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A Text Messaging (SMS) Intervention to Improve Adherence to Stimulant Medication in Adults With ADHD in the Primary Care Setting

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ClinicalTrials.gov Identifier: NCT04189575
Recruitment Status : Active, not recruiting
First Posted : December 6, 2019
Last Update Posted : August 24, 2020
Sponsor:
Collaborator:
Shire Human Genetic Therapies, Inc.
Information provided by (Responsible Party):
Joseph Biederman, MD, Massachusetts General Hospital

Study Description
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Brief Summary:

This study will assess the efficacy of the text messaging (SMS-based) disease management intervention to improve adherence to stimulants in adults with Attention Deficit/Hyperactivity Disorder (ADHD) within the Partners primary and psychiatry care settings.

Participants in the study will receive customized text messages twice a day, every day, for a duration of 9 months. The text messages will include reminders to adhere to the individualized medication regimen, reminders to call their clinician for a prescription refill followed by reminders to pick up medication from the pharmacy, and educational reminders about ADHD and its treatment


Condition or disease Intervention/treatment Phase
Attention Deficit/Hyperactivity Disorder Other: SMS Intervention Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 117 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Masking Description: All participants will be assigned to the text message intervention and therefore no masking is necessary.
Primary Purpose: Other
Official Title: A Text Messaging (SMS) Intervention to Improve Adherence to Stimulant Medication in Adults With ADHD in the Primary Care Setting
Actual Study Start Date : May 24, 2018
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: SMS Intervention
All subjects will receive customized text messages twice a day, every day for 9 months that will include reminders to adhere to the individualized medication regimen, reminders to call their clinician for a prescription refill followed by reminders to pick up medication from the pharmacy, and educational reminders about ADHD and its treatment.
 Other: SMS Intervention
Delivery of text messages will use the Rip Road Mobile platform.


Outcome Measures
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Primary Outcome Measures :
  1. Adherence to Stimulants [ Time Frame: 9 months ]
    Adherence will be analyzed using the timeliness of stimulant medication prescription renewals over the 9 month period.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male and female adults ages 18-55 years
  • Receipt of a prescription for stimulant medication by their primary care physician or psychiatrist
  • Proficient in English
  • Has a cellular phone with text messaging capabilities and is interested in and willing to receive free of charge planned text messages

Exclusion Criteria:

  • Investigator and his/her immediate family
  • Unwilling/unable to comply with study procedures
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04189575


Locations
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United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Shire Human Genetic Therapies, Inc.
More Information
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Responsible Party: Joseph Biederman, MD, Chief of the Clinical and Research Programs in Pediatric Psychopharmacology and Adult ADHD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT04189575    
Other Study ID Numbers: 2018-P-000591
First Posted: December 6, 2019    Key Record Dates
Last Update Posted: August 24, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Joseph Biederman, MD, Massachusetts General Hospital:
Attention Deficit/Hyperactivity Disorder
ADHD
SMS Intervention
Additional relevant MeSH terms:
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Hyperkinesis
Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
 Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases