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.
Diabetes type 2 in up to 10 years
Fails to complete the initial questionnaire
No Internet access in own home through computer or smart phone
Is pregnant or actively trying to get pregnant
Has a serious or life-threatening disease
Parallel
Clinical decision support
BehavioralBased 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.
Digital Lifestyle Coaching
BehavioralAs 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).
Integration to Standard Electronic Health Record
BehavioralData 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.
Change in a binary indicator, composed by a composite endpoint of HbA1c, systolic blood pressure, low-density lipoprotein cholesterol, no smoking, and normal albuminuria
The primary outcome is the one-year change in estimated ten-year cardiovascular risk assessed by SCORE2-Diabetes calculated from age, smoking status, systolic blood pres-sure, total and high-density lipoprotein cholesterol, age at diabetes diagnosis, HbA1c, and eGFR. As we will be focusing on one-year changes in SCORE2-Diabetes, we do not consider it a problem that SCORE2-Diabetes does not include prevalent cardiovascular disease in the risk calculation as this variable will be constant over the one-year period on almost all of the patients.
Change in HbA1c
Measured in mmol/mole as the number of persons with HbA1c less than 53 mmol/mole
Numbers change in level of use of hypertension, hypercholesterolemic and glucose-lowering drugs
Number of patients change in medication in accordance with the following guideline: Increased: 1. increased dosage of known drug 2. adding extra drug No change 1. same drug before and after 2. shift to another drug i.e. metformin to SGLT2 inhibitor or Victoza to Ozempic Reduced: 1. reduced dosage of known drug 2. reducing number of drugs
Change in quality of life measured by European Quality of life - 5 Dimensions - 5 level (EQ-5D-5L)
The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.
Change in weight
Measured in kilograms
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University of Southern Denmark
Lead sponsor
Steno Diabetes Center Odense
Collaborator
Odense University Hospital
Collaborator
Steno Diabetes Center Sjaelland
Collaborator
Aalborg University
Collaborator
Holbaek Sygehus
Collaborator
Slagelse Sygehus
Collaborator
