Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001725257
Ethics application status
Approved
Date submitted
8/10/2018
Date registered
19/10/2018
Date last updated
5/11/2021
Date data sharing statement initially provided
5/12/2018
Date results provided
5/11/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
While you're waiting - A waiting room-based, tablet-delivered program of educational videos designed to increase motivation to change lifestyle behaviours and improve clinic experience
Scientific title
While you're waiting - a randomised controlled trial designed to evaluate the impact of personalised cardiovascular disease-focused educational videos delivered in an outpatient clinic waiting room on patient satisfaction, motivation and lifestyle behaviour.
Secondary ID [1] 296250 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiovascular disease 309910 0
Condition category
Condition code
Cardiovascular 308693 308693 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Tablet Intervention:
Patients randomised to intervention will be given a tablet that, after administering the baseline questionnaire, delivers a curated series of educational videos.
The intervention will be offered for the duration of the waiting period (Approximately 30 minutes). Participants can return the tablet to clinic staff if they wish to cease the program. We will monitor adherence to the intervention by recording, within the online form, the amount of time participants spend on each video. This will be cross checked against video length.
The intervention is designed to be self-administered, however a co-investigator (medical student) will be present in the clinic to assist participants should they have any questions.
At the end of clinic, all participants complete a paper-based questionaire (approximately 2 minutes in length).
The 30 day follow up will be administered via a 3 minute phone call with a co-investigator, who will be blinded to treatment allocation of both the cluster randomised controlled trial and nested individual randomised controlled trial.

Nested Group:
Within the intervention group will be a nested individual trial. Participants will be allocated to view or not view a 1:30 video on compression only CPR. If a participant is allocated to the intervention group, this video will be the first delivered, regardless of previously entered knowledge and topics of interest.


Videos:
We have a library of 21 different educational videos approximately 1:30 - 5:30 in length. Videos delivered to the participant will be personalised according to self-reported health knowledge and topics of interest. The number of videos offered to each patient will depend on the number of topics selected. The topics of interest include Hypertension, Heart Attack, Diet, Physical Activity, Medication, General Health and Smoking. Video content includes presentation-style videos with experts, conversational-style educational videos and animation-based education. Most contain a combination of education and health advice. All videos have been assessed by an Expert Reviewers Panel of hospital clinicians, allied health and research staff. Participants will be given over-ear headphones so as not to disturb others in the waiting room.
Intervention code [1] 312579 0
Lifestyle
Comparator / control treatment
Patients randomised to control will complete the baseline questionaires. This, including the consent, will take approximately 5 minutes. After this, a thank you message is generated, and the patient returns the tablet to the front desk. All control patients will complete the end of clinic survey and 30 day phone-administered follow-up survey.
Control group
Active

Outcomes
Primary outcome [1] 307664 0
Motivation to change cardiovascular lifestyle behaviours:
The primary outcome was defined if a participant responded greater than or equal to 6 on a 7-point Likert scale measuring motivation to improve lifestyle behaviour for greater than or equal to 2/3 lifestyle behaviours (physical activity/diet/regular blood pressure measurement). Participants reported their agreement with three stem statements. “Attending the clinic today motivated me to improve my physical activity/diet/regularly measure my blood pressure.”
Timepoint [1] 307664 0
End of clinic visit
Primary outcome [2] 307665 0
Self-reported confidence to perform CPR:
Defined if participants respond greater than or equal to 4 on a 5-point Likert scale of agreement to “I am confident in my ability to perform CPR”
Timepoint [2] 307665 0
End of clinic
Secondary outcome [1] 352516 0
Clinic satisfaction: Defined if participants report greater than or equal to 6 on a 7-point Likert scale for greater than or equal to 2/3 of three statements on satisfaction, i.e. “I am satisfied with the waiting time/education/overall clinic today”
Timepoint [1] 352516 0
End of clinic
Secondary outcome [2] 352517 0
Willingness to perform CPR: Defined if participants respond “yes” to the question “Would you perform CPR on someone you know/a stranger”
Timepoint [2] 352517 0
End of clinic, 30 day follow up
Secondary outcome [3] 352518 0
CPR knowledge: True/false question: “To perform CPR, you MUST do breaths AND compressions” (correct answer = false)
Timepoint [3] 352518 0
End of clinic, 30 day follow up
Secondary outcome [4] 352520 0
Optimal lifestyle behaviours: Defined if participants reported optimal behaviour for greater than or equal to 2/3 lifestyle-related measures (greater than or equal to 30 minutes a day for most days of physical activity, greater than 4 serves of vegetables per day, and greater than 1 serve of fruit per day)
Timepoint [4] 352520 0
Pre-clinc, 30 day follow up
Secondary outcome [5] 352521 0
Motivation to improve physical activity and diet: Defined if participants report greater than or equal to 6 on a 7-point Likert scale for stem statements on physical activity and diet, i.e. “I am currently motivated to improve my physical activity/diet”
Timepoint [5] 352521 0
30 day follow up

Eligibility
Key inclusion criteria
- Over 18 years of age
- Attended the Rapid Access Cardiology Clinic Westmead for specialist assessment of chest low-intermediate risk chest pain
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Too unwell (physically or mentally) to participate in surveys
- Previously allocated to either condition of the study
- Insufficient English to understand video content or to participate in surveys

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Randomisation to intervention (with or without CPR) and control will be loaded into the back-end of the online program. This allocation will be concealed from staff consenting participants.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation sequence for both the overall trial and the nested group has been generated simply, using a computer generated sequence with allocation to control, intervention (lifestyle videos only) or intervention (lifestyle videos plus one CPR video).
The randomisation list has been generated in permuted blocks of 3 and 6 to avoid significant imbalance between intervention and control conditions.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Nested within the intervention arm will be an individual trial that allocates participants to receive or not receive an educational video on CPR
These groups will be analysed for awareness of and confidence to perform CPR
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
We assume 40% of control participants will respond ‘strongly agree’ or ‘very strongly agree’ to questions regarding motivation to change lifestyle at end of clinic (see appendix 2). This is based on previous work by Deci et al (2005) that showed patients undergoing specialist investigation of chest pain have a high autonomous/controlled motivation for lifestyle change (Mean 6.07/5.30 on a 7-point positively skewed Likert scale approximately 1 week post episode, [n=252, SD = 0.81/1.26]) Deci, E.L., Gagné, M., Mushlin, A.I. & Williams, G.C. Motivation for behavior change in patients with chest pain. Health Education 105, 304-321 (2005).
A sample size of 330 (2:1 intervention : control ratio) would, allowing for ~5% attrition, have 80% power to detect a relative increase of 41% (RR 1.41) in the intervention arm. That is, an absolute increase from 40% to 56.4%, or 16.4%.

In addition, regarding the CPR education, we assume (based on results of a convenience sample of persons entering Westmead Hospital in September 2018), that 50% of control participants would respond ‘agree’ or ‘strongly agree’ to the question ‘I am confident in my ability to perform CPR’. A sample size of 220 (1:1 intervention : control ratio) would, allowing for ~5% attrition, have 80% power to detect relative increase of 37% (RR 1.37) in the intervention arm. That is, an absolute increase from 50% to 68.5%, or 18.5%.

A full statistical analysis plan will be finalised prior to data analysis. Patients will be analysed in the arm they have been allocated using an intent to treat approach, with 2-sided tests and a p-value of <0.05 considered significant.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
7/12/2018
Actual
7/12/2018
Date of last participant enrolment
Anticipated
1/04/2020
Actual
1/04/2020
Date of last data collection
Anticipated
29/05/2020
Actual
29/05/2020
Sample size
Target
330
Accrual to date
Final
330
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 12079 0
Westmead Hospital - Westmead
Recruitment postcode(s) [1] 24241 0
2145 - Westmead

Funding & Sponsors
Funding source category [1] 300848 0
Government body
Name [1] 300848 0
Western Sydney Local Health District
Country [1] 300848 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
City road
Camperdown NSW 2050
Country
Australia
Secondary sponsor category [1] 300397 0
None
Name [1] 300397 0
Address [1] 300397 0
Country [1] 300397 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301615 0
Western Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 301615 0
Ethics committee country [1] 301615 0
Australia
Date submitted for ethics approval [1] 301615 0
24/04/2018
Approval date [1] 301615 0
28/08/2018
Ethics approval number [1] 301615 0
AU RED HREC/18/WMEAD/124

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

Contacts
Principal investigator
Name 87566 0
Prof Clara Chow
Address 87566 0
Westmead Applied Research Centre
Faculty of Medicine and Health
Darcy Road
Westmead Hospital | Westmead NSW | 2145
Country 87566 0
Australia
Phone 87566 0
+61 28890 3125
Fax 87566 0
Email 87566 0
clara.chow@sydney.edu.au
Contact person for public queries
Name 87567 0
Daniel McIntyre
Address 87567 0
Westmead Applied Research Centre
Faculty of Medicine and Health
Darcy Road
Westmead Hospital | Westmead NSW | 2145
Country 87567 0
Australia
Phone 87567 0
+61 431682939
Fax 87567 0
Email 87567 0
daniel.mcintyre@sydney.edu.au
Contact person for scientific queries
Name 87568 0
Daniel McIntyre
Address 87568 0
Westmead Applied Research Centre
Faculty of Medicine and Health
Darcy Road
Westmead Hospital | Westmead NSW | 2145
Country 87568 0
Australia
Phone 87568 0
+61 431682939
Fax 87568 0
Email 87568 0
daniel.mcintyre@sydney.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
If requested following publication, we may provide de-identified individual participant data that pertain to the published results only.
When will data be available (start and end dates)?
Data will be available following the publication of trial results and key trial papers, which we anticipate to be by December 2021. There is no end date determined as of yet for IPD availability.
Available to whom?
Data will be made available only to researchers who provide a methodologically sound proposal and after the signing of a non-disclosure agreement.
Available for what types of analyses?
Data will be available for any purpose deemed reasonable by investigators following review of a data use proposal.
How or where can data be obtained?
Data will be made available by emailing the principal investigator of this study at clara.chow@sydney.edu.au


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
SourceTitleYear of PublicationDOI
EmbaseEducation on cardiac risk and CPR in cardiology clinic waiting rooms: A randomised clinical trial.2021https://dx.doi.org/10.1136/heartjnl-2021-319290
EmbaseEngagement and fidelity of a cardiovascular disease prevention-focused digital health intervention in cardiology outpatient waiting rooms: A mixed-methods study.2023https://dx.doi.org/10.1136/bmjqs-2021-014664
N.B. These documents automatically identified may not have been verified by the study sponsor.