Proof of Concept Study Assessing Technology-Assisted Respiratory Adherence Prototype Version 3 in Individuals With COPD
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Interventions
- Device: TARA v3.2, both non-pharmacological and pharmacological self-management supportDevice: TARA v3.1, only non-pharmacological self-management support
- Registration Number
- NCT04795323
- Lead Sponsor
- Boehringer Ingelheim
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 5
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cohort 2: TARA v3.2, both non-pharmacological and pharmacological self-management support TARA v3.2, both non-pharmacological and pharmacological self-management support 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). Cohort 1: TARA v3.1, only non-pharmacological self-management support 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).
- Primary Outcome Measures
Name Time Method Number of Subjects With Increase From Baseline in the CRQ-SAI Dyspnea Domain Score at 12 Weeks of at Least 0.5 Baseline (week 0) and Week 12. Number of subjects with increase from baseline in the CRQ-SAI dyspnea domain score at 12 weeks of at least 0.5, the minimal clinically important difference (MCID). The CRQ-SAI questionnaire first asks participants to mark important, frequent activities that made them feel out of breath during the last 2 weeks. Participants are then asked to select the most important activities from the list, up to a maximum of 5 activities. Next, for each of these activities, which correspond to questions 1-5, the participants will mark their level of shortness of breath; there are 7 possible answers, ranging from 1 (being the worst: "extremely short of breath') to 7 (being the best: "not at all short of breath"). For each participant, the CRQ-SAI dyspnea domain score was calculated as the mean of numerical answers to the questions 1, 2, 3, 4, 5, excluding those questions not answered. Change was calculated as \[score at 12 weeks\] - \[score at baseline\].
Change From Baseline in the Chronic Respiratory - Self Administered Individualized (CRQ-SAI) Dyspnea Domain Score at 12 Weeks Baseline (week 0) and Week 12. The CRQ-SAI questionnaire first asks participants to mark important, frequent activities that made them feel out of breath during the last 2 weeks; they can select these activities from a list, and they can also add additional activities to the list. Participants are then asked to select the most important activities from the list, up to a maximum of 5 activities. Next, for each of these activities, which correspond to questions 1-5, the participants will mark their level of shortness of breath; there are 7 possible answers, ranging from 1 (being the worst: "extremely short of breath') to 7 (being the best: "not at all short of breath"). For each participant, the CRQ-SAI dyspnea domain score was calculated as the mean of numerical answers to the questions 1, 2, 3, 4, 5, excluding those questions not answered. Change was calculated as \[score at 12 weeks\] - \[score at baseline\].
- Secondary Outcome Measures
Name Time Method Change From Baseline in the Difficulty Domain of the Clinical Visits PROactive Physical Activity in COPD Instrument (C-PPAC) at Week 12 Baseline (week 0) and Week 12. C-PPAC (with focus on the difficulty domain score). The C-PPAC questionnaire has 12 questions about activities done in the last 7 days, and also records two scores (weekly steps and vector magnitude units) from an activity monitor. Three scores are generated from the C-PPAC (difficulty with physical activity, amount of physical activity and total physical activity). Only the difficulty domain score of the C-PPAC will be analyzed in this study.
For each participant, the raw score for the C-PPAC difficulty domain is calculated as the sum of the numerical answers to the 10 questions 3-12. Each numerical answer ranges from 0 (most difficult) to 4 (no difficulty). The range of the raw score is 0-40 (with 0 being the most difficult and 40 being no difficulty). This raw score is then scaled to a 0-100 Rasch scaled score (with 0 being the most difficult and 100 being no difficulty). Change was calculated as baseline value - week 12 score value.Change From Baseline in Average Number of Steps Measured by the Activity Tracker at Week 12 Baseline (week 0) and Week 12. Daily activity levels were measured using an activity tracker (Reemo) over 2-week periods. The average steps/day were counted over a period of up to 14 days at baseline and at Week 12. A "valid day" was defined as a day where the activity tracker records at least 8 active hours during waking hours (7 am to 10 pm local time for the participant). To calculate the average number of steps/day at baseline (also for Week 12), the data from the prior 14 days were examined. At least 4 valid days out of the 14 days were needed for analysis, but they did not have to be consecutive days. If there were fewer than 4 valid days, the average number of steps/day was not calculated. The average steps/day was calculated as the average over the valid days. Change was calculated as baseline value - week 12 score value.
Change From Baseline in Average Cadence (Steps/Min) Measured by the Activity Tracker at Week 12 Baseline (week 0) and Week 12. Daily activity levels were measured using an activity tracker (Reemo) over 2-week periods. Cadence (steps/min) was calculated as number of steps walked per day divided by the walk time per day (in minutes), then averaged over valid days to produce the average cadence. A "valid day" was defined as a day where the activity tracker records at least 8 active hours during waking hours (7 am to 10 pm local time for the participant). To calculate the average cadence (steps/min) at baseline (also for Week 12), the data from the prior 14 days were examined. At least 4 valid days out of the 14 days were needed for analysis, but they did not have to be consecutive days. If there were fewer than 4 valid days, the average cadence (steps/min) was not calculated. The average cadence (steps/min) was calculated as the average over the valid days. Change was calculated as baseline value - week 12 score value.
Trial Locations
- Locations (2)
Clinical Research of Gastonia
🇺🇸Gastonia, North Carolina, United States
Lowcountry Lung and Critical Care
🇺🇸Charleston, South Carolina, United States