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

Sponsor
Massachusetts General Hospital (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04189536
Collaborator
Shire (Industry)
125
Enrollment
1
Location
1
Arm
71.4
Anticipated Duration (Months)
1.8
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).

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
  • Other: SMS Intervention
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
125 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
An SMS Intervention to Improve Adherence to Stimulant Medications in Adults With ADHD
Actual Study Start Date :
Sep 19, 2016
Anticipated Primary Completion Date :
Sep 1, 2022
Anticipated Study Completion Date :
Sep 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.

Outcome Measures

Primary Outcome Measures

  1. 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:
No
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

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

Investigators

  • Principal Investigator: Joseph Biederman, MD, Massachusetts General Hospital

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:
NCT04189536
Other Study ID Numbers:
  • 2016-P-001087
First Posted:
Dec 6, 2019
Last Update Posted:
Jan 18, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
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 Jan 18, 2022