Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

The Evaluation of the Use of a New Physical Health Plan

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03178279
Recruitment Status : Recruiting
First Posted : June 6, 2017
Last Update Posted : March 7, 2018
Sponsor:
Collaborator:
South London and Maudsley NHS Foundation Trust
Information provided by (Responsible Party):
King's College London

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.


Condition or disease Intervention/treatment Phase
Psychosis Schizophrenia Other: Physical Health Plan Not Applicable

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Intervention Model: Single Group Assignment
Intervention 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)
Primary Purpose: Health Services Research
Official Title: An Evaluation of the Use of a Physical Health Plan With People With Psychosis
Actual Study Start Date : December 6, 2017
Estimated Primary Completion Date : November 2018
Estimated Study Completion Date : March 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Use of the Physical Health Plan
Use of the Physical Health Plan
Other: Physical Health Plan
Use of a Physical Health Plan by service users




Primary Outcome Measures :
  1. Change in uptake of physical healthcare by service users [ Time Frame: Baseline and six months ]
    Service users will have increased their access to physical healthcare services



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • unable to give informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03178279


Locations
Layout table for location information
United Kingdom
King's College London Recruiting
London, United Kingdom, SE5 8AF
Contact: Julie Williams    442078485087    julie.williams@kcl.ac.uk   
Principal Investigator: Fiona Gaughran         
Sponsors and Collaborators
King's College London
South London and Maudsley NHS Foundation Trust

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: King's College London
ClinicalTrials.gov Identifier: NCT03178279     History of Changes
Other Study ID Numbers: IRAS194626
First Posted: June 6, 2017    Key Record Dates
Last Update Posted: March 7, 2018
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by King's College London:
physical health

Additional relevant MeSH terms:
Layout table for MeSH terms
Schizophrenia
Psychotic Disorders
Mental Disorders
Schizophrenia Spectrum and Other Psychotic Disorders