Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT05496907 |
| Other study ID # |
289799 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
July 22, 2022 |
| Est. completion date |
December 2023 |
Study information
| Verified date |
August 2022 |
| Source |
King's College London |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
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 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.
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.
