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Clinical Trials/NCT02251080
NCT02251080
Completed
N/A

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

Wake Forest University Health Sciences1 site in 1 country10 target enrollmentSeptember 2014

Overview

Phase
N/A
Intervention
Not specified
Conditions
Attention Deficit Hyperactivity Disorder
Sponsor
Wake Forest University Health Sciences
Enrollment
10
Locations
1
Primary Endpoint
Compared measured adherence of Internet survey group to standard-of-care group
Status
Completed
Last Updated
9 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 2014
End Date
December 2015
Last Updated
9 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

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

Outcomes

Primary Outcomes

Compared measured adherence of Internet survey group to standard-of-care group

Time Frame: 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 Outcomes

  • Measured adherence by the MEMS® cap in relation to the patient reported adherence via the Internet survey(2 months)
  • Change in disease severity(baseline; month 1, month 2)

Study Sites (1)

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