Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623001029684
Ethics application status
Approved
Date submitted
29/08/2023
Date registered
22/09/2023
Date last updated
22/09/2023
Date data sharing statement initially provided
22/09/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
The right to rehabilitation for people with dementia: Implementation and evaluation of the "INCLUDE" interventions
Scientific title
Change in stigma and knowledge about dementia rehabilitation with "INCLUDE" education interventions for health professionals
Secondary ID [1] 310481 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dementia 331270 0
Condition category
Condition code
Neurological 328024 328024 0 0
Dementias
Public Health 328130 328130 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The "INCLUDE" education interventions for health professionals will consist of the following:

1. An on-line training module ‘What is dementia rehabilitation and the role of the allied health professional’. Topics will include the evidence for rehabilitations, barriers to access and ways participants can address some of the barriers. (approx. 2-3 hours in duration). Mode of administration is self-paced online learning (with set opening and closing dates for each e-module) with short articles, short videos, quizzes and reflection activities, Course participants will be expected to complete all e-modules in order to participate in the community of practice.

2. Dementia Training Australia (DTA) run a diagnosis and managing dementia training session 1.15 h x 3 webinars or 6 hours face to face for general practitioners and practice nurses– this will be evaluated as part of this study.
Content will include diagnosis and management of dementia, dementia rehabilitation and its benefits for people with dementia and their carers, role of allied health professionals in providing dementia rehabilitation and referrals for dementia rehabilitation. The mode of training will include trainer presentations and may include short videos, interactive activities and short quizzes.
Attendance of the DTA training will be monitored and recorded by DTA Australia through registration process and training attendance.

3. A Community of Practice (CoP) with the aim to improve interdisciplinary knowledge and dementia rehabilitation expertise, enhance collaboration between members and advocate for people with dementia being able to know about and access allied health (approx. 30 min to one hour, held at different times over 12 months).
Components of the CoP may include:
a. Access to members details (via online methods) to facilitate referrals and networking
b. Webinars
c. Digital newsletter with Allied Health (AH) related topics and research updates
d. Question and discussion board (online)
e. Region/satellite face to face and/or online meetings
f. Resources (provided online)
g. A power-point that can be used to inform and educate others of the role of allied health in dementia (provided online)
Participants of the CoP will be notified of each event (b-g) by emails and/or a monthly digital newsletter.

4. Resources to be provided during 1-3 (via online methods):
a. An ‘Allied health and dementia’ brochure (co-designed by the stakeholders, consumers, dementia advocates, clinicians and the research team)
b. A decision support and communication tool to help referrers understand and select allied health professionals for their clients, and illustrated by case studies (co-designed by the stakeholders, consumers, dementia advocates, clinicians and the research team).
Co-design process (completed in a previous study):
The lived experience experts and professionals participated in 3 workshops via zoom. Workshop 1 ‘gather the experience’ was run twice within one week (one for each group) understanding the experience. Three weeks later, Workshop 2 ‘understand the experience’ was run in a similar way. Three months later workshop 3 ‘improve the experience’ was run once with both workshop cohorts in attendance. All workshops ran for 90 minutes.

For Workshop 1, key findings from published systematic reviews and guidelines on the evidence for dementia rehabilitation, and relevant literature on barriers, were synthesised into briefing notes. The intent was to provide all workshop attendees with a broad scope of information to draw upon. To facilitate in-depth discussion, participants were divided into three breakout groups and were asked to provide their experience around stigma, knowledge, disempowerment, and pathways in relation to people with dementia accessing rehabilitation. Workshop 2 ran in the same format, but participants were asked to consider the barriers discussed in the previous workshop and provide their perspective on their experiences on what would help general practitioners, allied health professionals and people with dementia deliver and access rehabilitation. This included commenting on a number of existing information brochures and tools. Between Workshop 2 and 3 the research team considered the suggested solutions and sought further information from key organisations to determine feasibility and willingness to partner in implementation of solutions. Workshop 3 brought all participants together, for refinement of the solutions.

Allied health professionals, nurses, and other professionals who commence participation at the beginning of the 12-month study (around Jan/Feb 2024) will be invited to participate in all aspects of the INCLUDE solutions.

For allied health professionals, nurses, and other professionals who commence participation in mid-study (May 2024), they will be invited to participate in the e-module only.

The total time involved (if all activities are undertaken by health professionals) would be approximately 15 hours over the 12-month period.

The e-module attendance and completion will be monitored by the "HPEO" site which is a Moodle-based learning management system and has course analytics functions. Participation in the community of practice activities e.g. webinars, meetings and discussion boards will be recorded online and/or by research staff tracking the number of participants attending each event.
Intervention code [1] 326869 0
Behaviour
Intervention code [2] 326946 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 335902 0
Stigma about dementia rehabilitation using:
a) the General Practitioners’ Attitudes and Confidence towards Dementia Survey (GPACS-D) for GPs or
b) the Dementia Attitudes Scale (DAS) for allied health professionals and other health professionals, and
c) a customised survey regarding beliefs about dementia rehabilitation for GPs, allied health professionals and other health professionals.
Timepoint [1] 335902 0
Baseline (pre-education intervention=time 0), immediately after the e-module training ( time 1 approximately at month 2 post-commencement of the intervention) and follow-up (time 2 at month 12 post-commencement of the intervention)
Primary outcome [2] 335903 0
Knowledge about dementia rehabilitation using:
The Dementia knowledge assessment scale (DKAS) for all participants (GPs, Allied health professionals and other health professionals)
Timepoint [2] 335903 0
Baseline (pre-education intervention=time 0), immediately after the e-module training ( time 1 approximately at month 2 post-commencement of the intervention) and follow-up (time 2 at month 12 post-commencement of the intervention)
Primary outcome [3] 336006 0
Community of practice (Multidisciplinary collaboration in professional networks) using:
A social network analysis based on participants' responses to the following questions:
a) Do you know the following people (names of participants in this study)? Knowing each other is defined as ‘knowing the face, having talked to each with other, or having heard of.’
Responses could be one of the following:
-No
-Yes (know the face or have heard of)
-Yes (have talked to/corresponded with)

b) Have you had professional contact with the following people (names of participants in this study)? Professional contact is defined as ‘having had professional contact about at least one patient/client (any condition not just dementia) who you are treating / have treated (including referral letters, emails, telephone contact, team meetings).
Responses could be one of the following:
-No
-Yes (regarding one person with any condition, not just dementia)
-Yes (regarding more than one person with any condition, not just dementia)

c) Have you had professional contact with the following people (names of participants in this study) in relation to a person with dementia? Professional contact is defined as ‘having had professional contact about at least one person with dementia who you are treating / have treated (including referral letters, emails, telephone contact, team meetings).
Responses could be one of the following:
-No
-Yes (regarding one person with dementia)
-Yes (regarding more than one person with dementia)
Timepoint [3] 336006 0
Baseline (pre-education intervention=time 0) and follow-up (time 2 at month 12 post-commencement of the intervention)
Secondary outcome [1] 426070 0
Acceptability with the e-module in the INCLUDE education intervention:
measured with a survey and questions that have been designed specifically for this study (e.g. rated on an ordinal scale) immediately post the e-module.
Timepoint [1] 426070 0
Immediately after the e-module training ( time 1 approximately at month 2 post-commencement of the intervention)
Secondary outcome [2] 426071 0
Satisfaction with the e-module in the INCLUDE education intervention:
measured with a survey and questions that have been designed specifically for this study (e.g. rated on an ordinal scale) immediately post the e-module.
Timepoint [2] 426071 0
Immediately after the e-module training ( time 1 approximately at month 2 post-commencement of the intervention)
Secondary outcome [3] 426072 0
Perceived sustainability with the e-module in the INCLUDE education intervention:
measured with a survey and questions that have been designed specifically for this study (e.g. rated on an ordinal scale) immediately post the e-module.
Timepoint [3] 426072 0
Immediately after the e-module training ( time 1 approximately at month 2 post-commencement of the intervention)
Secondary outcome [4] 426073 0
Acceptability with the community of practice in the INCLUDE education intervention:
measured with a survey and questions that have been designed specifically for this study (e.g. rated on an ordinal scale) at 12 months for the community of practice (including webinars and resources).

A focus group will be used to determine the acceptability and usefulness of the education run by DTA 4 months post training.
The focus group (depending on the number of GPs or practice nurses that opt in the optional focus group) will be conducted online and limited to 10 people. It may involve a few focus groups at different times if more than 10 (or break out rooms). All GPs or practice nurses that have attended the DTA training AND who have opted in the focus group will be invited to participate in the focus group.
Timepoint [4] 426073 0
At follow up (time 2 at month 12 post-commencement of the intervention) for all participants (except for those in Mid-study intake) or at 4 months post DTA training (for GPs and practice nurses who attend this training and opt into the focus group)
Secondary outcome [5] 426074 0
Satisfaction with the community of practice in the INCLUDE education intervention:
measured with a survey and questions that have been designed specifically for this study (e.g. rated on an ordinal scale) at 12 months for the community of practice (including webinars and resources).

A focus group will be used to determine the acceptability and usefulness of the education run by DTA 4 months post training.
The focus group (depending on the number of GPs or practice nurses that opt in the optional focus group) will be conducted online and limited to 10 people. It may involve a few focus groups at different times if more than 10 (or break out rooms). All GPs or practice nurses that have attended the DTA training AND who have opted in the focus group will be invited to participate in the focus group.
Timepoint [5] 426074 0
At follow up (time 2 at month 12 post-commencement of the intervention) for all participants (except for those in Mid-study intake) or at 4 months post DTA training (for GPs and practice nurses who attend this training)
Secondary outcome [6] 426075 0
Perceived sustainability with the community of practice in the INCLUDE education intervention:
measured with a survey and questions that have been designed specifically for this study (e.g. rated on an ordinal scale) at 12 months for the community of practice (including webinars and resources).

A focus group will be used to determine the acceptability and usefulness of the education run by DTA 4 months post training.
The focus group (depending on the number of GPs or practice nurses that opt in the optional focus group) will be conducted online and limited to 10 people. It may involve a few focus groups at different times if more than 10 (or break out rooms). All GPs or practice nurses that have attended the DTA training AND who have opted in the focus group will be invited to participate in the focus group.
Timepoint [6] 426075 0
At follow up (time 2 at month 12 post-commencement of the intervention) for all participants (except for those in Mid-study intake) or at 4 months post DTA training (for GPs and practice nurses who attend this training)

Eligibility
Key inclusion criteria
Participants are 1) health professionals (including GPs, practice nurses, allied health professionals, specialists such as Geriatricians, Neurologists and Older age Psychiatrists), 2) working in East Melbourne, South East Melbourne primary health networks or Eastern, South Eastern suburbs of Melbourne, Australia and 3) likely to stay at the practice for 12 months.

Please note: The INCLUDE education interventions are for health professionals only. No patients or their carers will be involved in this intervention.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
None

Study design
Purpose of the study
Educational / counselling / training
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
Pre and post single group design
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Descriptive statistics will be used to:
1. describe the characteristics of participants, their work-setting and experience.
2. describe the number of each profession who agree to participate, and how many partake in each of the INCLUDE solutions.

Attitudes and knowledge: Change in pre and post intervention stigma, knowledge will be analysed using paired samples t-test or the signed ranked test.

Acceptability, sustainability and satisfaction: will be described using summary statistics or for open ended questions with content analysis. For focus group data, researchers will transcribe the focus group recordings, and thematic analysis will be used to analyse the data.

Social networks and collaboration: Data will be entered into a squared data-matrix with the health professionals in the rows and columns and values in the cells to indicate presence or absence of connection (1,0). The first stage of data analysis will focus on the total network and the area-specific networks. The second stage of data analysis focused on the networks of the individual health professionals (’ego networks’). These individual networks will be extracted from the total network for each health professionals, including the reported connections of the individual with others in the network and the connections between those others.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/11/2023
Actual
Date of last participant enrolment
Anticipated
2/09/2024
Actual
Date of last data collection
Anticipated
3/02/2025
Actual
Sample size
Target
500
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 25456 0
Dandenong Hospital- Monash Health - Dandenong
Recruitment hospital [2] 25457 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment hospital [3] 25458 0
Monash Medical Centre - Moorabbin campus - East Bentleigh
Recruitment hospital [4] 25459 0
Kingston Centre - Cheltenham
Recruitment hospital [5] 25460 0
Casey Hospital - Berwick
Recruitment hospital [6] 25461 0
Box Hill Hospital - Box Hill
Recruitment hospital [7] 25462 0
Angliss Hospital - Upper Ferntree Gully
Recruitment hospital [8] 25463 0
Maroondah Hospital - Ringwood East
Recruitment hospital [9] 25464 0
Peter James Centre - Forest Hill
Recruitment hospital [10] 25465 0
Frankston Hospital - Frankston
Recruitment hospital [11] 25466 0
Golf Links Road Rehabilitation Centre - Frankston
Recruitment hospital [12] 25467 0
Rosebud Hospital - Rosebud
Recruitment hospital [13] 25468 0
The Mornington Centre - Mornington
Recruitment postcode(s) [1] 41262 0
3101 - Kew
Recruitment postcode(s) [2] 41263 0
3103 - Balwyn
Recruitment postcode(s) [3] 41259 0
3122 - Hawthorn
Recruitment postcode(s) [4] 41261 0
3124 - Camberwell
Recruitment postcode(s) [5] 41250 0
3128 - Box Hill
Recruitment postcode(s) [6] 41264 0
3130 - Blackburn
Recruitment postcode(s) [7] 41254 0
3131 - Forest Hill
Recruitment postcode(s) [8] 41260 0
3134 - Ringwood
Recruitment postcode(s) [9] 41253 0
3135 - Ringwood East
Recruitment postcode(s) [10] 41269 0
3140 - Lilydale
Recruitment postcode(s) [11] 41265 0
3150 - Glen Waverley
Recruitment postcode(s) [12] 41266 0
3152 - Wantirna
Recruitment postcode(s) [13] 41251 0
3156 - Upper Ferntree Gully
Recruitment postcode(s) [14] 41247 0
3165 - East Bentleigh
Recruitment postcode(s) [15] 41246 0
3168 - Clayton
Recruitment postcode(s) [16] 41273 0
3171 - Springvale
Recruitment postcode(s) [17] 41272 0
3174 - Noble Park
Recruitment postcode(s) [18] 41245 0
3175 - Dandenong
Recruitment postcode(s) [19] 41271 0
3189 - Moorabbin
Recruitment postcode(s) [20] 41248 0
3192 - Cheltenham
Recruitment postcode(s) [21] 41255 0
3199 - Frankston
Recruitment postcode(s) [22] 41267 0
3805 - Narre Warren
Recruitment postcode(s) [23] 41249 0
3806 - Berwick
Recruitment postcode(s) [24] 41276 0
3915 - Hastings
Recruitment postcode(s) [25] 41257 0
3931 - Mornington
Recruitment postcode(s) [26] 41270 0
3936 - Dromana
Recruitment postcode(s) [27] 41256 0
3939 - Rosebud
Recruitment postcode(s) [28] 41274 0
3941 - Rye
Recruitment postcode(s) [29] 41275 0
3943 - Sorrento
Recruitment postcode(s) [30] 41268 0
3977 - Cranbourne

Funding & Sponsors
Funding source category [1] 314686 0
Government body
Name [1] 314686 0
Department of Health and Aged Care-Medical Research Future Fund
Country [1] 314686 0
Australia
Primary sponsor type
Government body
Name
Department of Health and Aged Care - Medical Research Future Fund.
Address
Department of Health and Aged Care Victoria (VIC) OfficeLevel 15, 595 Collins StreetMelbourne VIC 3000
Country
Australia
Secondary sponsor category [1] 316654 0
None
Name [1] 316654 0
Address [1] 316654 0
Country [1] 316654 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313700 0
Monash University Human Research Ethics Committee
Ethics committee address [1] 313700 0
Room 111, Chancellery Building D,26 Sports Walk, Clayton CampusResearch OfficeMonash University VIC 3800
Ethics committee country [1] 313700 0
Australia
Date submitted for ethics approval [1] 313700 0
27/06/2023
Approval date [1] 313700 0
05/07/2023
Ethics approval number [1] 313700 0
38423
Ethics committee name [2] 313705 0
Monash Health Human Research Ethics Committee
Ethics committee address [2] 313705 0
Research Support Services, Monash Health|Level 2, I Block, Monash Medical Centre, 246 Clayton Road, Clayton, 3168
Ethics committee country [2] 313705 0
Australia
Date submitted for ethics approval [2] 313705 0
16/08/2023
Approval date [2] 313705 0
Ethics approval number [2] 313705 0

Summary
Brief summary
There is evidence for rehabilitation interventions to reduce disability and improve wellbeing for people with dementia. However, experiences of people with dementia with rehabilitative treatments are almost non-existent. There are barriers and challenges at multiple levels: 1) Health professional stigma about the value of rehabilitation for people with dementia and their ability to engage in therapy, 2) Low levels of knowledge about the evidence for dementia rehabilitation exist, which is also likely to contribute to stigma, 3) People with dementia and their care partners find services hard to navigate and report needing information to empower them to ask for rehabilitation and support to access it, 4) No clear model or pathway in the system for providing rehabilitation for people with dementia.
Given the evidence for rehabilitation interventions to reduce disability and improve wellbeing in people with dementia, there is much need in addressing stigma and low knowledge, to overcome challenges to promote rehabilitation access for people with dementia. Co-design workshops have been held to determine strategies to address stigma and challenges to rehabilitation access for people with dementia. A package of solutions “INCLUDE” has been decided on (A dementia rehabilitation e-module, a community of practice, and GP/GP practice nurse dementia training). We will test and evaluate their implementation in the South Eastern and Eastern Melbourne Primary Health Network areas.
The specific aims are to determine:
1. The number, type, work setting, and proportion of health professionals (GPs, practice nurses, allied health professionals (AHPs) and other professionals) who agree to participate in the study and partake in any of the INCLUDE solutions
2. The effect of the INCLUDE solutions (e-module, GP training and Community of Practice) on change in stigma and knowledge about dementia rehabilitation
3. The effect of the e-module and community of practice on change in:
a. social networks
b. number of people seen with dementia by allied health professionals and
c. number of advocacy actions and changes to practice by members in their workplace
4. Acceptability, satisfaction and perceived sustainability with each of the INCLUDE solutions
Trial website
Trial related presentations / publications
Public notes
Please note; Monash Health HREC will grant multisite approval (when approved) for Monash Health, Eastern Health and Peninsula Health

Contacts
Principal investigator
Name 129066 0
A/Prof Michele Callisaya
Address 129066 0
2 Hastings Rd Ngarnga Centre, Frankston Hospital, Frankston VIC 3199
Country 129066 0
Australia
Phone 129066 0
+61 418295933
Fax 129066 0
Email 129066 0
michele.callisaya@monash.edu
Contact person for public queries
Name 129067 0
A/Prof Michele Callisaya
Address 129067 0
2 Hastings Rd Ngarnga Centre, Frankston Hospital, Frankston VIC 3199
Country 129067 0
Australia
Phone 129067 0
+61 418295933
Fax 129067 0
Email 129067 0
michele.callisaya@monash.edu
Contact person for scientific queries
Name 129068 0
Dr Angel Lee
Address 129068 0
2 Hastings Rd Ngarnga Centre, Frankston Hospital, Frankston VIC 3199
Country 129068 0
Australia
Phone 129068 0
+61 3 99044662
Fax 129068 0
Email 129068 0
angel.lee@monash.edu

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
20156Study protocol  angel.lee@monash.edu 386502-(Uploaded-29-08-2023-15-42-15)-Study-related document.pdf
20157Informed consent form  angel.lee@monash.edu 386502-(Uploaded-29-08-2023-15-58-38)-Study-related document.pdf
20158Ethical approval  angel.lee@monash.edu 386502-(Uploaded-29-08-2023-15-59-04)-Study-related document.pdf
20159Other  angel.lee@monash.edu Explanatory statements 386502-(Uploaded-29-08-2023-15-59-34)-Study-related document.pdf
20163Other  angel.lee@monash.edu Surveys:e-module 386502-(Uploaded-29-08-2023-16-01-02)-Study-related document.pdf
20164Other  angel.lee@monash.edu Surveys: May 2024 e-module 386502-(Uploaded-29-08-2023-16-02-13)-Study-related document.pdf
20165Other  angel.lee@monash.edu Surveys: DTA training 386502-(Uploaded-29-08-2023-16-03-04)-Study-related document.pdf



Results publications and other study-related documents

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