Clinical trial NCT02251080: Attention Deficit/Hyperactivity Disorder Internet Survey Study in a College Student Population
Official title: Attention Deficit/Hyperactivity Disorder (ADHD) Internet Survey Study in a College Student Population
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Attention Deficit Hyperactivity Disorder
Keywords: adherence
internet-based
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2014-09-26
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Approximately 44 male and female subjects ages 18 and over with ADHD and who are filling the medication at the Wake Forest University Student Health Center pharmacy will be eligible for recruitment. Subjects will be recruited from the Wake Forest University Student Health Center at their clinic visit.

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.

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

Primary outcomes:
measure: Compared measured adherence of Internet survey group to standard-of-care group
timeFrame: after one month; 2 months of commencing the study
Secondary outcomes:
measure: Measured adherence by the MEMS® cap in relation to the patient reported adherence via the Internet survey
timeFrame: 2 months
measure: Change in disease severity
timeFrame: baseline; month 1, month 2
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Guy K. Palmes, MD
role: PRINCIPAL_INVESTIGATOR
References: