Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000470695
Ethics application status
Approved
Date submitted
30/04/2014
Date registered
6/05/2014
Date last updated
11/08/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
What is the effect of two different entertainment education styles
on the knowledge and attitudes of older adults relating to
depression?
Scientific title
What is the effect of two different entertainment education styles
on the knowledge and attitudes of older adults relating to
depression?
Secondary ID [1] 284512 0
Nil
Universal Trial Number (UTN)
U1111-1156-1975
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression
 291772 0
Anxiety
 291773 0
Condition category
Condition code
Mental Health 292130 292130 0 0
Depression
Mental Health 292131 292131 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants (older adults in a hospital setting) will watch a documentary video that is approx. 10mins in length about three older people's experiences with depression and anxiety, including what it is, common signs and symptoms, reasons why people experience these and strategies to manage/prevent these feelings. The key outcomes will be motivation to seek assistance from a health professional to manage symptoms of depression following discharge from hospital, and knowledge of available treatment
options. The research design will be a Solomon randomised controlled trial. In this design only half of the participants in each group receive the pre-intervention questions but all participants complete the post-test questions. This allows the priming effect of asking pre-intervention questions to be isolated in the analysis, while still allowing the baseline comparability between groups to be investigated.
Intervention code [1] 289273 0
Other interventions
Comparator / control treatment
Participants will watch an instructional video that is approx. 10 minutes in length about depression and anxiety, including signs and symptoms, reasons why people experience these and strategies to manage/prevent them. Participants will then complete the same outcome measures as above, using the Solomon method.
Control group
Active

Outcomes
Primary outcome [1] 292013 0
Knowledge of signs/symptoms and treatment options for depression and anxiety. This will be assessed using a questionnaire designed specifically for this study, which will be administered pre intervention for half the participants and post intervention for all the participants
Timepoint [1] 292013 0
Immediately post intervention
Primary outcome [2] 292014 0
Motivation to seek assistance from a health care professional to manage/prevent symptoms of depression and anxiety. This will be assessed using a questionnaire designed specifically for this study, which will be administered pre intervention for half the participants and post intervention for all the participants
Timepoint [2] 292014 0
Immediately post-intervention
Secondary outcome [1] 307998 0
Enjoyment of video measured in the custom-designed questionnaire using Likert scales.
Timepoint [1] 307998 0
Immediately post intervention

Eligibility
Key inclusion criteria
-Must be receiving rehabilitation for a variety of geriatric conditions at a Monash Health site such as Kingston Centre or Casey Hospital
-Aged 65 years and over
-Cognitively intact (determined by GPCog screen)
-Sufficient English language skills
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
-Palliative

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Ward staff identified patients who potentially met the inclusion criteria and asked them whether they were willing to have researchers approach them. Patients who agreed to this were then provided with project descriptions (both written and verbal), thus allowing informed consent to be obtained.

Participants will be allocated to groups randomly using a computer-generated number sequence using permuted blocks produced by an investigator who is not involved in recruitment or data collection. The investigators will be blinded to the allocation
sequence until after the participants give consent and have completed the GPCog screening.

The interviewer will performed the allocation by opening an opaque, sealed envelope with the participant’s identification number on it, which contains the group allocation. Participants
will not blinded to the knowledge of the entertainment education video that they receive and the investigators conducting the assessments will also be aware of the participant’s group allocation during the pre and post intervention assessment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants were allocated to groups randomly using a computer-generated number sequence using permuted blocks produced by an investigator who was not involved in recruitment or data collection.

Solomon randomisation will be used to allow only half of the
participants in each group receive the pre-intervention questions but all participants complete the post-test questions. This allows the priming effect of asking pre-intervention questions to be isolated in the analysis, while still allowing the baseline comparability between groups to be investigated.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
12/05/2014
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 2383 0
Kingston Centre - Cheltenham
Recruitment hospital [2] 2384 0
Casey Hospital - Berwick
Recruitment postcode(s) [1] 8037 0
3192 - Cheltenham
Recruitment postcode(s) [2] 8038 0
3806 - Berwick

Funding & Sponsors
Funding source category [1] 289155 0
Hospital
Name [1] 289155 0
Internal departmental funding by Monash Health
Country [1] 289155 0
Australia
Funding source category [2] 289175 0
University
Name [2] 289175 0
Internal departmental funding by Monash University
Country [2] 289175 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Monash University Peninsula Campus
McMahons Road
Frankston Victoria 3199 Australia
Country
Australia
Secondary sponsor category [1] 287820 0
None
Name [1] 287820 0
N/A
Address [1] 287820 0
N/A
Country [1] 287820 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290926 0
Human Research Ethics Committee
Ethics committee address [1] 290926 0
Ethics committee country [1] 290926 0
Australia
Date submitted for ethics approval [1] 290926 0
05/12/2013
Approval date [1] 290926 0
22/01/2014
Ethics approval number [1] 290926 0
13407A

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

Contacts
Principal investigator
Name 48022 0
A/Prof Terence Haines
Address 48022 0
Allied Health Research Unit
Kingston Centre
Warrigal Road
Cheltenham VIC 3192
Country 48022 0
Australia
Phone 48022 0
61, 03, 92651822
Fax 48022 0
Email 48022 0
[email protected]
Contact person for public queries
Name 48023 0
Terence Haines
Address 48023 0
Allied Health Research Unit
Kingston Centre
Warrigal Road
Cheltenham VIC 3192
Country 48023 0
Australia
Phone 48023 0
+61, 03, 92651822
Fax 48023 0
Email 48023 0
[email protected]
Contact person for scientific queries
Name 48024 0
Terence Haines
Address 48024 0
Allied Health Research Unit
Kingston Centre
Warrigal Road
Cheltenham VIC 3192
Country 48024 0
Australia
Phone 48024 0
+61, 03, 92651822
Fax 48024 0
Email 48024 0
[email protected]

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

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

Documents added automatically
No additional documents have been identified.