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. 2024 Nov 11;25(1):751.
doi: 10.1186/s13063-024-08589-6.

Detailed statistical analysis plan for a guided self-determination intervention versus an attention control for outpatients with type 2 diabetes in the randomised OVERCOME trial

Anne Sophie Mathiesen  1   2   3 , Vibeke Zoffmann  4   5   6 , Jane Lindschou  7 , Janus Christian Jakobsen  7   8 , Christian Gluud  7   8 , Markus Harboe Olsen  7   9 , Bodil Rasmussen  10   5   6 , Emilie Haarslev Schröder Marqvorsen  4 , Mette Juel Rothmann  10   6   11
Affiliations

Detailed statistical analysis plan for a guided self-determination intervention versus an attention control for outpatients with type 2 diabetes in the randomised OVERCOME trial

Anne Sophie Mathiesen et al. Trials. .

Abstract

Background: Autonomy-supporting interventions may be a prerequisite to achieve better long-term management of type 2 diabetes. Evidence suggests that the guided self-determination (GSD) method might improve haemoglobin A1c and diabetes distress in people with type 1 diabetes. The evidence of an effect of a GSD intervention compared with an attention control group in adults with type 2 diabetes is unknown.

Methods/design: The trial is designed as a pragmatic, investigator-initiated, dual-centre, randomised, parallel-group, assessor-blinded, superiority clinical trial of persons with type 2 diabetes. A nurse will administer GSD intervention versus an attention control. The primary outcome is diabetes distress, and secondary outcomes are quality of life, depressive symptoms, and non-serious adverse events. Exploratory outcomes are haemoglobin A1c, motivation, and serious adverse events. Participants are assessed at baseline, 5-, and 12-month follow-up. Here, we present a detailed, comprehensive plan of all statistical analyses, including methods to handle missing data, and assessments of the underlying statistical assumptions. The statistical analyses will be conducted independently by two statisticians following the present plan.

Discussion: To mitigate the risk of analysis bias and increase the validity of the OVEROME trial, this statistical analysis plan was developed prior to unblinding of the trial results in concordance with the Declaration of Helsinki and the Conference on Harmonization of Good Clinical Practice Guidelines.

Trial registration: ClinicalTrials.gov NCT04601311. Registered on October 2020.

Keywords: Autonomy-supportive; Depression; Diabetes; Diabetes distress; Guided self-determination; HbA1c; Self-determination theory.

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Conflict of interest statement

Ethics approval and consent to participate The trial has been approved by the Danish Data Protection Agency (P-2020–864). The Ethics Committee of the Capital Region of Denmark reviewed the trial protocol on two occasions but exempted the trial protocol from full review (H-20003638) dated 16 January and 18 August 2020. All participants were given written and oral information and consideration time prior to signing informed consent. Consent for publication Not applicable. Competing interests The second author, Vibeke Zoffmann, is the founder of the GSD methods and thus inflicts a potential vested bias. As outlined in this statistical analysis plan, none of the investigators will be involved in the analyses, which will be executed by external statisticians. The remaining authors declare that they have no competing interests.

References

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    1. Zoffmann V, Kirkevold M. Relationships and their potential for change developed in difficult type 1 diabetes. SAGE publication. 2007;17(5):625–38. - PubMed
    1. Zoffmann V, Vistisen D, Due-Christensen M. Flexible guided self-determination intervention for younger adults with poorly controlled type 1 diabetes, decreased HbA1c and psychosocial distress in women but not in men: a real-life RCT. Diabetic medicine : a journal of the British Diabetic Association. 2015;32(9):1239–46. - PubMed

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