Attention Deficit/Hyperactivity Disorder Internet Survey Study in a College Student Population

Completed

• Conditions: Attention Deficit Hyperactivity Disorder

• Registration Number: NCT02251080
• Lead Sponsor: Wake Forest University Health Sciences

Brief Summary

Attention Deficit/Hyperactivity Disorder (ADHD) is a common condition in young adults. There are many safe oral therapies that require daily use to be effective. Because frequent follow-up visits have been shown to increase adherence to medication, we will determine if adherence to oral therapy for ADHD will improve with an intervention involving weekly internet-based contact without an office visit.

The primary aim is to determine the effectiveness of an Internet-based survey in improving adherence to therapy for ADHD. Subjects in this study will be either receive a weekly Internet-based survey assessing the prescribed medication and their ADHD, or to receive standard-of-care therapy in which they will take their medication. The following hypothesis is to be tested: A weekly Internet survey will promote improved adherence to oral ADHD medications.

Detailed Description

This is an investigator-blinded, prospective study of subjects diagnosed with ADHD.Forty-four subjects ages 18 years and older will be enrolled. An Internet-based survey will be piloted to evaluate its effect on adherence to oral ADHD medication. Subjects randomized in a 1:1 ratio to the Internet-survey group will log their impression of the state of their disease on a weekly basis. Subjects in both the intervention and control groups will receive standard-of-care medication, stimulants. Adherence to the medication will be assessed using Medication Event Monitoring System (MEMS®) caps, electronic monitors affixed to the medication containers. Investigators and subjects will be blinded to the adherence data until the final (Month 2) treatment visit.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2014-09
• Study First Submitted: 2014-09-24
• Study First Submitted QC: 2014-09-25
• Study First Posted: 2014-09-26
• Status Verified: 2015-12
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Last Update Submitted: 2017-04-18
• Last Update Posted: 2017-04-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• Any male or female 18 years or older of age with a diagnosis of mild to severe ADHD by a psychiatrist at Wake Forest University Student Health Clinic
• Use of the Wake Forest University Student Health Clinic Pharmacy to fill medication for ADHD
• Subject is a good candidate to receive a stimulant for the treatment of their ADHD
• Subject is capable of understanding and willing to provide a signed and dated written voluntary informed consent before any protocol specific procedures are performed
• The subject is able to complete the study and comply with study instructions, including attending all study visits
• Will be filling a prescription for ADHD

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Exclusion Criteria

• Subject is less than 18 years of age
• Inability to complete all study-related visits or inability to complete the Internet survey due to inadequate Internet access
• Patients who are homicidal, suicidal, or psychotic
• Female patients whose medications may be harmful during pregnancy must be on an acceptable form of birth control, otherwise they will not be eligible for participation

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Compared measured adherence of Internet survey group to standard-of-care group	after one month; 2 months of commencing the study	All subjects will be prescribed the standard-of-care treatment for ADHD, a stimulant. Adherence to standard-of-care medication for ADHD will be objectively measured using a bottle fitted with a Medication Monitoring System (MEMS®) cap and the percentage doses taken will be report as outcome.

Secondary Outcome Measures

Name	Time	Method
Measured adherence by the MEMS® cap in relation to the patient reported adherence via the Internet survey	2 months	The Internet survey results of all subjects randomized to receive the Internet survey will be compared to their measured adherence by the MEMS® cap.
Change in disease severity	baseline; month 1, month 2	Using validated measures the assessments will be done at baseline, month1, and month 2(end of study). Disease severity will be measured by DSM-V classification and by the ADHD Rating Scale IV with adult prompts, and Clinical Global Impressions, severity and improvement scales.

Trial Locations

Locations (1)

Wake Forest University Health Sciences; 🇺🇸 Winston-Salem, North Carolina, United States