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The Effects of a Self-management Intervention on Low Literacy Patients With Chronic Obstructive Pulmonary Disease (COPD)

31. mars 2011 oppdatert av: University of North Carolina, Chapel Hill

A Randomized Controlled Trial of a Literacy-sensitive Self-management Intervention for Chronic Obstructive Pulmonary Disease Patients

Purpose: To determine the role health literacy plays in the care continuum for Chronic Obstructive Pulmonary Disease (COPD) and the effect of a self-management intervention on inhaler technique use, time spent on self-management, and knowledge for COPD patients with low literacy.

Participants: The investigators will recruit patients from the University of North Carolina at Chapel Hill Ambulatory Care Center (ACC) who have a diagnosis of COPD.

Procedures (methods): Potential subjects with COPD will be identified through pharmacy claims data, clinic billing data and the electronic medical record. Eligibility will be prescreened by a research assistant (RA) using the electronic medical record prior to approaching potential subjects for consent. For the first part of the study, consenting subjects will complete a baseline health literacy assessment, a questionnaire, an inhaler technique assessment, and a diary of time spent in self-management activities. Pulmonary function tests (PFT) will be performed on all participants for whom PFTs have not been conducted within the previous 12 months. The questionnaire will include measures of COPD-related knowledge, self-management techniques, quality of care, access, quality of life, costs, healthcare utilization, exacerbations, and basic demographic information. The inhaler technique assessment will be administered by the research assistant using a pre-established protocol. The research assistant will abstract additional data from the medical record to assess the quality of care based on adherence to recommended COPD care guidelines. For the second part of the study, participants will be randomized to control and intervention arms. The self-management intervention will be an interactive experience, delivered by a trained research assistant, targeting self-management skills (inhaler use, using an action plan, etc), smoking cessation, and exercise/pulmonary rehabilitation. Those randomized to the control group will receive usual care. All participants will return 2-4 weeks after the intervention for a follow-up assessment of inhaler technique, COPD-related knowledge, and time spent in self-management.

Studieoversikt

Status

Fullført

Studietype

Intervensjonell

Registrering (Faktiske)

99

Fase

  • Ikke aktuelt

Kontakter og plasseringer

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

Studiesteder

    • North Carolina
      • Chapel Hill, North Carolina, Forente stater, 27599
        • University of North Carolina Hospitals Ambulatory Care Center

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

Beskrivelse

Inclusion Criteria:

  • are age 18 years or older and,
  • have been diagnosed with COPD
  • are active patients in the General Internal Medicine or Pulmonary Clinics at the Ambulatory Care Center
  • are being treated with inhaled medication for their COPD

Exclusion Criteria:

  • non-English speaking (intervention will be available in English only)
  • participants unable to complete the study (either with or without assistance)
  • patients who are currently experiencing an exacerbation

Studieplan

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

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Self-Management Intervention
participants who receive the one-on-one self-management intervention
patients will participate in a 1-on-1 interactive intervention, delivered by a trained research assistant targeting self-management skills (e.g. inhaler use, use of an action plan), smoking cessation, and exercise/pulmonary rehabilitation. All participants will return 2-4 weeks after the intervention for a follow-up assessment of inhaler technique use, COPD-related knowledge, and time spent in self-management.
Ingen inngripen: Usual Care
group receives no additional education or intervention then they would as usual care of their COPD

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
change in Inhaler use technique scores from baseline to follow-up
Tidsramme: baseline and at 2-4 weeks later
The inhaler technique assessment will be conducted by using a pre-established protocol developed to cover the major types of inhalers used by the COPD population. General principles included in the assessment include correct preparation, administration, and if appropriate re-administration of a dose. The assessment will be scored as number of steps completed correctly out of total number of steps assessed.
baseline and at 2-4 weeks later

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
time spent in self-management activities
Tidsramme: 2-4 weeks
participants will complete a time diary of all COPD related activities
2-4 weeks
change in COPD-related knowledge from baseline to follow-up
Tidsramme: baseline and 2-4 week follow-up
The baseline questionnaire will include measures of COPD-related knowledge, self-management techniques, quality of care, access to care, quality of life, costs, healthcare utilization, exacerbations, and basic demographic information.
baseline and 2-4 week follow-up
change in smoking status from baseline to follow-up
Tidsramme: baseline and 2-4 week follow-up
assessment of smoking status
baseline and 2-4 week follow-up

Samarbeidspartnere og etterforskere

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

Etterforskere

  • Hovedetterforsker: Daniel Jonas, MD, University of North Carolina
  • Hovedetterforsker: Katie Kiser, Pharm.D., University of North Carolina
  • Hovedetterforsker: Darren Dewalt, MD, University of North Carolina

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. januar 2008

Primær fullføring (Faktiske)

1. desember 2008

Studiet fullført (Faktiske)

1. desember 2008

Datoer for studieregistrering

Først innsendt

29. mars 2011

Først innsendt som oppfylte QC-kriteriene

31. mars 2011

Først lagt ut (Anslag)

1. april 2011

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

1. april 2011

Siste oppdatering sendt inn som oppfylte QC-kriteriene

31. mars 2011

Sist bekreftet

1. mars 2011

Mer informasjon

Begreper knyttet til denne studien

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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