NCT04795323

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

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)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pulmonary Disease, Chronic Obstructive

Interventions

Type	Name	Description
DEVICE	TARA v3.1, only non-pharmacological self-management support	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).
DEVICE	TARA v3.2, both non-pharmacological and pharmacological self-management support	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).

Timeline

• Start date: 2021-04-08
• Primary completion: 2022-03-08
• Completion: 2022-03-12
• First posted: 2021-03-12
• Last updated: 2023-12-21
• Results posted: 2023-12-21

Locations

2 sites across 1 country: United States