- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06996899
- Original Trial
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
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Nicole Norman
- Phone Number: 61 1800061963
- Email: nicole.norman@cdu.edu.au
Study Contact Backup
- Name: Brona Nic Giolla Easpaig
- Phone Number: 61 1800061963
- Email: b.nicgiollaeaspaig@cdu.edu.au
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Clinician/Staff users of the Health Improvement Profile
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.
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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.
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Experimental: Experimental: Client receiving the Health Improvement Profile
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. |
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:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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. |
From admission (enrolment) to post discharge period of 3 months (12 weeks)
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Feasibility: Time taken to recruit planned sample
Time Frame: Immediately after the inclusion of the last participant
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The time that was taken to recruit the planned sample size of participants
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Immediately after the inclusion of the last participant
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Feasibility: Retention
Time Frame: at the follow-up assessment 3 months post discharge from inpatient service
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Proportion of participants who completed the whole study by all participants who enrolled
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at the follow-up assessment 3 months post discharge from inpatient service
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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
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At the follow-up assessment 3 months post discharge from inpatient service
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Reason for dropping out
Time Frame: immediately on drop out notification or at 3 month follow up
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Feedback from participant to identify reason for dropping out
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immediately on drop out notification or at 3 month follow up
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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.
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Immediately on completion of the post discharge period at 3 months (12 weeks)
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Participant feedback
Time Frame: Immediately after completion of the follow up period of 3 months (12 weeks)
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Participant qualitative feedback using open ended questions on satisfaction with the Health Improvement Profile.
Analysed using standardised thematic analysis of the qualitative feedback.
|
Immediately after completion of the follow up period of 3 months (12 weeks)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
At completion of training, at the project interim point (3 months) and at end of project.
|
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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.
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Immediately at completion of the follow up period (3 months)
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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
|
At commencement (admission) to inpatient unit and after completion of follow up period 3 months (12 weeks)
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Biometric measure: Waist circumference
Time Frame: At commencement (admission) to inpatient unit and after completion of follow up period at 3 months (12weeks)
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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 |
At commencement (admission) to inpatient unit and after completion of follow up period at 3 months (12weeks)
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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
|
At commencement (admission) to inpatient unit and after completion of follow up period at 3 months (12weeks)
|
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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)
|
At commencement (admission) to inpatient unit and after completion of follow up period at 3 months (12weeks)
|
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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
|
At commencement (admission) to inpatient unit and after completion of follow up period at 3 months (12weeks)
|
|
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; |
At commencement (admission) to inpatient unit and after completion of follow up period at 3 months (12weeks)
|
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Biometric measure: Liver Function Test
Time Frame: At commencement (admission) to inpatient unit and after completion of follow up period at 3 months (12weeks)
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Outside of normal parameters (red flagged) Liver function test (LFTs) - components. • Alkaline phosphatase (ALP) IU/L; |
At commencement (admission) to inpatient unit and after completion of follow up period at 3 months (12weeks)
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Biometric measure: Liver Function Test
Time Frame: At commencement (admission) to inpatient unit and after completion of follow up period at 3 months (12weeks)
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Outside of normal parameters (red flagged) Liver function test (LFTs) - components. • Gamma- glutamyl transferase (GGT) IU/L; |
At commencement (admission) to inpatient unit and after completion of follow up period at 3 months (12weeks)
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Biometric measure: Liver Function Test
Time Frame: At commencement (admission) to inpatient unit and after completion of follow up period at 3 months (12weeks)
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Outside of normal parameters (red flagged) Liver function test (LFTs) - components. • Aspartate aminotransferase (AST) IU/L; |
At commencement (admission) to inpatient unit and after completion of follow up period at 3 months (12weeks)
|
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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; |
At commencement (admission) to inpatient unit and after completion of follow up period at 3 months (12weeks)
|
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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. |
At commencement (admission) to inpatient unit and after completion of follow up period at 3 months (12weeks)
|
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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
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At commencement (admission) to inpatient unit and after completion of follow up period at 3 months (12weeks)
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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)
|
At commencement (admission) to inpatient unit and after completion of follow up period at 3 months (12weeks)
|
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Biometric measure: Respiratory Rate
Time Frame: At commencement (admission) to inpatient unit and after completion of follow up period at 3 months (12weeks)
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Outside of normal parameters (red flagged) >20 Respiratory rate per minute (rpm)
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At commencement (admission) to inpatient unit and after completion of follow up period at 3 months (12weeks)
|
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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
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At commencement (admission) to inpatient unit and after completion of follow up period at 3 months (12weeks)
|
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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 |
At commencement (admission) to inpatient unit and after completion of follow up period at 3 months (12weeks)
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Biometric measure: Alcohol
Time Frame: At commencement (admission) to inpatient unit and after completion of follow up period at 3 months (12weeks)
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Outside of normal parameters (red flagged) Self reported: >units per day
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At commencement (admission) to inpatient unit and after completion of follow up period at 3 months (12weeks)
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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
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At commencement (admission) to inpatient unit and after completion of follow up period at 3 months (12weeks)
|
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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
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At commencement (admission) to inpatient unit and after completion of follow up period at 3 months (12weeks)
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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
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At commencement (admission) to inpatient unit and after completion of follow up period at 3 months (12weeks)
|
|
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
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At commencement (admission) to inpatient unit and after completion of follow up period at 3 months (12weeks)
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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 |
At commencement (admission) to inpatient unit and after completion of follow up period at 3 months (12weeks)
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Biometric measure: Diet
Time Frame: At commencement (admission) to inpatient unit and after completion of follow up period at 3 months (12weeks)
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Outside of normal parameters (red flagged) Intake (serving) per day of protein, fruit, vegetables
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At commencement (admission) to inpatient unit and after completion of follow up period at 3 months (12weeks)
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Biometric measure: Exercise
Time Frame: At commencement (admission) to inpatient unit and after completion of follow up period at 3 months (12weeks)
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Outside of normal parameters (red flagged) Self reported: minutes per day
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At commencement (admission) to inpatient unit and after completion of follow up period at 3 months (12weeks)
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Biometric measure: Eyes
Time Frame: At commencement (admission) to inpatient unit and after completion of follow up period at 3 months (12weeks)
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Outside of normal parameters (red flagged) Self reported: Concerns/no concerns |
At commencement (admission) to inpatient unit and after completion of follow up period at 3 months (12weeks)
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Biometric measure: Oral Health
Time Frame: At commencement (admission) to inpatient unit and after completion of follow up period at 3 months (12weeks)
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Outside of normal parameters (red flagged) Self reported: Concerns/no concerns |
At commencement (admission) to inpatient unit and after completion of follow up period at 3 months (12weeks)
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Disease Attributes
- Pathological Conditions, Signs and Symptoms
- Mental Disorders
- Chronic Disease
- Health Services Administration
- Health Care Quality, Access, and Evaluation
- Quality of Health Care
- Health Services
- Health Care Facilities Workforce and Services
- Behavioral Disciplines and Activities
- Directive Counseling
- Counseling
- Mental Health Services
- Quality Assurance, Health Care
- Motivational Interviewing
- Potentially Inappropriate Medication List
Other Study ID Numbers
- H24039
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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