Objective: Contagious disease outbreaks and related restrictions can lead to negative psychological outcomes, particularly in vulnerable populations at risk due to pre-existing medical conditions.... Show moreObjective: Contagious disease outbreaks and related restrictions can lead to negative psychological outcomes, particularly in vulnerable populations at risk due to pre-existing medical conditions. No randomised controlled trials (RCTs) have tested interventions to reduce mental health consequences of contagious disease outbreaks. The primary objective of the Scleroderma Patient-centered Intervention Network COVID-19 Home-isolation Activities Together (SPIN-CHAT) Trial is to evaluate the effect of a videoconference-based program on symptoms of anxiety. Secondary objectives include evaluating effects on symptoms of depression, stress, loneliness, boredom, physical activity, and social interaction.Methods: The SPIN-CHAT Trial is a pragmatic RCT that will be conducted using the SPIN-COVID-19 Cohort, a sub-cohort of the SPIN Cohort. Eligible participants will be SPIN-COVID-19 Cohort participants without a positive COVID-19 test, with at least mild anxiety (PROMIS Anxiety 4a v1.0 T-score >= 55), not working from home, and not receiving current counselling or psychotherapy. We will randomly assign 162 participants to intervention groups of 7 to 10 participants each or waitlist control. We will use a partially nested RCT design to reflect dependence between individuals in training groups but not in the waitlist control. The SPIN-CHAT Program includes activity engagement, education on strategies to support mental health, and mutual participant support. Intervention participants will receive the 4-week (3 sessions per week) SPIN-CHAT Program via video-conference. The primary outcome is PROMIS Anxiety 4a score immediately post-intervention.Ethics and dissemination: The SPIN-CHAT Trial will test whether a brief videoconference-based intervention will improve mental health outcomes among at-risk individuals during contagious disease outbreak. Show less
Brugts, J.J.; Veenis, J.F.; Radhoe, S.P.; Linssen, G.C.M.; Gent, M. van; Borleffs, C.J.W.; ... ; Boer, R.A. de 2019
Background Assessing haemodynamic congestion based on filling pressures instead of clinical congestion can be a way to further improve quality of life (QoL) and clinical outcome by intervening... Show moreBackground Assessing haemodynamic congestion based on filling pressures instead of clinical congestion can be a way to further improve quality of life (QoL) and clinical outcome by intervening before symptoms or weight gain occur in heart failure (HF) patients. The clinical efficacy of remote monitoring of pulmonary artery (PA) pressures (CardioMEMS; Abbott Inc., Atlanta, GA, USA) has been demonstrated in the USA. Currently, the PA sensor is not reimbursed in the European Union as its benefit when applied in addition to standard HF care is unknown in Western European countries, including the Netherlands. Aims To demonstrate the efficacy and cost-effectiveness of haemodynamic PA monitoring in addition to contemporary standard HF care in a high-quality Western European health care system. Methods The current study is a prospective, multi-centre, randomised clinical trial in 340 patients with chronic HF (New York Heart Association functional class III) randomised to HF care including remote monitoring with the CardioMEMS PA sensor or standard HF care alone. Eligible patients have at least one hospitalisation for HF in 12 months before enrolment and will be randomised in a 1:1 ratio. Minimum follow-up will be 1 year. The primary endpoint is the change in QoL as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ). Secondary endpoints are the number of HF hospital admissions and changes in health status assessed by EQ-5D-5L questionnaire including health care utilisation and formal cost-effectiveness analysis. Conclusion The MONITOR HF trial will evaluate the efficacy and cost-effectiveness of haemodynamic monitoring by CardioMEMS in addition to standard HF care in patients with chronic HF. Clinical Trial Registration number NTR7672. Show less
The overriding aim of my thesis was to study the relationship between blood pressure (BP) and cognitive and psychological functioning in older persons. Observational studies indicate that lower BP... Show moreThe overriding aim of my thesis was to study the relationship between blood pressure (BP) and cognitive and psychological functioning in older persons. Observational studies indicate that lower BP increases risk for cognitive decline in older persons. Older persons are at risk for impaired cerebral autoregulation, and lowering their BP may compromise cerebral blood flow and cognitive function. Contradictory to our hypothesis, the Discontinuation of Antihypertensive Treatment in Elderly people (DANTE) Study Leiden, a community-based randomized clinical trial in older persons (aged ≥75 years) with mild cognitive deficits, did not show that discontinuation of antihypertensive treatment improves cognitive functioning. The lack of the effect of this trial may be due to the unintentional inclusion of persons with a relatively intact cerebral autoregulation. Furthermore, we demonstrated that older persons with mild cognitive deficits and with orthostatic hypotension, who discontinued all their antihypertensive medication had an increased probability of being free from orthostatic hypotension 4 months later, compared to persons who continued their medication. Finally, in the DANTE MRI sub study, the relationship between BP and both conventional features of small vessel disease (SVD) and microstructural damage was explored, as well as the relation between microstructural damage and cognitive and psychological dysfunction. Show less
Maaden, T. van der; Vet, H.C.W. de; Achterberg, W.P.; Boersma, F.; Schols, J.M.G.A.; Mehr, D.R.; ... ; Steen, J.T. van der 2016
The Subacromial Impingement Syndrome (SIS) is the most prevalent disorder of the shoulder in primary health care. Acromionplasty, as the main surgical treatment of SIS, is one of the most performed... Show moreThe Subacromial Impingement Syndrome (SIS) is the most prevalent disorder of the shoulder in primary health care. Acromionplasty, as the main surgical treatment of SIS, is one of the most performed orthopedic surgeries. However, its results are highly variable. Possibly, there are different etiologic subgroups of patients, that might need specific treatment approaches. Several etiologic mechanisms have been described for subacromial narrowing or __impingement__: i.e. 1) structural causes, including acromion shape, subacromial bony spurs, osteophytes; 2) narrowing of the subacromial space due to humerus cranialisation in patients with (micro)instability, or scapular dyskinesia; 3) intrinsic mechanisms such as primary degenerative tendinopathy of the rotator cuff. The aim of this thesis is to unravel the clinical entity __Subacromial Impingement Syndrome__ and to develop methods for identifying distinct etiological patient subgroups that need specific diagnostics and treatment strategies. To this end, we explore the terminological problems and opinions on the main characteristics of SIS amongst international health practitioners, study the prevalence of previously reported etiologic mechanisms in patients with SIS symptoms, develop clinical and biomechanical methods to evaluate and categorize patients with SIS symptoms in diagnostic subgroups, and compare treatment outcomes in trials and follow-up studies. Show less
Unexplained Chronic Fatigue (CF) is of unknown aetiology, but research suggests a multifactorial nature in which biological/physical, psychological and social fators interact. Treatment approaches... Show moreUnexplained Chronic Fatigue (CF) is of unknown aetiology, but research suggests a multifactorial nature in which biological/physical, psychological and social fators interact. Treatment approaches for CF target mainly perpetuating factors of fatigue chronicity, such as lack of physical activity. This thesis describes a brief self-regulation-based intervention targeting physical activity for patients with CF. Prior to this intervention study we conducted a series of studies that were important for the development of the trial: (1) a validation of a measure of fatigue severity for the language and population in which we intended to implement the intervention, (2) a comparison of clinical characteristics and behavioural and cognitive determinants of CFS in a Dutch and a Portuguese patient sample, and (3) a systematic review and meta-analysis of behavioural interventions with a graded activity component conducted with CF patients. In a randomized controlled trial (n=91), the self-regulation based intervention led to significant sustained effects (1 year) on fatigue severity, quality of life and physical activity. Sustained benefits on fatigue severity were partially explained by progress on a personal physical activity goal, and use of self-regulation skills. Findings are discussed in terms of its implications for practice, methodological considerations and avenues for future research. Show less
Room for improvement is present in the treatment of migraine in primary care. However, inviting all patients who receive prescriptions for __2 triptans each month to have an evaluation consultation... Show moreRoom for improvement is present in the treatment of migraine in primary care. However, inviting all patients who receive prescriptions for __2 triptans each month to have an evaluation consultation with their general practitioner (GP), produces insufficient effect on headache outcomes and costs. However, it remains important to stay alert on patients who are candidate for preventive treatment. When discussing the possibility of preventive treatment, GPs should keep in mind possible barriers in patients. Also, GPs have to ask themselves if they do not deny patients a possibly effective treatment because of their own negative ideas towards preventive medication. Also, we learned that when designing pragmatic studies in primary care, there are methodological issues that make it harder to prove the effectiveness of an intervention. First, the outcomes of pragmatic studies in primary care can negatively affected by changes in the behaviour of GPs and patients in the control group. Second, the quality of life outcome measures that are often used in this type of research are harder to validate and to interpret than the more robust outcome measures that are used in clinical trials Show less
Brunschot, S. van; Grinsven, J. van; Voermans, R.P.; Bakker, O.J.; Besselink, M.G.H.; Boermeester, M.A.; ... ; Dutch Pancreatitis Study Grp 2013
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