BMC Pediatrics | |
A multicentre randomized controlled trial of an empowerment-inspired intervention for adolescents starting continuous subcutaneous insulin infusion - a study protocol | |
Anna Lindholm Olinder3  Gunnel Viklund2  Janeth Leksell1  Anna Lena Brorsson2  | |
[1] Department of Medical Sciences, Uppsala University, Uppsala, Sweden;Department of Women’s and Children’s Health, Karolinska Institute and Hospital, Stockholm, Sweden;Department of Clinical Science and Education, Karolinska Institute, Södersjukhuset, Stockholm, Sweden | |
关键词: Guided self-determination-Young (GSD-Y); Person-centred care; Parental involvement; Adolescence; Continuous subcutaneous insulin infusion (CSII); Type 1 diabetes; | |
Others : 1144032 DOI : 10.1186/1471-2431-13-212 |
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received in 2013-07-03, accepted in 2013-12-14, 发布年份 2013 | |
【 摘 要 】
Background
Continuous subcutaneous insulin infusion (CSII) treatment among children with type 1 diabetes is increasing in Sweden. However, studies evaluating glycaemic control in children using CSII show inconsistent results. The distribution of responsibility for diabetes self-management between children and parents is often unclear and needs clarification. There is much published support for continued parental involvement and shared diabetes management during adolescence. Guided Self-Determination (GSD) is an empowerment-based, person-centred, reflection and problem solving method intended to guide the patient to become self-sufficient and develop life skills for managing difficulties in diabetes self-management. This method has been adapted for adolescents and parents as Guided Self-Determination-Young (GSD-Y). This study aims to evaluate the effect of an intervention with GSD-Y in groups of adolescents starting on insulin pumps and their parents on diabetes-related family conflicts, perceived health and quality of life (QoL), and metabolic control. Here, we describe the protocol and plans for study enrolment.
Methods/design
This study is designed as a randomized, controlled, prospective, multicentre study. Eighty patients between 12–18 years of age who are planning to start CSII will be included. All adolescents and their parents will receive standard insulin pump training. The education intervention will be conducted when CSII is to be started and at four appointments in the first 4 months after starting CSII. The primary outcome is haemoglobin A1c levels. Secondary outcomes are perceived health and QoL, frequency of blood glucose self-monitoring and bolus doses, and usage of carbohydrate counting. The following instruments will be used: Disabkids, ‘Check your health’, the Diabetes Family Conflict Scale and the Swedish Diabetes Empowerment Scale. Outcomes will be evaluated within and between groups by comparing data at baseline, and at 6 and 12 months after starting treatment.
Discussion
In this study, we will assess the effect of starting an CSII together with the model of GSD to determine whether this approach leads to retention of improved glycaemic control, QoL, responsibility distribution and reduced diabetes-related conflicts in the family.
Trial registration
Current controlled trials: ISRCTN22444034
【 授权许可】
2013 Brorsson et al.; licensee BioMed Central Ltd.
【 预 览 】
Files | Size | Format | View |
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20150330070027464.pdf | 187KB | download | |
Figure 1. | 135KB | Image | download |
【 图 表 】
Figure 1.
【 参考文献 】
- [1]SWEDIABKIDS: Nationellt register för barn- och ungdomsdiabetes, Årsrapport, 2011 års resultat. 2011. https://www.ndr.nu/NDR2/ShowPDF.aspx?Document=NDR-Child/AnnualReport-2011.pdf webcite
- [2]International Diabetes Federation: Global IDF/ISPAD Guideline for Diabetes in Childhood and Adolescence. 2011. http://www.ispad.org/sites/default/files/resources/files/idf-ispad_diabetes_in_childhood_and_adolescence_guidelines_2011_0.pdf webcite
- [3]Sjöblad S: Barn- och ungdomsdiabetes. Lund: Studentlitteratur; 2008. 2. [uppdaterade och utvidgade] uppl. edn
- [4]The Diabetes Control and Complications Trial Research Group: The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. N Engl J Med 1993, 329(14):977-986.
- [5]Diabetes Control and Complications Trial. Diabetes Control and Complications Trial Research Group: Effect of intensive diabetes treatment on the development and progression of long-term complications in adolescents with insulin-dependent diabetes mellitus. J Pediatr 1994, 125(2):177-188.
- [6]Årsrapport 2010 SWEDIABKIDS. 2010. https://www.swediabkids.se/DocumentsAnnualReport.aspx webcite
- [7]Haugstvedt A, Wentzel-Larsen T, Rokne B, Graue M: Psychosocial family factors and glycemic control among children aged 1–15 years with type 1 diabetes: a population-based survey. BMC Pediatr 2011, 11:118. BioMed Central Full Text
- [8]Bangstad HJ, Danne T, Deeb L, Jarosz-Chobot P, Urakami T, Hanas R: Insulin treatment in children and adolescents with diabetes. Pediatr Diabetes 2009, 10(Suppl 12):82-99.
- [9]Palmer AJ, Roze S, Valentine WJ, Spinas G: The cost-effectiveness of continuous subcutaneous insulin infusion compared with multiple daily injections for the management of diabetes: response to Scuffham [corrected] and Carr. Diabet Med 2004, 21(12):1372. author reply 1372–1373
- [10]Scuffham P, Carr L: The cost-effectiveness of continuous subcutaneous insulin infusion compared with multiple daily injections for the management of diabetes. Diabet Med 2003, 20(7):586-593.
- [11]Cummins E, Royle P, Snaith A, Greene A, Robertson L, McIntyre L, Waugh N: Clinical effectiveness and cost-effectiveness of continuous subcutaneous insulin infusion for diabetes: systematic review and economic evaluation. Health Technol Assess 2010, 14(11):1-181. iii-iv, xi-xvi
- [12]Kordonouri O, Hartmann R, Danne T: Treatment of type 1 diabetes in children and adolescents using modern insulin pumps. Diabetes Res Clin Pract 2011, 93(Suppl 1):S118-S124.
- [13]Skogsberg L, Fors H, Hanas R, Chaplin JE, Lindman E, Skogsberg J: Improved treatment satisfaction but no difference in metabolic control when using continuous subcutaneous insulin infusion vs. multiple daily injections in children at onset of type 1 diabetes mellitus. Pediatr Diabetes 2008, 9(5):472-479.
- [14]Jakisch BI, Wagner VM, Heidtmann B, Lepler R, Holterhus PM, Kapellen TM, Vogel C, Rosenbauer J, Holl RW: Comparison of continuous subcutaneous insulin infusion (CSII) and multiple daily injections (MDI) in paediatric Type 1 diabetes: a multicentre matched-pair cohort analysis over 3 years. Diabet Med 2008, 25(1):80-85.
- [15]Sulli N, Shashaj B: Long-term benefits of continuous subcutaneous insulin infusion in children with Type 1 diabetes: a 4-year follow-up. Diabet Med 2006, 23(8):900-906.
- [16]Juliusson PB, Graue M, Wentzel-Larsen T, Sovik O: The impact of continuous subcutaneous insulin infusion on health-related quality of life in children and adolescents with type 1 diabetes. Acta Paediatr 2006, 95(11):1481-1487.
- [17]McMahon SK, Airey FL, Marangou DA, McElwee KJ, Carne CL, Clarey AJ, Davis EA, Jones TW: Insulin pump therapy in children and adolescents: improvements in key parameters of diabetes management including quality of life. Diabet Med 2005, 22(1):92-96.
- [18]Olinder AL, Kernell A, Smide B: Missed bolus doses: devastating for metabolic control in CSII-treated adolescents with type 1 diabetes. Pediatr Diabetes 2009, 10(2):142-148.
- [19]Burdick J, Chase HP, Slover RH, Knievel K, Scrimgeour L, Maniatis AK, Klingensmith GJ: Missed insulin meal boluses and elevated hemoglobin A1c levels in children receiving insulin pump therapy. Pediatrics 2004, 113(3 Pt 1):e221-e224.
- [20]Olinder AL, Nyhlin KT, Smide B: Clarifying responsibility for self-management of diabetes in adolescents using insulin pumps–a qualitative study. J Adv Nurs 2011, 67(7):1547-1557.
- [21]Olinder AL, Nyhlin KT, Smide B: Reasons for missed meal-time insulin boluses from the perspective of adolescents using insulin pumps: ‘lost focus’. Pediatr Diabetes 2011, 12(4 Pt 2):402-409.
- [22]Court JM, Cameron FJ, Berg-Kelly K, Swift PG: Diabetes in adolescence. Pediatr Diabetes 2009, 10(Suppl 12):185-194.
- [23]Silverstein J, Klingensmith G, Copeland K, Plotnick L, Kaufman F, Laffel L, Deeb L, Grey M, Anderson B, Holzmeister LA, et al.: Care of children and adolescents with type 1 diabetes: a statement of the American Diabetes Association. Diabetes Care 2005, 28(1):186-212.
- [24]Viklund G, Wikblad K: Teenagers’ perceptions of factors affecting decision-making competence in the management of type 1 diabetes. J Clin Nurs 2009, 18(23):3262-3270.
- [25]Graue M, Wentzel-Larsen T, Hanestad BR, Sovik O: Health-related quality of life and metabolic control in adolescents with diabetes: the role of parental care, control, and involvement. J Pediatr Nurs 2005, 20(5):373-382.
- [26]Cameron FJ, Skinner TC, De Beaufort CE, Hoey H, Swift PG, Aanstoot H, Aman J, Martul P, Chiarelli F, Daneman D, et al.: Are family factors universally related to metabolic outcomes in adolescents with Type 1 diabetes? Diabet Med 2008, 25(4):463-468.
- [27]Leonard BJ, Garwick A, Adwan JZ: Adolescents’ perceptions of parental roles and involvement in diabetes management. J Pediatr Nurs 2005, 20(6):405-414.
- [28]Schilling LS, Grey M, Knafl KA: The concept of self-management of type 1 diabetes in children and adolescents: an evolutionary concept analysis. J Adv Nurs 2002, 37(1):87-99.
- [29]Ekman I, Swedberg K, Taft C, Lindseth A, Norberg A, Brink E, Carlsson J, Dahlin-Ivanoff S, Johansson IL, Kjellgren K, et al.: Person-centered care–ready for prime time. Eur J Cardiovasc Nurs 2011, 10(4):248-251.
- [30]Zoffmann V, Kirkevold M: Realizing empowerment in difficult diabetes care: a guided self-determination intervention. Qual Health Res 2012, 22(1):103-118.
- [31]Husted GR, Thorsteinsson B, Esbensen BA, Hommel E, Zoffmann V: Improving glycaemic control and life skills in adolescents with type 1 diabetes: a randomised, controlled intervention study using the Guided Self-Determination-Young method in triads of adolescents, parents and health care providers integrated into routine paediatric outpatient clinics. BMC Pediatr 2011, 11:55. BioMed Central Full Text
- [32]Rodoo P, Ridefelt P, Aldrimer M, Niklasson F, Gustafsson J, Hellberg D: Population-based pediatric reference intervals for HbA1c, bilirubin, albumin, CRP, myoglobin and serum enzymes. Scand J Clin Lab Invest 2013, 73(5):361-367.
- [33]Baars RM, Atherton CI, Koopman HM, Bullinger M, Power M: The European DISABKIDS project: development of seven condition-specific modules to measure health related quality of life in children and adolescents. Health Qual Life Outcomes 2005, 3:70. BioMed Central Full Text
- [34]Wikblad K, Smide B, Leksell JK: Check your health validity and reliability of a measure of health and burden of diabetes. Scand J Caring Sci 2013. Apr 9 [Epub ahead of print]
- [35]Viklund G, Wikblad K: Self-perceived health and burden of diabetes in teenagers with type 1 diabetes: psychometric properties of the Swedish measure ‘check your health’. Acta Paediatr 2010, 99(3):422-426.
- [36]Hood KK, Butler DA, Anderson BJ, Laffel LM: Updated and revised Diabetes Family Conflict Scale. Diabetes Care 2007, 30(7):1764-1769.
- [37]Sand P, Kleiberg AN, Forsander G: The reliability and validity of the revised Diabetes Family Conflict Scale questionnaire, in a sample of Swedish children. Acta Paediatr 2013, 102(6):650-654.
- [38]Leksell J, Funnell M, Sandberg G, Smide B, Wiklund G, Wikblad K: Psychometric properties of the Swedish Diabetes Empowerment Scale. Scand J Caring Sci 2007, 21(2):247-252.