A Psychosocial Education Programme for Young People With Type 1 Diabetes - the Youth Empowerment Skills (YES)

NCT04670198 | Completed

• 1 other identifier: D-UK 19/0006055
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 5

Brief Summary

Adolescence is a period of intense physiological, psychological and social change. It can be a challenging period for young people with Type 1 diabetes and is associated with worsening blood sugar control and care disengagement. The investigators have co-designed with young people a psychologically modelled educational programme - Youth Empowerment Skills (YES), which aims to facilitate a positive adaption to living with diabetes while improving knowledge and self-management behaviours. Integrated programme components include social and peer-based learning, immersive simulations, and an outreach youth worker. The aim of this study is to test the feasibility of the YES programme (acceptance, implementability, recruitment and completion), and estimate its efficacy in relation to metabolic and psychosocial outcomes. The investigators will recruit young people with Type 1 diabetes and conduct a feasibility randomised controlled trial (waiting-list design) with integrated process evaluation. Sixty young people will be randomised to either YES intervention or waiting-list control and evaluate outcomes at 6-months; at this point the waiting list participants will be offered the YES intervention with further follow-up at 12 months.

Conditions

Diabetes Mellitus, Type 1

Keywords

Diabetes Mellitus, Type 1; Adolescent; Psychosocial Support Systems

Outcome Measures

Primary Outcomes (1)

• Glycated haemoglobin (HbA1c)

  HbA1c will be used to measure: 1. the number of participants achieving clinically significant reductions of 5.5mmol/mol or more and mean differences between groups over time 2. the standard deviation (SD) of the mean difference between the intervention and control group in HbA1c at 6 months; for the control group the SD of the mean difference between HbA1c at 12 months and pre-exposure (phase 2) and for the phase 1 intervention group the SD of the mean HbA1c difference between post (6 and 12 months) and pre-exposure.

  Baseline, 6 months, 12 months

Secondary Outcomes (12)

• Frequency of blood glucose monitoring

  Baseline, 6 months, 12 months

• Insulin adherence

  Baseline, 6 months, 12 months

• Self-Management of Diabetes in Adolescence Scale (SMOD-A)

  Baseline, 6 months, 12 months

• Confidence in Diabetes Self-Care Scale (CDSS)

  Baseline, 6 months, 12 months

• Diabetes Quality of Life Instrument (DQOL) (adapted for youth)

  Baseline, 6 months, 12 months

Study Arms (2)

Intervention

EXPERIMENTAL

The intervention arm will receive the Youth Empowerment Skills (YES) programme.

Behavioral: Youth Empowerment Skills

Waiting-list control

OTHER

The waiting-list control arm will receive usual care for six months before receiving the Youth Empowerment Skills (YES) programme.

Behavioral: Waiting-list control

Interventions

Youth Empowerment Skills BEHAVIORAL

The Youth Empowerment Skills (YES) programme is a novel psychoeducational intervention with simulation-based experiential learning tailored to the needs of young people. It is based on a social-cognitive learning model, and comprises attendance at 3 all-day YES sessions in non-healthcare settings (groups of 10); and then post-programme networking through social media and follow-up events facilitated by the youth worker. Sessions are led by a peer-educator and a health professional

Intervention

Waiting-list control BEHAVIORAL

Usual care for 6 months, followed by the YES programme.

Waiting-list control

Eligibility Criteria

• Age: 14 Years - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Diagnosis of Type 1 diabetes
• Sub-optimal glycaemic control (HbA1c 8.5%)
• No current or planned attendance at other structured education programmes

You may not qualify if:

• Severe, physical/mental illness
• Pregnancy
• Unstable retinopathy
• Significant learning difficulties

Sponsors & Collaborators

• King's College London: lead
• Guy's and St Thomas' NHS Foundation Trust: collaborator
• Diabetes UK: collaborator

Study Sites (5)

Guy's and St Thomas' NHS Foundation Trust

London, SE1 9RS, United Kingdom

Location

University Lewisham Hospital

London, SE13 6LH, United Kingdom

Location

Queen Elizabeth Hospital

London, SE18 4QH, United Kingdom

Location

King's College Hospital

London, SE5 9RS, United Kingdom

Location

St George's University Hospital HS Foundation Trust

London, SW17 0QT, United Kingdom

Location

Related Publications (1)

• Kariyawasam D, Soukup T, Parsons J, Sevdalis N, Baldellou Lopez M, Forde R, Ismail K, Jones M, Ford-Adams M, Yemane N, Pender S, Thomas S, Murrells T, Silverstien A, Forbes A. Protocol for a feasibility study and process evaluation of a psychosocially modelled diabetes education programme for young people with type 1 diabetes: the Youth Empowerment Skills (YES) programme. BMJ Open. 2022 Jun 9;12(6):e062971. doi: 10.1136/bmjopen-2022-062971.

  PMID: 35680254 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

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

Study Officials

• Angus Forbes

  King's College London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study has been designed as a waiting-list randomised controlled trial (RCT). Young people will be randomised to either the phase 1 YES group or the waiting-list control group. The phase 1 YES group will then attend the programme, both groups will be followed-up initially for 6 months, at which point the waiting-list control participants will attend the YES programme in phase 2. Both groups will then be followed-up for a further 6 months.

Study Record Dates

• First Submitted: November 17, 2020
• First Posted: December 17, 2020
• Study Start: June 1, 2021
• Primary Completion: March 31, 2023
• Study Completion: March 31, 2023
• Last Updated: October 6, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Data will be available at the end of the study.
• Access Criteria: Requests made to study researchers

Locations

GB (5)