An SMS Intervention to Improve Adherence to Stimulant Medications in Adults With ADHD

January 14, 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).

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 (Anticipated)

125

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 18 to 55 years
  • A diagnosis of Diagnostic and Statistical Manual Diploma in Social Medicine (DSM-V) Attention Deficit Hyperactivity Disorder based on clinical assessment
  • Is starting stimulant medication or has begun treatment with stimulant medication within six months of study enrollment
  • Proficient in English
  • Has a cellular phone with text messaging capabilities and is interested in and willing to receive text messages

Exclusion Criteria:

  • Serious chronic medical or psychiatric condition that, in the investigator's opinion, puts the subject at risk for taking a stimulant
  • Pregnant or nursing females
  • 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

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)

September 19, 2016

Primary Completion (Anticipated)

September 1, 2022

Study Completion (Anticipated)

September 1, 2022

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)

January 18, 2022

Last Update Submitted That Met QC Criteria

January 14, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016-P-001087

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.

Clinical Trials on Attention Deficit/Hyperactivity Disorder

Clinical Trials on SMS Intervention

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Myanmar

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe