The Evaluation of the Use of a New Physical Health Plan

NCT ID: NCT03178279

Last Updated: 2020-02-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-06

Study Completion Date

2019-09-30

Brief Summary

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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

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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.

Conditions

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Psychosis Schizophrenia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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.
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Use of the Physical Health Plan

Use of the Physical Health Plan

Group Type EXPERIMENTAL

Physical Health Plan

Intervention Type OTHER

Use of a Physical Health Plan by service users

Interventions

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Physical Health Plan

Use of a Physical Health Plan by service users

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* unable to give informed consent
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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South London and Maudsley NHS Foundation Trust

OTHER

Sponsor Role collaborator

King's College London

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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King's College London

London, , United Kingdom

Site Status

Countries

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United Kingdom

References

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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.

Reference Type DERIVED
PMID: 30675375 (View on PubMed)

Other Identifiers

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IRAS194626

Identifier Type: -

Identifier Source: org_study_id

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