The PsychOsis and Diabetes Service Model (PODS) Population Profile Study.

NCT05456984 | Completed DMC

• 1 other identifier: 307600
• Study Type: observational
• Target: 125
• Locations: 1 country
• Sites: 9

Brief 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.

Conditions

Type2Diabetes; Severe Mental Disorder

Outcome Measures

Primary Outcomes (8)

• 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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  1 day

Secondary Outcomes (1)

• Diabetes treatment

  1 day

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• King's College London: lead
• Burdett Trust for Nursing: collaborator

Study Sites (9)

Herne Hill Group Practice

London, SE24 9QP, United Kingdom

Location

Knight's Hill

London, SE27 0DF, United Kingdom

Location

Brixton Hill

London, SW2 1AE, United Kingdom

Location

Northwood Group Practice

London, SW2 3DX, United Kingdom

Location

Binfield Road Practice

London, SW4 6TB, United Kingdom

Location

Springfield Medical Centre

London, SW8 2SH, United Kingdom

Location

Beckett House

London, SW9 9DL, United Kingdom

Location

Grantham Practice

London, SW9 9DL, United Kingdom

Location

Stockwell Group Practice

London, SW9 9TJ, United Kingdom

Location

MeSH Terms

Conditions

Mental Disorders

Study Officials

• Kirsty Winkley

  King's College London University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2022
• First Posted: July 13, 2022
• Study Start: May 3, 2022
• Primary Completion: August 10, 2022
• Study Completion: August 10, 2022
• Last Updated: December 13, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Once the study is completed.
• Access Criteria: Email Kirsty Winkley to request access.

Locations

GB (9)