: RxTimerCapIndividuals who are taking only antidepressants and who are suboptimally adherent to these therapies, whose medications are all intended for once daily use, and who are randomized to receive a RxTimerCap. |
| Only depression meds, 1x daily use, Take-N-Slide | Experimental | Behavioral: Take-N-SlideIndividuals who are taking only antidepressants and who are suboptimally adherent to these therapies, whose medications are all intended for once daily use, and who are randomized to receive a Take-N-Slide. |
| Only depression meds, 1x daily use, pillbox | Experimental | Behavioral: PillboxIndividuals who are taking only antidepressants and who are suboptimally adherent to these therapies, whose medications are all intended for once daily use, and who are randomized to receive a standard pillbox. |
| Only depression meds, 1x daily use, control | No intervention | –Individuals who are taking only antidepressants and who are suboptimally adherent to these therapies, whose medications are all intended for once daily use, and who are randomized to continue with usual care. |
| Only depression meds, ≥1 med >1 daily use, RxTimerCap | Experimental | Behavioral: RxTimerCapIndividuals who are taking only antidepressants and who are suboptimally adherent to these therapies, who have at least one medication that is intended for use more than once daily, and who are randomized to receive a RxTimerCap. |
| Only depression meds, ≥1 med >1 daily use, pillbox | Experimental | Behavioral: PillboxIndividuals who are taking only antidepressants and who are suboptimally adherent to these therapies, who have at least one medication that is intended for use more than once daily, and who are randomized to receive a standard pillbox. |
| Only depression meds, ≥1 med >1 daily use, control | No intervention | –Individuals who are taking only antidepressants and who are suboptimally adherent to these therapies, who have at least one medication that is intended for use more than once daily, and who are randomized to continue with usual care. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Have 1 to 3 oral maintenance medications for chronic disease in the 12-month period prior to study eligibility evaluation
- Be suboptimally adherent to their qualifying medications, defined as a Medication Possession Ratio between 30% and 80% during the 12 months preceding identification of study eligibility
- Eligible for pharmacy benefits during the 12 months prior to being identified as being eligible for the study and expected to be eligible for pharmacy benefits through the end of the evaluation period.
Key exclusion criteria (1 listed)
- Enrolled in Ready Fill at Mail (a pharmacy benefit program whereby members elect to have medications shipped automatically to them at the time of refill due date or prescription renewal).
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 |
|---|---|---|
| RxTimerCapThe RxTimerCap is a pill bottle cap with a digital timer that shows the time elapsed since the medication was last taken. Patients randomized to receive the RxTimerCap will receive a one-time mailing with one device for each of the maintenance medications they were using at the time of identification for study eligibility; additionally, patients will receive an information card explaining the device's use which includes a telephone number at which they can get additional information. | Behavioural | All meds but depression, 1x daily use, RxTimerCap, All meds but depression, ≥1 med >1 daily use, RxTimerCap, Only depression meds, 1x daily use, RxTimerCap, Only depression meds, ≥1 med >1 daily use, RxTimerCap |
| Take-N-SlideThe Take-N-Slide device is a patented strip with toggles for each day of the week which are meant to be slid after taking a medication. Each Take-N-Slide can be removed and reused for the next prescription bottle. Patients randomized to receive Take-N-Slide will receive a one-time mailing with one device for each of the maintenance medications they were using at the time of identification for study eligibility; additionally, patients will receive an information card explaining the device's use which includes a telephone number at which they can get additional information. | Behavioural | All meds but depression, 1x daily use, Take-N-Slide, Only depression meds, 1x daily use, Take-N-Slide |
| PillboxThe standard pillbox is a plastic organization box with one compartment for every day of the week. Patients randomized to receive a pillbox will receive a one-time mailing with one device for each of the maintenance medications they were using at the time of identification for study eligibility; additionally, patients will receive an information card explaining the device's use which includes a telephone number at which they can get additional information. | Behavioural | All meds but depression, 1x daily use, pillbox, All meds but depression, ≥1 med >1 daily use, pillbox, Only depression meds, 1x daily use, pillbox, Only depression meds, ≥1 med >1 daily use, pillbox |
Primary outcome
Optimal medication adherence to all cardiovascular or non-depression chronic disease medications
Time frame: 12 months
Optimal adherence to all cardiovascular or non-depression chronic disease medications, defined as a Medication Possession Ratio (MPR) equal to or greater than 80% and assessed using administrative pharmacy claims
3 secondary outcomes
Optimal adherence to antidepressants
Time frame: 12 months
Optimal adherence to the targeted therapies in each randomization block independently
Time frame: 12 months
Optimal adherence to cardiovascular medications among subjects who are suboptimally adherent to these medications at time of randomization
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2016.
- Derived from this study: PubMed 33089492Al-Aqeel S, Gershuni O, Al-Sabhan J, Hiligsmann M. Strategies for improving adherence to antiepileptic drug treatment in people with epilepsy. Cochrane Database Syst Rev. 2020 Oct 22;10(10):CD008312. doi: 10.1002/14651858.CD008312.pub4.
- Derived from this study: PubMed 28241271Choudhry NK, Krumme AA, Ercole PM, Girdish C, Tong AY, Khan NF, Brennan TA, Matlin OS, Shrank WH, Franklin JM. Effect of Reminder Devices on Medication Adherence: The REMIND Randomized Clinical Trial. JAMA Intern Med. 2017 May 1;177(5):624-631. doi: 10.1001/jamainternmed.2016.9627.
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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.
Niteesh K Choudhry, MD, PhD principal investigator
Brigham and Women's Hospital/Harvard Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RxTimerCap, Take-N-Slide and Pillbox in people with Cardiovascular Disease and Diabetes, run by Brigham and Women's 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 6 inclusion and 1 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 11 Jan 2016. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Optimal medication adherence to all cardiovascular or non-depression chronic disease medications (time frame: 12 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 NCT02015806, which also lists 2 linked publications.
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 11 Jan 2016.