ANZCTR - Registration

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

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

ACTRN12616001726448

Ethics application status

Approved

Date submitted

8/12/2016

Date registered

16/12/2016

Date last updated

25/10/2021

Date data sharing statement initially provided

25/10/2021

Date results provided

25/10/2021

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]

'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

Anxiety

Quality of LIfe

Adjustment

Functional dependency

Condition category

Condition code

Mental Health

Depression

Mental Health

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]

Behaviour

Intervention code [2]

Prevention

Intervention code [3]

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]

Presence of current Major depressive disorder and persistent depressive disorder will be determined using the Structured Clinical interview SCID-5

Timepoint [1]

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]

Severity of Depressive symptom will be assessed using the Cornell Scale for Depression in Dementia

Timepoint [2]

Secondary outcome [1]

Level of Anxiety assessed using Geriatric Anxiety Inventory Pachana (2007) 20 item scale

Timepoint [1]

Secondary outcome [2]

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]

Secondary outcome [3]

Instrumental Activities of Daily Living Scale

Timepoint [3]

Secondary outcome [4]

Index of Relocation Adjustment

Timepoint [4]

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

Sex

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

Completed

Date of first participant enrolment

Anticipated

16/01/2017

Actual

7/02/2017

Date of last participant enrolment

Anticipated

31/12/2018

Actual

3/05/2019

Date of last data collection

Anticipated

31/07/2019

Actual

23/12/2019

Sample size

Target

308

Accrual to date

Final

216

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment postcode(s) [1]

3199 - Frankston South

Recruitment postcode(s) [2]

3020 - Sunshine

Recruitment postcode(s) [3]

3084 - Rosanna

Recruitment postcode(s) [4]

3187 - Brighton East

Recruitment postcode(s) [5]

3083 - Bundoora

Recruitment postcode(s) [6]

3090 - Plenty

Recruitment postcode(s) [7]

3021 - St Albans

Recruitment postcode(s) [8]

3181 - Windsor

Recruitment postcode(s) [9]

3804 - Narre Warren North

Recruitment postcode(s) [10]

3040 - Essendon

Recruitment postcode(s) [11]

3166 - Oakleigh

Recruitment postcode(s) [12]

3034 - Avondale Heights

Recruitment postcode(s) [13]

3170 - Waverley Gardens

Recruitment postcode(s) [14]

3046 - Glenroy

Recruitment postcode(s) [15]

3124 - Camberwell

Recruitment postcode(s) [16]

3101 - Kew

Recruitment postcode(s) [17]

3011 - Footscray

Recruitment postcode(s) [18]

3030 - Werribee

Recruitment postcode(s) [19]

3085 - Macleod

Recruitment postcode(s) [20]

3191 - Sandringham

Recruitment postcode(s) [21]

3052 - Parkville

Recruitment postcode(s) [22]

3136 - Croydon

Recruitment postcode(s) [23]

3810 - Pakenham

Recruitment postcode(s) [24]

3135 - Heathmont

Recruitment postcode(s) [25]

3162 - Caulfield

Recruitment postcode(s) [26]

3000 - Melbourne

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

NHMRC

Address [1]

16 Marcus Clarke Street
Canberra City ACT 2600

Country [1]

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]

University

Name [1]

Swinburne University of Technology

Address [1]

PO Box 218, Hawthorn
Victoria 3122 Australia

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Australian Catholic University's Human Research Ethics Committee

Ethics committee address [1]

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]

Australia

Date submitted for ethics approval [1]

11/06/2016

Approval date [1]

20/09/2016

Ethics approval number [1]

2016-142H

Ethics committee name [2]

Mercy Health Human Research Ethics Committee

Ethics committee address [2]

Mercy Health Human Research Ethics Committee
Administrative Office
Mercy Hospital for Women
6th Floor
163 Studley Road
Heidelberg Vic 3084

Ethics committee country [2]

Australia

Date submitted for ethics approval [2]

26/09/2016

Approval date [2]

25/10/2016

Ethics approval number [2]

R16/53AC

Ethics committee name [3]

Churches of Christ in Queensland Research Ethics Group

Ethics committee address [3]

41 Brookfield Road Kenmore
Queensland 4069

Ethics committee country [3]

Australia

Date submitted for ethics approval [3]

23/09/2016

Approval date [3]

12/12/2016

Ethics approval number [3]

Program to Enhance Adjustment to Residential Living (PEARL)

Ethics committee name [4]

Swinburne University of Technology Human Research Ethics Committee

Ethics committee address [4]

PO Box 218, Hawthorn 
Victoria 3122 Australia

Ethics committee country [4]

Australia

Date submitted for ethics approval [4]

12/02/2018

Approval date [4]

22/02/2018

Ethics approval number [4]

SHR Project 2018/04

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

Dr Tanya Davison

Address

Swinburne University of Technology John Street Hawthorn Victoria 3122
P O Box 218 Hawthorn Victoria 3122 Australia

Country

Australia

Phone

+61392144590

Fax

[email protected]

Contact person for public queries

Name

Tanya Davison

Address

Swinburne University of Technology John Street Hawthorn Victoria 3122
P O Box 218 Hawthorn Victoria 3122 Australia

Country

Australia

Phone

+61392144590

Fax

[email protected]

Contact person for scientific queries

Name

Tanya Davison

Address

Swinburne University of Technology John Street Hawthorn Victoria 3122
P O Box 218 Hawthorn Victoria 3122 Australia

Country

Australia

Phone

+61392144590

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

This was not specified in the participant information and consent form. Participants did not agree to their data being made available.

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
13751	Study protocol	23. Davison, T. E., McCabe, M. P., Busija, L., O’Connor, D. W., Camões Costa, V., & Byers, J. (2020). A cluster randomised controlled trial of the Program to Enhance Adjustment to Residential Living (PEARL): a novel psychological intervention to reduce depression in newly admitted aged care residents. BMC Geriatrics, 20, 98.	https://doi.org/10.1186/s12877-020-1492-5

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	A cluster randomised trial of the program to enhance adjustment to residential living (PEARL): a novel psychological intervention to reduce depression in newly admitted aged care residents.	2020	https://dx.doi.org/10.1186/s12877-020-1492-5
Embase	The effectiveness of the Program to Enhance Adjustment to Residential Living (PEARL) in reducing depression in newly admitted nursing home residents.	2021	https://dx.doi.org/10.1016/j.jad.2020.12.087

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically