The Potential Efficacy of the Chinese Health Improvement Profile- A Pilot Clustered Randomised Controlled Trial (CHIP)
Primary Purpose
Severe Mental Illness, Schizophrenia, Schizoaffective Disorder
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Chinese CHIP
Treatment as usual
Sponsored by
About this trial
This is an interventional health services research trial for Severe Mental Illness focused on measuring severe mental illness, physical health screening, randomised controlled trial, health behaviour change
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Chinese CHIP
Treatment as usual
Arm Description
Chinese Health Improvement Profile (CHIP) screening and intervention
Routine community mental health care and medical outpatient appointments
Outcomes
Primary Outcome Measures
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).
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).
Secondary Outcome Measures
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).
Satisfaction with services
Patients' satisfaction with the services received will be measured with the Chinese language version of the Client Satisfaction Questionnaire (CSQ8)
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).
Full Information
NCT ID
NCT02453217
First Posted
May 19, 2015
Last Updated
February 20, 2019
Sponsor
Wai-Tong Chien
Collaborators
Castle Peak Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02453217
Brief Title
The Potential Efficacy of the Chinese Health Improvement Profile- A Pilot Clustered Randomised Controlled Trial
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
March 31, 2016 (Actual)
Primary Completion Date
November 30, 2018 (Actual)
Study Completion Date
January 31, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Wai-Tong Chien
Collaborators
Castle Peak Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Severe Mental Illness, Schizophrenia, Schizoaffective Disorder, Bipolar Affective Disorder, Cardiovascular Health
Keywords
severe mental illness, physical health screening, randomised controlled trial, health behaviour change
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
144 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Chinese CHIP
Arm Type
Experimental
Arm Description
Chinese Health Improvement Profile (CHIP) screening and intervention
Arm Title
Treatment as usual
Arm Type
No Intervention
Arm Description
Routine community mental health care and medical outpatient appointments
Intervention Type
Behavioral
Intervention Name(s)
Chinese CHIP
Other Intervention Name(s)
CHIP
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Treatment as usual
Other Intervention Name(s)
TAU
Intervention Description
The routine community mental health care provided by the community psychiatric nursing service and outpatient clinic.
Primary Outcome Measure Information:
Title
Self-reported physical well being
Description
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).
Time Frame
6 months after intervention
Title
Self-reported physical well being
Description
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).
Time Frame
12 months after intervention
Secondary Outcome Measure Information:
Title
Self-reported mental health
Description
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).
Time Frame
6 months after intervention
Title
Satisfaction with services
Description
Patients' satisfaction with the services received will be measured with the Chinese language version of the Client Satisfaction Questionnaire (CSQ8)
Time Frame
12 months after intervention
Title
Self-reported mental health
Description
The perceived mental health will be measured using the widely used and well-established Chinese version of the SF12v2 (MCS-12 subscale).
Time Frame
12 months after intervention
Other Pre-specified Outcome Measures:
Title
The Chinese CHIP data (treatment group only)
Description
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.
Time Frame
12 months after intervention
Title
Physical state
Description
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.
Time Frame
12 months after intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel T Bressington, PhD
Organizational Affiliation
The Hong Kong Polytechnic University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Wai Tong Chien, PhD
Organizational Affiliation
Chinese University of Hong Kong
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
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.
Results Reference
background
PubMed Identifier
10259963
Citation
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. doi: 10.1016/0149-7189(82)90074-x.
Results Reference
background
PubMed Identifier
19538607
Citation
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.
Results Reference
background
PubMed Identifier
30711868
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 Disord. 2019 Apr 1;248:42-51. doi: 10.1016/j.jad.2019.01.030. Epub 2019 Jan 28.
Results Reference
result
PubMed Identifier
30030938
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.
Results Reference
result
PubMed Identifier
27863522
Citation
Bressington D, Mui J, Tse ML, Gray R, Cheung EF, Chien WT. Cardiometabolic health, prescribed antipsychotics and health-related quality of life in people with schizophrenia-spectrum disorders: a cross-sectional study. BMC Psychiatry. 2016 Nov 18;16(1):411. doi: 10.1186/s12888-016-1121-1.
Results Reference
derived
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The Potential Efficacy of the Chinese Health Improvement Profile- A Pilot Clustered Randomised Controlled Trial
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