Skip to content

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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02453217
Acronym
CHIP
Enrollment
144
Registered
2015-05-25
Start date
2016-03-31
Completion date
2019-01-31
Last updated
2019-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

severe mental illness, physical health screening, randomised controlled trial, health behaviour change

Brief summary

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

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.

Interventions

BEHAVIORALChinese CHIP

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.

OTHERTreatment as usual

The routine community mental health care provided by the community psychiatric nursing service and outpatient clinic.

Sponsors

Castle Peak Hospital
CollaboratorOTHER_GOV
Wai-Tong Chien
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Self-reported physical well being6 months after interventionThe 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).

Secondary

MeasureTime frameDescription
Self-reported mental health6 months after interventionThe 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).
Satisfaction with services12 months after interventionPatients' satisfaction with the services received will be measured with the Chinese language version of the Client Satisfaction Questionnaire (CSQ8)

Other

MeasureTime frameDescription
The Chinese CHIP data (treatment group only)12 months after interventionThe data recorded from the individual items of the CHIP will be compared between baseline and at 12 months after the start of the intervention.
Physical state12 months after interventionThe data relating to patients' physical state that are routinely recorded in medical, outpatient and nursing notes during study period will be recorded and compared between groups.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 11, 2026