Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000678291
Ethics application status
Approved
Date submitted
16/04/2018
Date registered
26/04/2018
Date last updated
8/05/2020
Date data sharing statement initially provided
8/05/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Improving the cardiometabolic health of people with psychosis: The Physical Health Nurse Consultant service
Scientific title
Improving the cardiometabolic health of people with psychosis: The Physical Health Nurse Consultant service
Secondary ID [1] 294596 0
APP1139596
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Comorbid cardiometabolic illness 307400 0
Psychosis 307401 0
Condition category
Condition code
Mental Health 306509 306509 0 0
Psychosis and personality disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
1. Cardiometabolic assessment undertaken by the Clinical Research Assistant. The assessment will comprise measurement of weight, height, triglycerides, HDL cholesterol, blood pressure, fasting plasma glucose, and assessment of health behaviours including smoking, nutrition, alcohol and physical activity. This will be one session of approximately 60 minutes duration. It will be repeated at each primary time point.
2. Risk management: The Physical Health Nurse Consultant (PHNC) will apply the Positive Cardiometabolic Health treatment framework based on assessment data and any additional information discussed with the consumer. The Cardiometabolic Health Treatment Framework was developed by Professor Jackie Curtis (member of the research team). It involves the assessment of risk based on the Cardiometabolic Health Assessment comprising: weight, height, triglycerides, HDL cholesterol, blood pressure, fasting plasma glucose, and assessment of health behaviours including smoking, nutrition, alcohol and physical activity.
3. Care coordination: Once the PHNC and consumer agree on an approach to physical healthcare, the PHNC provides care coordination including supported referral to appropriate programmes or services (GPs, dietitians, nutritionists, accredited exercise physiologists, weight loss centres, smoking cessation programs and other available services) as recommended by the treatment framework, communicates relevant clinical history, provides appointment reminders, and timely follow-up of results.
Parts 2 and 3 will occur in one appointment of approximately 45 minutes duration and will be repeated at each primary time point.
Intervention code [1] 300893 0
Early detection / Screening
Intervention code [2] 300909 0
Treatment: Other
Comparator / control treatment
Treatment as usual means no change to the usual care participants receive. Case managers of participants will be instructed to continue usual care, meaning they can also act on cardiometabolic assessment data if they choose. However research suggests most case managers do not address physical health as a part of usual care even when cardiometabolic assessment data are recorded
Control group
Active

Outcomes
Primary outcome [1] 305513 0
Body Mass Index, Height will be measured using tape measure, weight using balance scale,
Timepoint [1] 305513 0
Baseline and repeated at interim points in months 3, 6, 9, 12, 15, 18 and 21 with a final assessment in month 24 (primary endpoint)
Primary outcome [2] 305514 0
Total Cholesterol - Serum assay
Timepoint [2] 305514 0
Baseline and repeated at interim points in months 3, 6, 9, 12, 15, 18 and 21 with a final assessment in month 24 (primary endpoint)
Primary outcome [3] 305565 0
Fasting glucose Serum assay
Timepoint [3] 305565 0
Baseline and repeated at interim points in months 3, 6, 9, 12, 15, 18 and 21 with a final assessment in month 24 (primary endpoint)
Secondary outcome [1] 345563 0
Cost-effectiveness of physical health service delivery - Cost-effectiveness will be determined using the Assessing Cost Effectiveness (ACE) Prevention methodology with refinements by CID Goss and in accordance with Pharmaceutical Benefits Advisory Committee economic evaluation guidelines. Data will be accessed from assessment data and patient records
Timepoint [1] 345563 0
Baseline and repeated at interim points in months 3, 6, 9, 12, 15, 18 and 21 with a final assessment in month 24
Secondary outcome [2] 345623 0
health behaviour measures (smoking, second hand smoke, fruit intake, vegetable intake, alcohol use: daily intake, alcohol use: binge drinking, physical inactivity. These will be collected by self-report using 23 relevant questions from the National Health Survey (~5-10 minutes to complete).
Timepoint [2] 345623 0
Baseline and repeated at interim points in months 3, 6, 9, 12, 15, 18 and 21 with a final assessment in month 24
Secondary outcome [3] 345853 0
Consumer experience outcome data will be collected using the Patient Experience Questionnaire, a self-report instrument designed to measure access, acceptability, and shared decision making
Timepoint [3] 345853 0
Baseline and repeated at interim points in months 3, 6, 9, 12, 15, 18 and 21 with a final assessment in month 24

Eligibility
Key inclusion criteria
Consumers attending City Mental Health aged 18-65, diagnosed with a DSM-5 psychotic disorder will be eligible to participate.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Consumers will be excluded if they are unable to speak and read English, or unable or unwilling to provide informed consent

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)
Participants will be randomly selected from eligible consumers attending City Mental Health by a researcher not involved in the day-to-day conduct of the trial, according to ICH Guidelines for Clinical Trials using an automated web-based randomisation system.

Allocation concealment will be achieved using sequentially numbered opaque sealed envelopes. Investigators and clinicians assessing outcomes will be ignorant of future treatment allocation and will have no control over the order of patients randomised into the trial.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomised to the intervention or control group by a team member not involved in screening (eligibility and entry of participants) or data collection (baseline and follow-up assessments) using the process of minimisation, blocked on age and gender, to ensure excellent balance between groups (intervention and control groups). Team members conducting data analysis will not be involved in data collection, and treatment allocations will be blinded until after data are analysed.
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
Reviews of similar interventions have shown medium to large effects (range f is great than or equal to 0.2-0.8) on change in these outcomes. Hence to detect an effect size of f is great than or equal to 0.2 in primary and secondary outcome measures between groups at 24 months with nine repeated measures, we will require 56 participants in each arm to achieve 80% power using an alpha level of 0.05. The number of participants in each arm has been inflated (80 participants per arm) to account for up to 30% attrition from assessments. Hence a total of N=160 participants will be recruited into the RCT. We have assumed a correlation among repeated measures of 0.5. We are sufficiently powered (80%, alpha 0.05) to detect significant changes in all outcomes.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
1/09/2018
Actual
30/11/2018
Date of last participant enrolment
Anticipated
3/12/2018
Actual
28/06/2019
Date of last data collection
Anticipated
30/06/2021
Actual
Sample size
Target
160
Accrual to date
Final
111
Recruitment in Australia
Recruitment state(s)
ACT
Recruitment postcode(s) [1] 22410 0
2600 - Canberra

Funding & Sponsors
Funding source category [1] 299213 0
Government body
Name [1] 299213 0
National Health and Medical Research Council
Country [1] 299213 0
Australia
Primary sponsor type
University
Name
University of Newcastle
Address
School of Nursing and Midwifery
University of Newcastle
University Drive
Callaghan, 2308
NSW
Country
Australia
Secondary sponsor category [1] 298474 0
University
Name [1] 298474 0
Australian National University
Address [1] 298474 0
ANU Centre for Mental Health Research, Eggleston Rd & Mills Rd, Acton ACT 0200
Country [1] 298474 0
Australia
Secondary sponsor category [2] 298478 0
University
Name [2] 298478 0
Central Queensland University
Address [2] 298478 0
School of Health, Medical and Applied Sciences, CQU, 554/700 Yaamba Road, Norman Gardens QLD 4701
Country [2] 298478 0
Australia
Secondary sponsor category [3] 298479 0
University
Name [3] 298479 0
University of New South Wales
Address [3] 298479 0
School of Psychiatry, University of New South Wales, Northcott Dr, Campbell ACT 2612
Country [3] 298479 0
Australia
Other collaborator category [1] 280065 0
Government body
Name [1] 280065 0
Australian Institute for Health and Welfare
Address [1] 280065 0
1 Thynne St, Bruce ACT 2617
Country [1] 280065 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300133 0
Health Directorate Human Research Ethics Committee
Ethics committee address [1] 300133 0
Ethics committee country [1] 300133 0
Australia
Date submitted for ethics approval [1] 300133 0
15/03/2018
Approval date [1] 300133 0
10/05/2018
Ethics approval number [1] 300133 0

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

Contacts
Principal investigator
Name 82674 0
Prof Brenda Happell
Address 82674 0
School of Nursing and Midwifery
University of Newcastle
University Drive
Callaghan
New South Wales, 2308
Country 82674 0
Australia
Phone 82674 0
+61408513250
Fax 82674 0
Email 82674 0
brenda.happell@newcastle.edu.au
Contact person for public queries
Name 82675 0
Brenda Happell
Address 82675 0
School of Nursing and Midwifery
University of Newcastle
University Drive
Callaghan
New South Wales, 2308
Country 82675 0
Australia
Phone 82675 0
+61408513250
Fax 82675 0
Email 82675 0
brenda.happell@newcastle.edu.au
Contact person for scientific queries
Name 82676 0
Brenda Happell
Address 82676 0
School of Nursing and Midwifery
University of Newcastle
University Drive
Callaghan
New South Wales, 2308
Country 82676 0
Australia
Phone 82676 0
+61408513250
Fax 82676 0
Email 82676 0
brenda.happell@newcastle.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?

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
EmbaseImproving the cardiometabolic health of people with psychosis: A protocol for a randomised controlled trial of the Physical Health Nurse Consultant service.2018https://dx.doi.org/10.1016/j.cct.2018.09.001
N.B. These documents automatically identified may not have been verified by the study sponsor.