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

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

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.

Study Overview

• Status: Completed
• Conditions: Attention Deficit Hyperactivity Disorder

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.

• Study Type: Observational
• Enrollment (Actual): 10

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest University Health Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Internet-based Survey; Assessments completed over the 2-month study will include: disease severity as measured by DSM-V classification and by several validated measures including the ADHD Rating Scale IV with adult prompts, and Clinical Global Impressions, severity and improvement scales; adherence measures (MEMS® and pill counts); validated medication satisfaction measure (the Treatment Satisfaction Questionnaire for Medication); and quality of life measured using the validated WHO Quality of Life Brief measure (WHOQOL-BREF); and responses to a weekly Internet-based questionnaire of adherence and disease severity.
Standard-of-Care; Assessments completed over the 2-month study will include: disease severity as measured by DSM-V classification and by several validated measures including the ADHD Rating Scale IV with adult prompts, and Clinical Global Impressions, severity and improvement scales; adherence measures (MEMS® and pill counts); validated medication satisfaction measure (the Treatment Satisfaction Questionnaire for Medication); and quality of life measured using the validated WHO Quality of Life Brief measure (WHOQOL-BREF);

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Investigators: Principal Investigator: Guy K. Palmes, MD, Wake Forest University Health Sciences

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: September 24, 2014
• First Submitted That Met QC Criteria: September 25, 2014
• First Posted (Estimate): September 26, 2014

Study Record Updates

• Last Update Posted (Actual): April 20, 2017
• Last Update Submitted That Met QC Criteria: April 18, 2017
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Keywords: adherence; internet-based
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Dyskinesias; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Attention Deficit Disorder with Hyperactivity; Hyperkinesis
• Other Study ID Numbers: 00026657