Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624001053516
Ethics application status
Approved
Date submitted
8/02/2024
Date registered
29/08/2024
Date last updated
29/08/2024
Date data sharing statement initially provided
29/08/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
The impact of Digitally Delivered Dog Assisted Activities on Depression
Scientific title
Are Digitally Delivered Dog Assisted Activities, (DDDAA), effective in improving depression among elderly persons in residential care facilities (specifically in Modified Monash Areas (MMA) 3-5)?
Secondary ID [1] 311503 0
Nil
Universal Trial Number (UTN)
U1111-1303-9966
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 332838 0
Condition category
Condition code
Mental Health 329551 329551 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Dog assisted activities - face to face - arm 1
Dog assisted activities - virtual delivery- arm 2

The investigational product is Dog Assisted Activities delivered by Noosa and Hinterland rural therapy dogs. A trained and registered therapy dog (and handler) will visit each participant for twenty (20) minutes, twice a week, for three (3) consecutive weeks. The visits will be face to face in facility one, delivered digitally in facility two. The third facility will receive no animal assisted activities.


For each session, the participants will be given the option to see the dog in their own room or with others in the common area. . Each session will start with a greeting phase, when each participant will have the opportunity to be introduced to the dog and handler and told about the dog ( such as name, breed, age, likes and dislikes). Thereafter, the handler will commence the different activities, which may include any of the following: petting the dog, holding the dogs lead, having the dog sit on the residents bed so they could hug the dog and feel its warmth and throwing a toy for the dog to fetch. The handler would encourage the resident to reminisce about previous animals the resident had
owned and to share stories of that experience. However, no activities will be mandatory.

A Team Leader with experience with animal assisted intervention, in both face to face delivery and digital interventions, will supervise in each facility during all sessions to ensure adherence to protocol. Digital delivery will be provided through live zoom sessions that will not be recorded.. Team leaders will keep an attendance checklists, as well as keep record of which participant interacted with which individual dog and handler team.
Intervention code [1] 327951 0
Treatment: Other
Comparator / control treatment
The control groups will not be offered any therapy dog activities, and their treatment will continue as usual, including diverse group activities such as, music therapy, singing, exercise, occupational therapy and handicrafts.
Control group
Active

Outcomes
Primary outcome [1] 337347 0
Change in depressive scores on GDS
Timepoint [1] 337347 0
Baseline and completion of delivery (3 week interval)
Secondary outcome [1] 431522 0
Comparison of virtual versus face to face delivery
Timepoint [1] 431522 0
Baseline and completion of delivery period (3 weeks)

Eligibility
Key inclusion criteria
Adults aged 65 - 85
Resident in one of the three residential facilities targeted
Ability to speak, read and understand English
Either gender
Based on Mini Mental State Examination (MMSE), can achieve minimum score of 25 to ensure capacity to consent and participate .
Minimum score of 5 on the GDS.
Minimum age
65 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients who have current symptoms of psychosis or dementia
Co morbidities preventing participation based on clinical opinion
Patients who are unable to comply with the trial procedure
Patients who are receiving other canine based therapy or interventions
Patients who articulate a fear or dislike for dogs

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)
General randomisation using a table created by computer software and concealed through a central randomisation process
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a table created by computer software
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
We conducted a priori power analysis using G power. Based on a medium effect size (Cohen’s f=.33) observed in Jain et al. (2020) an alpha of .05, for 3 groups and two tie points a sample size of 39 (13 participants per group) was required for statistical power of 95%. To account for attrition rates of 10-20% an additional three participants per group will be included.
we will calculate summary measures such as means, medians, standard deviations, and proportions for each treatment group and cluster. This helps in understanding the characteristics of the project population.
Inferential statistics:
we will use appropriate statistical tests to compare the outcomes between treatment groups. These include t-tests, chi-square tests, and analysis of variance (ANOVA). These tests help determine if any observed differences are statistically significant.
. Clustering effects: As this is a pilot study, we are unable to explore the effects of confounding variables. However, we will include them as covariates in our statistical model The design is a mixed design analysis of variance (ANOVA) with the fixed factors time (pre-intervention, post intervention) and dog assistance group (control, face-to-face, digital), and the covariates of age and gender.
. Random effects: the project will incorporate random effects into the statistical models to account for the variability between clusters. Random effects models will allow for the estimation of both fixed effects (treatment effects) and random effects (cluster-specific effects).
Power analysis: we conducted a power analysis to determine the sample size required to detect a meaningful effect size with sufficient statistical power. This ensures that the project has enough participants and clusters to detect significant differences if they exist. This project is a pilot project and will be on the lowest possible scale to still detect a significant difference.
Intention-to-treat analysis: The data will be analysed according to the randomised treatment assignment (cluster) regardless of compliance or dropouts. This approach maintains the integrity of the randomisation and provides a more conservative estimate of treatment effects.

Sensitivity analysis: we will perform sensitivity analyses to assess the robustness of the results to different assumptions or missing data. This helps evaluate the potential impact of any deviations from the planned analysis.

Subgroup analysis: we will conduct subgroup analyses to explore whether treatment effects differ across different subgroups of participants. This can help identify potential effect modifiers and inform personalised treatment strategies.

Multiple comparisons: we will adjust for multiple comparisons to control the overall type I error rate. Techniques such as Bonferroni correction or false discovery rate (FDR) adjustment can be used to account for the increased chance of false positives when conducting multiple statistical tests.

Reporting guidelines: we will follow established reporting guidelines, such as the CONSORT (Consolidated Standards of Reporting Trials) statement, to ensure transparent and comprehensive reporting of the trial methodology, results, and interpretation.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
12/04/2024
Date of last participant enrolment
Anticipated
Actual
3/05/2024
Date of last data collection
Anticipated
Actual
28/06/2024
Sample size
Target
48
Accrual to date
Final
48
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 42023 0
4570 - Gympie

Funding & Sponsors
Funding source category [1] 317270 0
Self funded/Unfunded
Name [1] 317270 0
Dr. Abdullah Akram has funded this using his own personal funds
Country [1] 317270 0
Primary sponsor type
Individual
Name
Dr Abdullah Akram - Doctors at Godfields Plaza
Address
Country
Australia
Secondary sponsor category [1] 317919 0
None
Name [1] 317919 0
Address [1] 317919 0
Country [1] 317919 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314651 0
Bellberry Human Research Ethics Committee I
Ethics committee address [1] 314651 0
Ethics committee country [1] 314651 0
Australia
Date submitted for ethics approval [1] 314651 0
04/04/2023
Approval date [1] 314651 0
26/04/2023
Ethics approval number [1] 314651 0

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

Contacts
Principal investigator
Name 132286 0
Dr Abdullah Akram
Address 132286 0
Doctors at Goldfields. Shop 5/35 Nash Street,. Gympie QLD
Country 132286 0
Australia
Phone 132286 0
+61 0438001196
Fax 132286 0
Email 132286 0
[email protected]
Contact person for public queries
Name 132287 0
Suzanne Ramsden
Address 132287 0
Doctors at Goldfields. Shop 5/35 Nash Street,. Gympie QLD
Country 132287 0
Australia
Phone 132287 0
+61 417 540670
Fax 132287 0
Email 132287 0
[email protected]
Contact person for scientific queries
Name 132288 0
Suzanne Ramsden
Address 132288 0
Doctors at Goldfields. Shop 5/35 Nash Street. Gympie QLD
Country 132288 0
Australia
Phone 132288 0
+61 417 540670
Fax 132288 0
Email 132288 0
[email protected]

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?

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.