Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05456984 |
| Other study ID # |
307600 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
May 3, 2022 |
| Est. completion date |
August 10, 2022 |
Study information
| Verified date |
December 2022 |
| Source |
King's College London |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical 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). 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.
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.
