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Trial registered on ANZCTR


Registration number
ACTRN12619000676112
Ethics application status
Approved
Date submitted
10/04/2019
Date registered
6/05/2019
Date last updated
17/09/2021
Date data sharing statement initially provided
6/05/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
BEFRIENDAS study: The impact of befriending on depression, anxiety, social support and loneliness in older adults living in residential aged care facilities
Scientific title
BEFRIENDAS study: The impact of befriending on depression, anxiety, social support and loneliness in older adults living in residential aged care facilities
Secondary ID [1] 297175 0
Nil known
Universal Trial Number (UTN)
Trial acronym
BEFRIENDAS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 311223 0
Anxiety 311224 0
Loneliness 311225 0
Lack of social support 311226 0
Condition category
Condition code
Mental Health 309851 309851 0 0
Depression
Mental Health 309852 309852 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Up to half of people living in residential aged care facilities (RACFs) have significant depression symptoms. Many residents are socially isolated in RACFs even though they are in communal living, and social isolation is a contributor to depression. The literature provides some evidence for ‘befriending’ in alleviating depression, anxiety, social isolation and loneliness as well as improving quality of life and wellbeing, but few studies have been conducted for older adults living in RACFs. Befriending is non-directive emotional and social support generally provided on a regular basis by volunteers.
Volunteers will be recruited and trained using beyondblue resources and a manual for befriending. Befriending will be delivered by volunteers to residents at least weekly for four months. Befriending will be one-on-one and preferably face to face at RACFs, but can include telephone calls or skype calls if a face to face visit is not possible that week, to accumulate 30-60 minutes of befriending per week. Befriending conversations will consist of neutral topics of interest to both parties, including discussions around hobbies, family, neutral news topics, and other topics to be negotiated between the two parties and tailored to individual interests. Each befriending visit will be audio recorded to enable the project team to monitor a 10% random sample to test fidelity to treatment.
Intervention code [1] 313442 0
Treatment: Other
Comparator / control treatment
The control group will receive usual care. Usual care is defined as the regular, everyday care the older person receives in the residential care, including care from all health professionals and all medications that they would usually recieve. The control group will also receive befriending as a gesture of good will after the study is completed.
Control group
Active

Outcomes
Primary outcome [1] 318803 0
Depression as measured by the 15 item Geriatric Depression Scale
Timepoint [1] 318803 0
Baseline (T1), 2 months (T2) and 4 months (T3 - primary endpoint) after the commencement of the intervention
Secondary outcome [1] 366096 0
Anxiety as measured by the Geriatric Anxiety Inventory (20 item version)
Timepoint [1] 366096 0
Baseline (T1), 2 months (T2), and 4 months (T3) after the commencement of the intervention
Secondary outcome [2] 366097 0
Cost of delivering befriending based on quality of life measured by the EQ-5D-5L as the main measure of effectiveness
Timepoint [2] 366097 0
Baseline (T1), 2 months (T2), and 4 months (T3) after the commencement of the intervention
Secondary outcome [3] 366098 0
Loneliness as measured by the UCLA Loneliness Scale
Timepoint [3] 366098 0
Baseline (T1), 2 months (T2), and 4 months (T3) after the commencement of the intervention
Secondary outcome [4] 366099 0
Social support as measured by the Lubben Social Network Scale-6
Timepoint [4] 366099 0
Baseline (T1) and 4 months (T3) after the commencement of the intervention
Secondary outcome [5] 366100 0
Feasibility and acceptability of the befriending intervention as measured by comments in interviews
Timepoint [5] 366100 0
Interviews will be conducted with up to 15 residents depending on data saturation. These interviews will be conducted at the conclusion of the befriending intervention.
Secondary outcome [6] 369262 0
Health service usage in 4 months prior to timepoint - Total number of ED presentations, total number of inpatient hospital stays, GP consults, specialist consults (psychogeriatrician, psychologist, psychiatrist, other). This information will be obtained from resident files
Timepoint [6] 369262 0
Baseline (T1) and 4 months (T3) after the commencement of the intervention

Eligibility
Key inclusion criteria
Initial Eligibility criteria
1. Cornell Scale for Depression in Dementia (CSDD) score of 8 or greater as assessed by RACF staff (no longer than six months prior). The CSDD is routinely used in RACFs as part of funding reliability assessments and has been found to be a valid and reliable tool (Korner et al, 2006) or
2. Psychogeriatric Assessment Scale – Cognitive Impairment Scale (PAS-CIS; Jorm & Mackinnon, 1995) score equal to or less than 10, as assessed by RACF staff (no longer than six months prior) or
3. Clinical judgement of clinical care manager indicating significant depression or anxiety
symptoms, confirmed in further screening.
Further Eligibility screen
1. Geriatric Depression Scale (GDS;15 item version; Li et al, 2015) score of 4 or greater as assessed by the research team.
2. General Practitioner Assessment of Cognition (GPCOG; Brodaty et al, 2002) score of 4 or greater as assessed by the research assistants.
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria for residents:
-inability to give informed consent or understand English;
-PAS-CIS score greater than 10 (indicating moderate or severe cognitive impairment);
-progressive, unstable medical or neurological illness.
-under 65 years (Participants will be over 65 in line with the aims of the funding call).

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)
A trial statistician will be provided outside the project team. Participants will be randomly allocated to one of two groups after baseline assessment. A computer-generated random sequence available to the trial statistician but not other research staff will be used to produce random allocation. Randomization allocation will be provided to an un-blinded researcher (not the assessors who are blind to allocation) who will arrange for the allocated therapy to commence. The result of the revealed randomization will be confirmed by email to verify that the correct allocation has taken place.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A computer-generated random sequence will be used to produce random allocation using a randomized permuted block design with block size of 2 in order to maintain approximately balanced randomization throughout the trial.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
There are no equivalent RACF studies published on which to base an effect size for power calculations. We are aiming for a clinically significant change of greater than two points in the Geriatric Depression Scale 15 (Vinkers et al, 2004). Based on the average effect size of 0.27 for short term outcome studies of mostly older adults with depression in primary care settings, we estimate that with data collection spread over a 3 year period, and allowing for a higher dropout rate than usual of 20% given low life expectancy among RACF residents, recruiting 272 participants per arm would achieve 80% power, with a statistical significance of 0.05. This will require recruiting approximately 182 participants per year during the three year data collection period of the trial. In practice, participants will be recruited in blocks of two in each participating home, with two assigned to each group, to ensure balance.
Loss to follow-up: it is anticipated that loss to follow-up may be higher than in community studies because of low life expectancy in RACF settings, which is why drop outs have been estimated at higher than normal 20%.
Data analysis will investigate possible mediating variables explaining any relationship found between befriending and depression symptoms. Possible intervening variables of interest include baseline depression/anxiety (higher is worse); baseline cognition (higher is better); baseline social contacts (less is better); intensity of befriending (more face to face contact is better). Hypotheses: (i) Befriending will lead to greater improvement in depression scores than treatment as usual. (ii) Befriending will lead to greater reduction in anxiety scores than treatment as usual. (iii) social support will be improved by befriending (iv) loneliness will be reduced by befriending. Comparison will be made between participants who completed the study and those who dropped out to ensure that there is no difference between these two groups of participants. The adequacy of the randomisation procedures will be assessed by comparison of all baseline characteristics between the four study groups using ^2 for dichotomous variables and either ANOVA or Kruskall-Wallis test for continuous data. The primary and secondary outcomes (change over time in depression, loneliness, quality of life) will be analysed using the Generalised Estimating Equations (GEE) approach, a marginal model in which the effect of covariates on the outcome is averaged over individuals at each point in time and is compared over time (Liang and Zeger, 1986). An exchangeable working matric will be used to account for correlation and dependence between repeated measurements on the same individual over time while adjusting for study covariates.
Qualitative analysis: Digital recording of interviews will be analysed by extracting significant statements or codes. Each statement is compared to previous statements. As analysis progresses, categories or themes emerging will be tagged to address each of the key interview questions. As analysis continues, previous codes of information will be compared to new units in the same and in different categories. Repetitious codes will then be combined into key category clusters. Findings will be combined into exhaustive descriptions of the experiences and perceptions of participants and volunteers under each category, and emergent themes identified. Codes, categories and final themes will be validated by two researchers during the data analysis process.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
12/03/2019
Date of last participant enrolment
Anticipated
23/08/2022
Actual
Date of last data collection
Anticipated
31/12/2022
Actual
Sample size
Target
544
Accrual to date
93
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 301727 0
Government body
Name [1] 301727 0
The National Health and Medical Research Council
Country [1] 301727 0
Australia
Funding source category [2] 301737 0
Charities/Societies/Foundations
Name [2] 301737 0
Beyondblue
Country [2] 301737 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] 302574 0
None
Name [1] 302574 0
Address [1] 302574 0
Country [1] 302574 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302452 0
Austin Health Human Research Ethics Committee
Ethics committee address [1] 302452 0
Ethics committee country [1] 302452 0
Australia
Date submitted for ethics approval [1] 302452 0
04/12/2018
Approval date [1] 302452 0
19/12/2018
Ethics approval number [1] 302452 0
ND 45941/2018

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

Contacts
Principal investigator
Name 90266 0
Prof Colleen Doyle
Address 90266 0
National Ageing Research Institute
Gate 4, 34-54 Poplar Road
Parkville, VIC 3052
Country 90266 0
Australia
Phone 90266 0
+61 (03) 8387 2305
Fax 90266 0
Email 90266 0
c.doyle@nari.edu.au
Contact person for public queries
Name 90267 0
Marcia Fearn
Address 90267 0
National Ageing Research Institute
Gate 4, 34-54 Poplar Road
Parkville, VIC 3052
Country 90267 0
Australia
Phone 90267 0
+61 03 83872305
Fax 90267 0
Email 90267 0
m.fearn@nari.edu.au
Contact person for scientific queries
Name 90268 0
Marcia Fearn
Address 90268 0
National Ageing Research Institute
Gate 4, 34-54 Poplar Road
Parkville, VIC 3052
Country 90268 0
Australia
Phone 90268 0
+61 03 83872512
Fax 90268 0
Email 90268 0
m.fearn@nari.edu.au

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?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
1839Ethical approval    376802-(Uploaded-10-04-2019-11-58-05)-Study-related document.pdf



Results publications and other study-related documents

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

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseBEFRIENding for Depression, Anxiety and Social support in older adults living in Australian residential aged care facilities (BEFRIENDAS): randomised controlled trial protocol.2021https://dx.doi.org/10.1186/s12877-021-02233-7
N.B. These documents automatically identified may not have been verified by the study sponsor.