Proof of Concept Study Assessing Technology-Assisted Respiratory Adherence Prototype Version 3 in Individuals With COPD
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Pulmonary Disease, Chronic Obstructive
Intervention: TARA v3.1, only non-pharmacological self-management support; TARA v3.2, both non-pharmacological and pharmacological self-management support
Intervention description: Technology-Assisted Respiratory Adherence (TARA) is a digital behaviour change intervention (DBCI) intended to support patients with chronic obstructive pulmonary disease (COPD) in managing their condition by adopting and sustaining clinically recommended (evidence-based) self-management behaviours. TARA was used independently at home by patients via an internet-enabled device and was a fully online digital system that offered guidance on the self-management of COPD, targeting non-pharmacological self-management support (self-monitoring, pursed lip breathing, pacing and energy conservation, and adherence to prescribed rescue medication in TARA version 3.1 (v3.1). The study comprised a screening (pre-TARA) period (which included a 2-week run-in period), a 12-week intervention period (TARA study period), and a follow-up period (post-TARA).; Technology-Assisted Respiratory Adherence (TARA) is a digital behaviour change intervention (DBCI) intended to support patients with chronic obstructive pulmonary disease (COPD) in managing their condition by adopting and sustaining clinically recommended (evidence-based) self-management behaviours. TARA was used independently at home by patients via an internet-enabled device and was a fully online digital system that offered guidance on the self-management of COPD, targeting non-pharmacological self-management support (self-monitoring, pursed lip breathing, pacing and energy conservation, and adherence to prescribed rescue medication in TARA version 3.1 (v3.1). The study comprised a screening (pre-TARA) period (which included a 2-week run-in period), a 12-week intervention period (TARA study period), and a follow-up period (post-TARA).
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 5.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No

Summary:

      The study's primary aim is to assess whether there is a clinically significant reduction in
      breathlessness in symptomatic individuals with chronic obstructive respiratory disease
      (IwCOPD) following engagement with Technology-Assisted Respiratory Adherence prototype 3.

      The study's secondary aim is to assess whether there is an associated maintenance or increase
      in activities of daily living to support a positive benefit of Technology-Assisted
      Respiratory Adherence prototype 3 on breathlessness and whether there is an improvement in
      the physical activity experience of the patient.
    

Eligibility criteria:

        Inclusion criteria:

          -  Individuals with COPD (IwCOPD)

          -  Male or females

          -  Age ≥ 40 years

          -  Current or ex-smokers

          -  Modified Medical Research Council Dyspnoea Scale (mMRC) score ≥ 2 (i.e. evidence of
             activity-related breathlessness)

          -  Patients must have a prescription for either Spiriva Respimat or

        Stiolto Respimat as per one of the below scenarios:

          1. Participants must have a new prescription for either Spiriva Respimat or Stiolto
             Respimat (this could include a patient who has never received a maintenance
             bronchodilator for treatment before, or a patient who was previously on an alternative
             maintenance bronchodilator who is being switched to Spiriva Respimat or Stiolto
             Respimat to help with their COPD management).

          2. Participants currently on Spiriva Respimat or Stiolto Respimat who could benefit from
             engagement with Technology-Assisted Respiratory Adherence prototype version 3 (after
             discussion with their physician).

               -  Participants must be on a short-acting bronchodilator ("rescue medication")

               -  Participants must be willing to use the study specific activity tracker (Reemo
                  device) and be willing to complete all data collection requirements (within
                  Technology-Assisted Respiratory Adherence prototype version 3) plus on-line
                  questionnaires plus possible phone interview)

               -  Fluency in written English

               -  Access to a Smartphone with updated 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 with confirmed, suspected or recovered SARS-CoV-2 infection or if the patient
             had household or other contact with an individual with confirmed SARS-CoV-2 infection.

          -  Patient with a worsening COPD episode requiring medical intervention within 4 weeks of
             enrolment

          -  Patients who have completed a pulmonary rehabilitation (PR) or self-management program
             in the 3 months prior to enrolment or patients who are currently in a PR program

          -  Patients prescribed inhaled COPD medications other than Spiriva Respimat plus
             albuterol or Stiolto Respimat plus albuterol

          -  Patients with any contraindications for participating in the study (after discussion
             with their physician).

          -  Currently enrolled in another investigational device or drug 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 study

          -  Any self-reported medical or neuro-cognitive condition that would limit the ability of
             the participant to consent