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PackHealth: Asthma Engagement Tool

18 december 2017 uppdaterad av: Duke University

Assessing the Impact of a Patient-Clinician Engagement Tool on Patient Reported Outcomes and Engagement in Asthma

The purpose of this study is to test the impact of an innovative patient engagement solution on patient's quality of life and asthma-related outcomes, and evaluate the correlation between a patient reported outcome measure and clinical outcomes.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

Patient engagement is a critical part of improving patient care and outcomes. Current patient engagement strategies only focus on the patient-physician interaction and have been shown to be ineffective.

The need for a comprehensive approach to patient engagement is no different among patients with asthma as it is in any other chronic condition. Patients with asthma must make complicated health decisions daily that impact their social and occupational activities, quality of life, and treatment adherence. Obtaining, communicating, processing, and understanding non- biased health information are crucial in making appropriate and informed treatment decisions.

Pack Health LLC and Duke will develop a patient engagement toolkit known as "Packs" to help empower and engage patients. These disease-specific, evidence-based kits are scientifically designed to improve patient involvement in their own care. Each Pack draws on the science of change management and patient activation and contains three categories of materials

Studietyp

Interventionell

Inskrivning (Faktisk)

53

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Förenta staterna
    • North Carolina
      • Durham, North Carolina, Förenta staterna, 27705
        • Duke Asthma Allergy and Airway Center

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

Inclusion Criteria:

  • Patients with a physician diagnosis of asthma for at least the previous 12 months.
  • Asthma that is not well controlled by NAEPP guidelines.
  • Ability and willingness to provide informed consent

Exclusion Criteria:

  • Significant alcohol consumption of more than three alcoholic drinks per day or active substance abuse.
  • Chronic disease (other than asthma) that in the opinion of the investigator would prevent participation in the trial or put the participant at risk by participation e.g. chronic diseases of the lung (other than asthma), heart, liver, kidney, endocrine or nervous system or immunodeficiency that are not well addressed or controlled.
  • A diagnosis of cancer with ongoing treatment.
  • Any terminal illness or conditions that results in a life expectancy less than one year.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Stödjande vård
  • Tilldelning: N/A
  • Interventionsmodell: Enskild gruppuppgift
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Övrig: Asthma Patients
Patient engagement toolkit
Beteende: Patient engagement toolkit
Pack Health LLC and Duke will develop a patient engagement toolkit known as "Packs" to help empower and engage patients. These disease-specific, evidence-based kits are scientifically designed to improve patient involvement in their own care

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Rate of Asthma Exacerbations
Tidsram: 12 weeks prior to baseline
The average number of asthma events requiring treatment with oral corticosteroids, emergency room visits or hospitalizations that occurred 12 weeks before baseline.
12 weeks prior to baseline
Rate of Asthma Exacerbations
Tidsram: baseline to week 13
The average number of asthma events requiring treatment with oral corticosteroids, emergency room visits or hospitalizations from baseline to week 13
baseline to week 13

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change in Asthma Control
Tidsram: baseline, 13 weeks
Measured by the Asthma Control Test (ACT), patient self-administered tool for identifying those with poorly controlled asthma. The ACT assesses the frequency of dyspnea and general asthma symptoms, use of rescue medications, the effect of asthma on daily functioning, and overall self-assessment of asthma control. 5 items with 4-week recall. The score range is 5-25 with >19 representing good control and <18 representing poor control.
baseline, 13 weeks
Change in Asthma Symptoms
Tidsram: baseline, 13 weeks

Measured by asthma symptom utility index (ASUI). The Asthma Symptom utility Index (ASUI) is a brief, interviewer-administered, patient preference-based scale assessing frequency and severity of asthma-related symptoms and treatment side effects. Number of items 11 items with 2 week recall.

Scores range from 0 (worst possible symptoms) to 1 (no symptoms) Minimal Clinically Important Difference (MCID) > 0.09
baseline, 13 weeks
Change in Pulmonary Function Tests
Tidsram: baseline, 13 weeks
Measured by spirometry. We measured forced expiratory volume in one second (FEV1) and forced vital capacity both in liters. FEV1 is a measure of airflow obstruction. The change in lung function is the change in these measurements compared to baseline.
baseline, 13 weeks
Number of Emergency Department and Hospitalization Visits
Tidsram: Prior Year
Number of emergency department and hospitalizations visits will be recorded that occurred within the prior year.
Prior Year
Number of Emergency Department and Hospitalization Visits
Tidsram: 13 weeks
Number of emergency department and hospitalization visits will be recorded
13 weeks

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Duke University

Utredare

  • Huvudutredare: Njira Lugogo, MD, Duke University

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 augusti 2015

Primärt slutförande (Faktisk)

1 september 2016

Avslutad studie (Faktisk)

1 september 2016

Studieregistreringsdatum

Först inskickad

2 april 2015

Först inskickad som uppfyllde QC-kriterierna

7 april 2015

Första postat (Uppskatta)

10 april 2015

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

9 oktober 2018

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

18 december 2017

Senast verifierad

1 december 2017

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • Pro00057939

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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