Attention Deficit Hyperactivity Disorder Clinical Trial
Official title:
Attention Deficit/Hyperactivity Disorder (ADHD) Internet Survey Study in a College Student Population
Verified date | December 2015 |
Source | Wake Forest University Health Sciences |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 10 |
Est. completion date | December 2015 |
Est. primary completion date | December 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Wake Forest University Health Sciences | Winston-Salem | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Wake Forest University Health Sciences |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Compared measured adherence of Internet survey group to standard-of-care group | 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. | after one month; 2 months of commencing the study | |
Secondary | Measured adherence by the MEMS® cap in relation to the patient reported adherence via the Internet survey | The Internet survey results of all subjects randomized to receive the Internet survey will be compared to their measured adherence by the MEMS® cap. | 2 months | |
Secondary | Change in disease severity | 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. | baseline; month 1, month 2 |
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