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NCT Number: NCT06996899

Physical Health Improvement Intervention for People Admitted to Mental Health Service

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.

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Key information

Conditions

Physical Health Chronic Disease Chronic Diseases Disease Attributes Mental Disorders Mental Illnesses Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Health Improvement Profile (HIP)

Other

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.

Other names: Screening tool, motivational interviewing, behaviour change tool

Clinician Health Improvement Profile user training

Other

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.

Primary outcomes

  1. 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.

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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.

  7. 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

  1. Clinician Confidence

    Time frame: 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

  2. Client wellbeing

    Time frame: 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.

  3. Biometric measure: Body Mass Index (BMI)

    Time frame: 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

  4. Biometric measure: Waist circumference

    Time frame: 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

  5. Biometric measure: Pulse

    Time frame: 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

  6. Biometric measure: Blood pressure

    Time frame: 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)

  7. Biometric measure: Temperature

    Time frame: 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

  8. Biometric measure: Liver Function Test

    Time frame: 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.

    • Alanine aminotransferase (ALT) IU/L;

  9. Biometric measure: Liver Function Test

    Time frame: 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.

    • Alkaline phosphatase (ALP) IU/L;

  10. Biometric measure: Liver Function Test

    Time frame: 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.

    • Gamma- glutamyl transferase (GGT) IU/L;

  11. Biometric measure: Liver Function Test

    Time frame: 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.

    • Aspartate aminotransferase (AST) IU/L;

  12. Biometric measure: Liver Function Test

    Time frame: 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.

    • Bilirubin mmol/L;

  13. Biometric measure: Liver Function Test

    Time frame: 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.

  14. Biometric measures: Lipid Levels

    Time frame: 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

  15. Biometric measure: Glucose

    Time frame: 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)

  16. Biometric measure: Respiratory Rate

    Time frame: 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)

  17. Biometric measure: Sleep

    Time frame: 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

  18. Biometric measure: Smoking

    Time frame: 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

  19. Biometric measure: Alcohol

    Time frame: 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

  20. Biometric measure: Fluid intake

    Time frame: 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

  21. Biometric measure: Caffeine intake

    Time frame: 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

  22. Biometric Measure: Urine output

    Time frame: 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

  23. Biometric measure: Bowel Function

    Time frame: 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

  24. Biometric measure: Reproductive Health

    Time frame: 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

  25. Biometric measure: Diet

    Time frame: 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

  26. Biometric measure: Exercise

    Time frame: 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

  27. Biometric measure: Eyes

    Time frame: 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

  28. Biometric measure: Oral Health

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Brona Nic Giolla Easpaig

CONTACT

[email protected]

61 1800061963

Nicole Norman

CONTACT

[email protected]

61 1800061963

Sponsors and collaborators

Lead sponsor

Charles Darwin University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
May 30, 2025
Registry last updated
Mar 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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