Clinical trial NCT04795323: Proof of Concept Study Assessing Technology-Assisted Respiratory Adherence Prototype Version 3 in Individuals With COPD
Official title: Proof of Concept (Proof of Intervention Principles) Study Assessing Effects of Technology-Assisted Respiratory Adherence Prototype Version 3 (a Digital Behaviour Change Intervention, DBCI) on Proximal Clinical Outcomes and Mediators (Psychological Mediators, Self-management Behaviours) in Individuals With COPD (IwCOPD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pulmonary Disease, Chronic Obstructive
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2021-03-12
Enrollment: 5
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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

Primary outcomes:
measure: Change From Baseline in the Chronic Respiratory - Self Administered Individualized (CRQ-SAI) Dyspnea Domain Score at 12 Weeks
timeFrame: Baseline (week 0) and Week 12.
measure: Number of Subjects With Increase From Baseline in the CRQ-SAI Dyspnea Domain Score at 12 Weeks of at Least 0.5
timeFrame: Baseline (week 0) and Week 12.
Secondary outcomes:
measure: Change From Baseline in Average Number of Steps Measured by the Activity Tracker at Week 12
timeFrame: Baseline (week 0) and Week 12.
measure: Change From Baseline in Average Cadence (Steps/Min) Measured by the Activity Tracker at Week 12
timeFrame: Baseline (week 0) and Week 12.
measure: Change From Baseline in the Difficulty Domain of the Clinical Visits PROactive Physical Activity in COPD Instrument (C-PPAC) at Week 12
timeFrame: Baseline (week 0) and Week 12.
Other outcomes:
Locations:
city: Gastonia
country: United States
facility: Clinical Research of Gastonia
state: North Carolina
city: Charleston
country: United States
facility: Lowcountry Lung and Critical Care
state: South Carolina
Study officials:
References: