Proof of Concept Study Assessing Technology-Assisted Respiratory Adherence Prototype Version 3 in Individuals With COPD

Boehringer Ingelheim

Status and phase: Completed; Phase 2

Conditions: Pulmonary Disease, Chronic Obstructive

Treatments: Device: TARA v3.1, only non-pharmacological self-management support; Device: TARA v3.2, both non-pharmacological and pharmacological self-management support

Study type: Interventional

Funder types: Industry

Identifiers

NCT04795323

0352-2154

Details and patient eligibility

About

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.

Enrollment: 5 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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5 participants in 2 patient groups

Cohort 1: TARA v3.1, only non-pharmacological self-management support

Experimental group

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).

Treatment:

Device: TARA v3.1, only non-pharmacological self-management support

Cohort 2: TARA v3.2, both non-pharmacological and pharmacological self-management support

Experimental group

Description:

TARA is a digital behaviour change intervention (DBCI) intended to support patients with COPD in managing their condition by adopting and sustaining clinically recommended (evidence-based) self-management behaviours. TARA is used independently at home by patients via an internet-enabled device and is a fully online digital system that offers 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). Additionally, in TARA v3.2, pharmacological self-management support module (including modules on inhaler techniques and correct use of inhalers, plus a module to close track inhaler use and symptoms over a 7-day period) was included. The study comprised a screening (pre-TARA) period (included a 2-week run-in period), a 12-week intervention period (TARA study period), and a follow-up period (post-TARA).

Treatment:

Device: TARA v3.2, both non-pharmacological and pharmacological self-management support