Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
70 participants
INTERVENTIONAL
2011-10-31
2013-01-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
MobileMedMinder: A Networked Aide for Medication Compliances
NCT01597583
Comparing the Effectiveness of Different Appointment Reminder Methods
NCT06767423
Effect of Reminders on Adherence
NCT02411006
A Mobile Phone Based Medication Reminder Program
NCT02793830
Text Message Appointment Reminders
NCT01676337
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
1. 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.
2. 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.
3. 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.
4. 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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Beeper
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.
Beeper
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.
Cell Phone
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.
ARemind
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Beeper
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.
ARemind
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.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Greater than 18 years of age
* Self-report adherence \< 85%
Exclusion Criteria
* Non-English speaking
* Dementia (via mini mental status exam)
* Incarceration
* Legally blind and./or deaf
* User of pillboxes
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Boston University
OTHER
Boston Medical Center
OTHER
Harvard Medical School (HMS and HSDM)
OTHER
National Institute of Mental Health (NIMH)
NIH
Dimagi Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Vikram Sheel Kumar
Chief Medical Officer
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Vikram S Kumar, M.D.
Role: PRINCIPAL_INVESTIGATOR
Dimagi Inc.
Amy Baranoski, M.D.
Role: PRINCIPAL_INVESTIGATOR
Boston Medical Center
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Center for HIV/AIDS Care and Research, Boston Medical Center
Boston, Massachusetts, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.