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.

BACKGROUND: Diabetes 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 INTERVENTION: The 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. CONCLUSION: This 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 REGISTRATION: ClinicalTrial.gov NCT05571306. Registered on 07 October 2022.

Readiness for return to sport in non-surgically treated patients with anterior cruciate ligament injury following a public municipal rehabilitation program.

OBJECTIVES: To investigate the proportion of patients that pass a return to sport (RTS) test battery and assess changes in patient-reported outcomes and lower extremity muscle strength following three months of exericse-based rehabilitation in non-surgically treated patients with anterior cruciate ligament (ACL) injury. DESIGN: Prospective cohort study. SETTING: Clinical environment (public municipal). PARTICIPANTS: Thirty-nine ACL injured patients (54% female, median age (IQR) 28 years (24-35). MAIN OUTCOME MEASURES: The Knee Injury and Osteoarthritis Outcome Score, Knee Outcome Survey Activities of Daily Living Scale, single hop for distance, crossover hop for distance, side hop test, the Agility T-test, and quadriceps and hamstrings isometric maximal voluntary contraction (MVC). RESULTS: Following 3 months of rehabilitation, patients had statistically significant improvements in all patients-reported outcomes and in quadriceps and hamstring MVC. Of 28 patients who completed all RTS tests, 11% passed six RTS criteria, 14% five criteria, 11% four criteria, 4% three criteria, 18% two criteria, 21% one criterion, and 21% none of the criteria. CONCLUSIONS: The results suggest that three months of public municipal rehabilitation improves patient-reported outcomes and lower extremity muscle strength in non-surgically treated patients with ACL injury. However, only one in every 10 patients passed all RTS criteria.