Type 2 DiabetesNCT05496907
Psychosis and Type 2 Diabetes Study (PODS)
A study testing Diabetes specialist nurse-led collaborative care intervention in people with Type 2 Diabetes 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
- Type 2 Diabetes, Severe Mental Disorder
- What is being tested?
- Diabetes specialist nurse-led collaborative care intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 9 sitesUnited Kingdom
- Study dates
- 22 Jul 2022to Dec 2023
- Phase
- Interventional
- 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
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 the 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, they will be asked to elect a personal consultee nominee to consent on their behalf. If there is not anyone suitable, we will ask their clinical team to nominate a professional consultee. The research team will then contact this person and ask if they are happy to consent on the participants' 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).
- Self-reported pregnancy status (as would require intensive management in a dedicated clinic).
- 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
Official title: Developing an Integrated Model of Care for People With Severe Mental Illness and Type 2 Diabetes: the PsychOsis and Diabetes Service Model (PODS)
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 outlined by the NICE guidelines include: 3-6 monthly blood glucose measurement (HbA1c) with targets; blood pressure measurements and targets; 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.
Previous research has focused on upskilling mental health professionals or link workers in diabetes care, however, a primary care led focus to support individuals with T2D and SMI has not been investigated. This is an interventional study in Lambeth south London testing a new model of care for people with SMI and T2D that is led by the community DSN in collaboration with the PN and mental health team within the Hills Brook and Dales Primary Care Network (PCN). StockWELL PCN participants will act as controls. Participants will complete 7 validated questionnaires, a physical examination including a blood test and urine sample and a brief interview either face to face in their GP surgery. The intervention group will be invited to a clinic run by a DSN. Baseline measures will be repeated after 6 months in both groups. An exit interview will be conducted to determine participants thoughts on the intervention. This project has been funded by the Burdett Trust for Nursing.
Read the detailed description
The research team will approach the potential participants by contacting them directly and sending a invite letter and the participant information sheet to them by post. This contact is in accordance with consent for future contact given as part of a previous study (IRAS: 307600). Local staff resource/direct care team are not involved in the identification or recruitment of participants in this current application. If the participant contacts the research team, an appointment will be made to complete the consent process, this will occur either over the phone or face to face, depending on the participants' preference.
This will be an interventional study with a non-randomised control group of integrated nurse-led intervention with a 6 month follow up. Patients that belong to GP surgeries in the hills, brook and dales PCN, will automatically be put in the intervention arm, whereas patients who belong to a GP in the StockWELL PCN will be placed in the control group. The investigators will aim to recruit 30 participants in each group, so 60 in total.
After the participants consent, they will be asked to complete 7 validated questionnaires (Diabetes Distress Scale, International Physical Activity Questionnaire, Quality of Life Scale, Global Assessment of Functioning, Alcohol Usage Disorders Identification Test, Drug Abuse Screening Test and Empower Up). These can be found in the case report form, and participants answers will be recorded in the case report form. An Interview will also take place to determine severity of psychiatric symptoms using the Brief Psychiatric Rating Scale. This will take place either face to face at the participants GP surgery or over the phone, depending on the participants preference.
A physical assessment will be conducted including Blood pressure (mmHg), BMI (m/kg2), Urinary ACR (mg/mmol), and Blood Tests for HbA1c (mmol/mol), Glucose test (mmol/L), Total Cholesterol (mmol/mol), Renal Function (mL/min), this will be completed at the participants GP surgery by the direct care team.
This information will be written in a case report form and will kept in a locked filling cabinet in James Clerk Maxwell Building, King's College London (KCL). Data from the form will be entered onto the research REDCAP database by the research team.
Intervention group:
Participants from GP practices within the Hills Brooks and Dales PCN will be invited to face to face or virtual clinics with the DSN and PN. During the appointments the DSN and PN will try and help improve the individual's diabetes control by;
- The patients and health professionals will identify specific and measurable goals to work towards, which will be monitored and form part of a care plan.
- Support the patients' self-management for example medication taking.
- Carry out missing care processes or refer the patient to have them done.
- Discuss strategies on how to optimise a healthy lifestyle and how to improve glycaemic control.
- Sign-post patients to activities and support groups that may benefit their mental and physical wellbeing.
- Encourage patients to engage in regular reviews with DSN/PN to monitor progress and to promote proactive treatment amendments.
Control group:
Participants from 5 GPs in the StockWELL PCN will be invited to join the study by the research team. They will receive their usual diabetes and mental health care. If the research team discover any missing care processes, their care team will be made aware.
Follow-up:
The same measures that were completed at the beginning will be re-assessed again at 6 months, these include; 7 validated questionaries (Diabetes Distress Scale, International Physical Activity Questionnaire, Quality of Life Scale, Global Assessment of Functioning, Alcohol Usage Disorders Identification Test, Drug Abuse Screening Test and Empower Up. An Interview will also take place to determine severity of psychiatric symptoms using the Brief Psychiatric Rating Scale. This will take place either face to face at the participants GP surgery or over the phone, depending on the participants preference.
However, the investigators will also include the Patients Global Impression of Change to measure the overall change in quality of life since beginning the study from the patients' perspective.
A physical assessment will be conducted including Blood pressure (mmHg), BMI (m/kg2), Urinary ACR (mg/mmol), and Blood Tests for HbA1c (mmol/mol), Glucose test (mmol/L), Total Cholesterol (mmol/mol), Renal Function (mL/min), this will be completed at the participants GP surgery by the research team.
To evaluate the patients' experience of this new care pathway exit interviews with participants in the intervention group will be conducted by the research team either over the phone or face to face at the participants GP surgery, depending on their preference. This will approximately take 30 minutes. The interviews will be audio recorded and transcribed before being qualitatively analysed by the research team.
If the participant lacks capacity to consent, the investigators will ask them again in a few weeks to see whether capacity has been restored. If the participant still lacks capacity, their clinical team will be asked if there is a potential personal or professional consultee. The research team will contact this person and ask if they are happy to consent on the participants' behalf.
- Conditions
- Type 2 Diabetes, Severe Mental Disorder
- Being tested
- Diabetes specialist nurse-led collaborative care intervention
- Medical subject headings
- Diabetes Mellitus, Type 2, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diabetes specialist nurse-led collaborative care interventionBehavioural
10 sessions with a diabetes nurse to help improve physical and mental health outcomes
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | After the participants consent, they will be asked to complete 7 validated questionnaires. An interview will also take place to determine severity of psychiatric symptoms using the Brief Psychiatric Rating Scale. A physical assessment will be conducted including Blood pressure, BMI and Blood Tests for HbA1c, Glucose test, Total Cholesterol, Renal Function.
Participants in the intervention arm will see the diabetes nurse up to 10 times, during these sessions motivational interviewing will be used to discuss areas to improve, goal setting and action planning. Participants and the nurse will collaboratively discuss practical strategies to improve their HbA1c, blood pressure, cholesterol, BMI and mental health.
The same measures that were completed at the beginning will be re-assessed again at 6 months. Receives: Behavioral: Diabetes specialist nurse-led collaborative care intervention |
| Control | No intervention | Participants will be asked to complete the same 7 validated questionnaires, the brief psychiatric rating scale and a physical health assessment at the start. The will continue to receive standard care from their usual care professionals. The same measures that were completed at the beginning will be re-assessed again at 6 months. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness of Intervention using HbA1c levels
To compare the HbA1c of participants who receive the integrated diabetes nurse-led intervention with a non-randomised control group.
Measured: 6 months
Secondary outcomes (3)
Blood Pressure
The blood pressure of the intervention group will be compared to the control group after six months.
Measured: 6 months
Body Mass Index (BMI)
BMI, which is a person's weight (kg) divided by their height (m) squared (kg/m2), will be compared after 6 months between the intervention and the control group.
Measured: 6 months
Mental Health Outcome
Mental health will be assessed by the brief psychiatric rating scale. This is a seven point scale (1, not present; 2, very mild; 3, mild; 4, moderate; 5, moderately severe; 6, severe; 7, extremely severe). Thus, the range of possible BPRS total scores is from 18 to 126. A higher score would suggest a more severe psychiatrics symptoms.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2022
- Study start22 Jul 2022
- Primary completion5 Aug 2022
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kirsty Graham, Principal investigator, King's College London University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05496907
- Sponsor's protocol ID
- 289799
- Status last verified
- Aug 2022
- First submitted
- 2 Aug 2022
- Last updated
- 15 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 15 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing an Integrated Model of Care for People With Severe Mental Illness and Type 2 Diabetes: the PsychOsis and Diabetes Service Model (PODS)
- ClinicalTrials.gov ID
- NCT05496907
- Acronym / sponsor ID
- 289799
- Conditions
- Type 2 Diabetes, Severe Mental Disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (actual)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Study start
- 22 Jul 2022 (actual)
- Primary completion
- 5 Aug 2022 (actual)
- Study completion
- Dec 2023 (estimated)
- First posted
- 11 Aug 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 outlined by the NICE guidelines include: 3-6 monthly blood glucose measurement (HbA1c) with targets; blood pressure measurements and targets; 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.
Previous research has focused on upskilling mental health professionals or link workers in diabetes care, however, a primary care led focus to support individuals with T2D and SMI has not been investigated. This is an interventional study in Lambeth south London testing a new model of care for people with SMI and T2D that is led by the community DSN in collaboration with the PN and mental health team within the Hills Brook and Dales Primary Care Network (PCN). StockWELL PCN participants will act as controls. Participants will complete 7 validated questionnaires, a physical examination including a blood test and urine sample and a brief interview either face to face in their GP surgery. The intervention group will be invited to a clinic run by a DSN. Baseline measures will be repeated after 6 months in both groups. An exit interview will be conducted to determine participants thoughts on the intervention. This project has been funded by the Burdett Trust for Nursing.
Detailed description
The research team will approach the potential participants by contacting them directly and sending a invite letter and the participant information sheet to them by post. This contact is in accordance with consent for future contact given as part of a previous study (IRAS: 307600). Local staff resource/direct care team are not involved in the identification or recruitment of participants in this current application. If the participant contacts the research team, an appointment will be made to complete the consent process, this will occur either over the phone or face to face, depending on the participants' preference.
This will be an interventional study with a non-randomised control group of integrated nurse-led intervention with a 6 month follow up. Patients that belong to GP surgeries in the hills, brook and dales PCN, will automatically be put in the intervention arm, whereas patients who belong to a GP in the StockWELL PCN will be placed in the control group. The investigators will aim to recruit 30 participants in each group, so 60 in total.
After the participants consent, they will be asked to complete 7 validated questionnaires (Diabetes Distress Scale, International Physical Activity Questionnaire, Quality of Life Scale, Global Assessment of Functioning, Alcohol Usage Disorders Identification Test, Drug Abuse Screening Test and Empower Up). These can be found in the case report form, and participants answers will be recorded in the case report form. An Interview will also take place to determine severity of psychiatric symptoms using the Brief Psychiatric Rating Scale. This will take place either face to face at the participants GP surgery or over the phone, depending on the participants preference.
A physical assessment will be conducted including Blood pressure (mmHg), BMI (m/kg2), Urinary ACR (mg/mmol), and Blood Tests for HbA1c (mmol/mol), Glucose test (mmol/L), Total Cholesterol (mmol/mol), Renal Function (mL/min), this will be completed at the participants GP surgery by the direct care team.
This information will be written in a case report form and will kept in a locked filling cabinet in James Clerk Maxwell Building, King's College London (KCL). Data from the form will be entered onto the research REDCAP database by the research team.
Intervention group:
Participants from GP practices within the Hills Brooks and Dales PCN will be invited to face to face or virtual clinics with the DSN and PN. During the appointments the DSN and PN will try and help improve the individual's diabetes control by;
- The patients and health professionals will identify specific and measurable goals to work towards, which will be monitored and form part of a care plan.
- Support the patients' self-management for example medication taking.
- Carry out missing care processes or refer the patient to have them done.
- Discuss strategies on how to optimise a healthy lifestyle and how to improve glycaemic control.
- Sign-post patients to activities and support groups that may benefit their mental and physical wellbeing.
- Encourage patients to engage in regular reviews with DSN/PN to monitor progress and to promote proactive treatment amendments.
Control group:
Participants from 5 GPs in the StockWELL PCN will be invited to join the study by the research team. They will receive their usual diabetes and mental health care. If the research team discover any missing care processes, their care team will be made aware.
Follow-up:
The same measures that were completed at the beginning will be re-assessed again at 6 months, these include; 7 validated questionaries (Diabetes Distress Scale, International Physical Activity Questionnaire, Quality of Life Scale, Global Assessment of Functioning, Alcohol Usage Disorders Identification Test, Drug Abuse Screening Test and Empower Up. An Interview will also take place to determine severity of psychiatric symptoms using the Brief Psychiatric Rating Scale. This will take place either face to face at the participants GP surgery or over the phone, depending on the participants preference.
However, the investigators will also include the Patients Global Impression of Change to measure the overall change in quality of life since beginning the study from the patients' perspective.
A physical assessment will be conducted including Blood pressure (mmHg), BMI (m/kg2), Urinary ACR (mg/mmol), and Blood Tests for HbA1c (mmol/mol), Glucose test (mmol/L), Total Cholesterol (mmol/mol), Renal Function (mL/min), this will be completed at the participants GP surgery by the research team.
To evaluate the patients' experience of this new care pathway exit interviews with participants in the intervention group will be conducted by the research team either over the phone or face to face at the participants GP surgery, depending on their preference. This will approximately take 30 minutes. The interviews will be audio recorded and transcribed before being qualitatively analysed by the research team.
If the participant lacks capacity to consent, the investigators will ask them again in a few weeks to see whether capacity has been restored. If the participant still lacks capacity, their clinical team will be asked if there is a potential personal or professional consultee. The research team will contact this person and ask if they are happy to consent on the participants' behalf.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Diabetes specialist nurse-led collaborative care interventionAfter the participants consent, they will be asked to complete 7 validated questionnaires. An interview will also take place to determine severity of psychiatric symptoms using the Brief Psychiatric Rating Scale. A physical assessment will be conducted including Blood pressure, BMI and Blood Tests for HbA1c, Glucose test, Total Cholesterol, Renal Function. Participants in the intervention arm will see the diabetes nurse up to 10 times, during these sessions motivational interviewing will be used to discuss areas to improve, goal setting and action planning. Participants and the nurse will collaboratively discuss practical strategies to improve their HbA1c, blood pressure, cholesterol, BMI and mental health. The same measures that were completed at the beginning will be re-assessed again at 6 months. |
| Control | No intervention | –Participants will be asked to complete the same 7 validated questionnaires, the brief psychiatric rating scale and a physical health assessment at the start. The will continue to receive standard care from their usual care professionals. The same measures that were completed at the beginning will be re-assessed again at 6 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 the 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, they will be asked to elect a personal consultee nominee to consent on their behalf. If there is not anyone suitable, we will ask their clinical team to nominate a professional consultee. The research team will then contact this person and ask if they are happy to consent on the participants' 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).
- Self-reported pregnancy status (as would require intensive management in a dedicated clinic).
- 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diabetes specialist nurse-led collaborative care intervention10 sessions with a diabetes nurse to help improve physical and mental health outcomes | Behavioural | Intervention |
Primary outcome
Effectiveness of Intervention using HbA1c levels
Time frame: 6 months
To compare the HbA1c of participants who receive the integrated diabetes nurse-led intervention with a non-randomised control group.
3 secondary outcomes
Blood Pressure
Time frame: 6 months
Body Mass Index (BMI)
Time frame: 6 months
Mental Health Outcome
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 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 Graham 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?
A study testing Diabetes specialist nurse-led collaborative care intervention in people with Type 2 Diabetes 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: status not confirmed, as of the sponsor's last update on 15 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?
Results are not available in the source record.
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?
Effectiveness of Intervention using HbA1c levels (time frame: 6 months). 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 15 Dec 2022.