Occupational ExposureNCT04593901
Protecting Home Healthcare Workers: An Interactive Video-based App to Coach Workers Through Challenging Health and Safety-related Situations
A study testing Video and App Review in people with Occupational Exposure, run by Ohio State University at 1 site in United States.
Trial summary
This project will create a video-based app that empowers home healthcare workers to communicate with clients and their families about managing health and safety hazards in client homes. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Occupational Exposure
- What is being tested?
- Video and App Review
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2021to 7 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Home healthcare worker (including clinical, professional, and administrative staff)
- 18+ years of age
- 6 months of home healthcare experience
- access to computer/tablet/smartphone
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
About this study
This project will create a video-based app that empowers home healthcare workers to communicate with clients and their families about managing health and safety hazards in client homes. Using a participatory approach, home healthcare workers will 1) review and revise video scripts and recordings that demonstrate effective and less effective communication strategies when talking to clients, families, and other stakeholders about health and safety hazards and 2) contribute to the creation and review of an interactive app that they perceive to be useful, usable, and desirable.
Read the detailed description
This project includes two of three original aims. The first aim (Aim 1), already completed, created scripts based on real-world scenarios regarding speaking with clients and families about health and safety hazards in their homes.
Based on the data from Aim 1, the research team has prepared scripts describing each scenario. Each scenario includes two to three different approaches that represent successful, less successful, and/or unsuccessful examples of communicating about solving difficult or complex health and safety challenges. Each scenario includes a short introductory statement about the context of the scenario and two to three subsequent scripts and/or recordings that demonstrate the different communication approaches. Scenarios with successful communication strategies present the approach and outcomes that are consistent with best practices for HHW's in a given situation.
In Aims 2 and 3, participants will participate in either an individual or group interview using Zoom, Teams, or similar. They will review scripted scenarios and, as they are developed, video recordings based on the scripted scenarios. They will answer questions about the relevance of the information, how realistic the dialogue is, the usefulness of the information, and changes/improvements they would make. In addition, participants will review an app designed to allow users to select the videos they wish to view, and view successful, less successful, and unsuccessful communication approaches and outcomes.
- Conditions
- Occupational Exposure
- Being tested
- Video and App Review
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video and App ReviewBehavioural
Scenario Review: The scripts and/or videos will be iteratively reviewed by individual and small groups of home healthcare personnel using Zoom, Microsoft Teams, or similar. The participants will review scripts and/or recordings of the scripts and discuss how well each situation has been represented, how to improve it, and whether it is applicable in their agency.
App Review: Following review of the scenarios, participants will review the smartphone app currently under development, including the control buttons, their placements, and other features of the screen interface. The first 9-12 participants (approximately) will be asked to provide feedback on the app's layout, control locations, and overall appearance. Once suggested changes have been made, the app will then be reviewed by the remaining participants for final review and usability assessment.
| Study group | Role | What they receive |
|---|---|---|
| Video and App Review | Other | Single arm study in which home healthcare workers review and provide feedback on scripts and/or videos and on the usefulness, usability, and desirability of an interactive app in an iterative, participatory manner. Receives: Behavioral: Video and App Review |
What is being measured
The primary outcome is the main question the study is designed to answer.
Usefulness, Usability, Desirability Assessment
This flexible and individualized instrument uses a 5 point-Likert scale to assess whether the app was useful, easy to use, and appealing
Measured: The UUD Assessment is administered once 1 day a participant has reviewed the app in order to assess overall usability. It is completed only once by each participant.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2020
- Study start1 Feb 2021
- Primary completion7 Oct 2021
- Study completion7 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Occupational ExposureStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Study is pre-intervention that uses a participatory, iterative approach to develop an app for use in subsequent intervention studies.
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Kansas Medical Center
- Responsible party
- Principal investigator, Amy Darragh, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04593901
- Sponsor's protocol ID
- GRT00054864
- Status last verified
- Jul 2022
- First submitted
- 14 Oct 2020
- Last updated
- 14 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan as of yet given small n and qualitative nature of data.
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protecting Home Healthcare Workers: An Interactive Video-based App to Coach Workers Through Challenging Health and Safety-related Situations
- ClinicalTrials.gov ID
- NCT04593901
- Acronym / sponsor ID
- GRT00054864
- Conditions
- Occupational Exposure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Collaborators
- University of Kansas Medical Center
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 7 Oct 2021 (actual)
- Study completion
- 7 Oct 2021 (actual)
- First posted
- 20 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This project will create a video-based app that empowers home healthcare workers to communicate with clients and their families about managing health and safety hazards in client homes. Using a participatory approach, home healthcare workers will 1) review and revise video scripts and recordings that demonstrate effective and less effective communication strategies when talking to clients, families, and other stakeholders about health and safety hazards and 2) contribute to the creation and review of an interactive app that they perceive to be useful, usable, and desirable.
Detailed description
This project includes two of three original aims. The first aim (Aim 1), already completed, created scripts based on real-world scenarios regarding speaking with clients and families about health and safety hazards in their homes.
Based on the data from Aim 1, the research team has prepared scripts describing each scenario. Each scenario includes two to three different approaches that represent successful, less successful, and/or unsuccessful examples of communicating about solving difficult or complex health and safety challenges. Each scenario includes a short introductory statement about the context of the scenario and two to three subsequent scripts and/or recordings that demonstrate the different communication approaches. Scenarios with successful communication strategies present the approach and outcomes that are consistent with best practices for HHW's in a given situation.
In Aims 2 and 3, participants will participate in either an individual or group interview using Zoom, Teams, or similar. They will review scripted scenarios and, as they are developed, video recordings based on the scripted scenarios. They will answer questions about the relevance of the information, how realistic the dialogue is, the usefulness of the information, and changes/improvements they would make. In addition, participants will review an app designed to allow users to select the videos they wish to view, and view successful, less successful, and unsuccessful communication approaches and outcomes.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Study is pre-intervention that uses a participatory, iterative approach to develop an app for use in subsequent intervention studies.
| Arm | Type | Receives |
|---|---|---|
| Video and App Review | Other | Behavioral: Video and App ReviewSingle arm study in which home healthcare workers review and provide feedback on scripts and/or videos and on the usefulness, usability, and desirability of an interactive app in an iterative, participatory manner. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Home healthcare worker (including clinical, professional, and administrative staff)
- 18+ years of age
- 6 months of home healthcare experience
- access to computer/tablet/smartphone
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Video and App ReviewScenario Review: The scripts and/or videos will be iteratively reviewed by individual and small groups of home healthcare personnel using Zoom, Microsoft Teams, or similar. The participants will review scripts and/or recordings of the scripts and discuss how well each situation has been represented, how to improve it, and whether it is applicable in their agency. App Review: Following review of the scenarios, participants will review the smartphone app currently under development, including the control buttons, their placements, and other features of the screen interface. The first 9-12 participants (approximately) will be asked to provide feedback on the app's layout, control locations, and overall appearance. Once suggested changes have been made, the app will then be reviewed by the remaining participants for final review and usability assessment. | Behavioural | Video and App Review |
Primary outcome
Usefulness, Usability, Desirability Assessment
Time frame: The UUD Assessment is administered once 1 day a participant has reviewed the app in order to assess overall usability. It is completed only once by each participant.
This flexible and individualized instrument uses a 5 point-Likert scale to assess whether the app was useful, easy to use, and appealing
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2022.
- Individual participant dataSharing planned: No. No plan as of yet given small n and qualitative nature of data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Video and App Review in people with Occupational Exposure, run by Ohio State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Usefulness, Usability, Desirability Assessment (time frame: The UUD Assessment is administered once 1 day a participant has reviewed the app in order to assess overall usability. It is completed only once by each participant.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2022.