Back to resultsAn SMS Intervention to Improve Adherence to Stimulant Medications in Adults With ADHD
Primary Purpose
Attention Deficit/Hyperactivity Disorder
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
SMS Intervention
Sponsored by
About this trial
This is an interventional other trial for Attention Deficit/Hyperactivity Disorder focused on measuring Attention Deficit/Hyperactivity Disorder, ADHD, SMS Intervention
Eligibility Criteria
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
Sites / Locations
- Massachusetts General Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
SMS Intervention
Arm Description
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.
Outcomes
Primary Outcome Measures
Adherence to Stimulants
Adherence will be analyzed using the timeliness of stimulant medication prescription renewals over the 9 month period.
Secondary Outcome Measures
Full Information
NCT ID
NCT04189536
First Posted
December 4, 2019
Last Updated
January 14, 2022
Sponsor
Massachusetts General Hospital
Collaborators
Shire
1. Study Identification
Unique Protocol Identification Number
NCT04189536
Brief Title
An SMS Intervention to Improve Adherence to Stimulant Medications in Adults With ADHD
Official Title
An SMS Intervention to Improve Adherence to Stimulant Medications in Adults With ADHD
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 19, 2016 (Actual)
Primary Completion Date
September 2022 (Anticipated)
Study Completion Date
September 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
Shire
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit/Hyperactivity Disorder
Keywords
Attention Deficit/Hyperactivity Disorder, ADHD, SMS Intervention
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
125 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
SMS Intervention
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
SMS Intervention
Intervention Description
Delivery of text messages will use the Rip Road Mobile platform.
Primary Outcome Measure Information:
Title
Adherence to Stimulants
Description
Adherence will be analyzed using the timeliness of stimulant medication prescription renewals over the 9 month period.
Time Frame
9 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph Biederman, MD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
An SMS Intervention to Improve Adherence to Stimulant Medications in Adults With ADHD
We'll reach out to this number within 24 hrs