Clinical trial NCT06996899: Physical Health Improvement Intervention for People Admitted to Mental Health Service
Official title: Establishing Utility of a Physical Health Improvement Intervention in a Regional Mental Health Impatient Service: a Multimethod Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Physical Health
Mental Illnesses
Chronic Diseases
Keywords: Implementation Research
Health Improvement Profile
Lead sponsor: Charles Darwin University
Sponsor class: OTHER
First posted: 2025-05-30
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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

Eligibility criteria: 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

Primary outcomes:
measure: Feasibility of Health Improvement Profile
timeFrame: From admission (enrolment) to post discharge period of 3 months (12 weeks)
measure: Feasibility: Time taken to recruit planned sample
timeFrame: Immediately after the inclusion of the last participant
measure: Feasibility: Retention
timeFrame: at the follow-up assessment 3 months post discharge from inpatient service
measure: Feasibility: Drop out rate
timeFrame: At the follow-up assessment 3 months post discharge from inpatient service
measure: Reason for dropping out
timeFrame: immediately on drop out notification or at 3 month follow up
measure: Feasibility: Adherence
timeFrame: Immediately on completion of the post discharge period at 3 months (12 weeks)
measure: Participant feedback
timeFrame: Immediately after completion of the follow up period of 3 months (12 weeks)
Secondary outcomes:
measure: Clinician Confidence
timeFrame: At completion of training, at the project interim point (3 months) and at end of project.
measure: Client wellbeing
timeFrame: Immediately at completion of the follow up period (3 months)
measure: Biometric measure: Body Mass Index (BMI)
timeFrame: At commencement (admission) to inpatient unit and after completion of follow up period 3 months (12 weeks)
measure: Biometric measure: Waist circumference
timeFrame: At commencement (admission) to inpatient unit and after completion of follow up period at 3 months (12weeks)
measure: Biometric measure: Pulse
timeFrame: At commencement (admission) to inpatient unit and after completion of follow up period at 3 months (12weeks)
measure: Biometric measure: Blood pressure
timeFrame: At commencement (admission) to inpatient unit and after completion of follow up period at 3 months (12weeks)
measure: Biometric measure: Temperature
timeFrame: At commencement (admission) to inpatient unit and after completion of follow up period at 3 months (12weeks)
measure: Biometric measure: Liver Function Test
timeFrame: At commencement (admission) to inpatient unit and after completion of follow up period at 3 months (12weeks)
measure: Biometric measure: Liver Function Test
timeFrame: At commencement (admission) to inpatient unit and after completion of follow up period at 3 months (12weeks)
measure: Biometric measure: Liver Function Test
timeFrame: At commencement (admission) to inpatient unit and after completion of follow up period at 3 months (12weeks)
measure: Biometric measure: Liver Function Test
timeFrame: At commencement (admission) to inpatient unit and after completion of follow up period at 3 months (12weeks)
measure: Biometric measure: Liver Function Test
timeFrame: At commencement (admission) to inpatient unit and after completion of follow up period at 3 months (12weeks)
measure: Biometric measure: Liver Function Test
timeFrame: At commencement (admission) to inpatient unit and after completion of follow up period at 3 months (12weeks)
measure: Biometric measures: Lipid Levels
timeFrame: At commencement (admission) to inpatient unit and after completion of follow up period at 3 months (12weeks)
measure: Biometric measure: Glucose
timeFrame: At commencement (admission) to inpatient unit and after completion of follow up period at 3 months (12weeks)
measure: Biometric measure: Respiratory Rate
timeFrame: At commencement (admission) to inpatient unit and after completion of follow up period at 3 months (12weeks)
measure: Biometric measure: Sleep
timeFrame: At commencement (admission) to inpatient unit and after completion of follow up period at 3 months (12weeks)
measure: Biometric measure: Smoking
timeFrame: At commencement (admission) to inpatient unit and after completion of follow up period at 3 months (12weeks)
measure: Biometric measure: Alcohol
timeFrame: At commencement (admission) to inpatient unit and after completion of follow up period at 3 months (12weeks)
measure: Biometric measure: Fluid intake
timeFrame: At commencement (admission) to inpatient unit and after completion of follow up period at 3 months (12weeks)
measure: Biometric measure: Caffeine intake
timeFrame: At commencement (admission) to inpatient unit and after completion of follow up period at 3 months (12weeks)
measure: Biometric Measure: Urine output
timeFrame: At commencement (admission) to inpatient unit and after completion of follow up period at 3 months (12weeks)
measure: Biometric measure: Bowel Function
timeFrame: At commencement (admission) to inpatient unit and after completion of follow up period at 3 months (12weeks)
measure: Biometric measure: Reproductive Health
timeFrame: At commencement (admission) to inpatient unit and after completion of follow up period at 3 months (12weeks)
measure: Biometric measure: Diet
timeFrame: At commencement (admission) to inpatient unit and after completion of follow up period at 3 months (12weeks)
measure: Biometric measure: Exercise
timeFrame: At commencement (admission) to inpatient unit and after completion of follow up period at 3 months (12weeks)
measure: Biometric measure: Eyes
timeFrame: At commencement (admission) to inpatient unit and after completion of follow up period at 3 months (12weeks)
measure: Biometric measure: Oral Health
timeFrame: At commencement (admission) to inpatient unit and after completion of follow up period at 3 months (12weeks)
Other outcomes:
Locations:
Study officials:
References:
citation: Werkkala C, Valimaki M, Anttila M, Pekurinen V, Bressington D. Validation of the Finnish Health Improvement Profile (HIP) with patients with severe mental illness. BMC Psychiatry. 2020 Mar 11;20(1):112. doi: 10.1186/s12888-020-02511-5.
citation: Meepring S, Gray R, Li X, Chien WT, Li Y, Ho GWK, Kritkitrat P, Bressington D. Evaluating the efficacy of the Thai Health Improvement Profile intervention for preventing weight gain in people with early stage psychosis: A randomized controlled trial. Int J Nurs Stud. 2023 Oct;146:104570. doi: 10.1016/j.ijnurstu.2023.104570. Epub 2023 Jul 31.
citation: White J, Gray R, Jones M. The development of the serious mental illness physical Health Improvement Profile. J Psychiatr Ment Health Nurs. 2009 Jun;16(5):493-8. doi: 10.1111/j.1365-2850.2009.01375.x. Epub 2008 Mar 9.