Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000801819
Ethics application status
Approved
Date submitted
30/07/2012
Date registered
31/07/2012
Date last updated
31/07/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
A Pilot Study of Cardiometabolic Health Nursing in a Community Mental Health Service.
Scientific title
Amongst adult community mental health service consumers, is a Cardiometabolic Health Nurse more effective than usual care for improving access to primary care and self-reported health?
Secondary ID [1] 280876 0
Nil
Universal Trial Number (UTN)
U1111-1132-8204
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mental illness 286947 0
Cardiovascular disease 286948 0
Diabetes 286949 0
Condition category
Condition code
Mental Health 287285 287285 0 0
Depression
Cardiovascular 287286 287286 0 0
Coronary heart disease
Metabolic and Endocrine 287287 287287 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
An experienced clinical nurse will be appointed to the Cardiometabolic Health Nurse (CHN) position for the six-month trial. Participants randomly allocated to CHN care will attend a baseline CHN appointment involving cardiometabolic assessments including body mass index and waist-hip ratio, health behaviour assessments (eg diet and physical activity), blood pressure, and reviews of cardiometabolic and antipsychotic medication adherence and side-effects. During the subsequent 24-week intervention, the CHN will manage primary care of participants through strategies such as organising further CHN consultations or telephone appointments, providing health behaviour education, and organising referrals to other health professionals and ensuring that these linkages are maintained. All CHN participants will attend a follow-up appointment 24 weeks after their baseline appointment.
Intervention code [1] 285312 0
Early detection / Screening
Comparator / control treatment
Participants randomised to the usual care group will not attend a CHN appointment, thereby receiving usual standards of primary care within the mental health service for the 24-week trial.
Control group
Active

Outcomes
Primary outcome [1] 287562 0
Total number of primary health care services (eg. screening, referrals, lifestyle education) for cardiometabolic health disorders received, assessed by health record review.
Timepoint [1] 287562 0
Health record review will occur immediately post-intervention and will encompass six-months pre-intervention as well as the six-month intervention period.
Secondary outcome [1] 298401 0
Self-reported physical health assessed by Short Form Health Survey (SF-36v2).
Timepoint [1] 298401 0
Baseline (0-2 weeks), mid-term (12-14 weeks) and follow-up (24-26 weeks).
Secondary outcome [2] 298402 0
Self-reported mental health assessed by Short Form Health Survey (SF-36v2).
Timepoint [2] 298402 0
Baseline (0-2 weeks), mid-term (12-14 weeks) and follow-up (24-26 weeks).

Eligibility
Key inclusion criteria
Adult accessing community mental health services at the Central Queensland Mental Health Service.
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Incapable of providing informed consent
English not a first language

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)
Mental health nurses (MHNs) will be responsible for participant recruitment over a two-month period. MHNs will invite N = 154 adult consumers who they believe to meet eligibility criteria to participate in this study. MHNs will first provide a brief verbal description of the study, and then provide the consumer with a study information sheet and informed consent form. Completed informed consent forms will be provided to an independent biostatistician who will randomise participants to CHN or usual care using SPSS software. The CHN will be provided with contact details for participants allocated to CHN care for the purposes of arranging and following up on appointments; as a result the CHN will not be blinded to participant treatment allocation, and participants will not be blinded to treatment allocation as they will know whether or not they receive CHN care. A research assistant (RA) will be responsible for conducting telephone interviews with all study participants at three time-points. The RA will be blinded to treatment allocation of participants. Additionally MHNs will be blinded to treatment allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The biostatistician will perform simple randomisation of participants using the SPSS random sample of cases function(i.e. computerised sequence generation).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/10/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
154
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 285668 0
Government body
Name [1] 285668 0
Australian Centre for Health Services Innovation
Country [1] 285668 0
Australia
Primary sponsor type
Individual
Name
Brenda Happell
Address
Building 18, CQUniversity Australia
Bruce Highway, Rockhampton
QLD 4702
Country
Australia
Secondary sponsor category [1] 284500 0
Individual
Name [1] 284500 0
David Scott
Address [1] 284500 0
Building 18, CQUniversity Australia
Bruce Highway, Rockhampton
QLD 4702
Country [1] 284500 0
Australia
Other collaborator category [1] 276954 0
Individual
Name [1] 276954 0
Wendy Hoey
Address [1] 276954 0
Central Queensland Mental Health Service
Rockhampton Base Hospital
Canning Street, Rockhampton
QLD 4700
Country [1] 276954 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287715 0
Central Queensland Human Research Ethics Committee
Ethics committee address [1] 287715 0
Ethics committee country [1] 287715 0
Australia
Date submitted for ethics approval [1] 287715 0
Approval date [1] 287715 0
19/07/2012
Ethics approval number [1] 287715 0
HREC 12/QCQ/5

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

Contacts
Principal investigator
Name 34460 0
Address 34460 0
Country 34460 0
Phone 34460 0
Fax 34460 0
Email 34460 0
Contact person for public queries
Name 17707 0
Professor Brenda Happell
Address 17707 0
Institute for Health and Social Science Research
Building 18, Central Queensland University
Bruce Highway, Rockhampton
QLD 4702
Country 17707 0
Australia
Phone 17707 0
+61749232164
Fax 17707 0
+61749306402
Email 17707 0
[email protected]
Contact person for scientific queries
Name 8635 0
Professor Brenda Happell
Address 8635 0
Institute for Health and Social Science Research
Building 18, Central Queensland University
Bruce Highway, Rockhampton
QLD 4702
Country 8635 0
Australia
Phone 8635 0
+61749232164
Fax 8635 0
+61749306402
Email 8635 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.