The Evaluation of the Use of a New Physical Health Plan

Schizophrenia Clinical Trial

Official title:

An Evaluation of the Use of a Physical Health Plan With People With Psychosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03178279
• Other study ID #: IRAS194626
• Status: Completed
• Phase: N/A
• Start date: December 6, 2017
• Est. completion date: September 30, 2019

Study information

• Verified date: October 2019
• Source: King's College London
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

People suffering from psychotic illnesses (e.g. schizophrenia) have poorer physical health than the general population. The reasons include a lack of service user motivation to attend physical health checks and the tendency of health professionals to focus mainly on the mental disorder thus delaying the detection of physical health conditions.

Identifying people who have physical health needs is increasingly recognised as a priority. The investigators have developed a Physical Health Plan (PHP) which is completed by service users and identifies areas of physical health need. An action plan is then completed by the service user and care co-ordinator to address these issues.

The PHP is designed to be very simple to use and there will be 3 versions, 1. paper version,

2. 1 version implemented via the 'IMPARTS' computerised 'tablet' based system that has been separately evaluated (REC Ref 12/SC/0422) and 3. 1 version on an iPad via the MHL2 system via Mindwaves.

The investigators wish to pilot the use of this PHP in two community teams in the South London and Maudsley (SLaM) Trust. The pilot will be done in three stages.

Stage One: The investigators will undertake an initial qualitative study to refine the process of using the PHP using focus group consultations with staff and service users.

Stage Two: The investigators will then undertake a six month study to evaluate the uptake and use of the PHP. This will involve collecting data on how many people complete the PHP and what actions are taken following the completion of the PHP.

Stage Three: At the end of this six month period the investigators will undertake qualitative interviews with a selection of service users and staff to understand their experience of using the PHP.

The investigators hope to be able to use the results of this pilot study to introduce the use of the PHP into routine care.

Description:

The PHP is designed to be very simple to use and there will be 3 versions, 1. paper version,

2. 1 version implemented via the 'IMPARTS' computerised 'tablet' based system that has been separately evaluated (REC Ref 12/SC/0422) and 3. 1 version on an iPad via the Healthlocker system via Mindwaves.

The investigators wish to pilot the use of this PHP in two community teams in the South London and Maudsley (SLaM) Trust. The pilot will be done in three stages.

Stage One: The investigators will undertake an initial qualitative study to refine the process of using the PHP using focus group consultations with staff and service users.

Stage Two: The investigators will then undertake a six month study to evaluate the uptake and use of the PHP. This will involve collecting data on how many people complete the PHP and what actions are taken following the completion of the PHP.

Stage Three: At the end of this six month period the investigators will undertake qualitative interviews with a selection of service users and staff to understand their experience of using the PHP.

The investigators hope to be able to use the results of this pilot study to introduce the use of the PHP into routine care.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: September 30, 2019
• Est. primary completion date: March 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• using one of the community mental health teams recruiting in the study

Exclusion Criteria:

• unable to give informed consent

Related Conditions & MeSH terms

• Mental Disorders
• Psychosis
• Psychotic Disorders
• Schizophrenia

Intervention

Other:
• Physical Health Plan
Use of a Physical Health Plan by service users

Locations

Country	Name	City	State
United Kingdom	King's College London	London

Sponsors (2)

Lead Sponsor	Collaborator
King's College London	South London and Maudsley NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in uptake of physical healthcare by service users	Service users will have increased their access to physical healthcare services	Baseline and six months