Condition category
Circulatory System
Date applied
10/08/2005
Date assigned
08/09/2005
Last edited
16/07/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr David Osborn

ORCID ID

Contact details

UCL Department of Mental Health Sciences
Royal Free & University College Medical School
Hampstead Campus
Rowland Hill Street
London
NW3 2PF
United Kingdom
+44 (0)20 7472 6177
d.osborn@medsch.ucl.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

G0301032

Study information

Scientific title

Acronym

CaSMH

Study hypothesis

The intervention of a proactive nurse facilitator (PNF) will increase:
1. The rates of cardiovascular disease (CVD) risk factor screening uptake
2. Referral rates for risk reduction strategies (lifestyle and/or drug interventions) for people with severe mental illness (SMI) compared to 'treatment as usual'.

Ethics approval

Added 28/08/09: Camden and Islington Community Local Research Ethics Committee, letter of approval dated 05/07/2005, ref 05/Q0511/67.

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Screening

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Cardiovascular disease; severe mental illness

Intervention

All participating CMHTs will receive a CVD education pack for CMHT staff.
Half of participating CMHTs will be randomly assigned to receive the intervention - the services and expertise of a physical health nurse (or 'proactive nurse facilitator' - PNF) who will work within the CMHT for six months. The nurse will work proactively with existing NHS services to ensure that
a. All the CMHT's clients with SMI are offered screening for CVD risk factors and
b. That all clients who are identified as having CVD risk factors are offered appropriate risk reduction interventions (lifestyle and/or drug treatments)
Half of the CMHTs will be randomly assigned to the control group - their clients will receive 'usual care' from their GP and CMHT.
(NB: Camden & Islington Community LREC reference: 05/Q0511/67)

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

1. The proportion of service users who were (a) offered and (b) took up CVD screening.
2. The proportion of service users with CVD risk factors who were (a) offered and (b) took up appropriate referrals for risk reduction interventions (lifestyle and/or drug treatment).
3. These proportions will be compared between the intervention arm of the study (PNF services) and the control arm of the study (usual care).

Secondary outcome measures

Waiting times for CVD screening via GP or CMHT; waiting times for referrals to CVD risk reduction interventions; service user satisfaction with CVD screening and interventions; feasibility of collecting outcome data and appropriateness of outcome measures (to inform the design of future randomised controlled trials [RCTs]); economic evaluation of PNF service.

Overall trial start date

15/08/2005

Overall trial end date

31/05/2006

Reason abandoned

Eligibility

Participant inclusion criteria

1. Mental health service users under the care of adult community mental health teams (CMHTs) in Camden & Islington who are participating in the exploratory trial
2. Age 18 to 75 years
3. Diagnosed with severe mental illness (i.e. schizophrenia, bipolar affective disorder, schizoaffective disorder, persistent delusional disorder, or any other non-organic chronic psychosis)
4. Able to speak and understand English or willing to have an interpreter present during trial appointments

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Evaluation phase: 150-180 service users

Participant exclusion criteria

1. Age < 18 or >75 years
2. Primary diagnosis of learning disability, depressive illness, personality disorder, substance misuse (drugs or alcohol), dementia or other organic brain disease
3. Any individual whose current mental or physical state prevents them taking part in trial procedures or for whom participation would have a detrimental effect on their mental health

Recruitment start date

15/08/2005

Recruitment end date

31/05/2006

Locations

Countries of recruitment

United Kingdom

Trial participating centre

UCL Department of Mental Health Sciences
London
NW3 2PF
United Kingdom

Sponsor information

Organisation

University College London (UK)

Sponsor details

Royal Free & University College Medical School
Hampstead Campus
Rowland Hill Street
London
NW3 2PF
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Research council

Funder name

Medical Research Council (MRC) (UK), Brain Sciences Initiative Trial Platform Grant Ref: G0301032 ID: 68170

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20219096

Publication citations

  1. Results

    Osborn DP, Nazareth I, Wright CA, King MB, Impact of a nurse-led intervention to improve screening for cardiovascular risk factors in people with severe mental illnesses. Phase-two cluster randomised feasibility trial of community mental health teams., BMC Health Serv Res, 2010, 10, 61, doi: 10.1186/1472-6963-10-61.

Additional files

Editorial Notes