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TARA Working Prototype Engagement Evaluation: Feasibility Study

10. september 2020 oppdatert av: Boehringer Ingelheim

Mixed Methods (Quantitative, Qualitative) Feasability Study Assessing Engagement With the First Version of the TARA Working Prototype (a Digital Behaviour Change Intervention, DBCI) in Individuals With COPD

TARA is a Digital Behaviour Change Intervention (DBCI) for individuals with Chronic Obstructive Pulmonary Disease (COPD)(IwCOPD), which has been designed using a Human-Centred Design (HCD) methodology. HCD involves, among other elements, members of the target audience in evaluations at multiple stages within the design process.

This feasibility study is primarily designed to assess the acceptability of the DBCI test asset to the target audience. Acceptability as defined for the purpose of this study includes usability of the system, and perceived value and desirability to the end-user audience. As such, engagement in this context is deemed to mean the degree to which the test asset provides a usable, acceptable, desirable and valuable experience to its users during a time-limited trial.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

16

Fase

  • Ikke aktuelt

Kontakter og plasseringer

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

Studiesteder

  • Forente stater
    • Massachusetts
      • Somerville, Massachusetts, Forente stater, 02144
        • Medullan

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

40 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • Signed and dated written electronic informed consent (e-consent) in accordance with International Council on Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the study
  • Male or female patients
  • All patients must have a self-reported confirmation of a physician diagnosis of Chronic Obstructive Pulmonary Disease (COPD)(or chronic bronchitis or emphysema)
  • Age ≥ 40 years
  • Patients must be current or ex-smokers with a smoking history of at least 10 pack-years (pack years = [cigarettes per day/20] x years of smoking)
  • Modified Medical Research Council (mMRC) Score ≥ 1 (i.e. evidence of activity-related breathlessness)
  • Patients must have a current prescription for once daily maintenance bronchodilator in keeping with their approved labels as well as a short-acting bronchodilator ("rescue medication") for at least 3 months prior to study enrolment
  • Participants must be willing to use a smart watch and be willing to complete all data collection requirements (within TARA plus phone interview plus on-line questionnaires)
  • Patients must confirm that his/her treating physician has been informed about the patient's participation in the study (prior to TARA log-in)
  • Fluency in written English
  • Currently residing in US (for duration of study)
  • Not fully adherent (self-report) to once daily inhaled COPD medication (<80% on a protocol-specific participant self-assessment scale of medication adherence (0 - 100%))
  • Access to (and comfort with) a digital device (Desktop; Laptop; Tablet), with updated Firefox [version 67.0 and above] or Chrome [version 75.0.3770.80 and above] browsers installed (or willing to download up-to-date version for the study), and daily home access to internet
  • Need to have personal e-mail account that is used daily

Exclusion Criteria:

  • Patients with asthma
  • Patients who are currently prescribed oxygen therapy
  • Patients who have completed a pulmonary rehabilitation (PR) program in the 6 weeks prior to enrolment or patients who are currently in a PR program (rationale: PR programs typically include a self-management component which may interfere with study objectives)
  • Planned vacation period during the study period that requires overnight stays away from home
  • Major surgery performed within 6 weeks prior to enrolment or planned within 2 months after enrolment, e.g. hip replacement
  • Previous enrolment in this study
  • Currently enrolled in another investigational device or drug study/trial, or less than 30 days since ending another investigational device or drug trial(s), or receiving other investigational treatment(s)
  • Women who are pregnant, nursing, or who plan to become pregnant while in the trial
  • Current use of a Smartwatch and/or wrist-worn step counter and not willing to switch to the study-specific Smartwatch for the duration of study
  • Any medical or neuro-cognitive condition that would limit the ability of the participant to consent
  • Further exclusion criteria apply

Studieplan

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

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Enhetens gjennomførbarhet
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Alle fag
Enhet: Digital Behaviour Change Intervention
14 days

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
% of study participants achieving 80% or higher engagement score with their personal TARA program
Tidsramme: Up to 14 days
Up to 14 days
Study participant's motivation to engage with the TARA working prototype (version 1) and their perceptions of value and usefulness
Tidsramme: Up to 14 days
Qualitative assessment of motivation and perceptions of value and usefulness at different stages in the participant's journey through the prototype; data sourced via discussion in an exit interview at the end of the study.
Up to 14 days
Evidence of usability issues, patterns of dis-engagement or failures of use in particular pages or functional areas of the prototype
Tidsramme: Up to 14 days
Analysis of usage data of the site to explore if there are common points at which participants fail to progress, make mistakes or abandon interactions; Data will be sourced from individual and amalgamated usage analytics - data points will include drop-out rates for each of the main functional areas of the site and will be supplemented by within-page usage data An overall score for perceived ease-of-use will be generated using the 'System Usability Scale' (SUS), using self-reported data from the pre- and post-TARA participant questionnaire
Up to 14 days
Study participant's reports of usability or other issues from using the prototype
Tidsramme: Up to 14 days
Up to 14 days

Sekundære resultatmål

Resultatmål
Tidsramme
% of study participants who achieve a score of 8 or greater in Knowledge, Motivation, Confidence (KMC) assessments
Tidsramme: Up to 14 days
Up to 14 days
% of study participants who achieve a positive change in measures of motivation, activation, competence (self-efficacy) and stage of change
Tidsramme: Up to 14 days
Up to 14 days
% of study participants who report increases in adherence to once daily inhaled medication and reduction in Chronic Obstructive Pulmonary Disease (COPD) symptoms
Tidsramme: Up to 14 days
Up to 14 days

Samarbeidspartnere og etterforskere

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

Sponsor

Boehringer Ingelheim

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 (Faktiske)

26. september 2019

Primær fullføring (Faktiske)

3. desember 2019

Studiet fullført (Faktiske)

3. desember 2019

Datoer for studieregistrering

Først innsendt

3. september 2019

Først innsendt som oppfylte QC-kriteriene

9. september 2019

Først lagt ut (Faktiske)

11. september 2019

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

11. september 2020

Siste oppdatering sendt inn som oppfylte QC-kriteriene

10. september 2020

Sist bekreftet

1. september 2020

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 0352-2133

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

IPD-planbeskrivelse

Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents, except for the following exclusions:

1. studies in products where Boehringer Ingelheim is not the license holder; 2. studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; 3. studies conducted in a single center or targeting rare diseases (because of limitations with anonymization). For more details refer to: http://trials.boehringer-ingelheim.com/

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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