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Clinical Trials/NCT06996899
NCT06996899Not yet recruitingNot Applicable

Establishing Utility of a Physical Health Improvement Intervention in a Regional Mental Health Impatient Service: a Multimethod Study

Charles Darwin University0 sites25 target enrollmentStarted: July 1, 2025Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
25
Primary Endpoint
Feasibility of Health Improvement Profile

Study Overview

Brief Summary

This study aims to codesign and implement a physical health improvement behaviour change intervention for people being treated for a mental illness in a mental health inpatient unit of a regional hospital.

Detailed Description

People in regional areas with mental illness suffer high prevalence of preventable chronic health conditions. Multi-morbidity in people with mental illness contributes to a reduced life expectancy of up to 20 years. Many physical diseases are preventable and/or reversable if risk factors are identified early, and the right health promotion tools and interventions are provided. Addressing such a complex issue for people with mental illness requires an approach which is adaptable, has been co-designed with clinicians and consumers and is comprehensive to target individualised health behaviours.

This research uses the Health Improvement Profile (HIP) tool to help clinicians (e.g. nurses, doctors) to assess patients physical health and identify risk factors or early signs of chronic disease. Using the Health Improvement Profile (HIP) tool during admission the clinicians will work with clients to implement the most suitable health promotion tools to help improve physical health.

Using implementation research methodology and following the Consolidated Framework for Implementation Research (CFIR) the study is broken into the following 4 stages:

  • Identify
  • Adapt - codesign/adapt Health Improvement Profile (HIP) intervention and develop user training
  • Implement - into clinical areas to assist developing personalised Health Improvement Profile (HIP)
  • Evaluate - using both qualitative and quantitative data to determine feasibility of the Health Improvement Profile (HIP) and implementation in a regional health service

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Health Services Research
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •This study is being carried out in an inpatient service therefore clinical staff must be registered by their professional governing body with a minimum of 6 months employment at the service or within the region to participate in stages 2 and
  • •Graduate clinicians with less than 6 months working experience will be excluded from the study. Clinicians new to the region with less than 6 months working experience in location will be excluded from the study. Clinical roles within the facility include but not limited to:
  • •Nurses (enrolled or registered)
  • •Psychiatrists
  • •Psychologists
  • •Social Workers
  • •Clients of the inpatient mental health service eligible to be included in the study must be:
  • •Over the age of 18 years
  • •Able to read, understand and speak English
  • •A current or previous user of the hospital's services
  • •A current or previous user of the inpatient services
  • •A carer of someone who is a current or previous user of the inpatient mental health service
  • •Able to provide consent
  • •Not an employee
  • •Not a health professional

Exclusion Criteria

  • Not provided

Arms & Interventions

Clinician/Staff users of the Health Improvement Profile

Experimental

Experimental: Staff intervention group Participants will receive education and training on how to conduct comprehensive physical assessments for the 27 health parameters on the Health Improvement Profile (HIP) and how to use these assessment finding to determine the recommended actions (behaviours changes) to develop an individualised profile for the admitted patient.

Intervention: Clinician Health Improvement Profile user training (Other)

Experimental: Client receiving the Health Improvement Profile

Experimental

Experimental: Client intervention group Participants will have a comprehensive physical assessment conducted by a trained clinician (health professional in the mental health inpatient service. The assessments consist of 27 health parameters such as weight, Body Mass Index (BMI), blood pressure, blood glucose, cholesterol levels, and waist circumference, alongside questions on lifestyle factors like smoking, diet, and physical activity, as well as medication use and its side effects.

Using the assessment data clients will participate in the development of an individualised Health Improvement Plan (HIP) utilising the recommended behaviour change actions.

Intervention: Health Improvement Profile (HIP) (Other)

Outcomes

Primary Outcomes

Feasibility of Health Improvement Profile

Time Frame: From admission (enrolment) to post discharge period of 3 months (12 weeks)

Each Health Improvement Profile parameter has a column for recording the assessment result, followed by a column indicating the healthy 'green' range or indicating the unhealthy 'red' range (requiring action). The final column indicates the recommended action if the parameter falls into the 'red' range. Baseline assessment, (up to 27 assessment points for males and 26 assessment points for females) using the Health Improvement Profile (HIP) to identify the number of red flags, this is baseline assessment data which falls outside of normal healthy parameters. Baseline assessment will occur at pre intervention (at time of admission to the inpatient unit), during intervention use (at discharge from inpatient facility with a developed Health Improvement Profile) and post intervention (3months post discharge from inpatient facility) to determine physical health improvement against baseline assessment.

Feasibility: Time taken to recruit planned sample

Time Frame: Immediately after the inclusion of the last participant

The time that was taken to recruit the planned sample size of participants

Feasibility: Retention

Time Frame: at the follow-up assessment 3 months post discharge from inpatient service

Proportion of participants who completed the whole study by all participants who enrolled

Feasibility: Drop out rate

Time Frame: At the follow-up assessment 3 months post discharge from inpatient service

Number of participants who dropped out , did not continue with health improvement profile after discharging from inpatient service

Reason for dropping out

Time Frame: immediately on drop out notification or at 3 month follow up

Feedback from participant to identify reason for dropping out

Feasibility: Adherence

Time Frame: Immediately on completion of the post discharge period at 3 months (12 weeks)

Proportion (percentage %) of recommended actions on the Health Improvement Profile (HIP) which the patient self reports as completing up to 3 months post discharge.

Participant feedback

Time Frame: Immediately after completion of the follow up period of 3 months (12 weeks)

Participant qualitative feedback using open ended questions on satisfaction with the Health Improvement Profile. Analysed using standardised thematic analysis of the qualitative feedback.

Secondary Outcomes

  • Biometric measure: Liver Function Test(At commencement (admission) to inpatient unit and after completion of follow up period at 3 months (12weeks))
  • Clinician Confidence(At completion of training, at the project interim point (3 months) and at end of project.)
  • Client wellbeing(Immediately at completion of the follow up period (3 months))
  • Biometric measure: Body Mass Index (BMI)(At commencement (admission) to inpatient unit and after completion of follow up period 3 months (12 weeks))
  • Biometric measure: Waist circumference(At commencement (admission) to inpatient unit and after completion of follow up period at 3 months (12weeks))
  • Biometric measure: Pulse(At commencement (admission) to inpatient unit and after completion of follow up period at 3 months (12weeks))
  • Biometric measure: Blood pressure(At commencement (admission) to inpatient unit and after completion of follow up period at 3 months (12weeks))
  • Biometric measure: Temperature(At commencement (admission) to inpatient unit and after completion of follow up period at 3 months (12weeks))
  • Biometric measures: Lipid Levels(At commencement (admission) to inpatient unit and after completion of follow up period at 3 months (12weeks))
  • Biometric measure: Glucose(At commencement (admission) to inpatient unit and after completion of follow up period at 3 months (12weeks))
  • Biometric measure: Respiratory Rate(At commencement (admission) to inpatient unit and after completion of follow up period at 3 months (12weeks))
  • Biometric measure: Sleep(At commencement (admission) to inpatient unit and after completion of follow up period at 3 months (12weeks))
  • Biometric measure: Smoking(At commencement (admission) to inpatient unit and after completion of follow up period at 3 months (12weeks))
  • Biometric measure: Alcohol(At commencement (admission) to inpatient unit and after completion of follow up period at 3 months (12weeks))
  • Biometric measure: Fluid intake(At commencement (admission) to inpatient unit and after completion of follow up period at 3 months (12weeks))
  • Biometric measure: Caffeine intake(At commencement (admission) to inpatient unit and after completion of follow up period at 3 months (12weeks))
  • Biometric Measure: Urine output(At commencement (admission) to inpatient unit and after completion of follow up period at 3 months (12weeks))
  • Biometric measure: Bowel Function(At commencement (admission) to inpatient unit and after completion of follow up period at 3 months (12weeks))
  • Biometric measure: Reproductive Health(At commencement (admission) to inpatient unit and after completion of follow up period at 3 months (12weeks))
  • Biometric measure: Diet(At commencement (admission) to inpatient unit and after completion of follow up period at 3 months (12weeks))
  • Biometric measure: Exercise(At commencement (admission) to inpatient unit and after completion of follow up period at 3 months (12weeks))
  • Biometric measure: Eyes(At commencement (admission) to inpatient unit and after completion of follow up period at 3 months (12weeks))
  • Biometric measure: Oral Health(At commencement (admission) to inpatient unit and after completion of follow up period at 3 months (12weeks))

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Nicole Norman

Principle Investigator (PhD Candidate), Registered Nurse

Charles Darwin University

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