Attention Deficit/Hyperactivity Disorder Internet Survey Study in a College Student Population
18. April 2017 aktualisiert von: Wake Forest University Health Sciences
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.
Studienübersicht
Status
Abgeschlossen
Bedingungen
Detaillierte Beschreibung
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.
Studientyp
Beobachtungs
Einschreibung (Tatsächlich)
10
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
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North Carolina
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Winston-Salem, North Carolina, Vereinigte Staaten, 27157
- Wake Forest University Health Sciences
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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
18 Jahre und älter (Erwachsene, Älterer Erwachsener)
Akzeptiert gesunde Freiwillige
Nein
Studienberechtigte Geschlechter
Alle
Probenahmeverfahren
Wahrscheinlichkeitsstichprobe
Studienpopulation
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.
Beschreibung
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
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
Kohorten und Interventionen
Gruppe / Kohorte |
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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.
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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);
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
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Compared measured adherence of Internet survey group to standard-of-care group
Zeitfenster: after one month; 2 months of commencing the study
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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.
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after one month; 2 months of commencing the study
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
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Measured adherence by the MEMS® cap in relation to the patient reported adherence via the Internet survey
Zeitfenster: 2 months
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The Internet survey results of all subjects randomized to receive the Internet survey will be compared to their measured adherence by the MEMS® cap.
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2 months
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Change in disease severity
Zeitfenster: baseline; month 1, month 2
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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.
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baseline; month 1, month 2
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Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Ermittler
- Hauptermittler: Guy K. Palmes, MD, Wake Forest University Health Sciences
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn
1. September 2014
Primärer Abschluss (Tatsächlich)
1. Dezember 2015
Studienabschluss (Tatsächlich)
1. Dezember 2015
Studienanmeldedaten
Zuerst eingereicht
24. September 2014
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
25. September 2014
Zuerst gepostet (Schätzen)
26. September 2014
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
20. April 2017
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
18. April 2017
Zuletzt verifiziert
1. Dezember 2015
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 00026657
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