ANZCTR - Registration

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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

25/08/2024

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]

Nil

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Dementia

Condition category

Condition code

Neurological

Dementias

Public Health

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]

Behaviour

Intervention code [2]

Treatment: Other

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

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]

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]

Knowledge about dementia rehabilitation using:
The Dementia knowledge assessment scale (DKAS) for all participants (GPs, Allied health professionals and other health professionals)

Timepoint [2]

Primary outcome [3]

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]

Baseline (pre-education intervention=time 0) and follow-up (time 2 at month 12 post-commencement of the intervention)

Secondary outcome [1]

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]

Immediately after the e-module training ( time 1 approximately at month 2 post-commencement of the intervention)

Secondary outcome [2]

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]

Immediately after the e-module training ( time 1 approximately at month 2 post-commencement of the intervention)

Secondary outcome [3]

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]

Immediately after the e-module training ( time 1 approximately at month 2 post-commencement of the intervention)

Secondary outcome [4]

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]

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]

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]

Secondary outcome [6]

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]

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

Recruiting

Date of first participant enrolment

Anticipated

1/11/2023

Actual

1/11/2023

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

535

Final

Recruitment in Australia

Recruitment state(s)

ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Recruitment hospital [1]

Dandenong Hospital- Monash Health - Dandenong

Recruitment hospital [2]

Monash Medical Centre - Clayton campus - Clayton

Recruitment hospital [3]

Monash Medical Centre - Moorabbin campus - East Bentleigh

Recruitment hospital [4]

Kingston Centre - Cheltenham

Recruitment hospital [5]

Casey Hospital - Berwick

Recruitment hospital [6]

Box Hill Hospital - Box Hill

Recruitment hospital [7]

Angliss Hospital - Upper Ferntree Gully

Recruitment hospital [8]

Maroondah Hospital - Ringwood East

Recruitment hospital [9]

Peter James Centre - Forest Hill

Recruitment hospital [10]

Frankston Hospital - Frankston

Recruitment hospital [11]

Golf Links Road Rehabilitation Centre - Frankston

Recruitment hospital [12]

Rosebud Hospital - Rosebud

Recruitment hospital [13]

The Mornington Centre - Mornington

Recruitment postcode(s) [1]

3175 - Dandenong

Recruitment postcode(s) [2]

3168 - Clayton

Recruitment postcode(s) [3]

3165 - East Bentleigh

Recruitment postcode(s) [4]

3192 - Cheltenham

Recruitment postcode(s) [5]

3806 - Berwick

Recruitment postcode(s) [6]

3128 - Box Hill

Recruitment postcode(s) [7]

3156 - Upper Ferntree Gully

Recruitment postcode(s) [8]

3135 - Ringwood East

Recruitment postcode(s) [9]

3131 - Forest Hill

Recruitment postcode(s) [10]

3199 - Frankston

Recruitment postcode(s) [11]

3939 - Rosebud

Recruitment postcode(s) [12]

3931 - Mornington

Recruitment postcode(s) [13]

3122 - Hawthorn

Recruitment postcode(s) [14]

3134 - Ringwood

Recruitment postcode(s) [15]

3124 - Camberwell

Recruitment postcode(s) [16]

3101 - Kew

Recruitment postcode(s) [17]

3103 - Balwyn

Recruitment postcode(s) [18]

3130 - Blackburn

Recruitment postcode(s) [19]

3150 - Glen Waverley

Recruitment postcode(s) [20]

3152 - Wantirna

Recruitment postcode(s) [21]

3805 - Narre Warren

Recruitment postcode(s) [22]

3977 - Cranbourne

Recruitment postcode(s) [23]

3140 - Lilydale

Recruitment postcode(s) [24]

3936 - Dromana

Recruitment postcode(s) [25]

3189 - Moorabbin

Recruitment postcode(s) [26]

3174 - Noble Park

Recruitment postcode(s) [27]

3171 - Springvale

Recruitment postcode(s) [28]

3941 - Rye

Recruitment postcode(s) [29]

3943 - Sorrento

Recruitment postcode(s) [30]

3915 - Hastings

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

Department of Health and Aged Care-Medical Research Future Fund

Address [1]

Department of Health and Aged Care Victoria (VIC) OfficeLevel 15, 595 Collins StreetMelbourne VIC 3000

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Monash University Human Research Ethics Committee

Ethics committee address [1]

Room 111, Chancellery Building D,26 Sports Walk, Clayton CampusResearch OfficeMonash University VIC 3800

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

27/06/2023

Approval date [1]

05/07/2023

Ethics approval number [1]

38423

Ethics committee name [2]

Monash Health Human Research Ethics Committee

Ethics committee address [2]

Research Support Services, Monash Health|Level 2, I Block, Monash Medical Centre, 246 Clayton Road,  Clayton, 3168

Ethics committee country [2]

Australia

Date submitted for ethics approval [2]

16/08/2023

Approval date [2]

Ethics approval number [2]

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

A/Prof Michele Callisaya

Address

2 Hastings Rd Ngarnga Centre, Frankston Hospital, Frankston VIC 3199

Country

Australia

Phone

+61 418295933

Fax

[email protected]

Contact person for public queries

Name

Michele Callisaya

Address

2 Hastings Rd Ngarnga Centre, Frankston Hospital, Frankston VIC 3199

Country

Australia

Phone

+61 418295933

Fax

[email protected]

Contact person for scientific queries

Name

Angel Lee

Address

2 Hastings Rd Ngarnga Centre, Frankston Hospital, Frankston VIC 3199

Country

Australia

Phone

+61 3 99044662

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

What supporting documents are/will be available?

Doc. No.	Type	Email	Other Details	Attachment
20156	Study protocol	[email protected]		386502-(Uploaded-29-08-2023-15-42-15)-Study-related document.pdf
20157	Informed consent form	[email protected]		386502-(Uploaded-29-08-2023-15-58-38)-Study-related document.pdf
20158	Ethical approval	[email protected]		386502-(Uploaded-29-08-2023-15-59-04)-Study-related document.pdf
20159	Other	[email protected]	Explanatory statements	386502-(Uploaded-29-08-2023-15-59-34)-Study-related document.pdf
20163	Other	[email protected]	Surveys:e-module	386502-(Uploaded-29-08-2023-16-01-02)-Study-related document.pdf
20164	Other	[email protected]	Surveys: May 2024 e-module	386502-(Uploaded-29-08-2023-16-02-13)-Study-related document.pdf
20165	Other	[email protected]	Surveys: DTA training	386502-(Uploaded-29-08-2023-16-03-04)-Study-related document.pdf

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.

Trial Review

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