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

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ClinicalTrials.gov Identifier: NCT02453217
Recruitment Status : Completed
First Posted : May 25, 2015
Last Update Posted : February 22, 2019
Sponsor:
Collaborator:
Castle Peak Hospital
Information provided by (Responsible Party):
Wai-Tong Chien, The Hong Kong Polytechnic University

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.


Condition or disease Intervention/treatment Phase
Severe Mental Illness Schizophrenia Schizoaffective Disorder Bipolar Affective Disorder Cardiovascular Health Behavioral: Chinese CHIP Other: Treatment as usual Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 144 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Health Services Research
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
Actual Study Start Date : March 31, 2016
Actual Primary Completion Date : November 30, 2018
Actual Study Completion Date : January 31, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Chinese CHIP
Chinese Health Improvement Profile (CHIP) screening and 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 Name: CHIP

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

No Intervention: Treatment as usual
Routine community mental health care and medical outpatient appointments



Primary Outcome Measures :
  1. Self-reported physical well being [ Time Frame: 6 months after intervention ]
    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).

  2. Self-reported physical well being [ Time Frame: 12 months after intervention ]
    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 :
  1. Self-reported mental health [ Time Frame: 6 months after intervention ]
    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).

  2. Satisfaction with services [ Time Frame: 12 months after intervention ]
    Patients' satisfaction with the services received will be measured with the Chinese language version of the Client Satisfaction Questionnaire (CSQ8)

  3. Self-reported mental health [ Time Frame: 12 months after intervention ]
    The perceived mental health will be measured using the widely used and well-established Chinese version of the SF12v2 (MCS-12 subscale).


Other Outcome Measures:
  1. The Chinese CHIP data (treatment group only) [ Time Frame: 12 months after intervention ]
    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.

  2. Physical state [ Time Frame: 12 months after intervention ]
    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.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02453217


Sponsors and Collaborators
Wai-Tong Chien
Castle Peak Hospital
Investigators
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Principal Investigator: Daniel T Bressington, PhD The Hong Kong Polytechnic University
Study Director: Wai Tong Chien, PhD Chinese University of Hong Kong

Additional Information:
Publications of Results:
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Wai-Tong Chien, Professor and Associate Head (Research), The Hong Kong Polytechnic University
ClinicalTrials.gov Identifier: NCT02453217     History of Changes
Other Study ID Numbers: CHIP1214-V1
HSEARS2014202001 ( Other Identifier: Hong Kong Polytechnic University )
First Posted: May 25, 2015    Key Record Dates
Last Update Posted: February 22, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Wai-Tong Chien, The Hong Kong Polytechnic University:
severe mental illness
physical health screening
randomised controlled trial
health behaviour change
Additional relevant MeSH terms:
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Disease
Schizophrenia
Psychotic Disorders
Mental Disorders
Mood Disorders
Bipolar Disorder
Pathologic Processes
Schizophrenia Spectrum and Other Psychotic Disorders
Bipolar and Related Disorders
Iproplatin
Antineoplastic Agents