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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
Wai-Tong Chien
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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.

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

    First Posted
    May 19, 2015
    Last Updated
    February 20, 2019
    Sponsor
    Wai-Tong Chien
    Collaborators
    Castle Peak Hospital
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    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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