Digital Individualized and Collaborative Treatment of T2D in General Practice Based on Decision Aid

Summary

The purpose of this project is to improve life of patients with type 2 diabetes through an IT-supported lifestyle and treatment intervention.

The intervention is based on combining and adapting existing and effective elements into the IT system of the general practitioner. In this way we will integrate specialist supervised treatment in general practice, individual patient coaching, and improved information exchange and data mining.

The DICTA intervention consists of two integrated components: a patient-directed eHealth lifestyle coaching program delivered via the LIVA application, and a clinician-directed CDS tool embedded into the EPJ system.

1. eHealth lifestyle coaching: Individuals with T2D in the intervention group will receive individualized digital coaching from a health coach through the LIVA application. PROs are shared with GPs and health staff via the EPJ, enabling tailored, data-driven lifestyle support.
2. CDS: GPs receive real-time, individualized, algorithm-based pharmacological treatment recommendations for managing T2D, hypertension, and hypercholesterolemia, as appropriate.

This is expected to facilitate use, assure individually tailored solutions, optimize treatment effects, and strengthen patient engagement.

The study is a randomized controlled trial (RCT). It will include 400 patients with newly diagnosed type 2 diabetes. The patients will receive either treatment based on the intervention or usual care. After one year, we will assess quality of life and cardiovascular risk factors in both groups and evaluate if one group has improved management of their type 2 diabetes compared to the other.

If the intervention proves effective, implementation on a national scale is highly feasible, and the intervention could probably be adapted to other lifestyle-related chronic diseases in Denmark and in other countries.

Conditions

• Diabetes type2

Interventions

BEHAVIORAL

Clinical decision support

Based on the phenotyping and algorithms developed by the hospital specialists at Odense University Hospital and Holbæk Hospital in collaboration with GPs, the individual GPs and their patients will receive individualized recommendations on lifestyle interventions and pharmacological treatments. The GPs will receive specific clinical decision support (CDS) recommendations on what drugs to prescribe to each patient based on the phenotyping in accordance with a clinical decision support tool (Cambio) and the updated guidelines at all times (Sparrow 2019). The treatment advice to the GPs will be adjusted annually based on treatment effect, re-phenotyping, and updated knowledge of the treatment of T2D. Furthermore, psychiatric, socioeconomic and/or cultural challenges and other determinants for frailty will be a part of the individualized intervention provided to patients by the GPs, again based on the specialist advice.

BEHAVIORAL

Digital Lifestyle Coaching

As part of DICTA, the patients are offered a personal health coach (dietician, nurse, occupational therapist, or physiotherapist) through the complex eHealth intervention (Liva). Patients will receive personalized empathic, relation driven coaching on healthy lifestyle on the individual patient's preferences (e.g. increased physical activity, healthier diet, weight loss, smoking cessation, personal goal setting, tailored information, peer to peer support), including optimal pharmacological treatment (Komkova 2019). The collaborative eHealth tool will give health coaches access to patient registered outcome measurements (PRO), information. This forms the basis of the individual coaching and is partly supported by artificial intelligence (AI) to improve the coaching by the health coaches (Holzinger 2016).

BEHAVIORAL

Integration to Standard Electronic Health Record

Data on physical activity, steps, diet goal fulfillment, smoking status etc., are being provided for GPs in a web-based solution integrated into the GPs' health record system. Integration with the GP system XMO (covering 52% of all Danish GPs) has been finalized.

Sponsors & Collaborators

• Steno Diabetes Center Odense

  collaborator OTHER

• Odense University Hospital

  collaborator OTHER

• Steno Diabetes Center Sjaelland

  collaborator OTHER_GOV

• Aalborg University

  collaborator OTHER

• Holbaek Sygehus

  collaborator OTHER

• Slagelse Sygehus

  collaborator OTHER

• University of Southern Denmark

  lead OTHER

Principal Investigators

• Jens H Søndergaard · University of Southern Denmark

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-06-01

Primary Completion

2025-08-31

Completion

2025-12-30

Countries

• Denmark

Study Locations