ARemind: A Personalized System to Remind for Adherence

NCT01229722 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2019-03-20

Study results available
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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. 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.

Conditions

  • Medication Adherence

Interventions

DEVICE

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.

DEVICE

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.

Sponsors & Collaborators

  • Boston University

    collaborator OTHER
  • Boston Medical Center

    collaborator OTHER
  • Harvard Medical School (HMS and HSDM)

    collaborator OTHER
  • National Institute of Mental Health (NIMH)

    collaborator NIH
  • Dimagi Inc.

    lead INDUSTRY

Principal Investigators

  • Vikram S Kumar, M.D. · Dimagi Inc.

  • Amy Baranoski, M.D. · Boston Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-10-31
Primary Completion
2013-01-31
Completion
2013-01-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01229722 on ClinicalTrials.gov