Medication AdherenceARemindNCT01229722
ARemind: A Personalized System to Remind for Adherence
A study testing Beeper and ARemind in people with Medication Adherence, run by Dimagi Inc. at 1 site in United States.
Trial summary
The main aim of this phase II proposal is to continue and complete development of a cellular phone-based system that assists patients with their medication adherence. Adherence reports will be developed with feedback from patients and providers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Medication Adherence
- What is being tested?
- Beeper and ARemind
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2011to Jan 2013
- 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
- Stable ART (no change of ART for 3 months)
- Greater than 18 years of age
- Self-report adherence < 85%
Who cannot join
- HIV-infected patients not on ART
- Non-English speaking
- Dementia (via mini mental status exam)
- Incarceration
- Legally blind and./or deaf
- User of pillboxes
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for HIV/AIDS Care and Research, Boston Medical Center
Boston, Massachusetts, 02118
About this study
The main aim of this phase II proposal is to continue and complete development of a cellular phone-based system that assists patients with their medication adherence. Adherence reports will be developed with feedback from patients and providers. Software for patients to report their four day recall adherence through text messaging or short message service (SMS) or interactive voice response (IVR) will be built. An initial qualitative study will evaluate the adherence reports, 4-day adherence recalls, and inform the development of content for reminder text messages that could be resistant to user fatigue. A redesigned system will be tested through a 3-week longitudinal study of 15 patients with human immunodeficiency virus/acquired immunodeficiency syndrome (HIV/AIDS). An intervention module will have an analytics engine to track adherence levels and personalize delivery of reminder messages. A clinic appointment module will perform patient appointment reminders. The final system with these modules will be tested through a 24-week efficacy study. A total of 115 patients and providers will be involved in the three user studies.
Read the detailed description
The specific study aims are described below:
- Organize the Design, Evaluation, and Implementation Teams: The development of ARemind will be guided by design, evaluation and implementation teams. The design team will build the software architecture and execute the software development with inputs from the user studies. The evaluation team will prepare the institutional review board (IRB) submissions, develop the qualitative instruments, and analyze the qualitative and quantitative data. The implementation team will guide clinical and commercial design aspects including input on the remote adherence assessments, the intervention and clinic appointment modules, and the commercialization plan.
- Run first user study as a qualitative assessment of patient and provider preferences of ARemind: A web-based adherence report for providers will be developed. Software modules to assess adherence over the phone through 4-day SMS or IVR recalls will be created along with a protocol for performing phone-based unannounced pill counts. The interfaces will be tested as a part of in-depth qualitative semi-structured interviews with 15 providers and 15 patients to guide the system design.
- Study the content preferences through a second user study: A new version of ARemind (version 2.0) will be built based on the feedback from the first user study. It will include the three remote adherence assessment modules. It will be tested longitudinally for 3 weeks on 15 patients with HIV/AIDS. The patients will use Medication Event Monitoring System (MEMS) software, in the form of MEMS caps, and have weekly clinic visits with adherence counselors who will generate a composite adherence score at each visit. MEMS caps are electronic devices attached to a pill bottle which detect and record the time at which the bottles are opened and closed, using this as an estimate for the number of pills taken. These will be compared to the adherence scores from the remote adherence assessment modules. The patients will give qualitative feedback at each visit on the reminder messages to guide the design of content resistant to user fatigue.
- Explore the feasibility of ARemind through a third user study: An intervention module with an analytics engine will be built. It will personalize reminder messages based on adherence levels and facilitate patient phone calls with social workers/adherence counselors when appropriate. A clinic appointment reminder module will be created and interfaced with the health information exchange of Boston Medical Center (BMC). A new version of ARemind (version 3.0) will contain these new modules and content improved based upon the second study. ARemind 3.0 will be tested through a 24-week longitudinal study of 70 patients. Thirty five patients will be randomized to use cell phones with ARemind 3.0 (intervention) while 35 patients will use beepers (control). Patients will use MEMS caps for composite adherence scores that will be done at each of their 9 adherence visits during the study. Analysis of feasibility, efficacy, user-fatigue and cost-savings from improved adherence to medications and clinic appointments will be performed in this aim.
NOTE: OF THESE THREE USER STUDIES, THE FIRST TWO ARE CONSIDERED FEASIBILITY STUDIES WHILE THE LAST IS A MORE LONGITUDINAL CLINICAL STUDY. THIS REGISTRATION IN CLINICALTRIALS.GOV DEALS WITH THE THIRD USER STUDY, WHICH IS THE LONGEST, INVOLVES THE MOST PARTICIPANTS, AND DEMONSTRATES THE HIGHEST NUMBER OF INTERVENTIONS.
- Conditions
- Medication Adherence
- Being tested
- Beeper, ARemind
- Keywords
- adherence, reminders, text messages, SMS, mHealth
- Medical subject headings
- Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BeeperDevice
Also called ALRT Med Reminder Model PC100
Beepers are handheld portable devices which can be attached to a belt. At regular intervals corresponding to the participant's preferred reminder time, they buzz for a few minutes or until the participant presses a button to stop the buzzing.
ARemindDevice
ARemind will personalize reminder messages based on adherence levels and facilitate patient phone calls with social workers/adherence counselors when appropriate. It will also consist of a text-messaging or interactive voice response (IVR) or phone-based pill count remote adherence assessment module.
| Study group | Role | What they receive |
|---|---|---|
| Beeper | Active comparator | Patients randomized to the control arm (Beeper) will receive the standard of care at each clinic visit. The subjects will bring their HIV medications every 3 weeks (MEMS measure, pill count) and questioned on their adherence to antiretroviral therapy (ART) in the past 7 days. They will not receive any text messages addressing their adherence to ART between each study visit. Their providers will not be receiving any adherence reports but will be asked to assess their adherence at at the start of the trial (Time 1 or T1) and at subsequent clinic visit scheduled according to a frequency defined by standard of care. Receives: Device: Beeper |
| Cell Phone | Experimental | Participants will receive a text message reminder via ARemind at scheduled intervals, with varying frequency. They will also be subject to a remote adherence assessment, over text messages, interactive voice response (IVR), or a remote pill count with assistance over the phone from a counselor. Those who demonstrate lower adherence rates may receive a call from a counselor. Receives: Device: ARemind |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence to Anti-retroviral Therapy
MEMS pill caps or boxes will be used to monitor adherence. Each participant will place the drug containing the protease inhibitor, or, if no such drug is being taken, the drug with the highest dosing frequency, inside of a MEMS device, which automatically records each time the pillbox was opened. Participants will bring this to the clinic during their regularly scheduled visits, and those daily measurements will be downloaded to a clinic machine.
Measured: Assessed at Baseline and 8 timepoints (every 3 weeks) over 24 weeks. T1 (Baseline), T2 (12 weeks), and T3 (24 weeks) reported here.
Self-Report
Participants were asked to recall what pills they took and what they missed. Adherence was measured by self report as well as Wise Pill and pill count.
Measured: Assessed at Baseline and 8 timepoints (every 3 weeks) over 24 weeks. T1 (Baseline), T2 (12 weeks), and T3 (24 weeks) reported here.
Pill Count
During the clinic visits ever 3 weeks over the course of the study, participants will be asked to bring all their pill bottles and count the contents of each bottle with assistance from the study coordinator. This count will be compared with the refill history for that patient from the pharmacy in order to get a sense of how many pills they have taken.
Measured: Assessed at Baseline and 8 timepoints (every 3 weeks) over 24 weeks. T1 (Baseline), T2 (12 weeks), and T3 (24 weeks) reported here.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2010 (estimated)
- Study startOct 2011
- Primary completionJan 2013
- Study completionJan 2013
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.
- 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
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dimagi Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Boston University, Boston Medical Center, Harvard Medical School (HMS and HSDM), National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Vikram Sheel Kumar, Dimagi Inc.
- Investigators
- Vikram S Kumar, M.D., Principal investigator, Dimagi Inc.Amy Baranoski, M.D., Principal investigator, Boston Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01229722
- Sponsor's protocol ID
- 2R44MH080655-02
- Other IDs
- R44MH080655
- Acronym
- ARemind
- Status last verified
- Feb 2019
- First submitted
- 26 Oct 2010
- Last updated
- 20 Mar 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ARemind: A Personalized System to Remind for Adherence
- ClinicalTrials.gov ID
- NCT01229722
- Acronym / sponsor ID
- ARemind / 2R44MH080655-02
- Conditions
- Medication Adherence
- Keywords
- adherence, reminders, text messages, SMS, mHealth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Dimagi Inc.Industry (pharma, biotech, devices)
- Collaborators
- Boston University, Boston Medical Center, Harvard Medical School (HMS and HSDM), National Institute of Mental Health (NIMH)
- Study start
- Oct 2011
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 28 Oct 2010 (estimated)
- Results
- Posted 11 Aug 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main aim of this phase II proposal is to continue and complete development of a cellular phone-based system that assists patients with their medication adherence. Adherence reports will be developed with feedback from patients and providers. Software for patients to report their four day recall adherence through text messaging or short message service (SMS) or interactive voice response (IVR) will be built. An initial qualitative study will evaluate the adherence reports, 4-day adherence recalls, and inform the development of content for reminder text messages that could be resistant to user fatigue. A redesigned system will be tested through a 3-week longitudinal study of 15 patients with human immunodeficiency virus/acquired immunodeficiency syndrome (HIV/AIDS). An intervention module will have an analytics engine to track adherence levels and personalize delivery of reminder messages. A clinic appointment module will perform patient appointment reminders. The final system with these modules will be tested through a 24-week efficacy study. A total of 115 patients and providers will be involved in the three user studies.
Detailed description
The specific study aims are described below:
- Organize the Design, Evaluation, and Implementation Teams: The development of ARemind will be guided by design, evaluation and implementation teams. The design team will build the software architecture and execute the software development with inputs from the user studies. The evaluation team will prepare the institutional review board (IRB) submissions, develop the qualitative instruments, and analyze the qualitative and quantitative data. The implementation team will guide clinical and commercial design aspects including input on the remote adherence assessments, the intervention and clinic appointment modules, and the commercialization plan.
- Run first user study as a qualitative assessment of patient and provider preferences of ARemind: A web-based adherence report for providers will be developed. Software modules to assess adherence over the phone through 4-day SMS or IVR recalls will be created along with a protocol for performing phone-based unannounced pill counts. The interfaces will be tested as a part of in-depth qualitative semi-structured interviews with 15 providers and 15 patients to guide the system design.
- Study the content preferences through a second user study: A new version of ARemind (version 2.0) will be built based on the feedback from the first user study. It will include the three remote adherence assessment modules. It will be tested longitudinally for 3 weeks on 15 patients with HIV/AIDS. The patients will use Medication Event Monitoring System (MEMS) software, in the form of MEMS caps, and have weekly clinic visits with adherence counselors who will generate a composite adherence score at each visit. MEMS caps are electronic devices attached to a pill bottle which detect and record the time at which the bottles are opened and closed, using this as an estimate for the number of pills taken. These will be compared to the adherence scores from the remote adherence assessment modules. The patients will give qualitative feedback at each visit on the reminder messages to guide the design of content resistant to user fatigue.
- Explore the feasibility of ARemind through a third user study: An intervention module with an analytics engine will be built. It will personalize reminder messages based on adherence levels and facilitate patient phone calls with social workers/adherence counselors when appropriate. A clinic appointment reminder module will be created and interfaced with the health information exchange of Boston Medical Center (BMC). A new version of ARemind (version 3.0) will contain these new modules and content improved based upon the second study. ARemind 3.0 will be tested through a 24-week longitudinal study of 70 patients. Thirty five patients will be randomized to use cell phones with ARemind 3.0 (intervention) while 35 patients will use beepers (control). Patients will use MEMS caps for composite adherence scores that will be done at each of their 9 adherence visits during the study. Analysis of feasibility, efficacy, user-fatigue and cost-savings from improved adherence to medications and clinic appointments will be performed in this aim.
NOTE: OF THESE THREE USER STUDIES, THE FIRST TWO ARE CONSIDERED FEASIBILITY STUDIES WHILE THE LAST IS A MORE LONGITUDINAL CLINICAL STUDY. THIS REGISTRATION IN CLINICALTRIALS.GOV DEALS WITH THE THIRD USER STUDY, WHICH IS THE LONGEST, INVOLVES THE MOST PARTICIPANTS, AND DEMONSTRATES THE HIGHEST NUMBER OF INTERVENTIONS.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Beeper | Active comparator | Device: BeeperPatients randomized to the control arm (Beeper) will receive the standard of care at each clinic visit. The subjects will bring their HIV medications every 3 weeks (MEMS measure, pill count) and questioned on their adherence to antiretroviral therapy (ART) in the past 7 days. They will not receive any text messages addressing their adherence to ART between each study visit. Their providers will not be receiving any adherence reports but will be asked to assess their adherence at at the start of the trial (Time 1 or T1) and at subsequent clinic visit scheduled according to a frequency defined by standard of care. |
| Cell Phone | Experimental | Device: ARemindParticipants will receive a text message reminder via ARemind at scheduled intervals, with varying frequency. They will also be subject to a remote adherence assessment, over text messages, interactive voice response (IVR), or a remote pill count with assistance over the phone from a counselor. Those who demonstrate lower adherence rates may receive a call from a counselor. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Stable ART (no change of ART for 3 months)
- Greater than 18 years of age
- Self-report adherence < 85%
Key exclusion criteria (6 listed)
- HIV-infected patients not on ART
- Non-English speaking
- Dementia (via mini mental status exam)
- Incarceration
- Legally blind and./or deaf
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 |
|---|---|---|
| BeeperAlso: ALRT Med Reminder Model PC100Beepers are handheld portable devices which can be attached to a belt. At regular intervals corresponding to the participant's preferred reminder time, they buzz for a few minutes or until the participant presses a button to stop the buzzing. | Device | Beeper |
| ARemindARemind will personalize reminder messages based on adherence levels and facilitate patient phone calls with social workers/adherence counselors when appropriate. It will also consist of a text-messaging or interactive voice response (IVR) or phone-based pill count remote adherence assessment module. | Device | Cell Phone |
Primary outcome
Adherence to Anti-retroviral Therapy
Time frame: Assessed at Baseline and 8 timepoints (every 3 weeks) over 24 weeks. T1 (Baseline), T2 (12 weeks), and T3 (24 weeks) reported here.
MEMS pill caps or boxes will be used to monitor adherence. Each participant will place the drug containing the protease inhibitor, or, if no such drug is being taken, the drug with the highest dosing frequency, inside of a MEMS device, which automatically records each time the pillbox was opened. Participants will bring this to the clinic during their regularly scheduled visits, and those daily measurements will be downloaded to a clinic machine.
Self-Report
Time frame: Assessed at Baseline and 8 timepoints (every 3 weeks) over 24 weeks. T1 (Baseline), T2 (12 weeks), and T3 (24 weeks) reported here.
Participants were asked to recall what pills they took and what they missed. Adherence was measured by self report as well as Wise Pill and pill count.
Pill Count
Time frame: Assessed at Baseline and 8 timepoints (every 3 weeks) over 24 weeks. T1 (Baseline), T2 (12 weeks), and T3 (24 weeks) reported here.
During the clinic visits ever 3 weeks over the course of the study, participants will be asked to bring all their pill bottles and count the contents of each bottle with assistance from the study coordinator. This count will be compared with the refill history for that patient from the pharmacy in order to get a sense of how many pills they have taken.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Vikram S Kumar, M.D. principal investigator
Dimagi Inc.
Amy Baranoski, M.D. principal investigator
Boston Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Beeper and ARemind in people with Medication Adherence, run by Dimagi 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 3 inclusion and 6 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 20 Mar 2019. 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 11 Aug 2014). 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?
Adherence to Anti-retroviral Therapy (time frame: Assessed at Baseline and 8 timepoints (every 3 weeks) over 24 weeks. T1 (Baseline), T2 (12 weeks), and T3 (24 weeks) reported here.). The study lists 3 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 20 Mar 2019.