Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12614000043639
Ethics application status
Approved
Date submitted
7/01/2014
Date registered
17/01/2014
Date last updated
17/01/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
A person-centred model of residential respite care transition support: The Transition Support-Person Centred Care (TS-PCC) Program for family caregivers and care recipients with dementia
Scientific title
A randomised control trial of the use of the Transition Support - Person Centred Program (TS-PCC) compared with usual care, for family caregivers and care recipients with dementia, to improve the experience of residential respite care.
Secondary ID [1] 283831 0
Nil
Universal Trial Number (UTN)
U1111-1151-7620
Trial acronym
TS-PCC
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dementia 290809 0
Condition category
Condition code
Neurological 291178 291178 0 0
Dementias
Public Health 291253 291253 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The TC-PCC Intervention is a structured, person-centred approach aimed at facilitating a positive residential respite care experience for both people with dementia and their carers at each stage of the process of using residential respite care, from the preparation for respite care, through the respite experience and after the return home. Intervention will commence 1-2 weeks prior to admission and continues throughout the length of the respite admission (approximately 1-6 weeks) for a total duration ranging from 3-8 weeks depending on length of admission. A core feature of the Intervention is a liaison nurse, who will be the pivotal point of connection between the dyad and Residential Aged Care Facility (RACF) staff. The specific components of the Intervention include: A. Structured Person-Centred Communication (Respite Care Personal Profile; Pre-admission case conference between liaison nurse, care recipient and caregiver; up to daily call/email to care giver from liaison nurse to provide up to date feedback on care recipients status; exit interview from liaison nurse to give hand over to caregiver); and B. Person-Centred preparation for respite experience: prepare simple memory book to aid transition; familiar items bag; and carer comfort review to establish what support the caregiver needs.
Intervention code [1] 288517 0
Other interventions
Comparator / control treatment
The control group will receive usual care i.e standard admission procedures, handover and day to day care processes of the residential aged care facility.
Control group
Active

Outcomes
Primary outcome [1] 291163 0
A decrease in reported frequency of behavioural symptoms of dementia (informed by carer) measured by the Revised Memory and Behavior Checklist (teri et al., 1992)
Timepoint [1] 291163 0
Baseline (1-2 weeks pre admission), during admission (halfway through admission period), immediately post admission (up to 1 week after discharge) and medium term post admission (3 months post discharge)
Primary outcome [2] 291164 0
Quality of life for the person with dementia will be measured using the Quality of Life - Alzheimer's Disease - Long Term Care/Community
Timepoint [2] 291164 0
Measured at: pre admission, during admission (halfway through admission period), immediately post admission, and medium term post admission (3 months)
Primary outcome [3] 291166 0
Positive caring experience will be measured using the Positive Aspects of Caregiving scale
Timepoint [3] 291166 0
Will be measured at pre admission, immediately post admission, and medium term post admission (3 months)
Secondary outcome [1] 306162 0
Carer burden will be measured using the Zarit Caregiver Burden Inventory
Timepoint [1] 306162 0
Will be measured at pre admission, immediately post admission, and medium term post admission (3 months)
Secondary outcome [2] 306164 0
Sleep will be meausured for the person with dementia and the carer using the Geriatric Sleep Disturbance Scale
Timepoint [2] 306164 0
Will be measured pre-admission, during admission (approx. halfway through admission period), immediately post admission and medium term post admission (3 months)
Secondary outcome [3] 306165 0
The carers appraisal of the quality of care they provide to the person with dementia will be measured using the Exemplory Care Scale
Timepoint [3] 306165 0
Will be measured pre admission, immediately post admission and medium term post admission (3 months)
Secondary outcome [4] 306341 0
The intervention itself will also be assessed by questionnaire post admission to be completed by the carer, and by interview with the liaison nurses and care staff implementing the intervention. Carers and care staff will be asked about how effective they believed the intervention was, problems encountered and general feedback regarding the intervention. A cost effectiveness study is also being conducted for this intervention.
Timepoint [4] 306341 0
Staff surveys to be completed prior to commencement of the intervention phase, and during the intervention liaison nurses will keep a time diary of all related activities.

Eligibility
Key inclusion criteria
Group 1: Intervention group (n=10) - 65 years and older, with a diagnosis of dementia, with a confirmed booking for residential respite
Group 2: Control group (n=10) - 65 years and older, with a diagnosis of dementia, with a confirmed booking for residential respite
Group 3: Family caregiver intervention group (n=10): care giver of person with dementia, aged over 18 years, directly responsible for the care of participating person with dementia, have known person with dementia for more than 10 years, have 3 contacts per week with person with dementia
Group 4: Family caregiver control group (n=10): care giver of person with dementia, aged over 18 years, directly responsible for the care of participating person with dementia, have known person with dementia for more than 10 years, have 3 contacts per week with person with dementia
Group 5: Liaison Nurse (n=2): Registered, enrolled or endorsed enrolled nurses working at the intervention facilities, 21 years and older
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Carers under the age of 18 years, no diagnosis of dementia, no residential respite booking

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
To prevent cross contamination of intervention and control conditions, the facilities as a whole were allocated as either "intervention" or "control" through a randomisation process. This was done by an independent researcher before any participants were approached for enrolment. 4 participating units of a multi site residential aged care provider were randomised as control (n=2) or intervention (n=2). When carers make a booking for their family member with dementia to have residential respite at one of the 4 participating units, the admissions clerk (who is blind to group allocation) asks their permission to be contacted by the research team to participate in the study. Those who agree to participate receive the intervention or care as usual, dependent on which facility they are booked into.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
To prevent cross-contamination, stratified allocation by facility was employed. The four participating facilities were randomly allocated as either "intervention" or "control" via computerised random sequence generation. The person responsible for randomisation was blinded to facility names.
Participants are subsequently allocated to intervention or control groups according to which facility they book into.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
As this is a pilot study, formal sample size calculation was not conducted; however, we consulted with the RACF provider to estimate feasibility of sample size.
In order to determine whether the intervention achieves its aim, the change over time for all quantitative measures will be compared for the intervention and control groups. For example, the change in the number of behavioural and psychological symptoms exhibited by the PWD between the baseline (before admission) and “during” conditions will be compared according to whether or not they were in the intervention group. Similar comparisons will be made by looking at change between baseline, immediately after and three months after conditions in the various measures of behaviour, mood, quality of life, and sleep of the person with dementia and the quality of life, level of burden, carer experience, and sleep health of the carer. Statistical tests such as t-tests and ANCOVAs will be applied as warranted

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/09/2013
Actual
24/09/2013
Date of last participant enrolment
Anticipated
30/06/2014
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 7662 0
4017 - Sandgate

Funding & Sponsors
Funding source category [1] 288490 0
Government body
Name [1] 288490 0
Aged Care Service Improvement and Healthy Aging Grants Fund, Department of Health and Aging
Country [1] 288490 0
Australia
Primary sponsor type
University
Name
Queensland University of Technology
Address
Victoria Park Rd
Kelvin Grove QLD 4059
Country
Australia
Secondary sponsor category [1] 287257 0
Charities/Societies/Foundations
Name [1] 287257 0
Masonic Care Queensland
Address [1] 287257 0
60 Wakefield Street
SANDGATE Q 4017
Country [1] 287257 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290351 0
Masonic Care Queensland Human Research Ethics Committee
Ethics committee address [1] 290351 0
Ethics committee country [1] 290351 0
Australia
Date submitted for ethics approval [1] 290351 0
Approval date [1] 290351 0
12/11/2012
Ethics approval number [1] 290351 0
EC0038
Ethics committee name [2] 290373 0
Queensland University of Technology University Human Research Ethics Committee
Ethics committee address [2] 290373 0
Ethics committee country [2] 290373 0
Australia
Date submitted for ethics approval [2] 290373 0
Approval date [2] 290373 0
29/04/2013
Ethics approval number [2] 290373 0
1300000183

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

Contacts
Principal investigator
Name 45254 0
Dr Maria O'Reilly
Address 45254 0
School of Nursing, Queensland University of Technology
Victoria Park Road, Kelvin Grove, 4059 Qld.
Country 45254 0
Australia
Phone 45254 0
+61 7 31383057
Fax 45254 0
+61 7 31385941
Email 45254 0
[email protected]
Contact person for public queries
Name 45255 0
Maria O'Reilly
Address 45255 0
School of Nursing, Queensland University of Technology
Victoria Park Road, Kelvin Grove, 4059 Qld.
Country 45255 0
Australia
Phone 45255 0
+61 7 31383057
Fax 45255 0
+61 7 31385941
Email 45255 0
[email protected]
Contact person for scientific queries
Name 45256 0
Maria O'Reilly
Address 45256 0
School of Nursing, Queensland University of Technology
Victoria Park Road, Kelvin Grove, 4059 Qld.
Country 45256 0
Australia
Phone 45256 0
+61 7 31383057
Fax 45256 0
+61 7 31385941
Email 45256 0
[email protected]

No information has been provided regarding IPD availability


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
No additional documents have been identified.