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

Sponsor

Massachusetts General Hospital (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT04189575

Collaborator

Shire Human Genetic Therapies, Inc. (Industry)

117

Enrollment

Location

Arm

54.3

Anticipated Duration (Months)

2.2

Patients Per Site Per Month

Study Details

Study Description

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	N/A

Study Design

Study Type:

Interventional

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

Anticipated Primary Completion Date :

Jun 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

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.

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

Primary Outcome Measures

Adherence to Stimulants [9 months]
Adherence will be analyzed using the timeliness of stimulant medication prescription renewals over the 9 month period.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Massachusetts General Hospital	Boston	Massachusetts	United States	02114

Sponsors and Collaborators

Massachusetts General Hospital
Shire Human Genetic Therapies, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

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:

Dec 6, 2019

Last Update Posted:

Aug 31, 2021

Last Verified:

Aug 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Joseph Biederman, MD, Chief of the Clinical and Research Programs in Pediatric Psychopharmacology and Adult ADHD, Massachusetts General Hospital

Attention Deficit/Hyperactivity Disorder

ADHD

SMS Intervention

Additional relevant MeSH terms:

Hyperkinesis

Attention Deficit Disorder with Hyperactivity

Study Results

No Results Posted as of Aug 31, 2021