Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000252213
Ethics application status
Approved
Date submitted
19/12/2017
Date registered
16/02/2018
Date last updated
29/01/2019
Date data sharing statement initially provided
29/01/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
ICUTogether a web based recovery program for intensive care survivors: a randomised control trial
Scientific title
The Impact of a Mobile Health Intervention on the Mental Health and Wellbeing of Intensive Care Survivors: A Randomised Control Trial
Secondary ID [1] 293604 0
Nil
Universal Trial Number (UTN)
U1111-1206-7355
Trial acronym
ICUTogether
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Intensive Care Unit Survivor 305862 0
Condition category
Condition code
Mental Health 305066 305066 0 0
Other mental health disorders
Public Health 305606 305606 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is a web based recovery program, available to participants on their smart devices. They will have acess to the web based recovery program for 12 months after discharge. The mobile website will provide information about health and wellbeing during recovery and advice about exercise, sleep and nutrition in this population. Information will be provided about the recovery process per se and also detail the signs and symptoms of maladaptation during recovery and when and how participants should seek professional help. The website is not personalised to the participant however they will have access to their own profile page. Participants will be contacted at home via telephone to receive an orientation to the website and the researcher will visit the participant to offer support in initially using the website if required.
Participants will be encouraged to journal each day to enable them to reflect on their progress over time but also to explore their thoughts and feelings during recovery however the frequency of use of the website is at the discretion of the participants who will be encouraged to use the site as frequently as they wish. Participants will receive a weekly email summarising their participation over the previous seven days and indicating any days they have not participated along with a prompt to continue participating. Participants will be required to complete a symptom checker each week as well as an electronic journal when they wish to. These and other strategies will make the participants’ interaction with the site more engaging for the duration of the program. On submitting their weekly symptom checker entry an algorithm will be used to determine what message or list of recommended reading the participant will see by the generation of a simple score. An ‘alert’ score can be determined that will trigger an email notification to administrators when any participant submits an entry that reaches a threshold score and therefore gives cause for concern. Participants will not be able to advance through the site unless the symptom checker has been completed at least weekly.
A chat room will also be available should participants wish to post items to share with other participants in the study. The chat room will be monitored daily by the researchers who will manage any inappropriate comments by removing them from the chatroom and contacting the participant. The chatroom posts will also help the researchers to identify participants who may be having difficulties and recommend appropriate resources to them based on their posts. An inbuilt trigger word system will also be incorporated into the site to ensure any defamatory or offensive words are identified as soon as they are written and removed from the site.

Intervention code [1] 299862 0
Rehabilitation
Comparator / control treatment
The comparator is standard care. At the site of the study there is no specific care provisions provided to ICU survivors and are discharged back to their general practitioner with additional services provided as necessary.
Control group
Active

Outcomes
Primary outcome [1] 304238 0
Hospital Anxiety and Depression Scale (HADS). Used to identify the incidence of anxiety and depression in patients with a range of diseases and medical conditions (Montazeri, Vahdaninia, Ebrahimi, & Jarvandi, 2003)
Timepoint [1] 304238 0
2 weeks, 6 months and 12 months (primary endpoint) after discharge
Secondary outcome [1] 341334 0
Impact of Events Scale Revised (IES-R). Measure of subjective distress in response to a traumatic event (Weiss, Marmar, Metzler, & Ronfeldt, 1995). It comprises three subscales which represent the major symptom clusters of post-traumatic stress disorder (PTSD): intrusion, avoidance and hyperarousal (American Psychiatric Association, 2013).
Timepoint [1] 341334 0
2 weeks, 6 months and 12 months after discharge
Secondary outcome [2] 341335 0
5-level 5-dimension EuroQoL (EQ-5D-5L). Measure changes to health-related quality of life over time or between/ following interventions (Greene et al., 2015). The five dimensions within the survey are: mobility, self-care, usual activities, pain/discomfort and anxiety/depression.
Timepoint [2] 341335 0
2 weeks, 6 months and 12 months after discharge
Secondary outcome [3] 341336 0
Cost utility analysis will be conducted to determine whether the web based recovery program is a cost effective approach for improving the quality of life of ICU survivors when compared to usual care. The perspective taken for the economic analysis will be a societal perspective and will include costs incurred by individuals as well as health care providers. The identification of costs will be across four areas (1) intervention costs, (2) health care costs, (3) personal and family costs i.e. costs of alternative therapies and, (4) productivity costs.
Timepoint [3] 341336 0
12 months post discharge

Eligibility
Key inclusion criteria
Inclusion criteria includes:
1. ventilation in ICU for a minimum period of 24 hours
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria:
1. Diagnosis of a cognitive impairment either pre-existing or as a result of a critical illness/event

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)
Allocation concealment will be conducted by an independent researcher using sequentially numbered sealed opaque envelopes. The researcher conducting the consent process will be provided the sequentially numbered sealed opaque envelopes by the independent researcher. Enveloped containing the treatment allocation will be opened by the recruiting researcher on participant enrolment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomization will be conducted in blocks of 20 using statistical software STATA.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Not applicable
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size and statistical power were calculated for the primary outcome measure using G*Power 3.1.9.2 (Faul et al. 2007). In order to detect a 2-point difference (effect size 0.44) between the two groups on the HADS with an alpha of 0.05 and 80% power requires 81 participants in each group for a total sample size of 162 participants. Given the discharge rate of 80 patients per month and a recruitment rate of 30% it is estimated that it will take seven months to recruit the required sample size.
Data will be reported in accordance with the Consolidated Standards of reporting Trial (CONSORT). Characteristics of participants in each arm of the study will be summarised using descriptive statistics. The three outcome measures (HADS, IES, QoL) at follow-up will be analysed as dependent variables using regression modelling. Covariates will include baseline outcome measures, study allocation (intervention or control), age, gender, length of ICU stay, Apache II score, and level of family support. Analysis will be conducted on an intention to treat basis. A sub-analysis of the intervention group based on those who engaged with the mobile website compared to those who did not will also be conducted. Missing data will be addressed using multiple imputation assuming variables are missing at random. The researcher completing the data analysis will be blind to participant allocation status.
Summary statistics of frequency of use, time spent using the site, most frequently used elements and time spent on each screen will be reported.
For the cost utility analysis the incremental cost effectiveness ratio will be calculated by dividing the difference in costs between the intervention and control arms by the difference in QALYs. Results will be presented as scatterplots and cost effectiveness acceptability curves for a range of willingness to pay thresholds.No discounting is required as all costs and benefits will be measured within a one-year time period.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
5/03/2018
Actual
23/11/2018
Date of last participant enrolment
Anticipated
16/03/2020
Actual
Date of last data collection
Anticipated
15/03/2021
Actual
Sample size
Target
162
Accrual to date
2
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 9563 0
Joondalup Health Campus - Joondalup
Recruitment postcode(s) [1] 18316 0
6027 - Joondalup

Funding & Sponsors
Funding source category [1] 298220 0
University
Name [1] 298220 0
Edith Cowan University
Country [1] 298220 0
Australia
Primary sponsor type
Hospital
Name
Joondalup Health Campus
Address
Cnr Grand Blvd & Shenton Ave
Joondalup, WA 6027
Country
Australia
Secondary sponsor category [1] 297331 0
University
Name [1] 297331 0
Edith Cowan Univeristy
Address [1] 297331 0
270 Joondalup Drive,
Joondalup, WA, 6027
Country [1] 297331 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299227 0
Joondalup Health Campus Research Ethics Committee
Ethics committee address [1] 299227 0
Cnr Grand Blvd & Shenton Ave
Joondalup, WA 6027
Ethics committee country [1] 299227 0
Australia
Date submitted for ethics approval [1] 299227 0
10/04/2017
Approval date [1] 299227 0
02/06/2017
Ethics approval number [1] 299227 0
1646
Ethics committee name [2] 299230 0
Edith Cowan Univeristy Human Research Ethics Committee
Ethics committee address [2] 299230 0
270 Joondalup Drive,
Joondalup, WA, 6027
Ethics committee country [2] 299230 0
Australia
Date submitted for ethics approval [2] 299230 0
19/06/2017
Approval date [2] 299230 0
10/07/2017
Ethics approval number [2] 299230 0
18317

Summary
Brief summary
Annually, hundreds of thousands of people survive a life threatening event/illness and require admission to an intensive care unit. Many of those will experience significant and life changing psychological complications as a result. There are no evidence based recovery programs available within Australia or throughout the world which could help reduce the risk of these complications developing. This intervention study will evaluate a mobile health (m-health) recovery program by measuring the emotional and psychological well-being of participants over time. Outcome measures will include incidence and severity of anxiety and depression, Post-Traumatic Stress Disorder and health related quality of life.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 79726 0
Dr Beverley Ewens
Address 79726 0
School of Nursing and Midwifery, Edith Cowan University, 270 Joondalup Drive, Joondalup, WA 6027
Country 79726 0
Australia
Phone 79726 0
+618 6304 3542
Fax 79726 0
Email 79726 0
[email protected]
Contact person for public queries
Name 79727 0
Dr Beverley Ewens
Address 79727 0
School of Nursing and Midwifery, Edith Cowan University, 270 Joondalup Drive, Joondalup, WA 6027
Country 79727 0
Australia
Phone 79727 0
+618 6304 3542
Fax 79727 0
Email 79727 0
[email protected]
Contact person for scientific queries
Name 79728 0
Dr Beverley Ewens
Address 79728 0
School of Nursing and Midwifery, Edith Cowan University, 270 Joondalup Drive, Joondalup, WA 6027
Country 79728 0
Australia
Phone 79728 0
+618 6304 3542
Fax 79728 0
Email 79728 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.