Effectiveness-implementation hybrid type 2 trial evaluating two psychoeducational programmes for severe hypoglycaemia in type 1 diabetes: implementation study protocol
Introduction Two of the most acute and feared complications in type 1 diabetes (T1D) are hypoglycaemia and severe hypoglycaemia (SH). While impaired awareness of hypoglycaemia (IAH) can lead to SH with cognitive and motivational barriers implicated, the available education does not integrate behavio...
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BMJ Publishing Group
2019-11-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/9/11/e030370.full |
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| author | Nick Sevdalis Tayana Soukup Ioannis Bakolis Stephanie A Amiel Emma Lauretta Smith Louise Hull Andy Healey PWD Group |
| author_facet | Nick Sevdalis Tayana Soukup Ioannis Bakolis Stephanie A Amiel Emma Lauretta Smith Louise Hull Andy Healey PWD Group |
| author_sort | Nick Sevdalis |
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| description | Introduction Two of the most acute and feared complications in type 1 diabetes (T1D) are hypoglycaemia and severe hypoglycaemia (SH). While impaired awareness of hypoglycaemia (IAH) can lead to SH with cognitive and motivational barriers implicated, the available education does not integrate behavioural change techniques to address these. A novel Hypoglycaemia Awareness Restoration Programme despite optimised care (HARPdoc) is currently being tested against an established blood glucose awareness training (BGAT) within a parallel, two-arm, group randomised, blinded trial (with its own protocol; NCT02940873) with adults with T1D whose problems with hypoglycaemia and SH have persisted despite otherwise optimised insulin management. While both programmes are aimed at reducing hypoglycaemia, SH and IAH, it is the former that integrates behavioural change techniques.The aim of the current (implementation) study is to evaluate delivery of both HARPdoc and BGAT and explore associations between implementation outcomes and trial endpoints; as well as to develop an evidence-based implementation blueprint to guide implementation, sustainment and scale-up of the effective programmes.Methods and analysis Guided by the implementation science tools, frameworks, methods and principles, the current study was designed through a series of focus groups (n=11) with the key intervention stakeholders (n=28)—including (1) individuals with lived experience of T1D, IAH and a pilot version of the HARPdoc (n=6) and (2) diabetes healthcare professionals (n=22). A mixed-methods approach will be used throughout. Stakeholder engagement has underpinned study design and materials to maximise relevance, feasibility and impact.Ethics and dissemination The protocol has been reviewed and received ethical approval by the Harrow Research Ethics Committee (18/LO/1020; 240752) on 1 October 2018. The findings will be submitted to a peer-reviewed journal and presented at scientific meetings.Trial registration number NCT02940873; Pre-results. |
| format | Article |
| id | doaj-art-ebbe8f4c66054a0f95e4b1c069853f7f |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2019-11-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-ebbe8f4c66054a0f95e4b1c069853f7f2024-11-29T00:15:10ZengBMJ Publishing GroupBMJ Open2044-60552019-11-0191110.1136/bmjopen-2019-030370Effectiveness-implementation hybrid type 2 trial evaluating two psychoeducational programmes for severe hypoglycaemia in type 1 diabetes: implementation study protocolNick Sevdalis0Tayana Soukup1Ioannis Bakolis2Stephanie A Amiel3Emma Lauretta Smith4Louise Hull5Andy Healey6PWD Group7Centre for Implementation Science, King’s College London, London, UKCentre for Implementation Science, King’s College London, London, UKDepartment of Biostatistics and Health Informatics, Institute of Psychiatry, Psychology and Neuroscience, King’s College London, London, London, UKDepartment of Diabetes, Faculty of Life Sciences and Medicine, King’s College London, London, UKDepartment of Diabetes, School of Life Course Sciences, King’s College London, London, UKCentre for Implementation Science, Health Service and Population Research Department, King`s College London, London, UKHealth Service and Population Research Department, King’s College London, London, UKDepartment of Diabetes, King`s College London, People With Diabetes (PWD) Group: Mr Mike Kendall, Ms Lis Warren, Ms Victoria Ruszala, Ms Mel Stephenson, Mr Arthur Durrant, London, UKIntroduction Two of the most acute and feared complications in type 1 diabetes (T1D) are hypoglycaemia and severe hypoglycaemia (SH). While impaired awareness of hypoglycaemia (IAH) can lead to SH with cognitive and motivational barriers implicated, the available education does not integrate behavioural change techniques to address these. A novel Hypoglycaemia Awareness Restoration Programme despite optimised care (HARPdoc) is currently being tested against an established blood glucose awareness training (BGAT) within a parallel, two-arm, group randomised, blinded trial (with its own protocol; NCT02940873) with adults with T1D whose problems with hypoglycaemia and SH have persisted despite otherwise optimised insulin management. While both programmes are aimed at reducing hypoglycaemia, SH and IAH, it is the former that integrates behavioural change techniques.The aim of the current (implementation) study is to evaluate delivery of both HARPdoc and BGAT and explore associations between implementation outcomes and trial endpoints; as well as to develop an evidence-based implementation blueprint to guide implementation, sustainment and scale-up of the effective programmes.Methods and analysis Guided by the implementation science tools, frameworks, methods and principles, the current study was designed through a series of focus groups (n=11) with the key intervention stakeholders (n=28)—including (1) individuals with lived experience of T1D, IAH and a pilot version of the HARPdoc (n=6) and (2) diabetes healthcare professionals (n=22). A mixed-methods approach will be used throughout. Stakeholder engagement has underpinned study design and materials to maximise relevance, feasibility and impact.Ethics and dissemination The protocol has been reviewed and received ethical approval by the Harrow Research Ethics Committee (18/LO/1020; 240752) on 1 October 2018. The findings will be submitted to a peer-reviewed journal and presented at scientific meetings.Trial registration number NCT02940873; Pre-results.https://bmjopen.bmj.com/content/9/11/e030370.full |
| spellingShingle | Nick Sevdalis Tayana Soukup Ioannis Bakolis Stephanie A Amiel Emma Lauretta Smith Louise Hull Andy Healey PWD Group Effectiveness-implementation hybrid type 2 trial evaluating two psychoeducational programmes for severe hypoglycaemia in type 1 diabetes: implementation study protocol BMJ Open |
| title | Effectiveness-implementation hybrid type 2 trial evaluating two psychoeducational programmes for severe hypoglycaemia in type 1 diabetes: implementation study protocol |
| title_full | Effectiveness-implementation hybrid type 2 trial evaluating two psychoeducational programmes for severe hypoglycaemia in type 1 diabetes: implementation study protocol |
| title_fullStr | Effectiveness-implementation hybrid type 2 trial evaluating two psychoeducational programmes for severe hypoglycaemia in type 1 diabetes: implementation study protocol |
| title_full_unstemmed | Effectiveness-implementation hybrid type 2 trial evaluating two psychoeducational programmes for severe hypoglycaemia in type 1 diabetes: implementation study protocol |
| title_short | Effectiveness-implementation hybrid type 2 trial evaluating two psychoeducational programmes for severe hypoglycaemia in type 1 diabetes: implementation study protocol |
| title_sort | effectiveness implementation hybrid type 2 trial evaluating two psychoeducational programmes for severe hypoglycaemia in type 1 diabetes implementation study protocol |
| url | https://bmjopen.bmj.com/content/9/11/e030370.full |
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