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Diabetes Mellitus, Type 2EMERALDNCT03534921

Improving Diabetes Outcomes for People With Severe Mental Illness (SMI)

An observational study of Diabetes Mellitus, Type 2 and Severe Mental Disorder, run by University of York at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study aims to identify the determinants of diabetes and to explore variation in diabetes outcomes for people with severe mental illness (schizophrenia, schizoaffective disorder and bipolar disorder) in order to develop potential healthcare interventions that can be tested further. Read more about this study

Who is it for?
Ages 18 years and older
How many people
46,564 participants
Where
1 siteUnited Kingdom
Study dates
1 Apr 2018to 31 Oct 2019
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: - Dataset A: patients (with research-quality data) who received a diagnosis of severe mental illness (schizophrenia, schizoaffective disorder and bipolar disorder) at the age of 18 years or above, and who have at least one event of SMI in the study period (01/04/2000-31/03/2016) Dataset B: patients drawn from Dataset A who also have a diagnosis of type 2 diabetes mellitus (received on/after the age of 18). Dataset C: patients with diabetes but no diagnosis of severe mental illness matched to Dataset B on a ratio of 4:1 on the basis of age (+-2 years), gender and GP practice.

Who may be able to join

  • Patients aged 18 and over
  • Patients with diagnoses of severe mental illness, severe mental illness and type 2 diabetes, or with diabetes but no diagnosis of severe mental illness.
  • Patients with research-quality data.

Who cannot join

  • Patients under the age of 18
  • Patients without research quality data.
  • Patients who were diagnosed with Type 1 diabetes following a diagnosis of Type 2 diabetes.
  • Patients who have a code for a diabetic complication (e.g. diabetic retinopathy) but no diagnostic code for diabetes.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site
  • University of York

    York, Yorkshire, YO10 5DD

Other trials in United Kingdom

About this study

Official title: Improving Diabetes Outcomes for People With Severe Mental Illness (SMI): a Longitudinal Observational and Qualitative Study of Patients in England

This study aims to identify the determinants of diabetes and to explore variation in diabetes outcomes for people with severe mental illness (schizophrenia, schizoaffective disorder and bipolar disorder) in order to develop potential healthcare interventions that can be tested further.

The study utilises a mixed methods design comprising analysis of patient primary care records and interviews with patients living with comorbid SMI and diabetes, family carers and healthcare professionals involved in commissioning or delivering healthcare for this population. This entry on the Protocol Registration and Results System describes only the quantitative Work Package of the study in detail i.e. analysis of patient primary care records.

Read the detailed description

People living with severe mental illness (SMI) have a lower life expectancy (by around 20 years) than the general population, often dying of preventable or manageable illnesses (Woodhead et al., 2014). Diabetes contributes significantly to this health inequality, being 2-3 times more likely in people with SMI (Stubbs et al., 2015). This study aims to understand the determinants of type 2 diabetes and variation in diabetes outcomes for people with SMI in order to identify potential healthcare interventions that can be tested further.

Research questions:

  1. What are the socio-demographic and illness-related risk factors associated with
  2. developing type 2 diabetes in people with SMI?
  3. variation in diabetes and mental health outcomes in people with SMI and type 2 diabetes?
  4. How do physical and mental health outcomes differ between people with SMI and type 2 diabetes,
  5. compared to people with SMI without diabetes?
  6. compared to people with type 2 diabetes but no SMI?
  7. What factors influence access to, and receipt of, diabetes care for people with SMI, and how are diabetes healthcare interventions experienced by people with SMI?
  8. How and at what cost is type 2 diabetes monitored and managed in people with SMI compared to those without SMI?
  9. What healthcare interventions (e.g. medication, referrals and care pathways) are associated with better diabetes outcomes for people with SMI and type 2 diabetes?

The study has the following objectives:

  1. In people with SMI, to identify which socio-demographic, illness, family history and lifestyle factors are associated with the development of type 2 diabetes.
  2. In people with SMI and type 2 diabetes, to identify which socio-demographic, illness, family history and lifestyle factors are associated with variation in diabetes and mental health outcomes.
  3. In people with SMI, to compare healthcare interventions, physical and mental health outcomes in those with type 2 diabetes with those without diabetes.
  4. In people with type 2 diabetes, to compare healthcare interventions, physical and mental health outcomes in those with SMI and those without SMI.
  5. To understand the factors that influence access to, and receipt of, diabetes care for people with SMI, and explore the experience of diabetes healthcare by people with SMI.
  6. To compare diabetes care provision for people with and without SMI, and estimate costs for these.
  7. To identify which healthcare interventions (e.g. medication, referrals and care pathways) may be associated with better diabetes outcomes for people with SMI and type 2 diabetes.

Study design:

The study will utilise a convergent triangulation mixed methods design comprising a quantitative longitudinal observational study of individual patient records of adults with diagnosed SMI and diabetes held in the Clinical Practice Research Datalink (CPRD, a computerised database of anonymised primary care medical records drawn from a proportion of general practices in the UK) with qualitative interviews with patients, their family carers and healthcare professionals who commission or deliver services to this comorbid population. This entry on the Protocol Registration and Results System describes only the quantitative work stream of the study i.e. the interrogation of patient primary care records. The key healthcare outcomes to be examined are listed; however, a definitive list of outcomes will be agreed through a consensus process with project team members.

The complete study is organised in three work packages:

  1. Work Package One, which involves ongoing consultation with experts (service users and family members belonging to a Patient and Public Involvement (PPI) panel, healthcare staff and researchers) to refine questions and analyses, a synthesis of evidence on SMI and diabetes risks and outcomes, integrating the qualitative and quantitative studies, conducting co-design workshops to translate study findings into recommendations, and optimising the dissemination of findings.
  2. Work Package Two, which investigates the role of risk factors thought to influence i) development of type 2 diabetes in people with SMI (objective 1), and ii) variation in health outcomes in people with comorbid SMI and type 2 diabetes (objective 2). Further analyses involve a comparison of diabetes healthcare and outcomes for people with SMI and type 2 diabetes with outcomes for people with either condition alone (objectives 3 and 4), an examination of variations in type 2 diabetes screening, monitoring and management and estimation of the costs for these (objective 6); and an exploration of the role of these interventions in contributing to health outcomes (objective 7). These investigations will utilise the CPRD database, which is linked to other datasets, including Hospital Episode Statistics (HES) data, HES-Office of National Statistics mortality data, and Index of Multiple Deprivation (IMD) data. Three CPRD datasets will be analysed which will consist of linked records from the study period of 01 April 2000 to 31 March 2016. The first of these, Dataset A, will contain records of a cohort of adult patients with a diagnosis of SMI. Dataset B is constructed from Dataset A, and comprises those in Dataset A who also have a diagnosis of diabetes. Finally, Dataset C is a cohort of patients with diabetes but no record of SMI who are age and gender-matched to Dataset B on a ratio of 4:1.
  3. Work Package Three, which explores the experience of diabetes management and healthcare from three perspectives: patients, family members or friends who support them and healthcare professionals who commission or deliver services.

Dissemination

Findings will be translated into service recommendations through two multi-stakeholder co-design workshops. The first of these will identify further avenues of inquiry for the final stages of analysis and will develop draft recommendations to improve the organisation and delivery of healthcare for this comorbid population. The second workshop will further develop the recommendations based on the final analyses and will design interventions or care pathways, assessing their potential acceptability and feasibility for future evaluation and implementation.

A dissemination event will be held, presenting materials in a range of formats to maximise opportunities for knowledge exchange. Study outputs will include a final report for the funding body, scientific papers submitted to international peer-reviewed journals, short articles in practitioner journals, executive summaries published on websites, conference presentations, and other materials disseminated through clinical, academic and voluntary sector networks.

Keywords
Diabetes mellitus, Schizophrenia, Schizoaffective disorder, Bipolar disorder, Severe mental illness
Medical subject headings
Diabetes Mellitus, Type 2, Mental Disorders, Diabetes Mellitus, Schizophrenia, Psychotic Disorders, Bipolar Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT03534921
Study groupRoleWhat they receive
People with severe mental illness (SMI)In the study period 01/04/2000-31/03/2016, people with records on the Clinical Practice Research Datalink aged >=18 years with a record of severe mental illness so that at least one event occurs in the study period.
People with SMI and type 2 diabetesDrawn from the first cohort, this group also has a record of type two diabetes mellitus registered during the study period.
People with diabetes (matched controls)This cohort will be matched on a 4:1 ratio by age (+- 2 years), gender and general practitioner practice to the group of people with comorbid SMI and diabetes.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Diabetes status

    Clinical diagnosis of Type 2 diabetes

    Measured: 01/04/2000-31/03/2016

  2. Diabetes onset

    Time from diagnosis of SMI to diagnosis of type 2 diabetes

    Measured: 01/04/2000-31/03/2016

  3. Diabetic control

    Changes in HbA1c

    Measured: 01/04/2000-31/03/2016

  4. Cardiovascular control: Blood pressure

    Changes in blood pressure

    Measured: 01/04/2000-31/03/2016

  5. Cardiovascular control: Lipid profile

    Changes in serum cholesterol levels

    Measured: 01/04/2000-31/03/2016

  6. Diabetic complications 1: Glucose dysregulation

    Hyperglycaemic or hypoglycaemic events

    Measured: 01/04/2000-31/03/2016

  7. Diabetic complications 2: Micro-vascular complications

    Clinical diagnosis of micro-vascular complications e.g. peripheral neuropathy

    Measured: 01/04/2000-31/03/2016

  8. Diabetic complications 3: Macro-vascular complications

    Clinical diagnosis of macro-vascular complications e.g. myocardial infarction

    Measured: 01/04/2000-31/03/2016

  9. Mental Health Outcomes - Depression

    Clinician diagnosis of depression

    Measured: 01/04/2000-31/03/2016

  10. Mental Health Outcome - SMI relapse

    Clinician diagnosis of SMI relapse

    Measured: 01/04/2000-31/03/2016

  11. Mental Health Outcome - Anxiety

    Clinical diagnosis of anxiety

    Measured: 01/04/2000-31/03/2016

  12. Hospital admissions

    Number and type of admissions related to diabetes, severe mental illness or diabetic complications

    Measured: 01/04/2000-31/03/2016

  13. Mortality

    Patient death

    Measured: 01/04/2000-31/03/2016

  14. Healthcare costs

    Cost of primary care consultations

    Measured: 01/04/2000-31/03/2016

  15. Primary care consultations

    The number and type of primary care consultations

    Measured: 01/04/2000-31/03/2016

  16. Healthcare interventions - medication use

    Prescription of antipsychotic medication, antidepressant medication, antihypertensive medication

    Measured: 01/04/2000-31/03/2016

  17. Healthcare interventions - referrals

    Referrals for self-management education, diabetes clinics

    Measured: 01/04/2000-31/03/2016

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 May 2018
  2. Study start1 Apr 2018
  3. Primary completion31 Oct 2019
  4. Study completion31 Oct 2019

Resources

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-control
Time perspective
Retrospective
Enrolment
46,564 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03534921
Sponsor's protocol ID
15/70/26
Acronym
EMERALD
Status last verified
Mar 2020
First submitted
10 Apr 2018
Last updated
24 Mar 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Woodhead C, Ashworth M, Schofield P, Henderson M. Patterns of physical co-/multi-morbidity among patients with serious mental illness: a London borough-based cross-sectional study. BMC Fam Pract. 2014 Jun 11;15:117. doi: 10.1186/1471-2296-15-117.

    PubMed 24919453
  • Stubbs B, Vancampfort D, De Hert M, Mitchell AJ. The prevalence and predictors of type two diabetes mellitus in people with schizophrenia: a systematic review and comparative meta-analysis. Acta Psychiatr Scand. 2015 Aug;132(2):144-57. doi: 10.1111/acps.12439. Epub 2015 May 5.

    PubMed 25943829
  • Bellass S, Taylor J, Han L, Prady SL, Shiers D, Jacobs R, Holt RIG, Radford J, Gilbody S, Hewitt C, Doran T, Alderson SL, Siddiqi N. Exploring Severe Mental Illness and Diabetes: Protocol for a Longitudinal, Observational, and Qualitative Mixed Methods Study. JMIR Res Protoc. 2019 Sep 6;8(9):13407. doi: 10.2196/13407.

    PubMed 31493324

Questions about this trial

What is this clinical trial studying?

An observational study of Diabetes Mellitus, Type 2 and Severe Mental Disorder, run by University of York at 1 site 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 4 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 24 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 status (time frame: 01/04/2000-31/03/2016). The study lists 17 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03534921, which also lists 3 linked publications.

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 24 Mar 2020.

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