The Potential Efficacy of the Chinese Health Improvement Profile- A Pilot Clustered Randomised Controlled Trial

Study Overview
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Brief Summary
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The investigators programme of research will evaluate an existing physical health care screening intervention with the aim of helping Community Psychiatric Nurses (CPN) to improve the physical health wellbeing of people with a SMI. This pilot clustered randomised controlled trial aims to establish the potential efficacy and acceptability of the Chinese Health Improvement Profile (CHIP) in improving the physical health of people with severe mental illness.

Detailed Description
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This pilot study will use a non-blinded parallel group clustered randomised controlled trial design. The study will be carried out by CPNs with community-dwelling people aged 18-65 who have a psychiatric diagnosis of SMI (i.e. schizophrenia, schizoaffective disorder, other psychotic disorder or bipolar affective disorder) and at the point of recruitment are being treated in the community. It will investigate the potential clinical impact of the use of the CHIP tool when used by CPNs with this patient group. Because the CHIP is designed to be used as both an enhanced physical health risk screening tool and as an instrument to direct appropriate clinical interventions the investigators will ask the patients' allocated CPNs to recruit consenting patients , collect outcome measure data and where appropriate use the CHIP tool with patients that they work with within their routine clinical practice. Primary objective: To test the potential efficacy and acceptability of the CHIP intervention compared to treatment as usual on patients' physical well- being over a 12 month period. Secondary objectives: To measure and compare changes in perceived mental well-being between the groups as measured at baseline, and at 6 months and 12 months after the start of the intervention. To establish differences in the objective physical health state of patients between the groups at 12 months as indicated by data routinely recorded in medical/outpatient/nursing notes during the duration of study. To establish changes in health behaviours and physical indicators of cardiovascular risk within the intervention group between baseline and 12 months after the start of the intervention.

Official Title
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The Potential Efficacy and Acceptability of the Chinese Health Improvement Profile (CHIP) in Improving the Physical Health of People With Severe Mental Illness - A Pilot Clustered Randomised Controlled Trial

Conditions
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Severe Mental Illness, Schizophrenia, Schizoaffective Disorder, Bipolar Affective Disorder, Cardiovascular Health

Intervention / Treatment
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* Behavioral: Chinese CHIP
* Other: Treatment as usual


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Those psychiatric outpatients under the care of the community psychiatric nursing service who are: Aged 18-65 years; Having a case-note diagnosis (as confirmed by a registered clinician) within the illness group entitled severe mental illness (SMI) containing schizophrenia, schizoaffective disorder, other psychotic disorders, depressive or bipolar affective disorder (type 1 or 2); and Able to speak Chinese/English Able to provide written informed consent and considered safe and competent to participate in the study (as suggested by attending psychiatrist). Exclusion Criteria: Co-morbidity of learning disability or organic brain diseases.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Chinese CHIP<br>Chinese Health Improvement Profile (CHIP) screening and intervention | Behavioral: Chinese CHIP<br>* The CHIP physical health screening tool will be used by community psychiatric nurses in the treatment group to assess patients' physical health risk and identify problematic lifestyle behaviours. The findings from the assessment will be used to devise an individualized care plan with patients. This treatment plan may involve community psychiatric nurses collaborated with psychiatrists, drawing patients attention to indicators of physical health risk by using a traffic light system The community nurses will use motivational interviewing approaches to make patients be aware of their physical health risks and enhance their motivation to adopt healthier behaviours.<br>* Other names: CHIP;Other: Treatment as usual<br>* The routine community mental health care provided by the community psychiatric nursing service and outpatient clinic.<br>* Other names: TAU;|
| No Intervention: Treatment as usual<br>Routine community mental health care and medical outpatient appointments | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-reported physical well being | The primary outcome will be measured using the widely used and well-established Chinese version of the physical and mental health measure (SF12v2-PCS-12 subscale). | 6 months after intervention | 
| Self-reported physical well being | The primary outcome will be measured using the widely used and well-established Chinese version of the physical and mental health measure (SF12v2-PCS-12 subscale). | 12 months after intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-reported mental health | The perceived mental health will be measured using the widely used and well-established Chinese version of the physical and mental health measure (SF12v2-MCS-12 subscale). | 6 months after intervention | 
| Satisfaction with services | Patients' satisfaction with the services received will be measured with the Chinese language version of the Client Satisfaction Questionnaire (CSQ8) | 12 months after intervention | 
| Self-reported mental health | The perceived mental health will be measured using the widely used and well-established Chinese version of the SF12v2 (MCS-12 subscale). | 12 months after intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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health behaviour change, severe mental illness, physical health screening, randomised controlled trial