Anne Sophie Mathiesen1,2, Mette Juel Rothmann3,4,5,6, Vibeke Zoffmann7,8, Janus Christian Jakobsen9,10, Christian Gluud9, Jane Lindschou9, Mette Due-Christensen11,12, Bodil Rasmussen3,6,8, Emilie Marqvorsen7, Thordis Thomsen13,14. 1. Department of Endocrinology, Center for Cancer and Organ Diseases, Copenhagen University Hospital, Rigshospitalet, Blegdamsvej 9, 2100, Copenhagen, Denmark. anne.sophie.mathiesen@regionh.dk. 2. Steno Diabetes Center Odense, Odense University Hospital, Odense, Denmark. anne.sophie.mathiesen@regionh.dk. 3. Steno Diabetes Center Odense, Odense University Hospital, Odense, Denmark. 4. Department of Endocrinology, Odense University Hospital, Odense, Denmark. 5. Department of Clinical Research, University of Southern Denmark, Odense, Denmark. 6. School of Nursing and Midwifery, Faculty of Health, Deakin University, Melbourne, Australia. 7. The Research Unit Women's and Children's Health, The Julie Marie Center, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark. 8. Sector of Health Services Research, Department of Public Health, University of Copenhagen, Copenhagen, Denmark. 9. Copenhagen Trial Unit, Centre for Clinical Intervention Research, Rigshospitalet, Copenhagen, Denmark. 10. Department of Regional Health Research, The Faculty of Health Sciences, University of Southern Denmark, Odense, Denmark. 11. Faculty of Nursing, Midwifery and Palliative Care, King's College London, London, UK. 12. Steno Diabetes Center Copenhagen, The Capital Region of Denmark, Copenhagen, Denmark. 13. Department of Anaesthesiology, Herlev University Hospital, Herlev, Denmark. 14. Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark.
Abstract
BACKGROUND: Existing self-management and behavioural interventions for diabetes vary widely in their content, and their sustained long-term effectiveness is uncertain. Autonomy supporting interventions may be a prerequisite to achieve 'real life' patient engagement and more long-term improvement through shared decision-making and collaborative goal setting. Autonomy supportive interventions aim to promote that the person with diabetes' motivation is autonomous meaning that the person strives for goals they themselves truly believe in and value. This is the goal of self-determination theory and guided self-determination interventions. Self-determination theory has been reviewed but without assessing both benefits and harms and accounting for the risk of random errors using trial sequential analysis. The guided self-determination has not yet been systematically reviewed. The aim of this protocol is to investigate the benefits and harms of self-determination theory-based interventions versus usual care in adults with diabetes. METHODS/ DESIGN: We will conduct the systematic review following The Cochrane Collaboration guidelines. This protocol is reported according to the PRISMA checklist. A comprehensive search will be undertaken in the CENTRAL, MEDLINE, EMBASE, LILACS, PsycINFO, SCI-EXPANDED, CINAHL, SSCI, CPCI-S and CPCI-SSH to identify relevant trials. We will include randomised clinical trials assessing interventions theoretically based on guided self-determination or self-determination theory provided face-to-face or digitally by any healthcare professional in any setting. The primary outcomes will be quality of life, mortality, and serious adverse events. The secondary will be diabetes distress, depressive symptoms and adverse events not considered serious. Exploratory outcomes will be glycated haemoglobin and motivation. Outcomes will be assessed at the end of the intervention and at maximum follow-up. The analyses will be performed using Stata version 16 and trial sequential analysis. Two authors will independently screen, extract data from and perform risk of bias assessment of included studies using the Cochrane risk of bias tool. Certainty of the evidence will be assessed by GRADE. DISCUSSION: Self-determination theory interventions aim to promote a more autonomous patient engagement and are commonly used. It is therefore needed to evaluate the benefit and harms according to existing trials. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42020181144.
BACKGROUND: Existing self-management and behavioural interventions for diabetes vary widely in their content, and their sustained long-term effectiveness is uncertain. Autonomy supporting interventions may be a prerequisite to achieve 'real life' patient engagement and more long-term improvement through shared decision-making and collaborative goal setting. Autonomy supportive interventions aim to promote that the person with diabetes' motivation is autonomous meaning that the person strives for goals they themselves truly believe in and value. This is the goal of self-determination theory and guided self-determination interventions. Self-determination theory has been reviewed but without assessing both benefits and harms and accounting for the risk of random errors using trial sequential analysis. The guided self-determination has not yet been systematically reviewed. The aim of this protocol is to investigate the benefits and harms of self-determination theory-based interventions versus usual care in adults with diabetes. METHODS/ DESIGN: We will conduct the systematic review following The Cochrane Collaboration guidelines. This protocol is reported according to the PRISMA checklist. A comprehensive search will be undertaken in the CENTRAL, MEDLINE, EMBASE, LILACS, PsycINFO, SCI-EXPANDED, CINAHL, SSCI, CPCI-S and CPCI-SSH to identify relevant trials. We will include randomised clinical trials assessing interventions theoretically based on guided self-determination or self-determination theory provided face-to-face or digitally by any healthcare professional in any setting. The primary outcomes will be quality of life, mortality, and serious adverse events. The secondary will be diabetes distress, depressive symptoms and adverse events not considered serious. Exploratory outcomes will be glycated haemoglobin and motivation. Outcomes will be assessed at the end of the intervention and at maximum follow-up. The analyses will be performed using Stata version 16 and trial sequential analysis. Two authors will independently screen, extract data from and perform risk of bias assessment of included studies using the Cochrane risk of bias tool. Certainty of the evidence will be assessed by GRADE. DISCUSSION: Self-determination theory interventions aim to promote a more autonomous patient engagement and are commonly used. It is therefore needed to evaluate the benefit and harms according to existing trials. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42020181144.
Entities:
Keywords:
Depressive symptoms; Diabetes distress; Glycated haemoglobin; Guided self-determination method; Health education tools; Psychosocial support; Quality of life; Self-determination theory; Type 1 diabetes; Type 2 diabetes
Authors: W H Polonsky; B J Anderson; P A Lohrer; G Welch; A M Jacobson; J E Aponte; C E Schwartz Journal: Diabetes Care Date: 1995-06 Impact factor: 19.112