TARA Working Prototype Engagement Evaluation: Feasibility Study
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|ClinicalTrials.gov Identifier: NCT04085302|
Recruitment Status : Completed
First Posted : September 11, 2019
Last Update Posted : December 23, 2019
TARA is a Digital Behaviour Change Intervention (DBCI) for individuals with Chronic Obstructive Pulmonary Disease (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||Behavioral: Digital Behaviour Change Intervention||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||16 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Mixed Methods (Quantitative, Qualitative) Feasability Study Assessing Engagement With the First Version of the TARA Working Prototype (a Digital Behaviour Change Intervention, DBCI) in Individuals With COPD|
|Actual Study Start Date :||September 26, 2019|
|Actual Primary Completion Date :||December 3, 2019|
|Actual Study Completion Date :||December 3, 2019|
|Experimental: All subjects||
Behavioral: Digital Behaviour Change Intervention
- % of study participants achieving 80% or higher engagement score with their personal TARA program [ Time Frame: Up to 14 days ]
- Study participant's motivation to engage with the TARA working prototype (version 1) and their perceptions of value and usefulness [ Time Frame: Up to 14 days ]Qualitative assessment of motivation and perceptions of value and usefulness at different stages in the participant's journey through the prototype; data sourced via discussion in an exit interview at the end of the study.
- Evidence of usability issues, patterns of dis-engagement or failures of use in particular pages or functional areas of the prototype [ Time Frame: Up to 14 days ]Analysis of usage data of the site to explore if there are common points at which participants fail to progress, make mistakes or abandon interactions; Data will be sourced from individual and amalgamated usage analytics - data points will include drop-out rates for each of the main functional areas of the site and will be supplemented by within-page usage data An overall score for perceived ease-of-use will be generated using the 'System Usability Scale' (SUS), using self-reported data from the pre- and post-TARA participant questionnaire
- Study participant's reports of usability or other issues from using the prototype [ Time Frame: Up to 14 days ]
- % of study participants who achieve a score of 8 or greater in Knowledge, Motivation, Confidence (KMC) assessments [ Time Frame: Up to 14 days ]
- % of study participants who achieve a positive change in measures of motivation, activation, competence (self-efficacy) and stage of change [ Time Frame: Up to 14 days ]
- % of study participants who report increases in adherence to once daily inhaled medication and reduction in Chronic Obstructive Pulmonary Disease (COPD) symptoms [ Time Frame: Up to 14 days ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04085302
|United States, Massachusetts|
|Somerville, Massachusetts, United States, 02144|