Effect of PEP flute self-care versus usual care in early covid-19: non-drug, open label, randomised controlled trial in a Danish community setting.

OBJECTIVE: To determine whether positive expiratory pressure (PEP) by PEP flute self-care is effective in reducing respiratory symptoms among community dwelling adults with SARS-CoV-2 infection and early stage covid-19. DESIGN: Non-drug, open label, randomised controlled trial. SETTING: Capital Region and Region Zealand in Denmark from 6 October 2020 to 26 February 2021. PARTICIPANTS: Community dwelling adults, able to perform self-care, with a new SARS-CoV-2 infection (verified by reverse transcription polymerase chain reaction tests) and symptoms of covid-19. INTERVENTION: Participants were randomised to use PEP flute self-care in addition to usual care or have usual care only. Randomisation was based on permuted random blocks in a 1:1 ratio, stratified for sex and age (<60 or ≥60 years). The PEP self-care group was instructed to use a PEP flute three times per day during the 30 day intervention. MAIN OUTCOME MEASURES: Primary outcome was a change in symptom severity from baseline to day 30, as assessed by the self-reported COPD (chronic obstructive pulmonary disease) assessment test (CAT), which was adjusted for baseline values and stratification factors. Participants completed the CAT test questionnaire every day online. Secondary outcomes were self-reported urgent care visits due to covid-19, number of covid-19 related symptoms, and change in self-rated health, all within 30-days' follow-up. RESULTS: 378 participants were assigned to the PEP flute self-care intervention (n=190) or usual care only (n=188). In the PEP self-care group, the median number of days with PEP flute use was 21 days (interquartile range 13-25). For the intention-to-treat population, a group difference was observed in changes from baseline in CAT scores of -1.2 points (95% confidence interval -2.1 to -0.2; P=0.017) in favour of the PEP flute self-care group. At day 30, the PEP flute self-care group also reported less chest tightness, less dyspnoea, more vigour, and higher level of daily activities, but these differences were small, and no consistent effects were seen on the secondary outcomes. No serious adverse events were reported. CONCLUSIONS: In community dwelling adults with early covid-19, PEP flute self-care had a significant, yet marginal and uncertain clinical effect on respiratory symptom severity, as measured by CAT scores. TRIAL REGISTRATION: ClinicalTrials.gov NCT04530435.

PEP-CoV protocol: a PEP flute-self-care randomised controlled trial to prevent respiratory deterioration and hospitalisation in early COVID-19.

INTRODUCTION: Infection with SARS-CoV-2 may progress to severe pulmonary disease, COVID-19. Currently, patients admitted to hospital because of COVID-19 have better prognosis than during the first period of the pandemic due to improved treatment. However, the overall societal susceptibility of being infected makes it pivotal to prevent severe courses of disease to avoid high mortality rates and collapse of the healthcare systems. Positive expiratory pressure (PEP) self-care is used in chronic pulmonary disease and has been shown to prevent pneumonia in a high-risk cohort of patients with leukaemia. PEP flute self-care to prevent respiratory deterioration and hospitalisation in early COVID-19: a randomised trial (The PEP-CoV trial) examines the effectiveness on respiratory symptoms and need of hospital admission by regular PEP flute use among non-hospitalised individuals with confirmed SARS-CoV-2 infection and COVID-19 symptoms. METHODS AND ANALYSIS: In this randomised controlled trial, we hypothesise that daily PEP flute usage as add-on to usual care is superior to usual care as regards symptom severity measured by the COPD Assessment Test (CAT) at 30-day follow-up (primary outcome) and hospital admission through register data (secondary outcome). We expect to recruit 400 individuals for the trial. Participants in the intervention group receive a kit of 2 PEP flutes and adequate resistances and access to instruction videos. A telephone hotline offers possible contact to a nurse. The eight-item CAT score measures cough, phlegm, chest tightness, dyspnoea, activities of daily living at home, feeling safe at home despite symptoms, sleep quality and vigour. The CAT score is measured daily in both intervention and control arms by surveys prompted through text messages. ETHICS AND DISSEMINATION: The study was registered prospectively at www.clinicaltrials.gov on 27 August 2020 (NCT04530435). Ethical approval was granted by the local health research ethics committee (Journal number: H-20035929) on 23 July 2020. Enrolment of participants began on 6 October 2020. Results will be published in scientific journals. TRIAL REGISTRATION NUMBER: NCT04530435; Pre-results.

User evaluation of patient counselling, combining nurse consultation and eHealth in hand eczema.

BACKGROUND AND OBJECTIVE: This study reports the findings from a user evaluation of a counselling programme for hand eczema patients in which face-to-face encounters were supplemented with user access to a new website. PATIENTS AND METHODS: Patients treated for hand eczema in two different settings were included consecutively. Website utilization was examined by use of the transaction log. Comparisons were made between participants who used the website and those who did not. The patients' perspectives were explored by the use of interviews. RESULTS: Among potential website users (n = 140), 88 patients (63%) had an average of 5.1 site visits. At follow-up, the website users had improved more in quality of life (p = 0.014), current burden of disease (p = 0.053), and itching (p = 0.042). The website users reported more changes in habits than did the non-website users (p = 0.024). No differences in clinical severity of hand eczema were found. The interviewees were generally satisfied with the counselling and the website. The strict log-on procedures were considered to be an obstacle to using the site. The consecutive inclusion of participants was considered to be a barrier to engagement in the dialogue forum. CONCLUSIONS: The website users benefited from the website, although this was not substantiated by clinical measurements. The trial design partly hampered website utilization. An initial feasibility study could have been warranted.

Response shift in severity assessment of hand eczema with visual analogue scales.

BACKGROUND: Hand eczema is a common and fluctuating disease. Visual analogue scales (VASs) are used to assess disease severity, both currently and when at its worst. However, such patient-reported outcomes may be at risk of being flawed owing to recall bias or response shifts. OBJECTIVE: To explore whether the current state of hand eczema severity affects the recollection of the eczema when at its worst, thus resulting in a response shift. METHODS: We utilized a dataset from a recent clinical trial examining nurse counselling of hand eczema patients. The patients assessed the disease severity currently (VASnow ) and when at its worst (VASworst ), both at baseline and at a 6-month follow-up. RESULTS: The patients who reported improvement during the course were generally more likely to downwardly adjust their assessment of VASworst than patients reporting unchanged or worsened severity (odds ratio 1.94, p = 0.017). No other determinants were found. CONCLUSION: Patients may downwardly adjust their assessment of worst-ever disease severity according to the assessment of present disease severity. Regular photographic documentation of the hand eczema along with the patient's self-monitoring of symptoms as part of the treatment course could perhaps counteract this tendency for there to be severity habituation.

Effectiveness of the Healthy Skin Clinic--a randomized clinical trial of nurse-led patient counselling in hand eczema.

BACKGROUND: Hand eczema is a common disease, and continuous preventive skin protection and skin care must be adopted to prevent a chronic course. Hand eczema is not a uniform disease, and counselling must therefore be individually tailored. OBJECTIVES: To evaluate the effectiveness of a nurse-led counselling programme, the Healthy Skin Clinic, emphasizing the patient's self-management, resources, and risks. PATIENTS AND METHODS: Patients (n = 306) referred for diagnostic work-up and treatment of hand eczema were randomized and allocated either to the programme or to usual care. The primary outcome was clinical disease severity at follow-up. Secondary outcomes were quality of life, burden of disease, skin protective behaviours, and self-reported medication adherence. RESULTS: Patients in the intervention group had greater reductions in clinical severity and reported more beneficial behavioural changes at follow-up than those in the usual-care group. This was especially true of patients who were treated solely with topical corticosteroids and who had a primarily exogenous aetiology of hand eczema. However, the effect was very dependent on baseline disease severity. No differences in quality of life or burden of disease were found between the two groups. CONCLUSION: A tailored nurse-led programme of skin protection counselling may be recommended as an essential part of hand eczema treatment.

An analysis of gender differences in patients with hand eczema - everyday exposures, severity, and consequences.

BACKGROUND: Hand eczema is often related to high-risk occupations and aggravating exposures in everyday life. The disease is twice as frequent in women as in men, partly because of diverse exposure patterns. Other gender differences may be relevant for treatment and prevention. OBJECTIVES: To gain insights into the common features and differences between men and women with hand eczema. METHODS: The clinical disease severity of patients (n = 306) attending for dermatological treatment at two settings was assessed with the Hand Eczema Severity Index (HECSI). Self-reported medication adherence, aggravating factors, hand eczema-related consequences and quality of life were obtained from a questionnaire. RESULTS: Men and women had equal clinical severities of disease, with an overall median HECSI of 43. Self-reported medication adherence was equal between the genders, but, among patients aged > 40 years, more reported higher adherence. The impact of disease was larger in women than in men. Women reported significantly more aggravating factors and sick leave. Also, women had a more impaired quality of life than men at equal levels of disease severity, and this could be associated with the higher number of aggravating factors. CONCLUSION: Gender differences in hand eczema need to be considered in the dermatological treatment and counselling of patients.

Chronic hand eczema--self-management and prognosis: a study protocol for a randomised clinical trial.

BACKGROUND: Hand eczema has a one-year prevalence of approximately 10 % in the general Danish population. Often the disease becomes chronic with numerous implications for the individual's daily life, occupation and quality of life. However, no guidelines of self-management recommendations beyond the acute stage are given. Self-management of the disease is pivotal and involves self-monitoring of the condition, medication adherence, and preventive behaviour. Interventions best to support the individual in this ongoing process need to be developed. METHODS/DESIGN: This paper describes the design of a randomised clinical trial to test a newly developed intervention of individual counselling versus conventional information. 300 patients consecutively referred to dermatologic treatment at two different settings are individually randomised to either the intervention programme, named 'The Healthy Skin Clinic' or to the control group. Block-wise randomisation according to setting and gender is carried out.The intervention offers a tool for self-monitoring; basic and specific individual counselling; the possibility of asynchronous communication with the intervention team; and an electronic patient dialogue forum. Primary outcome variable is objective assessment of the hand eczema severity performed at baseline prior to randomisation, and repeated at six months follow-up. Secondary outcome variables are dermatology related life quality and perceived global burden of disease. DISCUSSION: The trial aims at evaluating a newly developed guidance programme which is expected to support self-management of patients referred to dermatology treatment due to chronic hand eczema. The design of the protocol is pragmatic with blinding of neither participants nor the investigator. Thus, in the interpretation of the results, the investigator takes into account effects that may be attributed to actors of the interventions rather than the intervention per se as well of potential observer bias. Inclusion criterions are wide in order to increase transferability of the results. TRIAL REGISTRATION: The trial is registered in ClinicalTrials.Gov with registration number NCT01482663.