An SMS Intervention to Improve Adherence to Stimulant Med... | NCT04189536

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

NCT04189536

Sponsor

Massachusetts General Hospital

Status

Unknown status

Last Update Posted

Jan 18, 2022Actual

Enrollment

125Estimated

Phase

Not Applicable

Conditions

Attention Deficit/Hyperactivity Disorder

Interventions

SMS Intervention

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 19, 2016Actual

Primary Completion Date

Sep 2022Estimated

Completion Date

Sep 2022Estimated

First Submitted Date

Dec 4, 2019

First Submission Date that Met QC Criteria

Dec 4, 2019

First Posted Date

Dec 6, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 14, 2022

Last Update Posted Date

Jan 18, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Joseph Biederman, MD, Chief of the Clinical and Research Programs in Pediatric Psychopharmacology and Adult ADHD, Massachusetts General HospitalPrincipal Investigator

Lead Sponsor

Massachusetts General HospitalOTHER

Collaborators

Name	Class
Shire	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

125Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
SMS Intervention	Experimental	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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
SMS Intervention	Other	Delivery of text messages will use the Rip Road Mobile platform.	SMS Intervention

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Adherence to Stimulants	Adherence will be analyzed using the timeliness of stimulant medication prescription renewals over the 9 month period.	9 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Joseph Biederman, MD	Massachusetts General Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Massachusetts General Hospital		Boston	Massachusetts	02114	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001289	Attention Deficit Disorder with Hyperactivity

Ancestor Terms

ID	Term
D019958	Attention Deficit and Disruptive Behavior Disorders
D065886	Neurodevelopmental Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided