Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000474358
Ethics application status
Approved
Date submitted
3/03/2017
Date registered
31/03/2017
Date last updated
31/03/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Improving cardiovascular health and quality of life in people with severe mental
illness: a randomised trial of a ‘partners in health’ intervention
Scientific title
Improving cardiovascular health and quality of life in people with severe mental
illness: a randomised trial of a ‘partners in health’ intervention
Secondary ID [1] 290948 0
APP1121334
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
cardiovascular disease (CVD) 301681 0
severe mental illness 301682 0
Condition category
Condition code
Cardiovascular 301389 301389 0 0
Other cardiovascular diseases
Mental Health 301390 301390 0 0
Other mental health disorders
Cardiovascular 301391 301391 0 0
Hypertension

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A 12-month 2-group randomised controlled trial with extended follow up to 24 months for the intervention group will be conducted to compare the Flinders Program intervention in addition to usual care, with usual care alone.
The Flinders Program incorporating cardiovascular risk interventions. It provides a framework and tools to engage the patient in a collaborative structured self management assessment, tailored planning, motivational enhancement, disease management, prevention, coordination and outcome measurement. It drives optimal use of current health services. It structures and provides motivational processes for: A quitting program, control of triglycerides and diabetes; one-on-one and group components of weight reduction programs; and initiation and adherence with BP-lowering and lipid medications. It can be delivered by any clinician and for the trial it will be delivered by trial mental health nurses.
The overall duration of the intervention is 20 weeks. The patient first completes the Partners in Health (PIH) scale to self-assess self-management knowledge, shared decision making, symptom management, adherence to medical management, impact of condition/s, and lifestyle behaviours. The nurse then conducts the Cue and Response (C&R) interview to understand patient strengths and barriers to change. This leads to shared decisions on issues requiring action. Nurse and patient identify the patient’s main (life) problem and set a medium term goal using the Problem and Goals tool (P&G). The Flinders Care Plan is used to document action issues for patient and nurse over the following 6-12 months. At scheduled follow-ups, the nurse monitors outcomes using PIH and P&G scores, helps the patient to achieve goals using motivational and problem-solving approaches, and uses the structured framework of the Care Plan to manage activities. The Flinders Program therefore integrates relevant evidence-based patient education programs and agreed medical, psychiatric and community services. The program can be delivered face-to-face, by phone and/or electronically to suit patient needs. A web version of the program allows patient and trial nurse to develop the care plan either face-to-face or via the web and is used for communication in real time, or asynchronously via text or email, to provide monitoring and motivational enhancement.

Number, duration and frequency of Flinders Program sessions conducted by the mental health nurse with the participant will be as follows:
- (Week1) 1 hour for the completion of the PIH Scale and C&R interview;
- (Week2) 1 hour for completion of the P&G and Care Plan
- (Week 4, 6, 8, 12, 16 and 20) 30 minutes for each scheduled follow-up sessions.

It is critical to engage GPs of SMI patients. For this trial, GPs will be engaged early through their collaboration with the patient and nurse regarding the issues identified in the Care Plan. GPs' role in providing usual physical health care (such as routine blood tests and prescription of lipid-lowering and BP medication will sit alongside the self-management Care Planning process. Integration of the GP role will be enabled via the Care Plan's ability to be finalised by the GP with MBS care plan eligibility (GPMP and TCA items) and trial-nurse follow-up and liaison between GP and patient where needed.
The sampling population will be patients of Southern Adelaide Local Health Network (SALHN), population 360,000.
Intervention code [1] 296895 0
Behaviour
Intervention code [2] 297456 0
Treatment: Other
Comparator / control treatment
Consenting patients will be randomly assigned to intervention or control with 1:1 allocation ratio. The control group will receive usual care from their government-funded clinical community mental health service. This will include case management from mental health care coordinators, depot clinic attendance for patients receiving intramuscular antipsychotic medications, monitoring by the clozapine clinic for those patients prescribed clozapine, review by the community mental health service psychiatrist, and any psychosocial support brokered by their care coordinator. Control group patients will also receive usual care from their GP.
Control group
Active

Outcomes
Primary outcome [1] 300972 0
Change at 12 months in the following measures:
Absolute CVD risk will be measured using the General CVD Risk Score. This measure applies from age 30 years and includes sex, age, systolic blood pressure, smoking in last week Y/N, diabetes, hypertensive medication Y/N, and either total and HDL cholesterol or BMI.
Timepoint [1] 300972 0
Change at 12 months post commencement of the intervention.
Primary outcome [2] 300975 0
Health-related quality of life will be measured by the SF36, a commonly used instrument, producing summary scores for mental health and physical health components. The Australian SF-6D scoring algorithm developed by CI Ratcliffe and colleagues will be applied to generate utilities and calculate quality adjusted life years.
Timepoint [2] 300975 0
Change at 12 months post commencement of the intervention.
Secondary outcome [1] 331299 0
7-day point prevalence smoking abstinence by self-report confirmed using breath carbon monoxide of <10ppm;
Timepoint [1] 331299 0
Baseline and 6 and 12 months
7-day point prevalence smoking abstinence
Secondary outcome [2] 331308 0
Self-management capacity will be measured by the 12-item version of the Partners in Health (PIH) instrument, measuring medical and psychosocial components of self-management.
Timepoint [2] 331308 0
Baseline and 6 and 12 months
Secondary outcome [3] 331309 0
Patient engagement will be measured based on SOLES, a 16-item measure. Engagement isessential for reducing CVD risk and will be an indicator of a recovery focused intervention.
Timepoint [3] 331309 0
Baseline and 6 and 12 months
Secondary outcome [4] 331310 0
Patient receipt of care consistent with the CCM will be measured using the 11-item version of the Patient Assessment of Chronic Illness Care.
Timepoint [4] 331310 0
Baseline and 6 and 12 months
Secondary outcome [5] 331311 0
Mental health measures extracted from clinical data: K10 measure of non-specific psychological distress.
Timepoint [5] 331311 0
Baseline and 6 and 12 months
Secondary outcome [6] 332626 0
Waist/height ratio
Timepoint [6] 332626 0
Baseline and 6 and 12 months
Secondary outcome [7] 332627 0
CVD incidence
Timepoint [7] 332627 0
Baseline and 6 and 12 months
Secondary outcome [8] 332628 0
The HoNOS measure of health and social functioning.
Timepoint [8] 332628 0
Baseline and 6 and 12 months.
Secondary outcome [9] 333359 0
Proportion of participants reporting 50 % or more reduction in smoking relative to baseline assessed by self-report.
Timepoint [9] 333359 0
Baseline and 6 and 12 months.

Eligibility
Key inclusion criteria
Diagnosis of schizophrenia, schizoaffective disorder, bipolar disorder, or depressive psychosis confirmed using the Mini-international neuropsychiatric interview; taking
antipsychotic medication for at least the past 2 months with the intention of continuing for the study duration; age at least 30 years which allows estimation of absolute CVD risk and matches patient age profile; and at least one risk factor (overweight/obesity, smoking, high blood pressure, blood lipids, glucose or diabetes).
Minimum age
30 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Inability to give informed consent; low English literacy; active psychosis or suicidality

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)
Mental Health Service staff (the existing care coordinators) enrolling patients will be blind to allocation of patients into either the intervention or control group at this initial stage. They will provide details of consenting participants to the trial coordinator.
Allocation will then involve the trial coordinator contacting the clinical trials call centre that is the holder of the allocation schedule (developed by the Statistician establishing the randomisation process for the trial. See below). The trial coordinator will then communicate and assign intervention group participants to the Mental Health Nurses who will contact these participants.

The Statistician is "off-site" and has no direct contact with the trial setting and will therefore be blinded for comparison of the data sets.
Due to their ongoing/existing care coordination role with patients, Mental Health Service staff may, at a later stage, become aware of the group to which patients on their caseload have been allocated within the trial, due to the patient telling them once the trial is underway. However, these staff will not be directly involved in delivering the Flinders Program intervention or collecting any self-reported baseline, 6, 12 and 24 month outcome measures from patient participants in the trial. This task will be undertaken by a dedicated research officer who is also separate to the mental health nurses conducting the intervention to ensure that they are blind to allocation for both the intervention and the control group.
Mental health nurses conducting the Flinders Program care planning cannot be blinded.
For blood measurements, lab staff will be blinded.
Patients cannot be blinded to receipt of the intervention but study information will present the equipoise position.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be blocked to keep group sizes equal, using a standard permutated block algorithm to protect concealment. To balance potential confounders, block randomisation within strata will be used, stratifying by median age and gender. A statistician will independently generate random sequences for each stratum and provide this to a clinical trials call centre.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Analyses will be conducted on an intention to treat basis and the trial conducted for reporting to CONSORT guidelines. Missing data will be imputed using multiple imputation. There are two primary outcomes: change in 10-year CVD risk and change in SF-36. To reduce skewness, change in 10-year CVD risk score will be ln-transformed. Random effects modelling (using Stata’s xtmixed command) will be employed to analyse each primary outcome, clustering over nurse delivering the intervention to account for possible correlated outcome measures, and adjusting for group, time and the product term group’x’time. Differences between groups across time will be assessed via the interaction term. Diagnostic tests to examine homoscedasticity and normality of residuals at each level will be carried out to ensure model validity.
The calculations for each primary outcome assume a Type I error rate of 2.5% to protect the overall Type I error rate of 5%. Using a conservative baseline mean (SD) CVD risk score of 10.5% (8.0%) (compared to our pilot data with mean CVD of 17%), this equates to a mean (SD) of 2.35 (2.08) for the ln-transformed data. Assuming a correlation of 0.5 between baseline and follow up scores for a sample of 304 (152/group), we have 80% power to detect a relative change of 20% in 10-year CVD risk on the ln-transformed scale. These changes are realistic and other current empirically-designed interventions providing coordination alone or self-management alone have achieved substantial levels of change whereas this intervention provides both and also includes management
of CVD risk. We will sample 358 participants in total to allow for an attrition rate of 15%. Using Australian data reported by Hope, we expect a mean (SD) baseline SF-36 mental health summary score of 55.2 (22.5). These findings are similar to other Australian samples with mental and physical health comorbidities. Based on changes in SF-36 scores from less comprehensive interventions across mental and physical health care we expect a mean 10 point difference between the control and intervention groups at 12 months. Assuming an SD of 35 and a correlation of 0.5 between baseline and follow-up we have approximately 95% power to detect this difference, assuming the same attrition rate.
We will also formally test the hypothesis that several of our secondary outcomes, self-management capacity, patient engagement and patient receipt of care, are mediators of the changes observed in our primary outcomes (CVD risk score and SF-36) by using mediation analysis.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
31/05/2017
Actual
Date of last participant enrolment
Anticipated
14/12/2018
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
358
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 7576 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [2] 7577 0
Noarlunga Health Service - Noarlunga Centre
Recruitment postcode(s) [1] 15470 0
5042 - Bedford Park
Recruitment postcode(s) [2] 15471 0
5168 - Noarlunga Centre

Funding & Sponsors
Funding source category [1] 295547 0
Government body
Name [1] 295547 0
NHMRC
Country [1] 295547 0
Australia
Primary sponsor type
Individual
Name
Professor Malcolm Battersby
Address
Flinders Human Behavior and Health Research Unit
Flinders University
Sturt Rd
Bedford Park 5042 SA
Country
Australia
Secondary sponsor category [1] 294368 0
Individual
Name [1] 294368 0
Professor Sharon Lawn
Address [1] 294368 0
Flinders Human Behavior and Health Research Unit
Flinders University
Sturt Rd
Bedford Park 5042 SA
Country [1] 294368 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296869 0
Southern Adelaide Clinical Human Research Ethics Committee
Ethics committee address [1] 296869 0
Ethics committee country [1] 296869 0
Australia
Date submitted for ethics approval [1] 296869 0
20/01/2017
Approval date [1] 296869 0
01/03/2017
Ethics approval number [1] 296869 0
469.16-HREC/16/SAC/484

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

Contacts
Principal investigator
Name 71818 0
Prof Malcolm Battersby
Address 71818 0
Flinders Human Behaviour and Health Research Unit
Flinders University
Sturt Rd
Bedford Park 5042 SA
Country 71818 0
Australia
Phone 71818 0
+61 8 8404 2314
Fax 71818 0
+61 8 8404 2101
Email 71818 0
[email protected]
Contact person for public queries
Name 71819 0
Sharon Lawn
Address 71819 0
Flinders Human Behaviour and Health Research Unit
Flinders University
Sturt Rd
Bedford Park 5042 SA
Country 71819 0
Australia
Phone 71819 0
+61 8 8404 2321
Fax 71819 0
+61 8 8404 2101
Email 71819 0
[email protected]
Contact person for scientific queries
Name 71820 0
Malcolm Battersby
Address 71820 0
Flinders Human Behaviour and Health Research Unit
Flinders University
Sturt Rd
Bedford Park 5042 SA
Country 71820 0
Australia
Phone 71820 0
+61 8 8404 2314
Fax 71820 0
+61 8 8404 2101
Email 71820 0
[email protected]

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What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
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Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseImproving cardiovascular health and quality of life in people with severe mental illness: Study protocol for a randomised controlled trial.2018https://dx.doi.org/10.1186/s13063-018-2748-7
N.B. These documents automatically identified may not have been verified by the study sponsor.