- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT02251080
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.
Panoramica dello studio
Stato
Descrizione dettagliata
Tipo di studio
Iscrizione (Effettivo)
Contatti e Sedi
Luoghi di studio
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North Carolina
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Winston-Salem, North Carolina, Stati Uniti, 27157
- Wake Forest University Health Sciences
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
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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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Compared measured adherence of Internet survey group to standard-of-care group
Lasso di tempo: 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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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Measured adherence by the MEMS® cap in relation to the patient reported adherence via the Internet survey
Lasso di tempo: 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
Lasso di tempo: 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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Collaboratori e investigatori
Investigatori
- Investigatore principale: Guy K. Palmes, MD, Wake Forest University Health Sciences
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Completamento primario (Effettivo)
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Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 00026657
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .