Physical Health Improvement Intervention for People Admitted to Mental Health Service

Not Applicable

Not yet recruiting

• Conditions: Physical Health; Mental Illnesses; Chronic Diseases

• Registration Number: NCT06996899
• Lead Sponsor: Charles Darwin University

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 Timeline

• Study First Submitted: 2024-12-13
• Status Verified: 2025-05
• Study First Submitted QC: 2025-05-27
• Last Update Submitted: 2025-05-27
• Study First Posted: 2025-05-30
• Last Update Posted: 2025-05-30
• Study Start: 2025-07
• Primary Completion: 2026-07
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 25

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 3. 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Feasibility of Health Improvement Profile	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	Immediately after the inclusion of the last participant	The time that was taken to recruit the planned sample size of participants
Feasibility: Retention	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	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	immediately on drop out notification or at 3 month follow up	Feedback from participant to identify reason for dropping out
Feasibility: Adherence	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	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 Outcome Measures

Name	Time	Method
Clinician Confidence	At completion of training, at the project interim point (3 months) and at end of project.	Participant qualitative feedback using open ended questions on confidence for clinicians undertaking the physical assessments and developing care plans
Client wellbeing	Immediately at completion of the follow up period (3 months)	Participant qualitative feedback using open ended questions via interview or focus group, on self general overall self reported wellbeing physically and mentally (no quantitative scale to be used), this is qualitative feedback on client wellbeing participating in the HIP project.
Biometric measure: Body Mass Index (BMI)	At commencement (admission) to inpatient unit and after completion of follow up period 3 months (12 weeks)	BMI (kg/m2) is calculated by dividing a person weight in kilograms by the square of their height in metres Outside of normal parameters (red flagged) Underweight \<18.50 Overweight ≥25.00
Biometric measure: Waist circumference	At commencement (admission) to inpatient unit and after completion of follow up period at 3 months (12weeks)	Measured in centimetres (cm) - measured by applying the tap measure midway between the top of the hip bone and bottom of ribs, in line with the belly button, wrap measuring tap around your waist.; Outside of normal measure (red flagged) Female \>80cm Male \>94cm
Biometric measure: Pulse	At commencement (admission) to inpatient unit and after completion of follow up period at 3 months (12weeks)	Beats per minute (BPM) Outside of normal parameters (red flagged) \<60bpm/\>100bpm
Biometric measure: Blood pressure	At commencement (admission) to inpatient unit and after completion of follow up period at 3 months (12weeks)	Outside of normal parameters (red flagged) ≥140/90 millimeters of mercury (mm Hg)
Biometric measure: Temperature	At commencement (admission) to inpatient unit and after completion of follow up period at 3 months (12weeks)	Outside of normal parameters (red flagged) \<36°Celcius \>37.5°Celcius
Biometric measure: Liver Function Test	At commencement (admission) to inpatient unit and after completion of follow up period at 3 months (12weeks)	Outside of normal parameters (red flagged) Liver function test (LFTs) - components.; • Total Protein Prothrombin Time (PT) g/L.
Biometric measures: Lipid Levels	At commencement (admission) to inpatient unit and after completion of follow up period at 3 months (12weeks)	Outside of normal parameters (red flagged) Total Cholesterol ≥6.2mmol/L LDL (bad cholesterol) ≥4.1mmol/L HDL (good cholesterol) \<2.1mmol/L Triglycerides ≥2.2mmol/L
Biometric measure: Glucose	At commencement (admission) to inpatient unit and after completion of follow up period at 3 months (12weeks)	Outside of normal parameters (red flagged) \<4.0 - \>7.0 millimoles of glucose per litre of blood (mmols/L)
Biometric measure: Respiratory Rate	At commencement (admission) to inpatient unit and after completion of follow up period at 3 months (12weeks)	Outside of normal parameters (red flagged) \>20 Respiratory rate per minute (rpm)
Biometric measure: Sleep	At commencement (admission) to inpatient unit and after completion of follow up period at 3 months (12weeks)	Outside of normal parameters (red flagged) Self reported: \<3hours per night \>8hours per night
Biometric measure: Smoking	At commencement (admission) to inpatient unit and after completion of follow up period at 3 months (12weeks)	Outside of normal parameters (red flagged); Self reported: Smoker - volume per day Passive smoker Non-smoker
Biometric measure: Alcohol	At commencement (admission) to inpatient unit and after completion of follow up period at 3 months (12weeks)	Outside of normal parameters (red flagged) Self reported: \>units per day
Biometric measure: Fluid intake	At commencement (admission) to inpatient unit and after completion of follow up period at 3 months (12weeks)	Outside of normal parameters (red flagged) Self reported: \<1litre/day \>3litres/day
Biometric measure: Caffeine intake	At commencement (admission) to inpatient unit and after completion of follow up period at 3 months (12weeks)	Outside of normal parameters (red flagged) Self reported: ≥600milligrams (mg) /day
Biometric Measure: Urine output	At commencement (admission) to inpatient unit and after completion of follow up period at 3 months (12weeks)	Outside of normal parameters (red flagged) Self reported: \<1litre/day \>2litres/day
Biometric measure: Bowel Function	At commencement (admission) to inpatient unit and after completion of follow up period at 3 months (12weeks)	Outside of normal parameters (red flagged) Bristol Stool Scale
Biometric measure: Reproductive Health	At commencement (admission) to inpatient unit and after completion of follow up period at 3 months (12weeks)	Outside of normal parameters (red flagged); Self reported: Sexual Transmitted Infection screening - recent/occasionally/never Female: menstrual cycle Regular 28day ovulation cycle (range:24---35 days) Male: prostate and testicular (self examination) recent/occasionally/never Sexual satisfaction: Satisfied/dissatisfied
Biometric measure: Diet	At commencement (admission) to inpatient unit and after completion of follow up period at 3 months (12weeks)	Outside of normal parameters (red flagged) Intake (serving) per day of protein, fruit, vegetables
Biometric measure: Exercise	At commencement (admission) to inpatient unit and after completion of follow up period at 3 months (12weeks)	Outside of normal parameters (red flagged) Self reported: minutes per day
Biometric measure: Eyes	At commencement (admission) to inpatient unit and after completion of follow up period at 3 months (12weeks)	Outside of normal parameters (red flagged); Self reported: Concerns/no concerns
Biometric measure: Oral Health	At commencement (admission) to inpatient unit and after completion of follow up period at 3 months (12weeks)	Outside of normal parameters (red flagged); Self reported: Concerns/no concerns