Clinical trial NCT04670198: A Psychosocial Education Programme for Young People With Type 1 Diabetes - the Youth Empowerment Skills (YES)
Official title: A Randomised Waiting-list Feasibility Study and Process Evaluation of a Psychosocial Education Programme for Young People With Type 1 Diabetes - the Youth Empowerment Skills (YES)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 1
Keywords: Diabetes Mellitus, Type 1
Adolescent
Psychosocial Support Systems
Lead sponsor: King's College London
Sponsor class: OTHER
Collaborators: name: Guy's and St Thomas' NHS Foundation Trust
name: Diabetes UK
First posted: 2020-12-17
Enrollment: 50
Sex: ALL
Minimum age (years): 14
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Detailed description: The study has been designed as a feasibility study with an integrated process evaluation following MRC guidance (Craig et al., 2008; Moore et al., 2015). The process evaluation data collection has been modelled on the COM_B and the Behaviour Change Wheel framework (BCW) frameworks (Michie et al., 2014; Barker et al., 2016) addressing: policy context; intervention functions; target behaviours; and outcomes. As part of the process evaluation the investigators will also use Consolidated Framework for Implementation Research (CFIR) to study how the programme can be optimally embedded within routine diabetes care, and to optimise the design of a subsequent trial (Murray et al., 2010). The investigators will conduct a feasibility randomised controlled trial (waiting-list design) with integrated process evaluation designed following the Medical Research Council's (MRC) Complex Intervention Evaluation Framework (Craig et al., 2008). 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.

The proportion of patients achieving the progression criteria and the target reduction in glycated haemoglobin (HbA1c) from baseline to follow-up (6 and 12 months) will be estimated in both intervention and waiting list control groups. The investigators will also estimate the standard deviation (SD) of the mean difference between the intervention and waiting list control groups in HbA1c at 6 and 12 months. These statistics will help to inform the sample size calculation of a larger trial.

The process evaluation will consider the setting, implementation, and mechanisms of action of the programme to support interpretation of the outcomes. The process evaluation uses a standardised taxonomy for understanding implementation (Julious, 2005; Proctor et al., 2011), and will assess: the reach, fidelity and receipt of the programme; acceptability, appropriateness and feasibility; unintended consequences; potential sustainability; and implementation costs and strategies. In addition, potential mechanisms of action will be elicited, including changes in behaviours, and how they relate to programme delivery and outcomes.

The investigators will use a mixed-method approach with validated implementation outcome surveys (Powell et al., 2015) and one-to-one interviews with young people, their relatives and healthcare professionals. The data collection tools and analytic models have been designed with reference to the BCW (Michie et al., 2014) and to provide the data for CFIR analysis, considering the barriers and facilitators to the intervention. To ensure relevance and feasibility, the data collection procedures will be refined with the study patient and public involvement groups. Data collection will be conducted at multiple time points to provide opportunities for data triangulation and subsequent theory generation.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Glycated haemoglobin (HbA1c)
timeFrame: Baseline, 6 months, 12 months
Secondary outcomes:
measure: Frequency of blood glucose monitoring
timeFrame: Baseline, 6 months, 12 months
measure: Insulin adherence
timeFrame: Baseline, 6 months, 12 months
measure: Self-Management of Diabetes in Adolescence Scale (SMOD-A)
timeFrame: Baseline, 6 months, 12 months
measure: Confidence in Diabetes Self-Care Scale (CDSS)
timeFrame: Baseline, 6 months, 12 months
measure: Diabetes Quality of Life Instrument (DQOL) (adapted for youth)
timeFrame: Baseline, 6 months, 12 months
measure: Brief Illness Perception Questionnaire (IPQ-B)
timeFrame: Baseline, 6 months, 12 months
measure: Emergency care events
timeFrame: Baseline, 6 months, 12 months
measure: Hypoglycaemia and severe hypoglycaemic events
timeFrame: Baseline, 6 months, 12 months
measure: Weight
timeFrame: Baseline, 6 months, 12 months
measure: Intervention Appropriateness Measure (IAM)
timeFrame: Within 3 months of intervention
measure: Feasibility of Intervention Measure (FIM)
timeFrame: Within 3 months of intervention
measure: Acceptability of Intervention Measure (AIM)
timeFrame: Within 3 months of intervention
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Guy's and St Thomas' NHS Foundation Trust
city: London
country: United Kingdom
facility: University Lewisham Hospital
city: London
country: United Kingdom
facility: Queen Elizabeth Hospital
city: London
country: United Kingdom
facility: King's College Hospital
city: London
country: United Kingdom
facility: St George's University Hospital HS Foundation Trust
Study officials:
affiliation: King's College London
name: Angus Forbes
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.