A Psychosocial Education Programme for Young People With Type 1 Diabetes

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-01

Study Completion Date

2023-03-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Diabetes Mellitus, Type 1

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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 Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Intervention

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

Group Type EXPERIMENTAL

Youth Empowerment Skills

Intervention Type 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

Waiting-list control

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

Group Type OTHER

Waiting-list control

Intervention Type BEHAVIORAL

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

Interventions

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Youth Empowerment Skills

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 Type BEHAVIORAL

Waiting-list control

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

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