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

18. april 2017 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Detaljert beskrivelse

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

Observasjonsmessig

Registrering (Faktiske)

10

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • North Carolina
      • Winston-Salem, North Carolina, Forente stater, 27157
        • Wake Forest University Health Sciences

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Sannsynlighetsprøve

Studiepopulasjon

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.

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
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);

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Compared measured adherence of Internet survey group to standard-of-care group
Tidsramme: after one month; 2 months of commencing the study
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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Measured adherence by the MEMS® cap in relation to the patient reported adherence via the Internet survey
Tidsramme: 2 months
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
Tidsramme: baseline; month 1, month 2
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Wake Forest University Health Sciences

Etterforskere

  • Hovedetterforsker: Guy K. Palmes, MD, Wake Forest University Health Sciences

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. september 2014

Primær fullføring (Faktiske)

1. desember 2015

Studiet fullført (Faktiske)

1. desember 2015

Datoer for studieregistrering

Først innsendt

24. september 2014

Først innsendt som oppfylte QC-kriteriene

25. september 2014

Først lagt ut (Anslag)

26. september 2014

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

20. april 2017

Siste oppdatering sendt inn som oppfylte QC-kriteriene

18. april 2017

Sist bekreftet

1. desember 2015

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 00026657

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