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

September 22, 2022 updated by: Joseph Biederman, MD, Massachusetts General Hospital

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

117

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adherence to Stimulants
Time Frame: 9 months
Adherence will be analyzed using the timeliness of stimulant medication prescription renewals over the 9 month period.
9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts General Hospital

Collaborators

Shire Human Genetic Therapies, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 24, 2018

Primary Completion (Anticipated)

June 1, 2023

Study Completion (Anticipated)

December 1, 2023

Study Registration Dates

First Submitted

December 4, 2019

First Submitted That Met QC Criteria

December 4, 2019

First Posted (Actual)

December 6, 2019

Study Record Updates

Last Update Posted (Actual)

September 26, 2022

Last Update Submitted That Met QC Criteria

September 22, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018-P-000591

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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