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

Schizophrenia Clinical Trial

— CHIP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02453217
• Other study ID #: CHIP1214-V1
• Secondary ID: HSEARS2014202001
• Status: Completed
• Phase: N/A
• Start date: March 31, 2016
• Est. completion date: January 31, 2019

Study information

• Verified date: February 2019
• Source: The Hong Kong Polytechnic University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 144
• Est. completion date: January 31, 2019
• Est. primary completion date: November 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bipolar Affective Disorder
• Bipolar Disorder
• Cardiovascular Health
• Disease
• Genetic Diseases, X-Linked
• Mental Disorders
• Mood Disorders
• Psychotic Disorders
• Schizoaffective Disorder
• Schizophrenia
• Severe Mental Illness

Intervention

Behavioral:
• Chinese 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.

Other:
• Treatment as usual
The routine community mental health care provided by the community psychiatric nursing service and outpatient clinic.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Wai-Tong Chien	Castle Peak Hospital

References & Publications (5)

Attkisson CC, Zwick R. The client satisfaction questionnaire. Psychometric properties and correlations with service utilization and psychotherapy outcome. Eval Program Plann. 1982;5(3):233-7. — View Citation

Bressington D, Mui J, Yu C, Leung SF, Cheung K, Wu CST, Bollard M, Chien WT. Feasibility of a group-based laughter yoga intervention as an adjunctive treatment for residual symptoms of depression, anxiety and stress in people with depression. J Affect Dis — View Citation

Bressington D, Yu C, Wong W, Ng TC, Chien WT. The effects of group-based Laughter Yoga interventions on mental health in adults: A systematic review. J Psychiatr Ment Health Nurs. 2018 Oct;25(8):517-527. doi: 10.1111/jpm.12491. Review. — View Citation

Ware, J.E., Jr., Kosinski, M., Dewey, J.E. How to Score Version 2 of the SF-36® Health Survey (Standard & Acute Forms). Lincoln, RI: QualityMetric Incorporated, 2000.

White J, Gray R, Jones M. The development of the serious mental illness physical Health Improvement Profile. J Psychiatr Ment Health Nurs. 2009 Jun;16(5):493-8. doi: 10.1111/j.1365-2850.2009.01375.x. Epub 2008 Mar 9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The Chinese CHIP data (treatment group only)	The data recorded from the individual items of the CHIP will be compared between baseline and at 12 months after the start of the intervention.	12 months after intervention
Other	Physical state	The 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.	12 months after intervention
Primary	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
Primary	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	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
Secondary	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
Secondary	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

External Links

•   A systematic review of effect of laughter yoga in adults
•   Feasibility of a group-based Laughter Yoga for depression