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

NCT04189536 | Unknown

• 1 other identifier: 2016-P-001087
• Study Type: interventional
• Target: 125
• Locations: 1 country
• Sites: 1

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). 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.

Conditions

Attention Deficit/Hyperactivity Disorder

Keywords

Attention Deficit/Hyperactivity Disorder; ADHD; SMS Intervention

Outcome Measures

Primary Outcomes (1)

• Adherence to Stimulants

  Adherence will be analyzed using the timeliness of stimulant medication prescription renewals over the 9 month period.

  9 months

Study Arms (1)

SMS Intervention

EXPERIMENTAL

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

Interventions

SMS Intervention OTHER

Delivery of text messages will use the Rip Road Mobile platform.

SMS Intervention

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Shire: collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Joseph Biederman, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of the Clinical and Research Programs in Pediatric Psychopharmacology and Adult ADHD

Study Record Dates

• First Submitted: December 4, 2019
• First Posted: December 6, 2019
• Study Start: September 19, 2016
• Primary Completion: September 1, 2022
• Study Completion: September 1, 2022
• Last Updated: January 18, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)