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Vision reduction is linked to reduced quality of life, self-care capacity, increased fall risk, cognitive decline and depression. Prevalence increases with age. In response, WHO recommends regular vision assessment at primary care level, such as general practice (GP), for adults +50 years. However, research on detection of age-related vision reduction in GP is limited. The objective is to assess the feasibility and clinical utility of implementing vision screening in Danish general practice following an annual control consultation for patients aged ≥70 years with minimum one chronic condition.
Complex health intervention in a Danish general practice setting. Testing a patient baseline questionnaire with 18 items on self-reported vision and quality of life in combination with three vision tests: Colenbrander Mixed Contrast Card Test for near vision, Amsler Grid test and Confrontational Visual Field Test. 18–20 GP clinics and 450 patients are planned to be included. After GP consultation, all patients visit a collaborating optometrist for a comprehensive vision assessment including refraction, intraocular pressure measurement, fundus photography and optical coherence tomography (OCT). Data and pictures from the optometrist are evaluated by an ophthalmologist, who refers to further follow-up and/or treatment if deemed necessary.
Feasibility outcomes: patient recruitment rate, patient adherence, as well as patients’ and health providers’ experiences with the intervention. Clinical outcomes: GP staff assessment of patient vision and patient-reported assessment compared with ophthalmologic assessment. This includes identifying the need for new glasses and detecting eye diseases that require further evaluation, monitoring or treatment. This study will provide evidence on the feasibility of integrating vision screening into routine general practice, potentially helping expedient referrals and improving detection and access to primary eye-health care for older adults.
The study is registered and approved by Danish Research Ethics and Data Protection, VEK F-23070033 and in ClinicalTrials.gov: NCT07015034. Findings will be disseminated in peer-review journals, academic conferences and with the public through patient organisations and public health events.
ClinicalTrials.gov; identifier: NCT07015034.
This study aimed to explore informal caregivers' (family members of patients) perspectives on their involvement in ongoing multidisciplinary treatment of diabetes-related foot ulcers in a highly specialised outpatient service with a multidisciplinary team structure that was still evolving. Using focus group interviews and template analysis, we identified patterns in caregivers' experiences, needs, and preferences. The findings suggest considerable potential to improve patient care through earlier caregiver involvement. While some caregivers reported positive experiences, many rarely or never attended consultations and struggled to define involvement in practical terms. However, caregivers consistently expressed a strong wish for earlier involvement—ideally at the time of diabetes diagnosis—to acquire the knowledge and skills needed to support patients between clinical visits. Caregivers play an important role in foot ulcer management, as complex regimens such as wound care, offloading, and lifestyle adjustments require ongoing support outside clinical settings. However, involvement may also create strain. Participants described emotional and practical burden, feelings of guilt, and uncertainty about their roles. The study highlights the need for structured caregiver education, clear communication, and systemic support to balance the benefits of caregiver involvement with the risk of caregiver burden.
To evaluate the acceptability, mechanisms of impact, and contextual factors affecting a 9-month, nurse-led self-management intervention specifically designed for newly diagnosed patients with inflammatory arthritis, from both the patient and healthcare professional (HPs) perspectives.
A qualitative longitudinal study.
Individual baseline and follow-up interviews were conducted with 12 patients (baseline n = 12; follow-up n = 10) and four focus group interviews were conducted with 4 HPs at key intervention stages. Interview guides were drafted with open-ended questions and iteratively refined across interviews to match the evolving stages of the intervention. Data analysis was conducted using template analysis. This study adhered to the Consolidated Criteria for Reporting Qualitative Studies (COREQ): 32-item checklist.
Patients valued the tailored individual sessions, which provided emotional support and improved their understanding of IA. Group sessions received mixed feedback, with some patients suggesting a need for more organisation. The intervention fostered a sense of community, reducing isolation and empowering patients to navigate the healthcare system better. HPs praised the patient-centred approach and emphasised the importance of training and organisational support.
Both patients and HPs highly accepted our nurse-led self-management intervention, though group sessions received mixed feedback. Key impact mechanisms were the proactive management of symptoms and lifestyle, and the intervention's tailored support and emotional guidance. The HPs experienced professional growth but scheduling occasionally conflicted with regular work.
This study has provided valuable information in understanding intervention mechanisms. Findings from the evaluation will be used to refine the intervention.
Two patients contributed to the development of the intervention, and a patient research partner was actively engaged in all phases of this study.
Fathers of preterm infants wish to be actively involved and attentive in caring for their children. The positive impacts of paternal caregiving on preterm infants’ cognitive and social development have been recognised. Awareness of the need to support fathers during early parenthood is increasing, but fathers may feel excluded when their infants are in the neonatal intensive care unit. Here, we present the protocol for a study involving the development and national implementation of a complex intervention supporting first-time fathers of preterm infants in early parenthood.
The study adheres to the Medical Research Council framework for complex interventions. A multicentre, prospective, non-blinded, quasi-experimental design will be applied to evaluate the effect of a clinical and technology-based intervention targeting both nurses and the fathers. Outcomes from participants enrolled during the control (2023–2024) and intervention (2025–2026) periods, comprising 295 fathers and their partners, will be compared. Effects on parental confidence, stress, depression and mood and family and reflective functioning as well as infants’ emotional and social development will be assessed. A comprehensive process evaluation will be applied using both qualitative and quantitative methods.
The study has been registered at Clinicaltrials.org [no. NCT0 6 116 747 (The SUPPORTED study – First-time Fathers of Preterm Infants), approved on 3 November 2023]. The Danish Data Protection Agency has approved the study (P-2022–792). The findings will be disseminated through peer-reviewed publications.
Continuous glucose monitoring (CGM) provides real-time glucose data for people with diabetes. However, detailed knowledge of its use in daily life remains limited. We aim to investigate the interaction between people with type 1 diabetes (T1D) and their CGM data and the impact of the interaction on glycaemia and diabetes distress.
This is a two-centre observational study of adults (n=500) with T1D using FreeStyle Libre 2. Over a period of 14 days, participants will continue their regular CGM use, record insulin doses and timing with smart insulin pens, track activity and sleep with an activity tracker, log all food intake in the LibreLink app and answer questions about quality of life and hypoglycaemia two times per day. Before the study period, the participants will complete a survey of 11 validated questionnaires assessing diabetes distress, hypoglycaemia awareness and other patient-reported outcomes (PROs). After the study period, the participants will complete two additional questionnaires assessing diabetes distress and health literacy.
The collected data will be used in two substudies with the overall aims of:
Substudy 1: to investigate how CGM is used in practice and the impact of the interaction on diabetes distress and glycaemia.
Substudy 2: to investigate whether and how CGM functions as a technological substitute for impaired awareness of hypoglycaemia, focusing on alarm data.
Endpoints will include CGM metrics, alarm data and PROs.
The Danish Data Protection Agency approved the study (P-2024–15985), and the regional committee on health research ethics has granted an ethical waiver (H-24014662). All participants have signed written informed consent forms before participating. The results will be published in an international peer-reviewed scientific journal by the study investigators and shared via www.clinicaltrials.gov. Participants who agreed to receive information about the study will be sent the results after publication.
ClinicalTrials.gov (NCT06453434).
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