Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000795695
Ethics application status
Approved
Date submitted
3/07/2023
Date registered
26/07/2023
Date last updated
25/08/2023
Date data sharing statement initially provided
26/07/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Implementation of a mindfulness program targeting resilience and staff burnout in aged care services
Scientific title
Efficacy of implementation of a mindfulness program targeting resilience and staff burnout in aged care
Secondary ID [1] 309998 0
N/A
Universal Trial Number (UTN)
U1111-1294-2589
Trial acronym
N/A
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Staff Burnout 330495 0
Condition category
Condition code
Mental Health 327343 327343 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Mindfulness in Motion (MIM) program is an eight-week workplace mindfulness intervention designed to help frontline healthcare staff reduce burnout and stress while building resilience. Developed by Dr. Maryanna Klatt at Ohio State University (OSU), the program has been in use for almost 20 years. The MIM program consists of weekly one-hour sessions delivered via an online video conferencing platform, by a trained MIM facilitator at the participants place of work. Up to 15 participants can attend the MIM training program. The activities conducted during the sessions include:
Reflective writing, didactic video, sharing reflections, experiential videos (on mindfulness meditation and gentle yoga) and closing meditation. To support participants' progress during the eight-week program, they will have access to audio and video resources through an online app. These resources will enable individual mindfulness and yoga self-practice for approximately 10-20 minutes, five times per week. Strategies to monitor adherence and intervention fidelity include attendance checklists, analytic data collected from a program App and a fidelity checklist.

To support the rollout of the MIM program a Mindfulness Action Group (MAG) will be recruited from across the trial sites. The MAG will undertake training to enable them to become facilitators of the MIM program. This training will occur in two 8-week sessions, approximately seven months before the commencement of the MIM intervention with staff at the trial sites. In the first instance, the MAG members will undertake the usual 8 week online MIM training program (as described above) as full participant in the program, which will be facilitated by staff at OSU. The MAG will subsequently undertake a MIM fidelity online training program for another three months run by OSU. Next, an intensive training occurs in which staff at OSU teaches MAG staff to teach the MIM 8-week protocol to their own sites. This online program teaches the MAG members the specifics of running the MIM program according to the protocol, using a train-the-facilitator model with online resources and coaching. The final step in the MAG training is to facilitate one’s own 8-week session at their respective trial sites.
Intervention code [1] 326442 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 335264 0
Change in staff burnout measured by the Maslach Burnout Inventory (MBI)
Timepoint [1] 335264 0
Three days prior to commencement of the MIM program, at completion of the MIM (8 weeks), two months post completion, 12 months post completion.
Secondary outcome [1] 423656 0
Change in perceived stress of aged care staff as measured by Perceived Stress Scale (PSS).
Timepoint [1] 423656 0
Three days prior to commencement of the MIM program (T1), at completion (8 weeks) (T2), two months post completion (T3), 12 months post completion (T4).
Secondary outcome [2] 423961 0
Change in work resilience of aged care staff as measured by the Conor-Davidson Resilience Scale,
Timepoint [2] 423961 0
Three days prior to commencement of the MIM program (T1), at completion (8 weeks) (T2), two months post completion (T3), 12 months post completion (T4)
Secondary outcome [3] 423962 0
Change in aged care staff work engagement as measured by the Utrecht Work Engagement Scale.
Timepoint [3] 423962 0
Three days prior to commencement of the MIM program (T1), at completion (8 weeks) (T2), two months post completion (T3), 12 months post completion (T4)
Secondary outcome [4] 423963 0
Change in staff sick leave, by audit of organizational employee sick leave data.
Timepoint [4] 423963 0
Two months post completion of the MIM program (T3) and 12 months post completion (T4).
Secondary outcome [5] 423964 0
Change in staff turnover as assessed by an audit of employee records at each organizstion
Timepoint [5] 423964 0
Two months post completion of the MIM program (T3) and 12 months post completion (T4).

Eligibility
Key inclusion criteria
For aged care staff to be eligible to participate in the MIM program they must meet the following criteria:
- Employed either part-time or full-time,
- Able to engage with the program for eight weeks and contribute to data collection pre, during and post the program.
-Able to download the MIM app on to a mobile device.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Staff who do not provide frontline care to older people at the participating aged care services.
Staff who are on reduced work duties due to occupational stress or burnout.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Descriptive statistics and inferential statistics (t-test)

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/02/2024
Actual
Date of last participant enrolment
Anticipated
1/03/2024
Actual
Date of last data collection
Anticipated
12/05/2025
Actual
Sample size
Target
75
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
TAS

Funding & Sponsors
Funding source category [1] 314176 0
Other
Name [1] 314176 0
Aged Care Research and Industry Innovation Australia
Country [1] 314176 0
Australia
Primary sponsor type
University
Name
University of Tasmania
Address
Rozelle Campus - University of Tasmania
Corner of Church and Glover streets, Lilyfield, NSW 2039
Country
Australia
Secondary sponsor category [1] 316184 0
None
Name [1] 316184 0
Address [1] 316184 0
Country [1] 316184 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313305 0
University Of Tasmania Human Research Ethics Committee
Ethics committee address [1] 313305 0
Ethics committee country [1] 313305 0
Australia
Date submitted for ethics approval [1] 313305 0
04/07/2023
Approval date [1] 313305 0
04/08/2023
Ethics approval number [1] 313305 0
29183

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 127670 0
A/Prof Sharon Andrews
Address 127670 0
University of Tasmania (Sydney/Rozelle Campus)
Corner of Church and Glover streets, Lilyfield, NSW 2039
Country 127670 0
Australia
Phone 127670 0
+61285727936
Fax 127670 0
Email 127670 0
[email protected]
Contact person for public queries
Name 127671 0
Sharon Andrews
Address 127671 0
University of Tasmania (Sydney/Rozelle Campus)
Corner of Church and Glover streets, Lilyfield, NSW 2039
Country 127671 0
Australia
Phone 127671 0
+61285727936
Fax 127671 0
Email 127671 0
[email protected]
Contact person for scientific queries
Name 127672 0
Sharon Andrews
Address 127672 0
University of Tasmania (Sydney/Rozelle Campus)
Corner of Church and Glover streets, Lilyfield, NSW 2039
Country 127672 0
Australia
Phone 127672 0
+61285727936
Fax 127672 0
Email 127672 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
We have not requested ethical approval for this


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
19597Study protocol  [email protected]
19598Ethical approval  [email protected]



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.