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The Evaluation of the Use of a New Physical Health Plan

Primary Purpose

Psychosis, Schizophrenia

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Physical Health Plan
Sponsored by
King's College London
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Psychosis focused on measuring physical health

Eligibility Criteria

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

Inclusion Criteria:

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

Exclusion Criteria:

  • unable to give informed consent

Sites / Locations

  • King's College London

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Use of the Physical Health Plan

Arm Description

Use of the Physical Health Plan

Outcomes

Primary Outcome Measures

Change in uptake of physical healthcare by service users
Service users will have increased their access to physical healthcare services

Secondary Outcome Measures

Full Information

First Posted
June 1, 2017
Last Updated
February 19, 2020
Sponsor
King's College London
Collaborators
South London and Maudsley NHS Foundation Trust
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1. Study Identification

Unique Protocol Identification Number
NCT03178279
Brief Title
The Evaluation of the Use of a New Physical Health Plan
Official Title
An Evaluation of the Use of a Physical Health Plan With People With Psychosis
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
December 6, 2017 (Actual)
Primary Completion Date
March 30, 2019 (Actual)
Study Completion Date
September 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
King's College London
Collaborators
South London and Maudsley NHS Foundation Trust

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychosis, Schizophrenia
Keywords
physical health

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
The study will take place in 2 community mental health teams and have 3 main stages. Stage 1: The investigators will undertake focus groups with service users and staff to test out the assumptions in the Theory of Change. Stage 2: The PHP will be available as a paper version and on iPad and smartphone. Each team will be asked to work with all of the people on their caseload to complete the PHP. Service users will be encouraged to complete the PHP whilst waiting for their appointment with their care co-ordinator. The completed PHP will then be emailed to the service user and to their care co-ordinator and they will then be asked to develop an action plan to address any gaps in the completed PHP. Each action plan and the progress made with the action plan will be recorded. This exploratory trial will last six months. Stage 3 The investigators will evaluate the experience of using the PHP using interviews with a random selection of service users and clinical staff.
Masking
None (Open Label)
Allocation
N/A
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Use of the Physical Health Plan
Arm Type
Experimental
Arm Description
Use of the Physical Health Plan
Intervention Type
Other
Intervention Name(s)
Physical Health Plan
Intervention Description
Use of a Physical Health Plan by service users
Primary Outcome Measure Information:
Title
Change in uptake of physical healthcare by service users
Description
Service users will have increased their access to physical healthcare services
Time Frame
Baseline and six months

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: using one of the community mental health teams recruiting in the study Exclusion Criteria: unable to give informed consent
Facility Information:
Facility Name
King's College London
City
London
ZIP/Postal Code
SE5 8AF
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30675375
Citation
Williams J, Sevdalis N, Gaughran F. Evaluation of a Physical health plan for people with psychosis: a protocol for a quality improvement study. Pilot Feasibility Stud. 2019 Jan 15;5:8. doi: 10.1186/s40814-019-0396-7. eCollection 2019.
Results Reference
derived

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The Evaluation of the Use of a New Physical Health Plan

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