Randomised controlled trial of a nurse coordination intervention for people living with dementia and their carers: study protocol

Introduction
The multifaceted impact of dementia means that people living with dementia require multidisciplinary care across different services and settings; however, these care transitions pose a risk of fragmented care. Models that improve integration and coordination of care in the community are needed.

Methods and analysis
This randomised control trial will test the effectiveness and cost effectiveness of a dementia nurse-led intervention to: (1) increase days lived in the community at 12-month follow-up (primary outcome) among people living with dementia and (2) improve quality of life for people living with dementia and their carers, compared with usual care. Participants are recruited from several sources including private and public geriatric medicine clinics, carer support groups and self-referral. People living with dementia and their carers are randomised as a dyad to (1) usual care or (2) dementia nurse-led care-coordination. The dementia nurse will provide care coordination and direct support through a tailored, integrated and patient-centred approach. The needs of people living with dementia will be identified and addressed, with a focus on improving the management of comorbidities, risk reduction and symptoms. Carers will also receive support. The model for people living with dementia will focus on days lived in their community as the outcome variable. Differences between groups in quality of life at 12-month follow-up will be assessed using linear mixed effects regression. Analysis will follow the intention to treat principles. People living with dementia and carers’ data will be analysed separately and collectively for the economic study.

Ethics and dissemination
The trial has been approved by the Hunter New England Research Ethics Committee (2023/ETH01221) and the University of Newcastle Ethics Committee (R-2024–0021). Trial findings will be disseminated via peer-reviewed publications and conference presentations. If the intervention is effective, the research team aims to further implement the intervention as usual care within the participating services and beyond.

Trial registration number
The trial was prospectively registered via the Australian New Zealand Clinical Trials Registry: ACTRN12624000235505. Registration date: 11 March 2024.

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Non-adherence to antidiabetic medications and associated factors among adult type 2 diabetes mellitus patients in Northeast Ethiopia: institutional based cross-sectional study

Background
Non-adherence to antidiabetic medication remains a major barrier to achieve optimal health outcomes among individuals with diabetes, particularly in developing countries. This issue exacerbates poor health outcomes and leads to the wastage of limited healthcare resources.

Objective
This study aimed to assess the prevalence of non-adherence to antidiabetic medications and identify associated factors among adult type 2 diabetes mellitus (DM) patients in the North Wollo zone.

Study design
An institutional-based cross-sectional study.

Setting
The study was conducted in three randomly selected public hospitals in the North Wollo zone: Woldia Comprehensive Specialized Hospital, Lalibela General Hospital and Mersa Primary Hospital.

Participants
A total of 327 adult type 2 DM patients receiving follow-up care were included. Participants were selected proportionally from each hospital using consecutive sampling. Inclusion criteria included individuals aged ≥18 years, on antidiabetic treatment for at least 6 months and actively on follow-up care during the study period. Patients with hearing impairment, severe illness or incomplete medical records were excluded.

Main outcome measures
Adherence was assessed using the Morisky Medication Adherence Scale-8, a validated eight-item, self-reported questionnaire. Scores ranged from 0 to 8, with adherence levels classified as high (≥8), medium (6–7.75) and low (

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Protocol of the Tailored Evidence-based Enhancements in Mental Health-Gamified and Individualized Follow-Up Treatment for Suicide (TEEM-GIFTS): a Multiphase Optimization Strategy (MOST) study implementing a gamified mHealth intervention to reduce postdischarge suicide risk in patients with mental disorders in Shenzhen

Introduction
Postdischarge suicide risk among psychiatric patients is a great concern. Gamified interventions have demonstrated promise in reducing the risk. This study aims to reduce postdischarge suicide risk through a mHealth intervention that engages and supports patients through gamified features. Built on our previous research, this study will develop, optimise and evaluate a gamified intervention under the Multi-phase Optimization Strategy (MOST) framework in implementation science.

Methods and analysis
This study will be conducted at the Shenzhen Kangning Hospital. Following the MOST framework, we will develop the gamified mHealth app (Tailored Evidence-based Enhancements in Mental Health (TEEM)) with four intervention components in the selection phase. In the optimisation phase, a factorial design randomised controlled trial (RCT) will be conducted to identify the optimised configuration. A total of 320 patients with mental disorders will be recruited and randomised into 16 groups to receive TEEM with different combinations of intervention components, with follow-ups scheduled at 1 week, 1 month, 2 months and 3 months after discharge. In the confirmation phase, we will assess the optimised TEEM through a standard RCT, comparing it to usual care. An additional 320 patients with mental disorders will be recruited for this phase, and the follow-up schedule is the same as in the optimisation phase. Psychiatric patients and family members, clinical and community mental health service providers will be recruited as the community team to help develop and evaluate the TEEM. Quantitative data will be analysed using the intention-to-treat approach and generalised estimating equations, and qualitative data will be coded and categorised to identify key themes.

Ethics/dissemination
The Ethics Committee Review Board of Shenzhen Kangning Hospital has approved this study. All participants will provide written informed consent prior to enrolment. The findings will be disseminated through peer-reviewed scientific journals and conference presentations, and a report will be submitted to the National Natural Science Foundation of China and the mental health authorities in the Shenzhen Municipal Health Commission.

Trial registration number
ClinicalTrials.gov, ID: NCT06358339

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How do doctors address heart failure patients disclosures of medication adherence problems during hospital and primary care consultations? An exploratory interaction-based observational cohort study

Objectives
To investigate how doctors and self-managing older patients with heart failure (HF) discuss the patients’ potential or ongoing medication adherence problems, and how such discussions evolve as patients transition from hospital to home, with particular focus on: (1) doctors’ communicative actions aimed at addressing patient disclosures of adherence problems and (2) patients’ feedback indicating whether their doctor’s supportive actions were acceptable to them.

Design
Exploratory interaction-based observational cohort study. Inductive microanalysis of authentic patient–doctor consultations, audio recorded for each patient at: (1) first ward visit in hospital, (2) discharge visit from hospital and (3) follow-up visit with general practitioner (GP).

Setting
Hospital and primary care, Norway (2022–2023).

Participants
25 patients with HF (+65 years) and their attending doctors (23 hospital doctors, 25 GPs).

Results
Analysis of 74 consultations revealed that 25 HF patients disclosed 23 practical adherence problems indicating risks of unintentional non-adherence (eg, limited resources to manage medications) and 39 perceptual problems indicating risks of intentional non-adherence (eg, worries, negative experience or stance). Doctors addressed 79% of patients’ disclosures by: (1) exploring the scope of the problem or (2) providing supportive actions to improve patients’ ability or motivation to adhere. We calculated nearly five times higher odds for doctors to address patients’ practical problems to their perceptual problems (OR 4.79, 95% CI 1.25 to 25.83). Unresolved problems included: (1) doctors addressed patients’ disclosures, but patients signalled the supportive actions were unsuitable (37%) and (2) doctors left disclosures unaddressed (21%).

Conclusions
In this explorative study, the doctors were more likely to address the patients’ adherence problems associated with unintentional non-adherence risks than those associated with intentional non-adherence risks. Even when doctors attempted to address HF patients’ medication adherence problems, half of the problems remained unresolved, usually because patients indicated that the doctor’s suggestion to improve their situation was against their preference.

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del Nido versus St. Thomas blood cardioplegia in the young (DESTINY) trial: protocol for a multicentre randomised controlled trial in children undergoing cardiac surgery

Introduction
Myocardial protection against ischaemia–reperfusion injury is a key determinant of heart function and outcome following cardiac surgery in children. However, myocardial injury still occurs routinely following aortic cross-clamping, as demonstrated by the ubiquitous rise in circulating troponin. del Nido cardioplegia was designed to protect the immature myocardium and is widely used in the USA but has not previously been available in the UK, where St. Thomas’ blood cardioplegia is most common. The del Nido versus St. Thomas’ blood cardioplegia in the young (DESTINY) trial will evaluate whether one solution is better than the other at improving myocardial protection by reducing myocardial injury, shortening ischaemic time and improving clinical outcomes.

Methods and analysis
The DESTINY trial is a multicentre, patient-blinded and assessor-blinded, parallel-group, individually randomised controlled trial recruiting up to 220 children undergoing surgery for congenital heart disease. Participants will be randomised in a 1:1 ratio to either del Nido cardioplegia or St. Thomas’ blood cardioplegia, with follow-up until 30 days following surgery. The primary outcome is area under the time–concentration curve for plasma high-sensitivity troponin I in the first 24 hours after aortic cross-clamp release. Secondary outcome measures include the incidence of low cardiac output syndrome and Vasoactive-Inotropic Score in the first 48 hours, total aortic cross-clamp time, duration of mechanical ventilation and lengths of stay in the paediatric intensive care unit and the hospital.

Ethics and dissemination
The trial was approved by the West Midlands—Coventry and Warwickshire National Health Service Research Ethics Committee (21/WM/0149) on 30 June 2021. Findings will be disseminated to the academic community through peer-reviewed publications and presentation at national and international meetings. Parents will be informed of the results through a newsletter in conjunction with a national charity.

Trial registration number
ISRCTN13638147; Pre-results.

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Design of a randomised, placebo-controlled, double-blind multicentre study assessing the effect of colchicine on the incidence of knee or hip replacements in symptomatic knee or hip osteoarthritis: the ECHO trial

Introduction
Osteoarthritis (OA) is a multifactorial disease in which low-grade inflammation is considered to play a pivotal role. Although colchicine is a widely used anti-inflammatory drug in the treatment of gout, its effect in OA is still disputed due to inconsistent results of short-term clinical trials. Therefore, we aim to evaluate the effect of long-term colchicine 0.5 mg once daily on the incidence of knee or hip replacements in patients with knee or hip OA.

Methods and analysis
The ECHO trial is a prospective, multicentre, randomised, double-blind, placebo-controlled, phase III trial in which 1200 participants with knee or hip OA tolerant to colchicine during a 30-day run-in period will be 1:1 randomised to colchicine 0.5 mg once daily or matching placebo using concealed allocation. The primary endpoint is the time from randomisation to the first knee or hip replacement assessed up to 4.5 years. Secondary endpoints include course of pain, physical function, joint space narrowing, low-grade inflammation, quality of life, clinical or radiological onset of OA in a new joint group other than present at baseline, number of participants using pain medication during the study, onset of new cardiovascular events (ie, myocardial infarction, ischaemia-driven coronary revascularisation, ischaemic stroke, peripheral artery disease or cardiovascular death) and direct and indirect costs related to treatment and disease burden due to OA. Harm-related endpoints include the number of (serious) adverse events, the number of withdrawals due to (serious) adverse events and changes in laboratory data (ie, serum creatinine, estimated glomerular filtration rate and alanine transferase) throughout the study. The primary analysis will be performed according to the intention-to-treat principle.

Ethics and dissemination
This trial has been approved by the Medical Ethics Review Committee East-Netherlands. Findings will be presented at scientific meetings and published in a peer-reviewed scientific journal.

Trial registration number
NCT06578182.

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Motivational interviewing for reducing rehospitalisation and improving patient activation among patients with heart failure or chronic obstructive pulmonary disease: a randomised controlled trial

Objectives
The aim is to evaluate the effects of a motivational interviewing-based intervention, Supporting Patient Activation in Transition to Home, on rehospitalisation and patient activation among patients with heart failure or chronic obstructive pulmonary disease.

Design
A randomised, controlled, analysis-blinded trial was conducted.

Setting
Participants were recruited from two hospitals in mid-Sweden and the intervention and interviews were conducted post-discharge.

Participants
207 participants with heart failure or chronic obstructive pulmonary disease were recruited. Participants were randomised to receive five motivational interviewing sessions post-discharge (n=103) or a control group (n=104).

Outcome measures
Rehospitalisation within 180 days post-discharge was retrieved, and patient activation was assessed using the Patient Activation Measure at baseline, 30, 90 and 180 days post-discharge. We used a generalised estimating equation to assess the difference in the secondary outcome, patient activation, between the intervention group and the control group during the 180-day follow-up.

Results
No statistically significant differences between the groups were found for rehospitalisation (p=0.33 to 0.41) or patient activation over time (B=–1.67, –0.71 and –0.83 (95% CI –5.45 to 2.10, –4.06 to 2.64 and –4.28 to 2.62), respectively).

Conclusion
Post-discharge motivational interviewing to decrease rehospitalisation or support patient activation does not seem beneficial for patients with heart failure or chronic obstructive pulmonary disease. The high disease burden may have limited patient participation in the intervention.

Trial registration number
NCT02823795.

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Characterizing suicidal thoughts and behaviours in individuals presenting to a psychiatric emergency department: a protocol for a multimethod approach for suicide prevention research

Introduction
Identifying individuals at risk of suicide remains an ongoing challenge. Previous research investigating risk factors for suicidal thoughts and behaviours (STB) has been informative for assessing suicide risk. However, the complex biological, psychological and sociocultural factors underlying STB have not been comprehensively captured to date, which has limited our understanding of how these factors interact to influence STB. Moreover, acute care settings, such as emergency departments (EDs), are often first points of contact for individuals with STB, highlighting a need for more research in these settings.

Methods and analysis
We aim to (1) characterize a cohort seeking care for STB and their clinical trajectories; (2) situate the cohort by comparing its characteristics and outcomes to other groups seeking emergency care; (3) explore their experiences of seeking care; and (4) examine blood-based biomarkers modulating risk for STB. Using a multimethod, prospective cohort design, we will follow up to 500 people aged 16 or older presenting to the ED with STB at a psychiatric hospital over 1 year. Analyses will involve descriptive statistics and latent profile analysis to characterize the cohort, hypothesis tests and regression models to situate the cohort, qualitative analysis based on a realist research framework to understand experiences, and within-participant comparisons of proteins, mRNA and epigenetic DNA modifications to examine biomarkers of contrasting states of STB.

Ethics and dissemination
This study was approved by the hospital’s Research Ethics Board with safeguards in place to ensure the well-being of participants and research team. An integrated knowledge translation approach will be used for dissemination, wherein patient and family advisors are engaged throughout each study phase. Findings will enhance our understanding of the multifactorial nature of suicide risk, inform strategies for prevention and provide important insights into characteristics, experiences and outcomes of individuals with STB, who are under-represented in mental health research.

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Dose Response of Incidental Physical Activity Against Cardiovascular Events and Mortality

Circulation, Volume 151, Issue 15, Page 1063-1075, April 15, 2025. BACKGROUND:Few middle-aged and older adults engage in regular leisure-time exercise. Incidental physical activity (IPA) encompasses activities of daily living outside the leisure-time domain. No dose-response study is available to guide IPA-focused interventions and guidelines. We examined the associations of device-assessed IPA intensities (vigorous [VIPA], moderate [MIPA], light [LIPA]) with major adverse cardiovascular events (MACE) and mortality, and we estimated the “health equivalence” of LIPA and MIPA against 1 minute of VIPA.METHODS:A total of 24 139 nonexercisers from the 2013 to 2015 UK Biobank accelerometry substudy (56.2% women) with a mean±SD age of 61.9±7.6 years were analyzed using a prospective cohort design. IPA energy expenditure and daily durations of VIPA, MIPA, and LIPA were calculated with a validated machine learning-based intensity classifier. MACE included incident stroke, myocardial infarction, and heart failure; CVD death; CVD mortality; and all-cause mortality.RESULTS:Analyses included 22 107 (MACE), 22 174 (CVD mortality), and 24 139 (all-cause mortality) participants, corresponding to 908/223/1071 events over 7.9 years of follow-up. IPA volume exhibited an L-shaped association with a nadir at ≈35 to 38 kJ·kg−1·d−1, corresponding to hazard ratios of 0.49 (95% CI, 0.39–0.61) for MACE, 0.33 (95% CI, 0.22–0.52) for CVD mortality, and 0.31 (95% CI, 0.25–0.38) for all-cause mortality. Any amounts of VIPA or MIPA were associated with lower risk, with a plateau of ≈14 minutes per day (VIPA) and 34 to 50 minutes per day (MIPA). The median VIPA (4.6 min/d) and MIPA (23.8 min/d) durations were associated with CVD mortality hazard ratio of 0.62 (95% CI, 0.46–0.83) and 0.50 (95% CI, 0.31–0.80), respectively. LIPA showed a subtle inverse gradient which was statistically significant only for CVD mortality at levels >130 minutes per day. One minute of VIPA was equivalent to 2.8 (MACE) to 3.4 (CVD mortality) minutes of MIPA and 34.7 (CVD mortality) to 48.5 (MACE) minutes of LIPA.CONCLUSIONS:Any daily IPA amount of vigorous or moderate intensity was associated with lower CVD risk in a dose-response manner. LIPA had weak associations with all outcomes. One minute of vigorous or ≈3.0 to 3.5 minutes of moderate IPA was associated with a similar degree of lower CVD risk. Our findings highlight the potential cardiovascular health value of incidental physical activity, especially for people who struggle to do structured exercise.

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Predictive value of burnout complaints and depressive symptoms for medically certified sickness absence among physicians in Sweden: a 1 year follow-up observational study

Objective
This study aimed to explore the predictive value of severe burnout complaints, symptom dimension of burnout and depressive symptoms for subsequent all-cause medically certified sickness absence (ACMCSA) during the pandemic among physicians in Sweden.

Design
A 1 year follow-up panel cohort observational study—the Longitudinal Occupational Health Survey for HealthCare in Sweden. At baseline (February–May 2021), a representative sample of 6699 physicians was drawn from the Swedish occupational register and invited to participate in the study. At follow-up (March–May 2022), the full sample (excluding those who died, retired, stopped working as a physician or migrated, n=94) was invited to answer the survey.

Setting
Swedish primary and specialist healthcare.

Participants
At baseline, the response rate was 41.3% (n=2761) of which 1575 also answered at follow-up.

Primary and secondary outcome measures
ACMCSA data came from the Swedish Social Insurance Agency. The Burnout Assessment Tool (BAT-23) was used to measure burnout, including a burnout total score and scores for the four symptom dimensions of exhaustion, mental distance, emotional impairment and cognitive impairment. Depressive symptoms were assessed using the Symptom Checklist-core depression (SCL-CD6). Associations between baseline burnout and depressive symptoms and subsequent ACMCSA were estimated with logistic regression analyses.

Results
ACMCSA was found in 9% of the participating physicians. In the sample, 4.7% had severe burnout complaints, and 3.7% had depressive symptoms. Burnout (OR=2.57; 95% CI=1.27 to 5.23) and the burnout symptom dimensions emotional impairment (OR=1.80; 95% CI=1.03 to 3.15) and cognitive impairment (OR=2.52; 95% CI=1.12 to 5.50) were associated with a higher likelihood of subsequent ACMCSA. Depressive symptoms were not associated with ACMCSA when adjusted for severe burnout complaints and other covariates.

Conclusion
This study demonstrates the distinction between burnout and depressive symptoms, particularly in predicting future ACMCSA. Early intervention targeting exhaustion and burnout may mitigate symptom development and reduce the risk of ACMCSA.

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Efficacy of Yijinjing for Soft Tissue Improvement in Patients with Non-specific Chronic Neck Pain: Study Protocol for a Multicenter Randomized Controlled Trial

Introduction
As a mind–body exercise, Yijinjing has shown benefits in enhancing the effects of manual therapy for the treatment of pain, disability and soft tissue status associated with non-specific chronic neck pain (NCNP). The efficacy of Yijinjing as an independent exercise regimen for the treatment of NCNP has not been established. This study is designed to assess the efficacy of Yijinjing in patients with NCNP, compared with cervical function training (CFT).

Methods and analysis
A total of 132 consenting NCNP participants will be randomly assigned in a 1:1 ratio to either the Yijinjing group or the CFT group (three times a week for 8 weeks). Both groups will undergo an 8-week intervention phase. Outcome variables will be assessed at baseline and at 4-week, 8-week and 12-week follow-up. The primary outcome measure is the change in visual analogue scale scores at week 8. Secondary outcomes include neck disability index, cervical range of motion and soft tissue status parameters.

Ethics and dissemination
This study has been approved by an independent ethics committee and will be carried out according to the principles of the Declaration of Helsinki, local laws and regulations. The results of this study will be disseminated through presentation at scientific conferences and publication in peer-reviewed journals.

Trial registration number
ITMCTR2024000323.

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Comparison of non-invasive and fluorescein tear film break-up time in a 65-year-old Norwegian population: a cross-sectional study

Objectives
Measurement of tear film stability is central in dry eye disease (DED) diagnosis. In this study, we aimed to compare the performance of two methods of tear film stability measurement: non-invasive tear break-up time (NIBUT) and fluorescein tear film break-up time (FTBUT).

Design
Cross-sectional study.

Setting and participants
The study involved 132 subjects of 65-year-old inhabitants of the Oslo region who were not seeking ophthalmic care.

Interventions
The participants underwent a battery of DED tests, including NIBUT measured on Oculus Keratograph 5M and a traditional method using fluorescein drops (FTBUT). Oculus Keratograph 5M measures two types of NIBUT:; appearance time of the first dry spot (NIBUTFirst) and average NIBUTAvg.

Results
74 participants (56%) were female and 58 were male (44%). Subjects presented with varying degrees of DED signs and symptoms. Mean values of NIBUTFirst and FTBUT from all the participants were significantly different (6.2±4.9 s vs 8.6±6.2 s, p

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