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

NCT ID: NCT04189536

Last Updated: 2022-01-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

125 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-19

Study Completion Date

2022-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Attention Deficit/Hyperactivity Disorder

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

SMS Intervention

Intervention Type OTHER

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

Interventions

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SMS Intervention

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shire

INDUSTRY

Sponsor Role collaborator

Massachusetts General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Joseph Biederman, MD

Chief of the Clinical and Research Programs in Pediatric Psychopharmacology and Adult ADHD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Joseph Biederman, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

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Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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2016-P-001087

Identifier Type: -

Identifier Source: org_study_id

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