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Trial registered on ANZCTR


Registration number
ACTRN12616001726448
Ethics application status
Approved
Date submitted
8/12/2016
Date registered
16/12/2016
Date last updated
14/02/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
PEARL - Program Enhancing Adjustment to Residential Living
Scientific title
A cluster RCT of a novel psychological intervention to reduce depression among at-risk older adults transitioning to residential aged care
Secondary ID [1] 290713 0
'Nil Known'
Universal Trial Number (UTN)
U1111-1190-6752
Trial acronym
PEARL
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 301275 0
Anxiety 301276 0
Quality of LIfe 301277 0
Adjustment 301278 0
Functional dependency 301279 0
Condition category
Condition code
Mental Health 301036 301036 0 0
Depression
Mental Health 301037 301037 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
PEARL program is an intervention designed to enhance new residents to permanent aged care adjust to residential living. It is designed to be suitable for the majority of depressed residents in residential aged care facilities (RACFs), including those with mild-moderate dementia. RACFs will be matched by organisation and facility size (number of permanent beds). Matched RACFs will be randomly allocated to the intervention 'care as usual' plus PEARL intervention or ' care as usual' (control group) using a random number generator by a biostatistician who is not otherwise involved in the project and blind to the allocated condition. Residents who are admitted to RACFs over a 24 month recruitment period will be referred to the study by the facility manager (or admission officer) and approached by a researcher for consent(directly or via next of kin as appropriate) and will be screened for eligibility within four weeks of their admission. Participants in RACFs allocated to the intervention group will receive the PEARL program. This intervention group is described as 'care as usual' plus PEARL intervention.
Depression is a serious issue in RACFs, affecting one third of older people, but current management approaches are inadequate. Late life depression is associated with higher mortality and increased care needs. The transition to a RACF is often highly traumatic and newly admitted residents are at an extreme risk of depression. The transition period therefore represents an ideal opportunity for early intervention. Currently, there are no interventions specifically targeting depressed aged care residents early in their admission to RACFs. The PEARL program addresses the key factors that facilitate adjustment to life in RACFs. They key factors include the resident's view or perception of the move, social support, self-efficacy, autonomy, perceived control and meaningful activity. These factors are aligned with the framework and key constructs of Self-Determination Theory (SDT) of autonomy, relatedness and competence, and Ryff's theoretical model of late life adjustment where environmental mastery, autonomy and purpose in life have been confirmed as essential components of psychological wellbeing and healthy ageing and predict successful adjustment to RACFs.
PEARL intervention uses SDT and behavior therapy framework to orient newly admitted residents to their environment and is designed to encourage collaboration with residents and staff to develop care approaches that enhance their purpose in life, autonomy and environmental mastery.
PEARL program is delivered over seven weeks and consists of three weekly 60 minute individual sessions with residents in a one-on-one format in the privacy of residents' own rooms plus two additional booster sessions provided two and four weeks after the final session to review and modify strategies. Session 1 will focus on orientation to the aged care facility and social support. Session 2 will focus on enhancing purpose in life through identification of residents' personal goals and values. Session 3 will assist residents enhance their autonomy and environmental mastery through identification of daily choices important to them and the development of strategies to maintain or adapt their level of autonomy within the RACF environment. The booster sessions will review the program and reinforce progress and assist residents address any concerns or problems.
PEARL is simple, brief, and adapted to the characteristics of each RACF and is tailored to each resident's needs, interests, aptitudes and background. Strategies selected to meet resident's needs are behavioral in nature specifically tailored to each individual's level of cognitive function.
PEARL program will be delivered by three trained clinicians using a highly structured treatment manual. Clinicians will have experience in RACFs settings, with a background in psychology, nursing, occupational therapy or social work. Treatment fidelity will be monitored using a random review of audio-taped sessions (5% of total sessions, spread across the 5 sessions) with sessions coded for adherence to the intervention manual. The clinicians will receive fortnightly individual clinical supervision with principle investigator during the first six month of the intervention period, thereafter reducing in frequency to meet their clinical needs.
RACF staff are actively involved in the implementation of PEARL intervention. A recent meta-analysis found that psychological treatments for depression that involved RACF staff collaboration achieved better outcomes. Thus, each session with a resident will be followed by a 30 minute consultation with a key staff member involved in their daily care and care plan development. To ensure successful collaboration with RACF staff, a one hour training session will be provided to RACF staff as group sessions to introduce the program to as many staff as possible and establish rapport with the research team. This training will incorporate key learning from the program. In addition, clinicians will provide ongoing support and supervision to RACF staff to assist them implement the selected strategies or modify individual care plans where necessary.
Intervention code [1] 296610 0
Behaviour
Intervention code [2] 296611 0
Prevention
Intervention code [3] 296612 0
Lifestyle
Comparator / control treatment
RACFs will be matched by organisation and facility size (number of permanent beds). Matched RACFs will be randomly allocated to the intervention 'care as usual' plus PEARL intervention or ' care as usual' (control group) using a random number generator by a biostatistician who is not otherwise involved in the project and blind to the allocated condition. Residents who are admitted to RACFs over a 24 month recruitment period will be referred to the study by the facility manager (or admission officer) and approached by a researcher for consent(directly or via next of kin as appropriate) and will be screened for eligibility within four weeks of their admission. Participants in RACFs allocated to the 'care as usual' (control) will not receive the PEARL program or any additional intervention. Participants in both groups will continue to receive the usual care offered to RACF residents including pharmacotherapy, ad hoc support from staff, and standard activities. 'Usual care' in Australian RACFs does not typically include psychotherapy. Changes in medications will be recorded and accounted for in our analyses.
Control group
Active

Outcomes
Primary outcome [1] 300458 0
Presence of current Major depressive disorder and persistent depressive disorder will be determined using the Structured Clinical interview SCID-5
Timepoint [1] 300458 0
Time point 1: T1 Base line - within 28 days of being admitted RACFs for all participants
Time point 2: 8 weeks after T1 base line
Time point 3: 16 weeks after T1 base line
Time point 4: 31 weeks after T1 baseline
Primary outcome [2] 300519 0
Severity of Depressive symptom will be assessed using the Cornell Scale for Depression in Dementia
Timepoint [2] 300519 0
Time point 1: T1 Base line - within 28 days of being admitted RACFs for all participants
Time point 2: 8 weeks after T1 base line
Time point 3: 16 weeks after T1 base line
Time point 4: 31 weeks after T1 baseline
Secondary outcome [1] 330015 0
Level of Anxiety assessed using Geriatric Anxiety Inventory Pachana (2007) 20 item scale
Timepoint [1] 330015 0
Time point 1: T1 Base line - within 28 days of being admitted RACFs for all participants
Time point 2: 8 weeks after T1 base line
Time point 3: 16 weeks after T1 base line
Time point 4: 31 weeks after T1 baseline
Secondary outcome [2] 330016 0
Quality of life - life satisfaction, leisure and participation, satisfaction with living situation, satisfaction with family relations, social relations and general wellbeing assessed using Quality of Life-AD (QoL-AD) Edelman et al (2005) 15 items
Timepoint [2] 330016 0
Time point 1: T1 Base line - within 28 days of being admitted RACFs for all participants
Time point 2: 8 weeks after T1 base line
Time point 3: 16 weeks after T1 base line
Time point 4: 31 weeks after T1 baseline
Secondary outcome [3] 330200 0
Instrumental Activities of Daily Living Scale
Timepoint [3] 330200 0
Time point 1: T1 Base line - within 28 days of being admitted RACFs for all participants
Time point 2: 8 weeks after T1 base line
Time point 3: 16 weeks after T1 base line
Time point 4: 31 weeks after T1 baseline
Secondary outcome [4] 330201 0
Index of Relocation Adjustment
Timepoint [4] 330201 0
Time point 1: T1 Base line - within 28 days of being admitted RACFs for all participants
Time point 2: 8 weeks after T1 base line
Time point 3: 16 weeks after T1 base line
Time point 4: 31 weeks after T1 baseline

Eligibility
Key inclusion criteria
(i) Older adults aged above 60 years
(ii) newly admitted first permanent placement within 28 days of admission to permanent care within residential aged care facility
(iii) a score above 15 on the Mini Mental Examination, based on NICE guidelines - indicative of mild to moderate cognitive impairment, or normal cognition
(iv) fluency in English
Minimum age
60 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
(i) acute severe medical illness likely to compromise participation in the program
(ii) severe or moderately severe cognitive impairment (Mini Mental Examination score below 15, based on NICE guidelines)
(iii) non-fluency in English

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
central randomisation by computer by a biostatistician
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Facilities within each strata were allocated a random ID, using randomised list generator provided by random.org. The facilities were then sorted in ascending sequence by their random ID, within their respective strata. To ensure 1:1.3 allocation ratio, two allocation sequences were then created, one for each stratum. For the below 100 beds stratum (12 facilities), the allocation sequence consisted of 5 “Intervention” and 7 “Control” codes. For the 100 beds and above stratum (20 facilities), the allocation sequence consisted of 9 “Intervention” and 11 “Control” codes. Each allocation sequence was then randomised using randomisation list generated by random.org and matched sequentially with our list of facilities.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Participants recruited from RACFs who are allocated to 'care as usual' plus PEARL intervention will receive the intervention.
Participants recruited from RACFs who are allocated to 'care as usual' (control) will not receive the intervention.
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Recruitment method:
We will recruit 308 participants from 22 RACFs with a mean of 92 bed places. A sample size calculator for cluster-randomised trials was used to estimate the required study sample size. Estimations were based on expectations of k = 22 RACFs, with an average of 14 participants each (n = 308) over a 24-month period, adjusted to allow for:
(i) a within-cluster correlation, reflected in an intra-class correlation of .054 and
(ii) a 6 month attrition rate of 25% based on previous research with newly admitted RACF residents. The final sample of n = 231 participants at follow-up will provide 80% power to detect a moderate effect (greater than d = .48) with 5% Type I error (two-sided). The assumptions used in our sample size estimations were based on current data on the Australian RACF population as well as our own Randomised Control Trials. Approximately one third of permanent RACF places are turned over each year. Since the RACFs in our study have a mean of 92 places, we estimate that 61 new residents will be admitted to each facility over the two-year study period. We assume that approximately half of the new residents in each RACF (n = 31) will have significant symptoms of depression and that 75% of those (n = 23) will present with normal cognition or mild-moderate dementia and speak fluent English. We have estimated that at least 14 of the 23 potential participants in each RACF (61%) will agree to participate, a conservative estimate based on previous trials.
Statistical analysis:
For the analysis of quantitative data, descriptive statistics will be used to summarise baseline characteristics and patterns of change over time in both RACFs and residents.
Primary analyses will be on an intention to treat basis, with supplementary ‘per protocol’ analyses. To account for the within-facility clustering of participants and repeated assessments, differences in the outcomes of the intervention and control groups will be compared with multilevel modelling. For each outcome, a separate three-level model will be specified, with repeated measurements as level 1, individuals as level 2, and RACFs as level 3. The models will include group allocation, assessment time, and group by time interaction as predictors and baseline values of the corresponding outcome, medication use at each assessment time, and organisational climate (measured at the level of a RACF) as covariates. Individual and RACF will be modelled as random effects and the remaining variables will be modelled as fixed effects. Supplementary analyses will test treatment allocation by cognitive impairment interaction to examine whether the effect of intervention differs according to the presence of cognitive impairment. Our sample size will allow us to detect a moderate interaction effect (eta squared = 0.06) with 80% power (alpha=0.05, 2-sided). To explore the mediational role of environmental mastery, autonomy, purpose in life and adjustment to RACF, multilevel path analysis (with individuals clustered within RACFs) will be undertaken, using both baseline and follow up data, and controlling for organisational climate. In all analyses, missing outcomes data will be handled with conditional maximum likelihood estimation; missing baseline data will be checked for randomness and imputed accordingly. The impact of possible non-random attrition will be explored with simulation analyses.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 14849 0
3000 - Melbourne
Recruitment postcode(s) [2] 14840 0
3011 - Footscray
Recruitment postcode(s) [3] 14824 0
3020 - Sunshine
Recruitment postcode(s) [4] 14830 0
3021 - St Albans
Recruitment postcode(s) [5] 14841 0
3030 - Werribee
Recruitment postcode(s) [6] 14835 0
3034 - Avondale Heights
Recruitment postcode(s) [7] 14833 0
3040 - Essendon
Recruitment postcode(s) [8] 14837 0
3046 - Glenroy
Recruitment postcode(s) [9] 14844 0
3052 - Parkville
Recruitment postcode(s) [10] 14828 0
3083 - Bundoora
Recruitment postcode(s) [11] 14825 0
3084 - Rosanna
Recruitment postcode(s) [12] 14842 0
3085 - Macleod
Recruitment postcode(s) [13] 14829 0
3090 - Plenty
Recruitment postcode(s) [14] 14839 0
3101 - Kew
Recruitment postcode(s) [15] 14838 0
3124 - Camberwell
Recruitment postcode(s) [16] 14847 0
3135 - Heathmont
Recruitment postcode(s) [17] 14845 0
3136 - Croydon
Recruitment postcode(s) [18] 14848 0
3162 - Caulfield
Recruitment postcode(s) [19] 14834 0
3166 - Oakleigh
Recruitment postcode(s) [20] 14836 0
3170 - Waverley Gardens
Recruitment postcode(s) [21] 14831 0
3181 - Windsor
Recruitment postcode(s) [22] 14826 0
3187 - Brighton East
Recruitment postcode(s) [23] 14843 0
3191 - Sandringham
Recruitment postcode(s) [24] 14823 0
3199 - Frankston South
Recruitment postcode(s) [25] 14832 0
3804 - Narre Warren North
Recruitment postcode(s) [26] 14846 0
3810 - Pakenham

Funding & Sponsors
Funding source category [1] 295146 0
Government body
Name [1] 295146 0
NHMRC
Address [1] 295146 0
16 Marcus Clarke Street
Canberra City ACT 2600
Country [1] 295146 0
Australia
Primary sponsor type
Individual
Name
Dr Tanya Davison
Address
Institute for Health and Ageing
Australian Catholic University
Level 6
215 Spring Street
Melbourne Vic 3000
Country
Australia
Secondary sponsor category [1] 293965 0
University
Name [1] 293965 0
Australian Catholic University
Address [1] 293965 0
Melbourne Campus
115 Victoria Parade Fitzroy Victoria 3065
Country [1] 293965 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296492 0
Australian Catholic University's Human Research Ethics Committee
Ethics committee address [1] 296492 0
Research Services Office
Office of the Deputy Vice Chancellor (Research)
Australian Catholic University
Z Block, Level A, Room 13
1100 Nudgee Road
Nudgee QLD 4014
Ethics committee country [1] 296492 0
Australia
Date submitted for ethics approval [1] 296492 0
11/06/2016
Approval date [1] 296492 0
20/09/2016
Ethics approval number [1] 296492 0
2016-142H
Ethics committee name [2] 296493 0
Mercy Health Human Research Ethics Committee
Ethics committee address [2] 296493 0
Mercy Health Human Research Ethics Committee
Administrative Office
Mercy Hospital for Women
6th Floor
163 Studley Road
Heidelberg Vic 3084
Ethics committee country [2] 296493 0
Australia
Date submitted for ethics approval [2] 296493 0
26/09/2016
Approval date [2] 296493 0
25/10/2016
Ethics approval number [2] 296493 0
R16/53AC
Ethics committee name [3] 299632 0
Churches of Christ in Queensland Research Ethics Group
Ethics committee address [3] 299632 0
41 Brookfield Road Kenmore
Queensland 4069
Ethics committee country [3] 299632 0
Australia
Date submitted for ethics approval [3] 299632 0
23/09/2016
Approval date [3] 299632 0
12/12/2016
Ethics approval number [3] 299632 0
Program to Enhance Adjustment to Residential Living (PEARL)

Summary
Brief summary
The transition to Residential Aged Care Facilities is often traumatic and newly admitted residents are at risk of depression. The transition period represents an ideal opportunity for early intervention.
AIMS
*To facilitate the adjustment of older adults new to permanent residential aged care.
*To improve new residents’ quality of life and reduce the severity and incidence of depression.
METHOD
*A cluster randomised controlled trial of a psychological intervention consisting of 5 individual sessions with residents.
*A key element of the intervention is that it is tailored to each resident’s needs, interests, aptitudes and background.
OUTCOMES
*Reduced severity of depressive symptoms in newly admitted residents, improved quality of life and adjustment to the residential aged care environment.
*PEARL program is likely to improve staff practices and competence in developing tailored care plans that meet the psychological needs of newly admitted aged care residents.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 71046 0
Dr Tanya Davison
Address 71046 0
Swinburne University of Technology John Street Hawthorn Victoria 3122
P O Box 218 Hawthorn Victoria 3122 Australia
Country 71046 0
Australia
Phone 71046 0
+61392144590
Fax 71046 0
Email 71046 0
tdavison@swin.edu.au
Contact person for public queries
Name 71047 0
Dr Tanya Davison
Address 71047 0
Swinburne University of Technology John Street Hawthorn Victoria 3122
P O Box 218 Hawthorn Victoria 3122 Australia
Country 71047 0
Australia
Phone 71047 0
+61392144590
Fax 71047 0
Email 71047 0
tdavison@swin.edu.au
Contact person for scientific queries
Name 71048 0
Dr Tanya Davison
Address 71048 0
Swinburne University of Technology John Street Hawthorn Victoria 3122
P O Box 218 Hawthorn Victoria 3122 Australia
Country 71048 0
Australia
Phone 71048 0
+61392144590
Fax 71048 0
Email 71048 0
tdavison@swin.edu.au

No information has been provided regarding IPD availability
Summary results
No Results