Cluster Randomised Controlled Trial of the Serious Mental Illness Health Improvement Profile [HIP]

ISRCTN	ISRCTN41137900
DOI	https://doi.org/10.1186/ISRCTN41137900
Secondary identifying numbers	8505

Submission date: 04/03/2011
Registration date: 04/03/2011
Last edited: 27/09/2019

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Ms Jacqueline White
Scientific

Faculty of Health and Social Care
University of Hull
Cottingham Road
Hull
HU6 7RX
United Kingdom

Email	Jacqueline.white@hull.ac.uk

Study information

Study design	Randomised interventional treatment
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Cluster Randomised Controlled Trial of the Serious Mental Illness Health Improvement Profile [HIP]
Study acronym	HIP Cluster RCT
Study objectives	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(s)	Cambridge 4 Research Ethics Committee on 04/11/2010 (ref:10/H0305/733)
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	04/04/2011
Completion date	07/04/2014

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	Planned Sample Size 50 Nurses, 250 patients; UK sample size 50 Nurses, 250 patients
Key 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
Key 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
Date of first enrolment	04/04/2011
Date of final enrolment	07/04/2014

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Faculty of Health and Social Care,

Hull
HU6 7RX
United Kingdom

Sponsor information

Norfolk and Waveney Mental Health NHS Foundation Trust (UK)
Hospital/treatment centre

Hellesdon Hospital, Drayton High Road
Norwich
NR6 5BE
England
United Kingdom

"ROR"	https://ror.org/03400ft78

Funders

Funder type

Government

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

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?
Protocol article	protocol	04/07/2011		Yes	No
Results article	results	01/10/2014		Yes	No
Results article	results	01/05/2018	27/09/2019	Yes	No

Editorial Notes

27/09/2019: Publication reference added.
01/10/2018: Publication reference added.