Attention Deficit/Hyperactivity Disorder Internet Survey Study in a College Student Population
18 april 2017 bijgewerkt door: 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.
Studie Overzicht
Toestand
Voltooid
Gedetailleerde beschrijving
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.
Studietype
Observationeel
Inschrijving (Werkelijk)
10
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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North Carolina
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Winston-Salem, North Carolina, Verenigde Staten, 27157
- Wake Forest University Health Sciences
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar en ouder (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Bemonsteringsmethode
Kanssteekproef
Studie Bevolking
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.
Beschrijving
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
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
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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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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Compared measured adherence of Internet survey group to standard-of-care group
Tijdsspanne: 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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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Measured adherence by the MEMS® cap in relation to the patient reported adherence via the Internet survey
Tijdsspanne: 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
Tijdsspanne: 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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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Onderzoekers
- Hoofdonderzoeker: Guy K. Palmes, MD, Wake Forest University Health Sciences
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 september 2014
Primaire voltooiing (Werkelijk)
1 december 2015
Studie voltooiing (Werkelijk)
1 december 2015
Studieregistratiedata
Eerst ingediend
24 september 2014
Eerst ingediend dat voldeed aan de QC-criteria
25 september 2014
Eerst geplaatst (Schatting)
26 september 2014
Updates van studierecords
Laatste update geplaatst (Werkelijk)
20 april 2017
Laatste update ingediend die voldeed aan QC-criteria
18 april 2017
Laatst geverifieerd
1 december 2015
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 00026657
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