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Physical Health Improvement Intervention for People Admitted to Mental Health Service

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06996899
Enrollment
25
Registered
2025-05-30
Start date
2026-07-01
Completion date
2028-12-01
Last updated
2026-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Diseases, Mental Illnesses, Physical Health

Keywords

Implementation Research, Health Improvement Profile

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

Interventions

OTHERHealth Improvement Profile (HIP)

The Health Improvement Profile (HIP) is a comprehensive physical assessment conducted by a trained clinician which aims to link evidence based interventions for flagged abnormal health parameters. There are 27 health parameters assessed 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. Client participant will collaborate with their clinician in developing an individualised Health Improvement Profile which identifies suitable health behaviours interventions to improve physical health. Health behaviours may be associated with diet, exercise, sleep, hygiene (including oral care) and mindfulness.

OTHERClinician Health Improvement Profile user training

Clinician/staff participants will receive Health Improvement Profile user training on how to conduct the comprehensive physical assessments for 27 health parameters and how to link the evidence based actions to develop an individualised Health Improvement Profile for clients admitted to inpatient service. Training includes online videos simulating assessments and completing the Health Improvement Profile and face to face workshops.

Sponsors

Charles Darwin University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Intervention model description

The one group is all adults admitted to the inpatient mental health service . The parallel group is the clinicians/staff working in the patient mental health service.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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 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

Design outcomes

Primary

MeasureTime frameDescription
Feasibility of Health Improvement ProfileFrom 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 sampleImmediately after the inclusion of the last participantThe time that was taken to recruit the planned sample size of participants
Feasibility: Retentionat the follow-up assessment 3 months post discharge from inpatient serviceProportion of participants who completed the whole study by all participants who enrolled
Feasibility: Drop out rateAt the follow-up assessment 3 months post discharge from inpatient serviceNumber of participants who dropped out , did not continue with health improvement profile after discharging from inpatient service
Reason for dropping outimmediately on drop out notification or at 3 month follow upFeedback from participant to identify reason for dropping out
Feasibility: AdherenceImmediately 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 feedbackImmediately 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

MeasureTime frameDescription
Biometric measure: Blood pressureAt 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: TemperatureAt 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 TestAt 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. • Alanine aminotransferase (ALT) IU/L;
Biometric measures: Lipid LevelsAt 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: GlucoseAt 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 RateAt 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: SleepAt 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: SmokingAt 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: AlcoholAt 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 intakeAt 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 intakeAt 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: Reproductive HealthAt 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: DietAt 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: ExerciseAt 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: EyesAt 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: Urine outputAt 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: Oral HealthAt 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: Bowel FunctionAt 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
Clinician ConfidenceAt 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 wellbeingImmediately 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 circumferenceAt 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: PulseAt 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

Contacts

CONTACTNicole Norman
nicole.norman@cdu.edu.au61 1800061963
CONTACTBrona Nic Giolla Easpaig
b.nicgiollaeaspaig@cdu.edu.au61 1800061963

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 20, 2026