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Can Diabetes Distress be Reduced by Improving Entry to Care for Type 2 Diabetes Patients

NCT05571306 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 512

Last updated 2023-06-18

No results posted yet for this study

Summary

Care recommendations for type 2 diabetes mellitus (T2DM) patients are clearly defined in Danish clinical guidelines: patients are offered three consultations with the general practice (GP), patients must be referred for a municipal start-up conversation, and cross-sectoral collaboration is vital to succeeding in the treatment of T2DM patients. This framework is often reported as inadequate by the patients, which increases the risk of high levels of diabetes distress (DD). Diabetes distress is the burden of living with T2DM and is associated with deleterious physical and mental health outcomes, including poor glycemic control, recurved wellbeing, and increased all-course mortality.

This project evaluates the efficacy of an entry-to-care intervention, seeking to strengthen and structure the cross-sectoral collaboration, targeting DD in people recently diagnosed with T2DM.

Intervention The intervention progresses throughout the first three months of the diagnosis. It is divided into core components: Improvements of cross-sectoral communication and information sharing, ensure systematism in care, guarantee participation at a "one-stop-shop" and a start-up conversation at the municipal, and improve patients coping skills.

Research plan This cluster-randomized control trial is conducted in the Region of Southern Denmark, with each GP randomly assigned to intervention or control. Changes in DD are the primary outcome. Data will be collected through an electronic questionnaire at baseline and 4, 12 months after diagnosis.

Perspective and expected outcomes A decrease in DD levels causes; higher level of self-care, quality of life, self-management, glycemic control and decrease the risk of severe complications and all-cause mortality. The intervention will be extrapolated to other patient groups where cross-sectoral collaboration is part of the care, increasing the treatment for these patient groups as well.

Conditions

Interventions

OTHER

four core components care

The intervention progresses throughout the first three months for the recently diagnosed T2DM patients and is divided into four core components: 1) Improve of cross-sectoral communication and information sharing, 2) ensure systematism in care, 3) guarantee participation at a "one-stop-shop" and a start-up conversation at the municipality, and 4) improve patients coping skills.

Sponsors & Collaborators

  • University of Southern Denmark

    lead OTHER

Principal Investigators

  • Jens Søndergaard, Phd · Research Unit of General Practice (University of Southern Denmark)

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-01
Primary Completion
2024-12-31
Completion
2024-12-31

Countries

  • Denmark

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05571306 on ClinicalTrials.gov