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Physical Co-morbidity, Poor Health Behaviour and Health Promotion in Verona Patients With Functional Psychoses (PHYSICO-DSM-VR)

Primary Purpose

Psychotic Disorders, Bipolar Disorders

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Health Promotion Intervention
Sponsored by
Azienda ULSS di Verona e Provincia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Psychotic Disorders focused on measuring health promotion, lifestyles, physical comorbidity, risk factors, behavioural change

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • ICD-10 diagnosis of affective or non-affective functional psychosis (codes F20-22, F24, F25, F28-F31, F23.3, F33.3)
  • one or more contacts with the CMHS in the 3 months preceding the beginning of the recruitment
  • Age 18-65

Exclusion Criteria:

  • moderate or severe mental handicap (learning disability)
  • organic brain disorders
  • lack of capacity to consent to inclusion
  • subjects already involved in individual treatment related to diet and physical exercise
  • subjects deemed unable or unfit to participate in the proposed physical activities

Sites / Locations

  • UOC 4° Servizio Psichiatria - ULSS 20
  • UOC 1° Servizio Psichiatria - ULSS 20
  • UOC 2° Servizio Psichiatria - ULSS 20
  • UOC 3° Servizio Psichiatria - ULSS 20

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Control

Arm Description

"Health Promotion Intervention" package including elements of psychoeducation on healthy lifestyles and practical sessions of physical activity, with the use of motivational techniques.

Control subjects receive treatment as usual at the Community Mental Health Services of the Department of Mental Health.

Outcomes

Primary Outcome Measures

Change in the number of participants that comply with WHO recommendations on diet and/or exercise
Following the criteria proposed by World Health Organization for a healthy lifestyle: at least 5 servings of fruit/vegetables per day and at least 30 minutes of moderate physical activity per day 5 days a week. Achieving at least one more criterion than baseline at follow up is considered a success.

Secondary Outcome Measures

Physical examination
Physical examination by psychiatrist
Long term chronic disease inventory (items 2.1-2.24; MOD.ISTAT/IMF-8/B.04-05-ISTAT)
Questionnaire assessing chronic diseases, administered by investigators
Change in blood pressure
Change in pulses
Change in Body Mass Index
Change in waist circumference
Change in glycemia
Change in haemoglobin A1C
Change in LDL cholesterol
Change in HDL cholesterol
Change in triglyceridemia
Electrocardiogram
Medication History Schedule
Ad hoc form filled in by psychiatrist on present and previous psychopharmacological or non psychopharmacological medications taken by the participant
36 Item Short Form Health Survey
Verona Service Satisfaction Scale - European Version

Full Information

First Posted
May 30, 2016
Last Updated
June 22, 2016
Sponsor
Azienda ULSS di Verona e Provincia
Collaborators
FONDAZIONE CARIVERONA, Universita di Verona
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1. Study Identification

Unique Protocol Identification Number
NCT02807688
Brief Title
Physical Co-morbidity, Poor Health Behaviour and Health Promotion in Verona Patients With Functional Psychoses
Acronym
PHYSICO-DSM-VR
Official Title
PHYSICO-DSM-VR - Physical Co-morbidity, Poor Health Behaviour and Health Promotion in Verona Patients With Functional Psychoses: a Prevalence Study and a Randomised Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
March 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Azienda ULSS di Verona e Provincia
Collaborators
FONDAZIONE CARIVERONA, Universita di Verona

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The study evaluates the efficacy of health promotion strategies on diet and physical activity in patients with psychosis. Half of the participants will receive an intervention protocol based on education and behavioural change, while half will not receive it.
Detailed Description
Epidemiological studies investigating the mortality and physical health of mental patients have provided substantial evidence of an excess mortality and of a substantially higher prevalence of physical co-morbidity as compared to the general population. These findings have been related to a higher prevalence of risk factors like high blood pressure, high plasma cholesterol and obesity, unhealthy lifestyles, medication side-effects. The number of clinical trials and intervention studies in this area is still scanty and their scientific strength is relatively modest. The present research project aims at implementing preventive strategies related to dietary habits and physical exercise, and studying their efficacy with a randomized controlled study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychotic Disorders, Bipolar Disorders
Keywords
health promotion, lifestyles, physical comorbidity, risk factors, behavioural change

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
325 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
"Health Promotion Intervention" package including elements of psychoeducation on healthy lifestyles and practical sessions of physical activity, with the use of motivational techniques.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Control subjects receive treatment as usual at the Community Mental Health Services of the Department of Mental Health.
Intervention Type
Behavioral
Intervention Name(s)
Health Promotion Intervention
Intervention Description
The intervention package consists of the following elements: i. educational sessions on the importance of diet and fitness; ii. motivational interviews to maintain participants in the program, to discuss participants' physical conditions, habits and opinions as to diet and fitness; iii. monitoring the participation in the program and health behaviour, specifically for diet and fitness, and adherence to the intervention on diet and fitness; iv. regular physical exercise under the guide and supervision of an expert trainer.
Primary Outcome Measure Information:
Title
Change in the number of participants that comply with WHO recommendations on diet and/or exercise
Description
Following the criteria proposed by World Health Organization for a healthy lifestyle: at least 5 servings of fruit/vegetables per day and at least 30 minutes of moderate physical activity per day 5 days a week. Achieving at least one more criterion than baseline at follow up is considered a success.
Time Frame
baseline, month 1, month 2, month 3, month 4, month 5 and month 6
Secondary Outcome Measure Information:
Title
Physical examination
Description
Physical examination by psychiatrist
Time Frame
baseline
Title
Long term chronic disease inventory (items 2.1-2.24; MOD.ISTAT/IMF-8/B.04-05-ISTAT)
Description
Questionnaire assessing chronic diseases, administered by investigators
Time Frame
baseline
Title
Change in blood pressure
Time Frame
baseline, month 1, month 2, month 3, month 4, month 5 and month 6
Title
Change in pulses
Time Frame
baseline, month 1, month 2, month 3, month 4, month 5 and month 6
Title
Change in Body Mass Index
Time Frame
baseline, month 1, month 2, month 3, month 4, month 5 and month 6
Title
Change in waist circumference
Time Frame
baseline, month 1, month 2, month 3, month 4, month 5 and month 6
Title
Change in glycemia
Time Frame
baseline and month 6
Title
Change in haemoglobin A1C
Time Frame
baseline and month 6
Title
Change in LDL cholesterol
Time Frame
baseline and month 6
Title
Change in HDL cholesterol
Time Frame
baseline and month 6
Title
Change in triglyceridemia
Time Frame
baseline and month 6
Title
Electrocardiogram
Time Frame
baseline
Title
Medication History Schedule
Description
Ad hoc form filled in by psychiatrist on present and previous psychopharmacological or non psychopharmacological medications taken by the participant
Time Frame
baseline
Title
36 Item Short Form Health Survey
Time Frame
beginning and month 6
Title
Verona Service Satisfaction Scale - European Version
Time Frame
beginning and month 6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: ICD-10 diagnosis of affective or non-affective functional psychosis (codes F20-22, F24, F25, F28-F31, F23.3, F33.3) one or more contacts with the CMHS in the 3 months preceding the beginning of the recruitment Age 18-65 Exclusion Criteria: moderate or severe mental handicap (learning disability) organic brain disorders lack of capacity to consent to inclusion subjects already involved in individual treatment related to diet and physical exercise subjects deemed unable or unfit to participate in the proposed physical activities
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lorenzo Burti, Professor
Organizational Affiliation
Universita di Verona
Official's Role
Principal Investigator
Facility Information:
Facility Name
UOC 4° Servizio Psichiatria - ULSS 20
City
San Bonifacio
State/Province
Verona
ZIP/Postal Code
37047
Country
Italy
Facility Name
UOC 1° Servizio Psichiatria - ULSS 20
City
Verona
ZIP/Postal Code
37126
Country
Italy
Facility Name
UOC 2° Servizio Psichiatria - ULSS 20
City
Verona
ZIP/Postal Code
37126
Country
Italy
Facility Name
UOC 3° Servizio Psichiatria - ULSS 20
City
Verona
ZIP/Postal Code
37134
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Physical Co-morbidity, Poor Health Behaviour and Health Promotion in Verona Patients With Functional Psychoses

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