ARemind: A Personalized System to Remind for Adherence

NCT01229722 | Completed Results DMC

• 2 other identifiers: 2R44MH080655-02R44MH080655
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

adherence; reminders; text messages; SMS; mHealth

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  Assessed at Baseline and 8 timepoints (every 3 weeks) over 24 weeks. T1 (Baseline), T2 (12 weeks), and T3 (24 weeks) reported here.

Study Arms (2)

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.

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.

Device: ARemind

Interventions

Beeper DEVICE

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.

Also known as: ALRT Med Reminder Model PC100

Beeper

ARemind DEVICE

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.

Cell Phone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Stable ART (no change of ART for 3 months)
• Greater than 18 years of age
• Self-report adherence \< 85%

You may not qualify if:

• HIV-infected patients not on ART
• Non-English speaking
• Dementia (via mini mental status exam)
• Incarceration
• Legally blind and./or deaf
• User of pillboxes

Sponsors & Collaborators

• Dimagi Inc.: lead
• Boston University: collaborator
• Boston Medical Center: collaborator
• Harvard Medical School (HMS and HSDM): collaborator
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Center for HIV/AIDS Care and Research, Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

MeSH Terms

Conditions

Medication Adherence

Condition Hierarchy (Ancestors)

Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Limitations and Caveats

There were technical challenges interfacing with the wireless pill management device.

Results Point of Contact

• Title: Dr. Vikram Kumar
• Organization: Dimagi Inc.

information@dimagi.com

6176492214

Study Officials

• Vikram S Kumar, M.D.

  Dimagi Inc.

  PRINCIPAL INVESTIGATOR

• Amy Baranoski, M.D.

  Boston Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Medical Officer

Study Record Dates

• First Submitted: October 26, 2010
• First Posted: October 28, 2010
• Study Start: October 1, 2011
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: March 20, 2019
• Results First Posted: August 11, 2014

Record last verified: 2019-02

Locations

US (1)