Condition category
Mental and Behavioural Disorders
Date applied
04/03/2011
Date assigned
04/03/2011
Last edited
11/01/2012
Prospective/Retrospective
Prospectively 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

Ms Jacqueline White

ORCID ID

Contact details

Faculty of Health and Social Care
University of Hull
Cottingham Road
Hull
HU6 7RX
United Kingdom
Jacqueline.white@hull.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

8505

Study information

Scientific title

Acronym

HIP Cluster RCT

Study hypothesis

Patients with serious mental illness who have had a health check by a nurse trained in the HIP Programme will have better physical health related quality of life at 12 months than patients who receive treatment as usual

Ethics approval

Cambridge 4 Research Ethics Committee on 04/11/2010 (ref:10/H0305/733)

Study design

Randomised interventional treatment

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

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

Condition

Topic: Mental Health Research Network; Subtopic: Bipolar affective disorder, Schizophrenia; Disease: Schizophrenia, Bipolar affective disorder, Schizoaffective disorder

Intervention

The HIP Programme - The Serious Mental Illness Physical Health Improvement Profile (HIP) and HIP training package for nurses; Follow Up Length: 12 month(s); Study Entry : Single Randomisation only

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

PCS SF-36v2; Timepoint(s): 1 year follow-up

Secondary outcome measures

1. MCS SF-36v2
2. EQ-5D
3. Levels of health care resource use
4. PHASe (adapted)
5. QRISK®2
6. HIP Audit Form
7. Patient Semi-structured Interview Schedule, Nurse Focus Group Interview
8. Schedule and Psychiatrist/GP Telephone Interview Schedule

Overall trial start date

04/04/2011

Overall trial end date

07/04/2014

Reason abandoned

Eligibility

Participant inclusion criteria

1.Registered mental health nurse (MHN) working in a community mental health setting
2. Registered with the Nursing and Midwifery Council [NMC] for at least 6 months
3. Employed at Agenda for Change band 5-7
4. Working in one of the community mental health teamsacross the study sites
5. Has at least 5 patients on their caseload with a primary diagnosis of serious mental illness (SMI) (as confirmed by the Team Leader)

Patients:
1. Aged over 18
2. On the caseload of the MHN participant at the start of the project
3. Has a primary diagnosis of SMI (as confirmed by the last recorded diagnosis in the patient record either being schizophrenia, schizoaffective or bipolar disorder as confirmed by the Team Leader).; Target Gender: Male & Female ; Lower Age Limit 18 no age limit or unit specified

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size 50 Nurses, 250 patients; UK sample size 50 Nurses, 250 patients

Participant exclusion criteria

Following screening by the Research Assistant, MHNs will not be included if they:

1. Are still in preceptorship following recent Nursing and Midwifery Council [NMC] registration as a MHN
2. Are about to go on maternity leave
3. Are pregnant or up to 6 months post partum

Following screening by the Trial Coordinator and the Team Leader patients with SMI will not be included if they:

1. Currently lack the capacity to consent to treatment as documented by a heath professional on Form 4 in their case notes (NWMHFT, 2005) as they would also be considered unable to consent to participation in research.
2. Have a serious or unstable medical condition (e.g. advanced/incurable cancer; severe co-morbidity such as people on renal haemodialysis, end-stage Chronic obstructive pulmonary disease (COPD) and New York Heart Association (NYHA) classification grade 3 or 4 heart failure; severe unpredictable pain)
3. Where the Team Leader considers participation in the trial will put the patient, nurse or research assistant at increased risk or increased cost to the service to manage risk

Recruitment start date

04/04/2011

Recruitment end date

07/04/2014

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Faculty of Health and Social Care,
Hull
HU6 7RX
United Kingdom

Sponsor information

Organisation

Norfolk and Waveney Mental Health NHS Foundation Trust (UK)

Sponsor details

Hellesdon Hospital
Drayton High Road
Norwich
NR6 5BE
United Kingdom

Sponsor type

Government

Website

Funders

Funder type

Government

Funder name

National Institute for Health Research (NIHR) (UK)- Research for Patient Benefit (RfPB) (ref: Grant Codes: PB-PG-1208-18122)

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. 2011 protocol in http://www.ncbi.nlm.nih.gov/pubmed/21726440

Publication citations

  1. Protocol

    White J, Gray RJ, Swift L, Barton GR, Jones M, The serious mental illness health improvement profile [HIP]: study protocol for a cluster randomised controlled trial., Trials, 2011, 12, 167, doi: 10.1186/1745-6215-12-167.

Additional files

Editorial Notes