ARemind: A Personalized System to Remind for Adherence

This study has been completed.
Sponsor:
Collaborators:
Boston University
Boston Medical Center
Harvard Medical School
Information provided by (Responsible Party):
Vikram Sheel Kumar, Dimagi Inc.
ClinicalTrials.gov Identifier:
NCT01229722
First received: October 26, 2010
Last updated: July 22, 2014
Last verified: July 2014
Results First Received: February 10, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Supportive Care
Condition: Medication Adherence
Interventions: Device: Beeper
Device: ARemind

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Beeper Patients randomized to the control arm (Beeper) will receive the standard of care at each clinic visit. Although the frequency of the study visit is higher than what is observed in standard of care, the subjects will simply asked to 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. The decision to restrict the provision of adherence reports to providers and adherence reinforcement messages to intervention group subjects is appropriate, as it is not yet known whether or not the interventions are more effective than the standard of care.
Cell Phone

Participants will receive a text message reminder 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.


Participant Flow:   Overall Study
    Beeper     Cell Phone  
STARTED     34     36  
COMPLETED     30     36  
NOT COMPLETED     4     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Beeper Patients randomized to the control arm (Beeper) will receive the standard of care at each clinic visit. Although the frequency of the study visit is higher than what is observed in standard of care, the subjects will simply asked to 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. The decision to restrict the provision of adherence reports to providers and adherence reinforcement messages to intervention group subjects is appropriate, as it is not yet known whether or not the interventions are more effective than the standard of care.
Cell Phone

Participants will receive a text message reminder 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.

Total Total of all reporting groups

Baseline Measures
    Beeper     Cell Phone     Total  
Number of Participants  
[units: participants]
  30     36     66  
Age  
[units: years]
Mean ± Standard Deviation
  46.73  ± 9.04     48.11  ± 10.49     47.48  ± 9.81  
Gender  
[units: participants]
     
Female     13     9     22  
Male     17     27     44  



  Outcome Measures

1.  Primary:   Adherence to Anti-retroviral Therapy   [ Time Frame: daily, for the 6 month duration of the third user study, from October 2011 through March 2012 ]

2.  Primary:   Self-Report   [ Time Frame: every 3 weeks, for the 6 month duration of the third user study, from October 2011 through March 2012 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

3.  Primary:   Pill Count   [ Time Frame: every 3 weeks, for the 6 month duration of the third user study, from October 2011 through March 2012 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Vikram Kumar
Organization: Dimagi Inc.
phone: 6176492214
e-mail: information@dimagi.com


No publications provided


Responsible Party: Vikram Sheel Kumar, Dimagi Inc.
ClinicalTrials.gov Identifier: NCT01229722     History of Changes
Other Study ID Numbers: 2R44MH080655-02, R44MH080655
Study First Received: October 26, 2010
Results First Received: February 10, 2014
Last Updated: July 22, 2014
Health Authority: United States: Institutional Review Board