Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000070437
Ethics application status
Approved
Date submitted
7/01/2016
Date registered
22/01/2016
Date last updated
30/01/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Lifeful - a Pilot Study of Restorative Care Program in Residential Aged Care
Scientific title
Feasibility of the Lifeful Restorative Care Program in Residential Aged Care
Secondary ID [1] 288181 0
Nil
Universal Trial Number (UTN)
U1111-1177-8294
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Residential Aged Care 297084 0
Condition category
Condition code
Public Health 297478 297478 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Staff will be trained to improve the utilization of residents existing care plans and to improve their overall engagement with the residents. The intervention will involve providing all consenting staff 12 hours of training over 12 months (four training sessions of three hours in duration every 3 months). Nurses and recreational activity officers will receive an additional 3 hours of training. Facility management will be supported in making changes to care planning and handover procedures. The support will be provided by the chief investigator to problem solve any obstacles or concerns that may arise when changing practice.
Training will be offered to all staff in units participating in the pilot study. Facility management will be supported by the chief investigator and research staff in making changes to care planning and handover procedures. The training will be interactive and delivered through a combination of visual presentations, discussions, worksheets, group exercises and role plays. The training sessions will be run by the chief investigator, research assistant or nominated employee of the facility (e.g., clinical nurse educator). All staff will be trained on the following components: (i) the importance of engagement, (ii) improving communication skills, (iii) using resident’s life story as part of their care plans, (iv) care planning as a team, (v) helping elicit resident goals, (vi) having a focus carer for each resident, (vii) understanding how to select and modify activities for people with dementia, (viii) encouraging social engagement and physical activity for residents, (ix) facilitating autonomy, choice and control (x) increasing the status of residents, (xi) increasing incidental exercising, (xii) risk, safety and physical activity, (xiii) incorporating quality of life and engagement conversations during handovers, (xiv) encouraging and enabling more independence through activities of daily living, (xv) sustaining the program Lifeful beyond the year and (xvi) staff self-care.
An additional 3-hour training session will be provided to the Recreational Activity Officers with the following content: (i) developing activity plans based on care plans, (ii) having a selection of tailored individual and group activities for residents, (iii) monitoring activity plans for each resident to ensure every resident has engaged in a meaningful activity and (iv) manipulating the environment to encourage engagement in activities.
An additional 3-hour training session will be provided to registered nurses where the following content will be covered: (i) clinical leadership – leading care planning teams, (ii) assessing function, utilizing the resident’s strengths, (iii) task analysis for activities of daily living (writing care plans to encourage greater independence), and (iv) incorporating quality of life and engagement conversations during handovers.
Descriptive counts will be kept of the training sessions, durations, and topics covered, and staff attendance at training. In addition, there will be a focus group to examine staff experience during the program, including how well they feel the program was adopted and adhered to.
There will be tool box sessions to reinforce material presented in the main training sessions and problem solve any obstacles during handover. These sessions will be facilitated by the Clinical Nurse Educator or facility manager. These sessions will be held once between training sessions or staff handovers and will vary from 5 to 15 minutes depending on the other items on the meeting and handover agenda. Toolbox sessions will run for the duration of the intervention (12 months).
Intervention code [1] 293615 0
Behaviour
Comparator / control treatment
No control group. The study is a pre-post interventional study.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 296887 0
Primary outcome is the feasibility of a delivering and evaluating Lifeful (a restorative care program). Descriptive counts will be kept of the training sessions, durations, and topics covered, and staff attendance at training. Counts will also be kept of the number of residents who consent to participate and drop out rates.
Timepoint [1] 296887 0
The primary outcome will be measured every three months.
Secondary outcome [1] 319630 0
One of the secondary outcomes will be to observe staff behavior change as assessed by attendance to staff training, completion of care plan audits for resident interviews, goal setting and completion of 'all about me sheets', focus carer involvement in care plan reviews, use of individualised activities with residents and use of activity diaries for resident participation. We will also describe whether suggested changes to care planning and handover procedures occur.
Timepoint [1] 319630 0
This outcome will be measured every three months.
Secondary outcome [2] 319766 0
Obstacles experienced in adhering to Lifeful will be assessed by a focus group which will examine staff experience during the program, including how well they feel the program was adopted and adhered to.
Timepoint [2] 319766 0
The focus group will occur at the end of the training sessions.
Secondary outcome [3] 319907 0
Demographic details from resident’s care file - age, sex, marital status, education, prior highest ranked occupation, duration in the residential aged care facility, diagnoses and duration of dementia (if present), and care plan and activities and engagement in progress notes.
Timepoint [3] 319907 0
0 months, 6 months and 12 months.
Secondary outcome [4] 320084 0
Quality of life of residents assessed by the Adult Social Care Outcomes Toolkit (ASCOT; Netten, Beadle-Brown, Caiels, Forder, Malley et al.): care home interview schedule (CHINT3), care home resident interview schedule (CHResidentINT3) and care homes observation schedule (CHOBS3)
Timepoint [4] 320084 0
0 months, 6 months and 12 months.
Secondary outcome [5] 320085 0
Daily functioning of residents (i.e. activities of daily living) assessed by Disability Assessment for Dementia (DAD; Gelinas, Gauthier, McIntyre, & Gauthier, 1999).
Timepoint [5] 320085 0
0 months, 6 months and 12 months.
Secondary outcome [6] 320086 0
Depression of residents assessed by Depression in Dementia (Alexopoulos, Abrams, Young & Shamoian, 1988)
Timepoint [6] 320086 0
0 months, 6 months and 12 months.
Secondary outcome [7] 320087 0
Physical mobility of residents as assessed by Short Physical Performance Battery (Guralnik, Simonsick, Ferrucci, Glynn, Berkman et al. 1994)
Timepoint [7] 320087 0
0 months, 6 months and 12 months.
Secondary outcome [8] 320088 0
Social engagement of residents assessed by Brief Sense of Community Scale (Peterson, Speer, & McMillan, 2008)
Timepoint [8] 320088 0
0 months, 6 months and 12 months.
Secondary outcome [9] 320089 0
Behavioural and psychological symptoms of dementia of residents assessed by Cohen Mansfield Agitation Inventory (Werner, Cohen-Mansfield, Koroknay, & Braun, 1994).
Timepoint [9] 320089 0
0 months, 6 months and 12 months.
Secondary outcome [10] 320090 0
Demographic details of care staff - age, sex, education and qualifications, occupation, position, number of hours per week, length of time they have worked in the residential aged care facility and length of time working in aged care
Timepoint [10] 320090 0
0 months, 6 months and 12 months.
Secondary outcome [11] 320091 0
Job satisfaction of care staff- Nursing Home Nurse Aide Job Satisfaction Questionnaire (NHNA – JSQ; Castle, 2007).
Timepoint [11] 320091 0
0 months, 6 months and 12 months.
Secondary outcome [12] 320092 0
Person centred care of care staff Person Centred Assessment Tool (Edvardsson, Fetherstonhaugh, Nay & Gibson, 2010)
Timepoint [12] 320092 0
0 months, 6 months and 12 months.
Secondary outcome [13] 320093 0
Feedback from person responsible/family on the restorative care program assessed by short interview
Timepoint [13] 320093 0
12 months

Eligibility
Key inclusion criteria
The inclusion criteria for residents will be: those who are living in the nominated units.
The inclusion criteria for person’s responsible will be: those who are responsible for residents in the nominated units.
The inclusion criteria of care staff will be: permanent employees of the nominated units, those who are able to read, write and communicate fluently in English and they consent to participation.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
The exclusion criteria of residents will be: withdrawal of consent, death, and relocation away from the residential aged care facility.
The exclusion criteria of person’s responsible will be: withdrawal of consent, death or relocation of the resident for whom they are responsible for.
The exclusion criteria of care staff will be: withdrawal of consent, cessation of employment at the residential aged care facility.

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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Given that it is a pilot study, it has not been designed to be powered to detect significant differences before and after the intervention. However the target sample sizes for staff, residents and person’s responsible size meet recommendations for pilot studies (Hertzog, 2008). Descriptive data will be produced of recruitment and attrition rates, as well as number of staff trained at each time point.

Care staff focus groups will be recorded and transcribed. Thematic analysis will be conducted using NVIVO focusing on barriers and reported changes in staff attitudes and behaviours and impact on residents. Care plan and progress note audit data will also be qualitatively analysed.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/02/2016
Actual
4/02/2016
Date of last participant enrolment
Anticipated
1/05/2017
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 15194 0
2290 - Redhead
Recruitment postcode(s) [2] 12808 0
2474 - Kyogle
Recruitment postcode(s) [3] 12810 0
2782 - Wentworth Falls

Funding & Sponsors
Funding source category [1] 292578 0
University
Name [1] 292578 0
University of Sydney
Country [1] 292578 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
Room M309B, M Block, 75 East Street, Lidcombe, NSW 2141
Country
Australia
Secondary sponsor category [1] 291300 0
None
Name [1] 291300 0
Address [1] 291300 0
Country [1] 291300 0
Other collaborator category [1] 278745 0
University
Name [1] 278745 0
University of New South Wales
Address [1] 278745 0
Centre for Healthy Brain Ageing, UNSW, Sydney, NSW 2052
Country [1] 278745 0
Australia
Other collaborator category [2] 278746 0
University
Name [2] 278746 0
Western Sydney University
Address [2] 278746 0
Narellan Road, Campbelltown NSW 2560
Country [2] 278746 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294060 0
Human Research Ethics Committee - University of Sydney
Ethics committee address [1] 294060 0
THE UNIVERSITY OF SYDNEY
Level 2, Margaret Telfer Building (K07), The University of Sydney, NSW, 2006
Ethics committee country [1] 294060 0
Australia
Date submitted for ethics approval [1] 294060 0
30/10/2015
Approval date [1] 294060 0
17/12/2015
Ethics approval number [1] 294060 0
2015/910

Summary
Brief summary
Restorative care to date has focused on physical and daily function but not considered social engagement and quality of life. This highlights the need to develop a restorative care program focusing on quality of life which specifically includes those with cognitive impairment.
The significance of this research is that if we show that Lifeful is feasible we will apply for funding to conduct a well-powered randomized controlled trial. This larger trial will add to a growing body of literature on restorative residential aged care, and is timely given the increasing focus of the Australian Aged Care Quality Agency and Department of Health on quality of life.
The pilot study aims are to examine:
1. To investigate the feasibility of a delivering and evaluating restorative care program (Lifeful),
2. To investigate staff behavior change and obstacles experienced in adhering to the program
3. To investigate the suitability of the outcome measures.

The hypotheses are:
1. It will be feasible to deliver the Lifeful training program to at least 80% of staff working on study units and it will be feasible to recruit at least 80% of residents to participate in the evaluation of the program
2. Care staff will improve engagement with residents as demonstrated by the person-centred assessment tool, as reported in focus groups and through an audit of resident care plans and progress notes.
3. The outcome measures chosen will be suitable i.e. residents can answer the questions, there are no floor or ceiling effects, they capture the changes on outcomes reported by staff in focus groups
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 62266 0
A/Prof Lee-Fay Low
Address 62266 0
Room 309B M Block Cumberland Campus. The University of Sydney. 75 East Street Lidcombe, NSW 2141
Country 62266 0
Australia
Phone 62266 0
+61 2 9036 7368
Fax 62266 0
Email 62266 0
lee-fay.low@sydney.edu.au
Contact person for public queries
Name 62267 0
Dr Shruti Venkatesh
Address 62267 0
Room 306 M Block Cumberland Campus. The University of Sydney. 75 East Street Lidcombe, NSW 2141
Country 62267 0
Australia
Phone 62267 0
+61 2 9351 9837
Fax 62267 0
Email 62267 0
shruti.venkatesh@sydney.edu.au
Contact person for scientific queries
Name 62268 0
A/Prof Lee-Fay Low
Address 62268 0
Room 309B M Block Cumberland Campus. The University of Sydney. 75 East Street Lidcombe, NSW 2141
Country 62268 0
Australia
Phone 62268 0
+61 2 9036 7368
Fax 62268 0
Email 62268 0
lee-fay.low@sydney.edu.au

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

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