ArticleTrials2024
Effect of an entry-to-care intervention on diabetes distress in individuals with newly diagnosed type 2 diabetes: a study protocol for a cluster-randomized trial.
Article in Trials, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT05571306 (Can Diabetes Distress be Reduced by Improving Entry to Care for People With Type 2 Diabetes Mellitus), which is not on this map. Cited by 2 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Can Diabetes Distress be Reduced by Improving Entry to Care for People With Type 2 Diabetes Mellitus: A Cluster-randomized Trial
Who cites it
2 citing papers in PubMed, 2 citations in OpenAlex.
Corrections and comments
- Erratum issued
Authors and funding
6 authors at 2 institutions in 1 country.
Funding
Abstract
backgroundDiabetes distress (DD) affects at least 36% of T2DM patients and is often associated with insufficient support and care. This study examines an intervention that targets DD through enhanced cross-sectoral collaboration and treatment during the first 3 months following diagnosis. The intervention aims to improve care and self-management and to reduce DD. METHODS AND
interventionThe study is designed as a cluster-randomized trial with the intervention focusing on four key elements of diabetes care: effective cross-sectoral communication and information sharing, systematic care, a "one-stop-shop" health screening and start-up conversation at the municipality, and improving patient insights into own care. This study requires 32 clusters (16/arm) to achieve 80% power and a 5% significance cut-off, with 270 patients required. GP recruitment occurred from May to Dec 2022. Patient recruitment is ongoing from May 2022 to Aug 2023. GPs were randomized 1:1 using computer-generated blocks of six. Participating GPs are located in Southern Denmark and are not participating in other trials. Patients must be 18 + years of age, have a T2DM diagnosis, and be fluent in spoken and written Danish. DD is the primary outcome and will be measured at baseline, at four months, and again at a 12-month follow-up. Secondary outcomes include quality of care, self-management, quality of life, and clinical factors. Tertiary outcomes comprise depression, stress, resilience, sleep quality, and social network quality.
conclusionThis study is among the first clinical trials exploring the development of DD from diagnosis to 12 months post-diagnosis. Many previous interventions did not directly target DD as the primary outcome. This research provides new insights into DD progression in patients newly diagnosed with T2DM and examines an intervention designed to lower DD in early diabetes stages, contributing to a better understanding of the development of DD and how this intervention affects patient well-being.
trial registrationClinicalTrial.gov NCT05571306. Registered on 07 October 2022.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.