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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04189536
Other study ID # 2016-P-001087
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date September 19, 2016
Est. completion date September 2022

Study information

Verified date January 2022
Source Massachusetts General Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 125
Est. completion date September 2022
Est. primary completion date September 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 55 Years
Eligibility 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 Design


Related Conditions & MeSH terms

  • Attention Deficit Disorder with Hyperactivity
  • Attention Deficit/Hyperactivity Disorder
  • Hyperkinesis

Intervention

Other:
SMS Intervention
Delivery of text messages will use the Rip Road Mobile platform.

Locations

Country Name City State
United States Massachusetts General Hospital Boston Massachusetts

Sponsors (2)

Lead Sponsor Collaborator
Massachusetts General Hospital Shire

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Adherence to Stimulants Adherence will be analyzed using the timeliness of stimulant medication prescription renewals over the 9 month period. 9 months
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