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
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|
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.
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.
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||144 participants|
|Intervention Model:||Parallel Assignment|
|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|
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
- 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).
- 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).
- 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).
- 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)
- 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).
- 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.
- 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.
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
|Principal Investigator:||Daniel T Bressington, PhD||The Hong Kong Polytechnic University|
|Study Director:||Wai Tong Chien, PhD||Chinese University of Hong Kong|