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

NCT04880005 | Recruiting DMC

• 1 other identifier: FEA - DICTA
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief 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. 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. 2.CDS: GPs receive real-time, individualized, algorithm-based pharmacological treatment recommendations for managing T2D, hypertension, and hypercholesterolemia, as appropriate.

Conditions

Diabetes type2

Keywords

diabetes type 2 management; digital behavioral coaching; lifestyle change; health behavior change; weight loss; interactive advice; participant engagement; quality of life

Outcome Measures

Primary Outcomes (1)

• 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.

  12 months

Secondary Outcomes (12)

• Change in HbA1c

  12 months

• Numbers change in level of use of hypertension, hypercholesterolemic and glucose-lowering drugs

  12 months

• Change in quality of life measured by European Quality of life - 5 Dimensions - 5 level (EQ-5D-5L)

  12 months

• Change in weight

  12 months

• Change in abdominal circumference to hip circumference

  12 months

Study Arms (2)

The intervention group

EXPERIMENTAL

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.

Behavioral: Clinical decision support; Behavioral: Digital Lifestyle Coaching; Behavioral: Integration to Standard Electronic Health Record

Control group

NO INTERVENTION

Usual care

Interventions

Clinical decision support BEHAVIORAL

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.

Also known as: Individualized data-driven recommendations to GPs

The intervention group

Digital Lifestyle Coaching BEHAVIORAL

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).

Also known as: Individual digital coaching of T2D patients

The intervention group

Integration to Standard Electronic Health Record BEHAVIORAL

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.

Also known as: Presentation of patient registered outcomes to GPs

The intervention group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diabetes type 2 in up to 10 years

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Southern Denmark: lead
• Steno Diabetes Center Odense: collaborator
• Odense University Hospital: collaborator
• Steno Diabetes Center Sjaelland: collaborator
• Aalborg University: collaborator
• Holbaek Sygehus: collaborator
• Slagelse Sygehus: collaborator

Study Sites (1)

Research Unit for General Practice, Department for Public Health, University of Southern Denmark

Odense, Region Syddanmark, Denmark

RECRUITING

Related Publications (10)

• Bo A, Thomsen RW, Nielsen JS, Nicolaisen SK, Beck-Nielsen H, Rungby J, Sorensen HT, Hansen TK, Sondergaard J, Friborg S, Lauritzen T, Maindal HT. Early-onset type 2 diabetes: Age gradient in clinical and behavioural risk factors in 5115 persons with newly diagnosed type 2 diabetes-Results from the DD2 study. Diabetes Metab Res Rev. 2018 Mar;34(3). doi: 10.1002/dmrr.2968. Epub 2017 Dec 21.

  PMID: 29172021 BACKGROUND

• Lean MEJ, Leslie WS, Barnes AC, Brosnahan N, Thom G, McCombie L, Peters C, Zhyzhneuskaya S, Al-Mrabeh A, Hollingsworth KG, Rodrigues AM, Rehackova L, Adamson AJ, Sniehotta FF, Mathers JC, Ross HM, McIlvenna Y, Welsh P, Kean S, Ford I, McConnachie A, Messow CM, Sattar N, Taylor R. Durability of a primary care-led weight-management intervention for remission of type 2 diabetes: 2-year results of the DiRECT open-label, cluster-randomised trial. Lancet Diabetes Endocrinol. 2019 May;7(5):344-355. doi: 10.1016/S2213-8587(19)30068-3. Epub 2019 Mar 6.

  PMID: 30852132 BACKGROUND

• Christensen DH, Nicolaisen SK, Berencsi K, Beck-Nielsen H, Rungby J, Friborg S, Brandslund I, Christiansen JS, Vaag A, Sorensen HT, Nielsen JS, Thomsen RW. Danish Centre for Strategic Research in Type 2 Diabetes (DD2) project cohort of newly diagnosed patients with type 2 diabetes: a cohort profile. BMJ Open. 2018 Apr 7;8(4):e017273. doi: 10.1136/bmjopen-2017-017273.

  PMID: 29627803 BACKGROUND

• Stidsen JV, Nielsen JS, Henriksen JE, Friborg SG, Thomsen RW, Olesen TB, Olsen MH, Beck-Nielsen H. Protocol for the specialist supervised individualised multifactorial treatment of new clinically diagnosed type 2 diabetes in general practice (IDA): a prospective controlled multicentre open-label intervention study. BMJ Open. 2017 Dec 10;7(12):e017493. doi: 10.1136/bmjopen-2017-017493.

  PMID: 29229652 BACKGROUND

• Brandt V, Brandt CJ, Glintborg D, Arendal C, Toubro S, Brandt K Sustained Weight Loss during 20 Months using a Personalized Interactive Internet Based Dietician Advice Program in a General Practice Setting, International Journal on Advances in Life Sciences, vol 3 no 1 & 2, year 2011,

  BACKGROUND

• Haste A, Adamson AJ, McColl E, Araujo-Soares V, Bell R. Web-Based Weight Loss Intervention for Men With Type 2 Diabetes: Pilot Randomized Controlled Trial. JMIR Diabetes. 2017 Jul 7;2(2):e14. doi: 10.2196/diabetes.7430.

  PMID: 30291100 BACKGROUND

• Brandt CJ, Clemensen J, Nielsen JB, Sondergaard J. Drivers for successful long-term lifestyle change, the role of e-health: a qualitative interview study. BMJ Open. 2018 Mar 12;8(3):e017466. doi: 10.1136/bmjopen-2017-017466.

  PMID: 29530904 BACKGROUND

• Brandt CJ, Sogaard GI, Clemensen J, Sndergaard J, Nielsen JB. General Practitioners' Perspective on eHealth and Lifestyle Change: Qualitative Interview Study. JMIR Mhealth Uhealth. 2018 Apr 17;6(4):e88. doi: 10.2196/mhealth.8988.

  PMID: 29666045 BACKGROUND

• Brandt CJ, Sogaard GI, Clemensen J, Sondergaard J, Nielsen JB. Determinants of Successful eHealth Coaching for Consumer Lifestyle Changes: Qualitative Interview Study Among Health Care Professionals. J Med Internet Res. 2018 Jul 5;20(7):e237. doi: 10.2196/jmir.9791.

  PMID: 29980496 BACKGROUND

• Komkova A, Brandt CJ, Hansen Pedersen D, Emneus M, Sortso C. Electronic Health Lifestyle Coaching Among Diabetes Patients in a Real-Life Municipality Setting: Observational Study. JMIR Diabetes. 2019 Mar 12;4(1):e12140. doi: 10.2196/12140.

  PMID: 30860486 BACKGROUND

MeSH Terms

Conditions

Weight Loss

Condition Hierarchy (Ancestors)

Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jens H Søndergaard

  University of Southern Denmark

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Carl J Brandt, PhD

CONTACT

+45 2014 1566; cbrandt@health.sdu.dk

Michael Olesen, Prof.

CONTACT

+45 6550 3830; michael.olsen@dadlnet.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2021
• First Posted: May 10, 2021
• Study Start: June 1, 2021
• Primary Completion: August 31, 2025
• Study Completion: December 30, 2025
• Last Updated: September 2, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: All data will become available when published starting july of 2022 and to be held accessible until January 2030
• Access Criteria: Accessible partly on the website and partly upon request to the PI

Locations

DK (1)