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

Wai-Tong Chien

Status: Completed

Conditions: Severe Mental Illness; Cardiovascular Health; Schizophrenia; Bipolar Affective Disorder; Schizoaffective Disorder

Treatments: Behavioral: Chinese CHIP; Other: Treatment as usual

Study type: Interventional

Funder types: Other

Identifiers

NCT02453217

CHIP1214-V1

HSEARS2014202001 (Other Identifier)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 144 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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144 participants in 2 patient groups

Chinese CHIP

Experimental group

Description:

Chinese Health Improvement Profile (CHIP) screening and intervention

Treatment:

Other: Treatment as usual

Behavioral: Chinese CHIP

Treatment as usual

No Intervention group

Description:

Routine community mental health care and medical outpatient appointments