TARA Working Prototype [Version 2]: Feasibility Study
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04320524|
Recruitment Status : Withdrawn (Due to Covid, the study could not be initiated as planned.)
First Posted : March 25, 2020
Last Update Posted : November 23, 2020
TARA is a Digital Behaviour Change Intervention (DBCI) for Individuals with COPD (IwCOPD), which has been designed using a Human-Centred Design (HCD) methodology. HCD involves, among other elements, members of the target audience in evaluations at multiple stages within the design process.
This feasibility study is primarily designed to assess the acceptability of the DBCI test asset to the target audience. Acceptability as defined for the purpose of this study includes usability of the system, and perceived value and desirability to the end-user audience. As such, engagement in this context is deemed to mean the degree to which the test asset provides a usable, acceptable, desirable and valuable experience to its users during a time-limited trial.
|Condition or disease||Intervention/treatment||Phase|
|Pulmonary Disease, Chronic Obstructive||Device: Technology-Assisted Respimat Adherence Digital Behaviour Change Intervention||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Device Feasibility|
|Official Title:||Mixed Methods (Quantitative, Qualitative) Feasability Study Assessing Engagement With the TARA Working Prototype [Version 2] (a Digital Behaviour Change Intervention, DBCI) and Effects of TARA on Behavioural Targets and Medication Adherence in Individuals With COPD|
|Estimated Study Start Date :||February 17, 2021|
|Estimated Primary Completion Date :||July 12, 2021|
|Estimated Study Completion Date :||September 6, 2021|
|Experimental: All subjects||
Device: Technology-Assisted Respimat Adherence Digital Behaviour Change Intervention
- Patient interaction with TARA (engagement via usage data) [ Time Frame: up to 3 weeks ]Data sourced from individual and amalgamated usage analytics. Data points collected from TARA Patient database / usage analytics, recording the completion with time and date stamps by the users of key sections of the TARA program. An overall score for perceived ease-of-use will be generated using the System Usability Scale (SUS) participant questionnaire
- Assessment of usability issues [ Time Frame: up to 3 weeks ]
Qualitative assessment of participant's feedback on any usability issues, areas of confusion or lack of clarity whilst using TARA working prototype (version 2).
Data sourced from participant's reports, emails and exit interviews.
- Assessment of motivation and perception [ Time Frame: up to 3 weeks ]Qualitative assessment of data sourced through the prototype and via discussion in the exit interview
- Percent of individuals with COPD who achieve improvements in intention (Readiness for Change) measured by the Readiness for Change Questionnaire [ Time Frame: up to 3 weeks ]
- Percent of individuals with COPD who achieve improvements in autonomous motivation measured by the Treatment Self-Regulation Questionnaire (TSRQ) [ Time Frame: up to 3 weeks ]
- Percent of individuals with COPD who achieve confidence measured by the Perceived Competence Scale; PCS) [ Time Frame: up to 3 weeks ]
- Percent of participants who increased adherence to once daily inhaled medication, based on Test of Adherence to Inhalers (TAI) Questionnaire [ Time Frame: up to 3 weeks ]
- Percent of participants who report increases in adherence to once daily inhaled medication, based on study-specific medication adherence question [ Time Frame: up to 3 weeks ]Medication adherence question: "During the last 7 days, how many times did you forget to take your daily inhaler ?"
- Percent of participants who report increases in adherence to once daily inhaled medication, based on prescription re-fill confirmation [ Time Frame: up to 3 weeks ]
- Percent of participants who report increases in adherence to once daily inhaled medication, based on TARA daily check-in data. [ Time Frame: up to 3 weeks ]
- Percent of study participants who report a reduction in COPD symptoms measured via the COPD Assessment test (CAT) [ Time Frame: up to 3 weeks ]