TY - JOUR
T1 - Protocol for a feasibility study and process evaluation of a psychosocially modelled diabetes education programme for young people with type 1 diabetes
T2 - the Youth Empowerment Skills (YES) programme
AU - Kariyawasam, Dulmini
AU - Soukup, Tayana
AU - Parsons, Judith
AU - Sevdalis, Nick
AU - Baldellou Lopez, Maria
AU - Forde, Rita
AU - Ismail, Khalida
AU - Jones, Marie
AU - Ford-Adams, Martha
AU - Yemane, Nardos
AU - Pender, Siobhan
AU - Thomas, Stephen
AU - Murrells, Trevor
AU - Silverstien, Alex
AU - Forbes, Angus
N1 - Publisher Copyright:
© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY. Published by BMJ.
PY - 2022/6/9
Y1 - 2022/6/9
N2 - INTRODUCTION: Adolescence is a challenging period for young people with type 1 diabetes, associated with worsening glycaemia and care disengagement. Educational interventions in this period tend to focus on diabetes-specific skills, with less emphasis on the psychosocial challenges associated with diabetes experienced by young people. To address this limitation, we codesigned with young people a psychosocially modelled programme of diabetes education, named 'Youth Empowerment Skills' (YES). The programme aims to facilitate a positive adaptation to life with diabetes and engagement with diabetes care through peer-based learning, immersive simulations and support from an outreach youth worker. Here, we present a protocol for a feasibility study of the YES programme.METHODS AND ANALYSIS: The study was designed following the Medical Research Council Complex Intervention Evaluation Framework to: test the feasibility (acceptance, implementability, recruitment and completion) of the YES programme; and estimate its efficacy in relation to metabolic and psychosocial outcomes. The study will take place in diabetes centres serving socioculturally diverse populations. We will conduct a feasibility randomised controlled trial (waiting-list design) with integrated process evaluation. Fifty young people with type 1 diabetes (aged 14-19 years) will be randomly allocated to either the YES intervention or a waiting-list control. Randomisation acceptability will be assessed with provision for a preference allocation. Outcomes will be evaluated at 6 months, at which point the waiting list participants will be exposed to the YES programme with further follow-up to 12 months. A simultaneous process evaluation will use a mixed-methods approach collecting qualitative and quantitative data. Study findings will be used to optimise the intervention components, outcome measures and recruitment methods to inform a subsequent definitive trial.ETHICS AND DISSEMINATION: The protocol has ethical approval from the UK Health Research Authority (approval IRAS project ID: 279877). Findings will be disseminated in multiple formats for lay and professional audiences.PROTOCOL DATE AND VERSION: 7 April 2021, V.1.1.TRIAL REGISTRATION NUMBER: NCT04670198.
AB - INTRODUCTION: Adolescence is a challenging period for young people with type 1 diabetes, associated with worsening glycaemia and care disengagement. Educational interventions in this period tend to focus on diabetes-specific skills, with less emphasis on the psychosocial challenges associated with diabetes experienced by young people. To address this limitation, we codesigned with young people a psychosocially modelled programme of diabetes education, named 'Youth Empowerment Skills' (YES). The programme aims to facilitate a positive adaptation to life with diabetes and engagement with diabetes care through peer-based learning, immersive simulations and support from an outreach youth worker. Here, we present a protocol for a feasibility study of the YES programme.METHODS AND ANALYSIS: The study was designed following the Medical Research Council Complex Intervention Evaluation Framework to: test the feasibility (acceptance, implementability, recruitment and completion) of the YES programme; and estimate its efficacy in relation to metabolic and psychosocial outcomes. The study will take place in diabetes centres serving socioculturally diverse populations. We will conduct a feasibility randomised controlled trial (waiting-list design) with integrated process evaluation. Fifty young people with type 1 diabetes (aged 14-19 years) will be randomly allocated to either the YES intervention or a waiting-list control. Randomisation acceptability will be assessed with provision for a preference allocation. Outcomes will be evaluated at 6 months, at which point the waiting list participants will be exposed to the YES programme with further follow-up to 12 months. A simultaneous process evaluation will use a mixed-methods approach collecting qualitative and quantitative data. Study findings will be used to optimise the intervention components, outcome measures and recruitment methods to inform a subsequent definitive trial.ETHICS AND DISSEMINATION: The protocol has ethical approval from the UK Health Research Authority (approval IRAS project ID: 279877). Findings will be disseminated in multiple formats for lay and professional audiences.PROTOCOL DATE AND VERSION: 7 April 2021, V.1.1.TRIAL REGISTRATION NUMBER: NCT04670198.
UR - http://www.scopus.com/inward/record.url?scp=85131710857&partnerID=8YFLogxK
U2 - 10.1136/bmjopen-2022-062971
DO - 10.1136/bmjopen-2022-062971
M3 - Article
C2 - 35680254
SN - 2044-6055
VL - 12
SP - e062971
JO - BMJ Open
JF - BMJ Open
IS - 6
ER -
