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
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 di...
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BMJ Publishing Group
2022-06-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/12/6/e062971.full |
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| author | Nick Sevdalis Khalida Ismail Tayana Soukup Trevor Murrells Dulmini Kariyawasam Stephen Thomas Judith Parsons Angus Forbes Rita Forde Maria Baldellou Lopez Marie Jones Martha Ford-Adams Nardos Yemane Siobhan Pender Alex Silverstien |
| author_facet | Nick Sevdalis Khalida Ismail Tayana Soukup Trevor Murrells Dulmini Kariyawasam Stephen Thomas Judith Parsons Angus Forbes Rita Forde Maria Baldellou Lopez Marie Jones Martha Ford-Adams Nardos Yemane Siobhan Pender Alex Silverstien |
| author_sort | Nick Sevdalis |
| collection | DOAJ |
| description | 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. |
| format | Article |
| id | doaj-art-34b7827f52f2425b93bea65ce9777478 |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2022-06-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-34b7827f52f2425b93bea65ce97774782025-02-01T13:15:10ZengBMJ Publishing GroupBMJ Open2044-60552022-06-0112610.1136/bmjopen-2022-062971Protocol 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) programmeNick Sevdalis0Khalida Ismail1Tayana Soukup2Trevor Murrells3Dulmini Kariyawasam4Stephen Thomas5Judith Parsons6Angus Forbes7Rita Forde8Maria Baldellou Lopez9Marie Jones10Martha Ford-Adams11Nardos Yemane12Siobhan Pender13Alex Silverstien14Centre for Behavioural and Implementation Science Interventions, National University of Singapore Yong Loo Lin School of Medicine, SingaporeDepartment of Psychological Medicine, King`s College London Institute of Psychiatry Psychology and Neuroscience, London, UKCentre for Implementation Science, King’s College London, London, UKFlorence Nightingale Faculty of Nursing, Midwifery and Palliative Care, King`s College London, London, UKDiabetes & Endocrinology, Guy`s and St Thomas` Hospitals NHS Trust, London, UKDepartment of Diabetes and Endocrinology, Guy’s and St.Thomas ‘NHS foundation Trust, London, UKProgramme Manager for Contraception, Primary Care Directorate, Southwark Primary Care Trust, London, UKDivision of Care in Long-term Conditions, King`s College London, London, UKFlorence Nightingale Faculty of Nursing, Midwifery & Palliative Care, King`s College London, London, UKCentre for Implementation Science, King`s College London Institute of Psychiatry Psychology and Neuroscience, London, UKDepartment of Diabetes and Endocrinology, Guy’s and St.Thomas ‘NHS foundation Trust, London, UKPaediatric Diabetes Department, King`s College Hospital NHS Foundation Trust, London, UKDepartment of Diabetes and Endocrinology, Guy’s and St.Thomas ‘NHS foundation Trust, London, UKDepartment of Diabetes and Endocrinology, Guy’s and St.Thomas ‘NHS foundation Trust, London, UKDivision of Care Long-term Conditions, King`s College London Florence Nightingale Faculty of Nursing, Midwifery and Palliative Care, London, UKIntroduction 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.https://bmjopen.bmj.com/content/12/6/e062971.full |
| spellingShingle | Nick Sevdalis Khalida Ismail Tayana Soukup Trevor Murrells Dulmini Kariyawasam Stephen Thomas Judith Parsons Angus Forbes Rita Forde Maria Baldellou Lopez Marie Jones Martha Ford-Adams Nardos Yemane Siobhan Pender Alex Silverstien 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 |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| url | https://bmjopen.bmj.com/content/12/6/e062971.full |
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