Randomised controlled trial of a person-centred transition programme for adolescents with type 1 diabetes (STEPSTONES-DIAB): a study protocol
Introduction Adolescence is a critical period for youths with chronic conditions, when they are supposed to take over the responsibility for their health. Type 1 diabetes (T1D) is one of the most common chronic conditions in childhood and inadequate self-management increases the risk of short-term a...
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BMJ Publishing Group
2020-04-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/10/4/e036496.full |
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| author | Philip Moons Ewa-Lena Bratt Anna Lena Brorsson Anna Ek Elisabeth Jelleryd Torun Torbjörnsdotter Carina Sparud-Lundin |
| author_facet | Philip Moons Ewa-Lena Bratt Anna Lena Brorsson Anna Ek Elisabeth Jelleryd Torun Torbjörnsdotter Carina Sparud-Lundin |
| author_sort | Philip Moons |
| collection | DOAJ |
| description | Introduction Adolescence is a critical period for youths with chronic conditions, when they are supposed to take over the responsibility for their health. Type 1 diabetes (T1D) is one of the most common chronic conditions in childhood and inadequate self-management increases the risk of short-term and long-term complications. There is a lack of evidence regarding the effectiveness of transition programmes. As a part of the Swedish Transition Effects Project Supporting Teenagers with chrONic mEdical conditionS research programme, the objective of this study is to evaluate the effectiveness and experiences of different transitional care models, including a person-centred transition programme aiming to empower adolescents with T1D to become active partners in their health and care.Methods and analysis In this randomised controlled trial, patients are recruited from two paediatric diabetes clinics at the age of 16 years. Patients are randomly assigned to either the intervention group (n=70) where they will receive usual care plus the structured transition programme, or to the control group (n=70) where they will only receive usual care. Data will be collected at 16, 17 and 18.5 years of age. In a later stage, the intervention group will be compared with adolescents in a dedicated youth clinic in a third setting. The primary outcome is patient empowerment. Secondary outcomes include generic, diabetes-specific and transfer-specific variables.Ethics and dissemination The study has been approved by the Ethical Review Board in Stockholm (Dnr 2018/1725-31). Findings will be reported following the Consolidated Standards of Reporting Trials statement and disseminated in peer-reviewed journals and at international conferences.Trial registration number NCT03994536 |
| format | Article |
| id | doaj-art-099c175f95bb457d8b1e9da434cc684e |
| institution | OA Journals |
| issn | 2044-6055 |
| language | English |
| publishDate | 2020-04-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-099c175f95bb457d8b1e9da434cc684e2025-08-20T02:19:54ZengBMJ Publishing GroupBMJ Open2044-60552020-04-0110410.1136/bmjopen-2019-036496Randomised controlled trial of a person-centred transition programme for adolescents with type 1 diabetes (STEPSTONES-DIAB): a study protocolPhilip Moons0Ewa-Lena Bratt1Anna Lena Brorsson2Anna Ek3Elisabeth Jelleryd4Torun Torbjörnsdotter5Carina Sparud-Lundin6University of Gothenburg, Goteborg, Sweden1 Institute of Health and Care Sciences, Goteborgs Universitet, Goteborg, SwedenDepartment of Neurobiology, Care Sciences and Society, Karolinska Institutet, Stockholm, SwedenDivision of Pediatrics, Department of Clinical Science, Intervention and Technology, Karolinska Institutet, Stockholm, SwedenDepartment of Paediatric Diabetes, Astrid Lindgren`s Children’s Hospital, Karolinska University Hospital, Stockholm, SwedenDepartment of Paediatric Diabetes, Astrid Lindgren`s Children’s Hospital, Karolinska University Hospital, Stockholm, SwedenGothenburg Centre for Person-Centred Care (GPCC), University of Gothenburg, Gothenburg, SwedenIntroduction Adolescence is a critical period for youths with chronic conditions, when they are supposed to take over the responsibility for their health. Type 1 diabetes (T1D) is one of the most common chronic conditions in childhood and inadequate self-management increases the risk of short-term and long-term complications. There is a lack of evidence regarding the effectiveness of transition programmes. As a part of the Swedish Transition Effects Project Supporting Teenagers with chrONic mEdical conditionS research programme, the objective of this study is to evaluate the effectiveness and experiences of different transitional care models, including a person-centred transition programme aiming to empower adolescents with T1D to become active partners in their health and care.Methods and analysis In this randomised controlled trial, patients are recruited from two paediatric diabetes clinics at the age of 16 years. Patients are randomly assigned to either the intervention group (n=70) where they will receive usual care plus the structured transition programme, or to the control group (n=70) where they will only receive usual care. Data will be collected at 16, 17 and 18.5 years of age. In a later stage, the intervention group will be compared with adolescents in a dedicated youth clinic in a third setting. The primary outcome is patient empowerment. Secondary outcomes include generic, diabetes-specific and transfer-specific variables.Ethics and dissemination The study has been approved by the Ethical Review Board in Stockholm (Dnr 2018/1725-31). Findings will be reported following the Consolidated Standards of Reporting Trials statement and disseminated in peer-reviewed journals and at international conferences.Trial registration number NCT03994536https://bmjopen.bmj.com/content/10/4/e036496.full |
| spellingShingle | Philip Moons Ewa-Lena Bratt Anna Lena Brorsson Anna Ek Elisabeth Jelleryd Torun Torbjörnsdotter Carina Sparud-Lundin Randomised controlled trial of a person-centred transition programme for adolescents with type 1 diabetes (STEPSTONES-DIAB): a study protocol BMJ Open |
| title | Randomised controlled trial of a person-centred transition programme for adolescents with type 1 diabetes (STEPSTONES-DIAB): a study protocol |
| title_full | Randomised controlled trial of a person-centred transition programme for adolescents with type 1 diabetes (STEPSTONES-DIAB): a study protocol |
| title_fullStr | Randomised controlled trial of a person-centred transition programme for adolescents with type 1 diabetes (STEPSTONES-DIAB): a study protocol |
| title_full_unstemmed | Randomised controlled trial of a person-centred transition programme for adolescents with type 1 diabetes (STEPSTONES-DIAB): a study protocol |
| title_short | Randomised controlled trial of a person-centred transition programme for adolescents with type 1 diabetes (STEPSTONES-DIAB): a study protocol |
| title_sort | randomised controlled trial of a person centred transition programme for adolescents with type 1 diabetes stepstones diab a study protocol |
| url | https://bmjopen.bmj.com/content/10/4/e036496.full |
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