Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000251123
Ethics application status
Approved
Date submitted
1/02/2019
Date registered
20/02/2019
Date last updated
26/04/2019
Date data sharing statement initially provided
20/02/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluating a specialist dementia training program for home care workers
Scientific title
RCT to evaluate the PITCH program (Promoting Independence Through quality dementia Care at Home)
Secondary ID [1] 297199 0
APP1137705
Universal Trial Number (UTN)
U1111-1227-3738
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dementia 311248 0
Condition category
Condition code
Neurological 309867 309867 0 0
Dementias
Public Health 309868 309868 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study aims to evaluate the impact of a dementia-specific training program (PITCH) delivered to home care workers who provide services to clients with dementia.

INTERVENTION
The PITCH program is a face-to-face training program for home care workers, specifically tailored in content for relevance to paid carers who service clients with dementia. The PITCH training program includes participant training materials and workbook with content on dementia and its impact/symptoms, person-centered care, effective communication, values, understanding triggers for behaviours and effective response, and resources for further reading. Program delivery includes case studies, role modelling and group discussions designed to provide experiential learning. The PITCH program is delivered face-to-face by an experienced trainer at two half-day sessions.

DESIGN
Approximately 120 people living with dementia at home and receiving a home care service will participate in the trial, as well as their family carers and paid home care staff. Over 200 home care workers will be trained in the PITCH program. The RCT will evaluate PITCH related outcomes for up to 12 months. All participants will be controls at baseline (0 months), with home care workers randomised to receive the intervention (PITCH) at one of two time-points during the RCT, and with all participants in the intervention receiving training by the end of the RCT.

RECRUITMENT
We will recruit from amongst our partner aged care service providers who provide home care services in Australia. We will recruit clients, their family carers (or non-relative carers), and home care workers.

CONSENT
Five Participant Information Sheet/Consent Forms have been developed to meet the needs of different participant groups: person with dementia, person responsible, family carer, non-relative carer and home care worker.

Client: Research staff will assess the potential participant's capacity to consent using the approach recommended by the Dementia Collaborative Research Centre.
If the researcher thinks that capacity is impaired, then an appropriate person responsible/medical treatment decision-maker may provide consent on behalf of the participant.

Family Carer / Home care worker: The researchers will contact potential family carer and home care worker participants, explain the project in detail and organise a time for the researcher to visit the participant to obtain informed consent. Separate Participant Information Sheet/Consent Form documents have been developed for the home care worker, family carer and non-relative carer.

WITHDRAWAL
Participants may withdraw from the study at any time. with no effect on their employment or relationship with their employer, the research team or the National Ageing Research Institute. The research team has experience in working with people with dementia, family carers and home care workers. Every effort will be made to support participants in the study and to mitigate the risk of withdrawal.

To maximise adherence to the PITCH program by home care workers, training will be undertaken during their normal working hours. They will receive their usual pay for attending interviews and training, and backfill payment will be made to the service providers. Attendance at training will be monitored, with any non-attendance followed up. The PITCH training program will also include several brief assessments, which will allow the research team to monitor training adherence.
Intervention code [1] 313455 0
Treatment: Other
Comparator / control treatment
This parallel cluster RCT will investigate the effectiveness of PITCH training on improving client, family carer and home care worker outcomes in real life settings, with clusters defined by service region. The participants in this RCT are clients, family carers, and home care workers, though only the home care workers will receive the intervention. Consistent with parallel cluster design, clusters of participants will be exposed to the intervention (PITCH training) sequentially over time, and will remain exposed to the intervention for the duration of the study. Home care workers randomised to the intervention group will receive the PITCH training at two months. Those randomised to the control group condition will carry out their usual work (business as usual) until they receive PITCH training at eight months. However, all participants will be administered the trial measures at Time Point 1, Time Point 2, and Time Point 3, regardless of training date. Both home care worker groups will remain in the study until RCT completion at 13 months.
Control group
Active

Outcomes
Primary outcome [1] 318818 0
Home care worker self-reported capacity and effectiveness in caring for a person with dementia (Sense of Competency in Dementia Care Staff, SCIDS)
Timepoint [1] 318818 0
Baseline, 6 months (primary timepoint) and 12 months post
Secondary outcome [1] 366135 0
Home care worker knowledge of dementia (Dementia Knowledge Assessment Scale, DKAS)
Timepoint [1] 366135 0
Baseline, 6 months and 12 months post
Secondary outcome [2] 366136 0
Home care worker attitude towards people with dementia (Dementia Attitudes Scale, DAS)
Timepoint [2] 366136 0
Baseline, 6 months and 12 months post
Secondary outcome [3] 366137 0
Home care worker stress related to the caring of people with dementia (Strain in Dementia Care Scale, SDCS)
Timepoint [3] 366137 0
Baseline, 6 months and 12 months post
Secondary outcome [4] 366138 0
Client quality of life (Adult Social Care Outcomes Toolkit SCT4, ASCOT)
Timepoint [4] 366138 0
Baseline, 6 months and 12 months post
Secondary outcome [5] 366139 0
Client experience receiving home care (Consumer Experience Report Pilot Draft, CER-Draft)
Timepoint [5] 366139 0
Baseline, 6 months, 12 months.
Secondary outcome [6] 366140 0
Client health-related quality of life (DEMQOL)
Timepoint [6] 366140 0
Baseline, 6 months and 12 months post
Secondary outcome [7] 366141 0
Client neuropsychiatric symptomatology (Neuropsychiatric Inventory, NPI).
Timepoint [7] 366141 0
Baseline, 6 months and 12 months post
Secondary outcome [8] 366142 0
Client functional disability (Disability Assessment for Dementia Scale, DAD).
Timepoint [8] 366142 0
Baseline, 6 months and 12 months post
Secondary outcome [9] 366144 0
Family Carer personal strain and role strain providing care to another person (Zarit Burden Interview, ZBI)
Timepoint [9] 366144 0
Baseline, 6 months and 12 months post
Secondary outcome [10] 366355 0
Economic measure: ICEpop CAPability measure for Older people (ICECAP-O)

Costs associated with the training and support provided to home care workers, and additional costs from clients and their families, will be captured. Health care service costs will be obtained from Medicare Benefits Schedule (MBS) and Pharmaceutical Benefits Scheme (PBS) data. This will include costs to participants and their use of other support services.

The ICECAP-O is a health and wellbeing-related quality of life measurement instrument important for older people. This scale will be administered to the client and family carer (as a proxy).

A prospective economic evaluation will be used to inform the cost-effectiveness of the PITCH program. Incremental costs will be estimated relative to the controls. In regards to outcomes, quality of life measures will be used to estimate a Quality Adjusted Life Year (QALY) profile for participants. This will be used to estimate the cost per QALY. Statistical uncertainty and sensitivity analyses will be attached to all results.
Timepoint [10] 366355 0
Baseline, 6 months and 12 months post
Secondary outcome [11] 366405 0
Economic measure: EuroQol 5 Dimensions 5 Levels (EQ-5D-5L)

The EQ-5D-5L or EQ-5D-5L Proxy Version measures quality of life and has either self-report or proxy versions. The scale will be administered to the client and family carer (as a proxy).

A prospective economic evaluation will be used to inform the cost-effectiveness of the PITCH program. Incremental costs will be estimated relative to the controls. In regards to outcomes, quality of life measures will be used to estimate a Quality Adjusted Life Year (QALY) profile for participants. This will be used to estimate the cost per QALY. Statistical uncertainty and sensitivity analyses will be attached to all results.

Costs associated with the training and support provided to home care workers, and additional costs from clients and their families, will be captured. Health care service costs will be obtained from Medicare Benefits Schedule (MBS) and Pharmaceutical Benefits Scheme (PBS) data. This will include costs to participants and their use of other support services.
Timepoint [11] 366405 0
Baseline, 6 months and 12 months post

Eligibility
Key inclusion criteria
Clients: Adult with a likelihood of/diagnosis of any dementia and receiving a home care service. No age restrictions. May or may not have capacity to provide informed consent to participate in research.

Family carers: Adult relative or someone who knows the client well (non-relative carer). Aged at least 18 years. Either living with the client or significantly close by, as to be ‘on call’. Spend a minimum of six hours with the client each week. Have capacity to provide informed consent to participate in research.

Home care workers: Adult employed by a home care provider and are the front-line service worker for clients. Have capacity to provide informed consent to participate in research.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Client unable to provide informed consent and person responsible/medical treatment decision-maker cannot sign acknowledgement form on behalf of client.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled 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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other
Other design features
This is a parallel cluster RCT. Home care workers will be randomised using REDCap software. Randomisation will be conducted by independent research staff (i.e. research staff who are not also conducting participant interviews to collect outcome measure data).
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
All quantitative data collected will be fully described using means and standard deviations for normally distributed, continuous data, medians and interquartile ranges for non-normally distributed data and numbers and percentages for categorical data.
Primary (SCIDS) and secondary measures (DKAS, ASCOT) will be analysed using Linear mixed models with random (participant, cluster) and fixed effect (time, treatment, time*treatment). Intention-to-treat methods will be used to handle missing data.
All-cause client transition from the home will analysed using survival analysis, employing Cox Proportional Hazards modelling and Kaplan-Meier survival curves. Clients of HCWs who did and did not receive PITCH training will be compared using Log rank tests.
A prospective economic evaluation will be used to inform the cost-effectiveness of the PITCH program. Incremental costs will be estimated relative to the controls. In regards to outcomes, quality of life measures will be used to estimate a Quality Adjusted Life Year (QALY) profile for participants. This will be used to estimate the cost per QALY. Statistical uncertainty and sensitivity analyses will be attached to all results.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
29/04/2019
Actual
Date of last participant enrolment
Anticipated
30/09/2019
Actual
Date of last data collection
Anticipated
30/09/2020
Actual
Sample size
Target
320
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC

Funding & Sponsors
Funding source category [1] 301750 0
Government body
Name [1] 301750 0
National Health and Medical Research Council
Country [1] 301750 0
Australia
Primary sponsor type
Other
Name
National Ageing Research Institute
Address
34-54 Poplar Road
Parkville Vic 3052
Country
Australia
Secondary sponsor category [1] 301494 0
None
Name [1] 301494 0
Address [1] 301494 0
Country [1] 301494 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302473 0
Austin Health Human Research Ethics Committee
Ethics committee address [1] 302473 0
Ethics committee country [1] 302473 0
Australia
Date submitted for ethics approval [1] 302473 0
04/09/2018
Approval date [1] 302473 0
22/01/2019
Ethics approval number [1] 302473 0
HREC/45314/Austin-2018

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

Contacts
Principal investigator
Name 90342 0
A/Prof Briony Dow
Address 90342 0
National Ageing Research Institute
34-54 Poplar Road
Parkville Vic 3052
Country 90342 0
Australia
Phone 90342 0
+61 3 8387 2305
Fax 90342 0
Email 90342 0
[email protected]
Contact person for public queries
Name 90343 0
Anita Goh
Address 90343 0
National Ageing Research Institute
34-54 Poplar Road
Parkville Vic 3052
Country 90343 0
Australia
Phone 90343 0
+61 3 8387 2305
Fax 90343 0
Email 90343 0
[email protected]
Contact person for scientific queries
Name 90344 0
Steven Savvas
Address 90344 0
National Ageing Research Institute
34-54 Poplar Road
Parkville Vic 3052
Country 90344 0
Australia
Phone 90344 0
+61 3 8387 2305
Fax 90344 0
Email 90344 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


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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

Documents added automatically
SourceTitleYear of PublicationDOI
EmbasePromoting Independence Through quality dementia Care at Home (PITCH): a research protocol for a stepped-wedge cluster-randomised controlled trial.2021https://dx.doi.org/10.1186/s13063-021-05906-1
EmbaseWhat constitutes 'good' home care for people with dementia? An investigation of the views of home care service recipients and providers.2022https://dx.doi.org/10.1186/s12877-021-02727-4
N.B. These documents automatically identified may not have been verified by the study sponsor.