MRC Cardiovascular Screening and Mental Health Project: Pilot of screening intervention
| ISRCTN | ISRCTN58625025 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN58625025 |
| Secondary identifying numbers | G0301032 |
- Submission date
- 10/08/2005
- Registration date
- 08/09/2005
- Last edited
- 16/07/2012
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr David Osborn
Scientific
Scientific
UCL Department of Mental Health Sciences
Royal Free & University College Medical School
Hampstead Campus
Rowland Hill Street
London
NW3 2PF
United Kingdom
| Phone | +44 (0)20 7472 6177 |
|---|---|
| d.osborn@medsch.ucl.ac.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Screening |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | |
| Study acronym | CaSMH |
| Study objectives | 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(s) | Added 28/08/09: Camden and Islington Community Local Research Ethics Committee, letter of approval dated 05/07/2005, ref 05/Q0511/67. |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 15/08/2005 |
| Completion date | 31/05/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 75 Years |
| Sex | Both |
| Target number of participants | Evaluation phase: 150-180 service users |
| Key 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 |
| Key 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 |
| Date of first enrolment | 15/08/2005 |
| Date of final enrolment | 31/05/2006 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
UCL Department of Mental Health Sciences
London
NW3 2PF
United Kingdom
NW3 2PF
United Kingdom
Sponsor information
University College London (UK)
University/education
University/education
Royal Free & University College Medical School
Hampstead Campus
Rowland Hill Street
London
NW3 2PF
England
United Kingdom
"ROR" |
https://ror.org/02jx3x895 |
|---|
Funders
Funder type
Research council
Medical Research Council (MRC) (UK), Brain Sciences Initiative Trial Platform Grant Ref: G0301032 ID: 68170
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 10/03/2010 | Yes | No |
