Type2DiabetesNCT05456984
The PsychOsis and Diabetes Service Model (PODS) Population Profile Study.
An observational study of Type2Diabetes and Severe Mental Disorder, run by King's College London at 9 sites in United Kingdom.
Trial summary
People with severe mental illness (SMI), defined as psychotic and bipolar disorders, die 17-20 years earlier than the general population, the most common cause of death being cardiovascular diseases (CVD). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type2Diabetes, Severe Mental Disorder
- How many people
- 125 participants
- Where
- 9 sitesUnited Kingdom
- Study dates
- 3 May 2022to 10 Aug 2022
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participant will all have type 2 diabetes and a severe mental illness. They will be recruited from two primary care networks (HBD and StockWELL), both of these are situated in Lambeth, London.
Who may be able to join
- All participants will need to have a diagnosis of type 2 diabetes and bipolar affective disorder or psychosis.
- Capacity to consent; if participant does not currently have capacity to consent, we will ask them again in a few weeks to see whether capacity has been restored. If the participant still lacks capacity, we will ask the potential participant/their clinical team if there is a professional or a personal nominee to consent on their behalf.
- Participants must be 18 years or older.
Who cannot join
- Adults without an SMI diagnosis.
- Adults with SMI and other types of diabetes, e.g. type 1 diabetes or gestational diabetes (as different management).
- Pregnancy.
- Dementia.
- Organic psychosis.
- Moderate-severe learning disabilities
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United Kingdom9 sites
Herne Hill Group Practice
London, SE24 9QP
Knight's Hill
London, SE27 0DF
Brixton Hill
London, SW2 1AE
Northwood Group Practice
London, SW2 3DX
Binfield Road Practice
London, SW4 6TB
Springfield Medical Centre
London, SW8 2SH
Beckett House
London, SW9 9DL
Grantham Practice
London, SW9 9DL
Stockwell Group Practice
London, SW9 9TJ
About this study
People with severe mental illness (SMI), defined as psychotic and bipolar disorders, die 17-20 years earlier than the general population, the most common cause of death being cardiovascular diseases (CVD). The major contributor to CVD mortality in SMI is the increased prevalence of type 2 diabetes (T2D) compared to the general population. T2D is a paradigm of a single condition that progresses to multiple conditions. T2D requires annual reviews of 9 diabetes care processes and for patients to adopt multiple self-care tasks to prevent diabetes complications. The 9 diabetes care processes include: 3-6 monthly blood glucose measurement (HbA1c) with appropriate targets; blood pressure measurements and targets depending on diabetes complication status; annual blood cholesterol measurement; kidney function testing with urinary albumin; kidney function testing with serum creatinine; weight check; smoking status; diabetes annual eye screening; and annual foot examination.
In the National Diabetes Audit 2016-17, people with SMI and T2D were 10% less likely to take up all 9 diabetes care processes and have worse glycaemic control as a result. Therefore the aim of this study is to determine who is receiving these care processes and to develop new care pathways/interventions that support this population.
This project is a cross-sectional study and will take place in Lambeth south London, an area with high prevalence of SMI, and therefore T2D, and deprivation. W aim to profile the entire population of people with SMI and T2D within the Hills Brook and Dales and StockWELL Primary Care Networks. The investigators will access the participants medical records and record details of their latest physical health assessment and ask them to complete 7 validated questionnaires and brief informal interview either face to face in their GP surgery or over the phone. This project has been funded by the Burdett Trust for Nursing.
Read the detailed description
The practice manager at each participating GP practices will run a combined search using read codes for SMI and for type 2 diabetes on the Egton Medical Information System (EMIS) electronic patient record. This will generate a list/register of all the people who potentially meet the study inclusion criteria. Next GPs or practice staff will invite the potentially eligible to participate in the study by sending them a letter and the participant information sheet. The participant will be asked to contact the research team if they would like to participate or have any further questions. If they agree to the study they receive an information sheet and consent form and will have the opportunity to ask the research team about the study.
It is expected that the total of eligible participants will be 578 from HBD and 472 for StockWELL PCN. This is because HBD PCN have a total of 57,863 patients and StockWELL have 47,199. Type 2 diabetes prevalence for Lambeth is around 5% and there are 5253 people with diabetes from the 2 PCNs which means that based on the estimated prevalence of SMI and T2D in primary care of 20%, the total population of potentially eligible participants will be in the region of 1,000. It is anticipated that 20% of people will respond to the study invitation which would mean a total population of around 200 and depending on the time available to recruit participants and the rate at which GP practices join the study and run the searches, the investigators aim to recruit at least 120 within the study period.
This will be a population-based cross-sectional survey of the total population of people with SMI and T2D registered with HBD PCN and StockWELL PCN. The research team will carry out a case note review of identifiable electronic medical records at the clinical site, information that will be selected will include the date of both diagnoses, duration of both diagnoses and medication history after consent has been obtained. This information will be written in a pseudoanonymised case report form with an ID number replacing patient identifiers and will then be kept in a locked filling cabinet in James Clerk Maxwell Building, King's College London.
The research team will ask the participant to complete 7 validated questionnaires (Diabetes Distress Scale, International Physical Activity Scale, Quality of Life Scale, self-report Global Assessment of Functioning, Alcohol Usage Disorders Identification Test, Drug Abuse Screening Test and Empower Up). This will be done either over the phone or in person and the participants GP surgery, depending on their preference.
The GP Practice will be asked to conduct a routine physical health assessment on the participant, if they have not had one in the last 3 months. This would be part of their routine clinical care and consist of HbA1c (mmol/mol); BP (mmHg); eGFR (mL/min); cholesterol (mmol/mol); BMI (m/kg2).
The research worker will then conduct a brief interview, they will rate the severity of psychiatric symptoms using a validated rating scale and they will discuss how the participant accesses support for diabetes self-management, whether they have any experience of digital interventions and their thoughts on them and finally, preferences on where and how, they receive their diabetes support. This will be carried out either over the phone or in person, depending on the participants preference and will take about 30 minutes.
If the participant lacks capacity to consent, they will be asked to consent again in a few weeks to see whether capacity has been restored. If the participant still lacks capacity or they lose capacity during the study, the participant or clinical team will be asked to elect a personal or professional and consultee. The research team will contact them and ask if they are happy to consent on the participants behalf.
- Conditions
- Type2Diabetes, Severe Mental Disorder
- Medical subject headings
- Mental Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
Diabetes Distress Scale
To profile the current psychological and physical status of patients registered in the Hills Brook and Dales PCN and the StockWELL PCN. The Diabetes Distress Scale will be administered.
Measured: 1 day
International Physical Activity Questionnaire
To profile the current psychological and physical status of patients registered in the Hills Brook and Dales PCN and the StockWELL PCN. The International Physical Activity Questionnaire will be administered.
Measured: 1 day
Quality of Life Scale
To profile the current psychological and physical status of patients registered in the Hills Brook and Dales PCN and the StockWELL PCN. The Quality of Life Scale will be administered.
Measured: 1 day
Global Assessment of Functioning
To profile the current psychological and physical status of patients registered in the Hills Brook and Dales PCN and the StockWELL PCN. The Global Assessment of Functioning scale will be administered.
Measured: 1 day
Alcohol usage disorder identification test
To profile the current psychological and physical status of patients registered in the Hills Brook and Dales PCN and the StockWELL PCN. The Alcohol Usage Disorders Identification Test will be administered.
Measured: 1 day
Drug abuse screening test
To profile the current psychological and physical status of patients registered in the Hills Brook and Dales PCN and the StockWELL PCN. The Drug Abuse Screening Test will be administered.
Measured: 1 day
Brief psychiatric rating scale
To profile the current psychological and physical status of patients registered in the Hills Brook and Dales PCN and the StockWELL PCN. The Brief Psychiatric Rating Scale will be administered.
Measured: 1 day
Empower up
To profile the current psychological and physical status of patients registered in the Hills Brook and Dales PCN and the StockWELL PCN. The Empower Up Questionnaire will be administered.
Measured: 1 day
Secondary outcomes (1)
Diabetes treatment
Investigators will use an open interview to find out where and how the participant would like their diabetes treatment.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2022
- Study start3 May 2022
- Primary completion10 Aug 2022
- Study completion10 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type2DiabetesStudies of the same condition, open and under way.
- More trials run by King's College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 125 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Collaborators
- Burdett Trust for Nursing
- Responsible party
- Sponsor
- Investigators
- Kirsty Winkley, Principal investigator, King's College London University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05456984
- Sponsor's protocol ID
- 307600
- Status last verified
- Dec 2022
- First submitted
- 25 Mar 2022
- Last updated
- 13 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymised data can be shared if requested.
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The PsychOsis and Diabetes Service Model (PODS) Population Profile Study.
- ClinicalTrials.gov ID
- NCT05456984
- Acronym / sponsor ID
- 307600
- Conditions
- Type2Diabetes, Severe Mental Disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Collaborators
- Burdett Trust for Nursing
- Study start
- 3 May 2022 (actual)
- Primary completion
- 10 Aug 2022 (actual)
- Study completion
- 10 Aug 2022 (actual)
- First posted
- 13 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
People with severe mental illness (SMI), defined as psychotic and bipolar disorders, die 17-20 years earlier than the general population, the most common cause of death being cardiovascular diseases (CVD). The major contributor to CVD mortality in SMI is the increased prevalence of type 2 diabetes (T2D) compared to the general population. T2D is a paradigm of a single condition that progresses to multiple conditions. T2D requires annual reviews of 9 diabetes care processes and for patients to adopt multiple self-care tasks to prevent diabetes complications. The 9 diabetes care processes include: 3-6 monthly blood glucose measurement (HbA1c) with appropriate targets; blood pressure measurements and targets depending on diabetes complication status; annual blood cholesterol measurement; kidney function testing with urinary albumin; kidney function testing with serum creatinine; weight check; smoking status; diabetes annual eye screening; and annual foot examination.
In the National Diabetes Audit 2016-17, people with SMI and T2D were 10% less likely to take up all 9 diabetes care processes and have worse glycaemic control as a result. Therefore the aim of this study is to determine who is receiving these care processes and to develop new care pathways/interventions that support this population.
This project is a cross-sectional study and will take place in Lambeth south London, an area with high prevalence of SMI, and therefore T2D, and deprivation. W aim to profile the entire population of people with SMI and T2D within the Hills Brook and Dales and StockWELL Primary Care Networks. The investigators will access the participants medical records and record details of their latest physical health assessment and ask them to complete 7 validated questionnaires and brief informal interview either face to face in their GP surgery or over the phone. This project has been funded by the Burdett Trust for Nursing.
Detailed description
The practice manager at each participating GP practices will run a combined search using read codes for SMI and for type 2 diabetes on the Egton Medical Information System (EMIS) electronic patient record. This will generate a list/register of all the people who potentially meet the study inclusion criteria. Next GPs or practice staff will invite the potentially eligible to participate in the study by sending them a letter and the participant information sheet. The participant will be asked to contact the research team if they would like to participate or have any further questions. If they agree to the study they receive an information sheet and consent form and will have the opportunity to ask the research team about the study.
It is expected that the total of eligible participants will be 578 from HBD and 472 for StockWELL PCN. This is because HBD PCN have a total of 57,863 patients and StockWELL have 47,199. Type 2 diabetes prevalence for Lambeth is around 5% and there are 5253 people with diabetes from the 2 PCNs which means that based on the estimated prevalence of SMI and T2D in primary care of 20%, the total population of potentially eligible participants will be in the region of 1,000. It is anticipated that 20% of people will respond to the study invitation which would mean a total population of around 200 and depending on the time available to recruit participants and the rate at which GP practices join the study and run the searches, the investigators aim to recruit at least 120 within the study period.
This will be a population-based cross-sectional survey of the total population of people with SMI and T2D registered with HBD PCN and StockWELL PCN. The research team will carry out a case note review of identifiable electronic medical records at the clinical site, information that will be selected will include the date of both diagnoses, duration of both diagnoses and medication history after consent has been obtained. This information will be written in a pseudoanonymised case report form with an ID number replacing patient identifiers and will then be kept in a locked filling cabinet in James Clerk Maxwell Building, King's College London.
The research team will ask the participant to complete 7 validated questionnaires (Diabetes Distress Scale, International Physical Activity Scale, Quality of Life Scale, self-report Global Assessment of Functioning, Alcohol Usage Disorders Identification Test, Drug Abuse Screening Test and Empower Up). This will be done either over the phone or in person and the participants GP surgery, depending on their preference.
The GP Practice will be asked to conduct a routine physical health assessment on the participant, if they have not had one in the last 3 months. This would be part of their routine clinical care and consist of HbA1c (mmol/mol); BP (mmHg); eGFR (mL/min); cholesterol (mmol/mol); BMI (m/kg2).
The research worker will then conduct a brief interview, they will rate the severity of psychiatric symptoms using a validated rating scale and they will discuss how the participant accesses support for diabetes self-management, whether they have any experience of digital interventions and their thoughts on them and finally, preferences on where and how, they receive their diabetes support. This will be carried out either over the phone or in person, depending on the participants preference and will take about 30 minutes.
If the participant lacks capacity to consent, they will be asked to consent again in a few weeks to see whether capacity has been restored. If the participant still lacks capacity or they lose capacity during the study, the participant or clinical team will be asked to elect a personal or professional and consultee. The research team will contact them and ask if they are happy to consent on the participants behalf.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participant will all have type 2 diabetes and a severe mental illness. They will be recruited from two primary care networks (HBD and StockWELL), both of these are situated in Lambeth, London.
Key inclusion criteria (3 listed)
- All participants will need to have a diagnosis of type 2 diabetes and bipolar affective disorder or psychosis.
- Capacity to consent; if participant does not currently have capacity to consent, we will ask them again in a few weeks to see whether capacity has been restored. If the participant still lacks capacity, we will ask the potential participant/their clinical team if there is a professional or a personal nominee to consent on their behalf.
- Participants must be 18 years or older.
Key exclusion criteria (6 listed)
- Adults without an SMI diagnosis.
- Adults with SMI and other types of diabetes, e.g. type 1 diabetes or gestational diabetes (as different management).
- Pregnancy.
- Dementia.
- Organic psychosis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Diabetes Distress Scale
Time frame: 1 day
To profile the current psychological and physical status of patients registered in the Hills Brook and Dales PCN and the StockWELL PCN. The Diabetes Distress Scale will be administered.
International Physical Activity Questionnaire
Time frame: 1 day
To profile the current psychological and physical status of patients registered in the Hills Brook and Dales PCN and the StockWELL PCN. The International Physical Activity Questionnaire will be administered.
Quality of Life Scale
Time frame: 1 day
To profile the current psychological and physical status of patients registered in the Hills Brook and Dales PCN and the StockWELL PCN. The Quality of Life Scale will be administered.
Global Assessment of Functioning
Time frame: 1 day
To profile the current psychological and physical status of patients registered in the Hills Brook and Dales PCN and the StockWELL PCN. The Global Assessment of Functioning scale will be administered.
Alcohol usage disorder identification test
Time frame: 1 day
To profile the current psychological and physical status of patients registered in the Hills Brook and Dales PCN and the StockWELL PCN. The Alcohol Usage Disorders Identification Test will be administered.
Drug abuse screening test
Time frame: 1 day
To profile the current psychological and physical status of patients registered in the Hills Brook and Dales PCN and the StockWELL PCN. The Drug Abuse Screening Test will be administered.
Brief psychiatric rating scale
Time frame: 1 day
To profile the current psychological and physical status of patients registered in the Hills Brook and Dales PCN and the StockWELL PCN. The Brief Psychiatric Rating Scale will be administered.
Empower up
Time frame: 1 day
To profile the current psychological and physical status of patients registered in the Hills Brook and Dales PCN and the StockWELL PCN. The Empower Up Questionnaire will be administered.
1 secondary outcome
Diabetes treatment
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2022.
- Individual participant dataSharing planned: Yes. Anonymised data can be shared if requested.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kirsty Winkley principal investigator
King's College London University
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type2Diabetes and Severe Mental Disorder, run by King's College London at 9 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diabetes Distress Scale (time frame: 1 day). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2022.