Psychosis and Type 2 Diabetes Study (PODS)

NCT05496907 | Unknown DMC

• 1 other identifier: 289799
• Study Type: interventional
• Target: 16
• 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 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.

Conditions

Type 2 Diabetes; Severe Mental Disorder

Outcome Measures

Primary Outcomes (1)

• 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.

  6 months

Secondary Outcomes (3)

• Blood Pressure

  6 months

• Body Mass Index (BMI)

  6 months

• Mental Health Outcome

  6 months

Study Arms (2)

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.

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.

Interventions

Diabetes specialist nurse-led collaborative care intervention BEHAVIORAL

10 sessions with a diabetes nurse to help improve physical and mental health outcomes

Intervention

Eligibility Criteria

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

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 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.

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).
• Self-reported pregnancy status (as would require intensive management in a dedicated clinic).
• Dementia.
• Organic psychosis.
• Moderate-severe learning disabilities

Sponsors & Collaborators

• King's College London: lead

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

Diabetes Mellitus, Type 2; Mental Disorders

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Kirsty Graham

  King's College London University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2022
• First Posted: August 11, 2022
• Study Start: July 22, 2022
• Primary Completion: August 5, 2022
• Study Completion: December 1, 2023
• Last Updated: December 15, 2022

Record last verified: 2022-08

Data Sharing

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

Locations

GB (9)