Protocol for the Digital, Individualized, and Collaborative Treatment of Type 2 Diabetes in General Practice Based on Decision Aid (DICTA) - A Randomized Controlled Trial

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• Diabetes type 2 in up to 10 years

Locations
Other Locations
Denmark
Research Unit for General Practice, Department for Public Health, University of Southern Denmark
RECRUITING
Odense
Contact Information
Primary
Carl J Brandt, PhD
cbrandt@health.sdu.dk
+45 2014 1566
Backup
Michael Olesen, Prof.
michael.olsen@dadlnet.dk
+45 6550 3830
Time Frame
Start Date: 2021-06-01
Estimated Completion Date: 2025-12-30
Participants
Target number of participants: 400
Treatments
Experimental: The intervention group
The three core elements of the intervention are: 1) individualized data-driven recommendations to GPs on how to treat each individual T2D patient, as well as 2) individualized digital coaching of T2D patients, and 3) on-line presentation of patient registered outcomes (PRO) to GPs.
No_intervention: Control group
Usual care
Sponsors
Collaborators: Steno Diabetes Center Odense, Odense University Hospital, Aalborg University, Slagelse Sygehus, Steno Diabetes Center Sjaelland, Holbaek Sygehus
Leads: University of Southern Denmark

This content was sourced from clinicaltrials.gov

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