Doctor Referral of Overweight People to Low Energy total diet replacement Treatment (DROPLET): pragmatic randomised controlled trial

Abstract Objective To test the effectiveness and safety of a total diet replacement (TDR) programme for routine treatment of obesity in a primary care setting. Design Pragmatic, two arm, parallel group, open label, individually randomised controlled trial. Setting 10 primary care practices in Oxfordshire, UK. Participants 278 adults who were obese and seeking support to lose weight: 138 were assigned to the TDR programme and 140 to usual care. 73% of participants were re-measured at 12 months. Interventions The TDR programme comprised weekly behavioural support for 12 weeks and monthly support for three months, with formula food products providing 810 kcal/day (3389 kJ/day) as the sole food during the first eight weeks followed by reintroduction of food. Usual care comprised behavioural support for weight loss from a practice nurse and a diet programme with modest energy restriction. Main outcome measures The primary outcome was weight change at 12 months analysed as intention to treat with mixed effects models. Secondary outcomes included biomarkers of cardiovascular and metabolic risk. Adverse events were recorded. Results Participants in the TDR group lost more weight (−10.7 kg) than those in the usual care group (−3.1 kg): adjusted mean difference −7.2 kg (95% confidence interval −9.4 to −4.9 kg). 45% of participants in the TDR group and 15% in the usual care group experienced weight losses of 10% or more. The TDR group showed greater improvements in biomarkers of cardiovascular and metabolic risk than the usual care group. 11% of participants in the TDR group and 12% in the usual care group experienced adverse events of moderate or greater severity. Conclusions Compared with regular weight loss support from a practice nurse, a programme of weekly behavioural support and total diet replacement providing 810 kcal/day seems to be tolerable, and leads to substantially greater weight loss and greater improvements in the risk of cardiometabolic disease. Trial registration International Standard Randomised Controlled Trials No ISRCTN75092026 .

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Extended follow-up of a short total diet replacement programme: results of the Doctor Referral of Overweight People to Low Energy total diet replacement Treatment (DROPLET) randomised controlled trial at 3 years

International Journal of Obesity ◽

10.1038/s41366-021-00915-1 ◽

2021 ◽

Author(s):

Nerys M. Astbury ◽

Rhiannon M. Edwards ◽

Fitsum Ghebretinsea ◽

Milensu Shanyinde ◽

Jill Mollison ◽

...

Keyword(s):

Blood Pressure ◽

Randomised Controlled Trial ◽

Usual Care ◽

Practice Nurse ◽

Disease Risk ◽

Controlled Trial ◽

Mean Difference ◽

Behavioural Support ◽

Total Diet ◽

Randomised Controlled

Abstract Objectives To test the long-term effectiveness of a total diet replacement programme (TDR) for routine treatment of obesity in a primary care setting. Methods This study was a pragmatic, two-arm, parallel-group, open-label, individually randomised controlled trial in adults with obesity. The outcomes were change in weight and biomarkers of diabetes and cardiovascular disease risk from baseline to 3 years, analysed as intention-to-treat with mixed effects models. Interventions The intervention was TDR for 8 weeks, followed by food-reintroduction over 4 weeks. Behavioural support was provided weekly for 8 weeks, bi-weekly for the next 4 weeks, then monthly for 3 months after which no further support was provided. The usual care (UC) group received dietary advice and behavioural support from a practice nurse for up to 3 months. Results Outcome measures were collected from 179 (66%) participants. Compared with baseline, at 3 years the TDR group lost −6.2 kg (SD 9.1) and usual care −2.7 kg (SD 7.7); adjusted mean difference −3.3 kg (95% CI: −5.2, −1.5), p < 0.0001. Regain from programme end (6 months) to 3 years was greater in TDR group +8.9 kg (SD 9.4) than UC + 1.2, (SD 9.1); adjusted mean difference +6.9 kg (95% CI 4.2, 9.5) P < 0.001. At 3 years TDR led to greater reductions than UC in diastolic blood pressure (mean difference −3.3 mmHg (95% CI:−6.2; −0.4) P = 0.024), and systolic blood pressure (mean differences −3.7 mmHg (95% CI: −7.4; 0.1) P = 0.057). There was no evidence of differences between groups in the change from baseline to 3 years HbA1c (−1.9 mmol/mol (95% CI: −0.7; 4.5; P = 0.15), LDL cholesterol concentrations (0.2 mmol/L (95% CI −0.3, 0.7) P = 0.39), cardiovascular risk score (QRISK2) (−0.37 (95% CI −0.96; 0.22); P = 0.22). Conclusions Treatment of people with obesity with a TDR programme compared with support from a practice nurse leads to greater weight loss which persists to at least 3 years, but there was only evidence of sustained improvements in BP and not in other aspects of cardiometabolic risk.

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Home-based Reach-to-Grasp training for people after stroke is feasible: a pilot randomised controlled trial

Clinical Rehabilitation ◽

10.1177/0269215516661751 ◽

2016 ◽

Vol 31 (7) ◽

pp. 891-903 ◽

Cited By ~ 7

Author(s):

AJ Turton ◽

P Cunningham ◽

F van Wijck ◽

HJM Smartt ◽

CA Rogers ◽

...

Keyword(s):

Randomised Controlled Trial ◽

Usual Care ◽

Usual Care Group ◽

Controlled Trial ◽

Care Group ◽

Reach To Grasp ◽

Arm Pain ◽

Home Based ◽

Wolf Motor Function Test ◽

Randomised Controlled

Objective: To determine feasibility of a randomised controlled trial (RCT) of home-based Reach-to-Grasp training after stroke. Design: single-blind parallel group RCT. Participants: Residual arm deficit less than 12 months post-stroke. Interventions: Reach-to-Grasp training in 14 one-hour therapist’s visits over 6 weeks, plus one hour self-practice per day (total 56 hours). Control: Usual care. Main Measures: Action Research Arm Test (ARAT), Wolf Motor Function Test (WMFT), pre-randomisation, 7, 12, 24 weeks post-randomisation. Results: Forty-seven participants (Reach-to-Grasp=24, usual care=23) were randomised over 17 months. Reach-to-Grasp participants received a median (IQR) 14 (13,14) visits, and performed 157 (96,211) repetitions per visit; plus 30 minutes (22,45) self-practice per day. Usual care participants received 10.5 (5,14) therapist visits, comprising 38.6 (30,45) minutes of arm therapy with 16 (6,24) repetitions of functional tasks per visit. Median ARAT scores in the reach-to-grasp group were 8.5 (3.0,24.0) at baseline and 14.5 (3.5,26.0) at 24 weeks compared to median of 4 at both time points (IQR: baseline (3.0,14.0), 24 weeks (3.0,30.0)) in the usual-care group. Median WMFT tasks completed at baseline and 24 weeks were 6 (3.0,11.5) and 8.5 (4.5,13.5) respectively in the reach-to-grasp group and 4 (3.0,10.0), 6 (3.0,14.0) in the usual care group. Incidence of arm pain was similar between groups. The study was stopped before 11 patients reached the 24 weeks assessment. Conclusions: An RCT of home-based Reach-to-Grasp training after stroke is feasible and safe. With ARAT being our preferred measure it is estimated that 240 participants will be needed for a future two armed trial.

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MEDication reminder APPs to improve medication adherence in Coronary Heart Disease (MedApp-CHD) Study: a randomised controlled trial protocol

BMJ Open ◽

10.1136/bmjopen-2017-017540 ◽

2017 ◽

Vol 7 (10) ◽

pp. e017540 ◽

Cited By ~ 22

Author(s):

Karla Santo ◽

Clara K Chow ◽

Aravinda Thiagalingam ◽

Kris Rogers ◽

John Chalmers ◽

...

Keyword(s):

Coronary Heart Disease ◽

Heart Disease ◽

Medication Adherence ◽

Randomised Controlled Trial ◽

Usual Care ◽

Usual Care Group ◽

Controlled Trial ◽

Care Group ◽

Randomised Controlled ◽

Medication Reminder

IntroductionThe growing number of smartphone health applications available in the app stores makes these apps a promising tool to help reduce the global problem of non-adherence to long-term medications. However, to date, there is limited evidence that available medication reminder apps are effective. This study aims to determine the impact of medication reminder apps on adherence to cardiovascular medication when compared with usual care for people with coronary heart disease (CHD) and to determine whether an advanced app compared with a basic app is associated with higher adherence.Methods and analysisRandomised controlled trial with follow-up at 3 months to evaluate the feasibility and effectiveness of medication reminder apps on medication adherence compared with usual care. An estimated sample size of 156 patients with CHD will be randomised to one of three groups (usual care group, basic medication reminder app group and advanced medication reminder app group). The usual care group will receive standard care for CHD with no access to a medication reminder app. The basic medication reminder app group will have access to a medication reminder app with a basic feature of providing simple daily reminders with no interactivity. The advanced medication reminder app group will have access to a medication reminder app with additional interactive and customisable features. The primary outcome is medication adherence measured by the eight-item Morisky Medication Adherence Scale at 3 months. Secondary outcomes include clinical measurements of blood pressure and cholesterol levels, and medication knowledge. A process evaluation will also be performed to assess the feasibility of the intervention by evaluating the acceptability, utility and engagement with the apps.Ethics and disseminationEthical approval has been obtained from the Western Sydney Local Health Network Human Research Ethics Committee (AU/RED/HREC/1/WMEAD/3). Study findings will be disseminated via usual scientific forums.Trial registration numberACTRN12616000661471; Pre-results

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Can exercise influence survival following breast cancer: Results from a randomised, controlled trial.

Journal of Clinical Oncology ◽

10.1200/jco.2017.35.15_suppl.10067 ◽

2017 ◽

Vol 35 (15_suppl) ◽

pp. 10067-10067 ◽

Cited By ~ 3

Author(s):

Sandra Christine Hayes ◽

Megan Steele ◽

Rosa Spence ◽

Christopher Pyke ◽

Christobel Saunders ◽

...

Keyword(s):

Breast Cancer ◽

Usual Care ◽

Usual Care Group ◽

Exercise Intervention ◽

Controlled Trial ◽

Disease Free Survival ◽

Exercise Group ◽

Care Group ◽

Randomised Controlled ◽

Disease Free

10067 Background: Exercise for Health was a randomised, controlled trial designed to evaluate an 8-month translational exercise intervention, commencing 6-weeks post-surgery for newly diagnosed breast cancer. Outcomes for this follow-up exploratory analysis were overall- and disease-free survival. Methods: Consenting urban-based women (n = 194) were randomized to one of two exercise groups (intervention delivered either face-to-face or over the telephone) or a usual care group, while consenting rural/regional women (n = 143) were randomised to either the telephone-delivered exercise group or usual care group. For the purposes of these analyses, exercise groups and usual care groups were combined (exercise group, n = 207; usual care group, n = 130). Analyses were done on an intention-to-treat basis and trials were registered with the Australian New Zealand Clinical Trials Registry (ACTRN12606000233527; 12609000809235). Results: Participant disease and treatment characteristics were similar to the wider breast cancer population in Queensland, Australia, and 42% of the sample resided in rural or regional areas. After a median follow-up of 101 months, there were 15/130 (11.5%) survival events in the usual care group, compared with 11/207 (5.3%) events in the exercise group. Disease-free events for the usual care versus exercise group were 23/130 (17.7%) and 25/207 (12.1%), respectively. The corresponding unadjusted hazard ratio for the exercise group for overall survival was 0.45 (95% CI = 0.21-0.97; p = 0.037), and for disease-free survival was 0.66 (95% CI = 0.38-1.17; p = 0.155). Conclusions: Epidemiological evidence consistently shows a positive relationship between physical activity and survival post-breast cancer, but is unable to establish causality. These exploratory findings suggest that an exercise intervention delivered during and beyond conventional treatment for breast cancer and that was designed to cater for all women, irrespective of place of residence and access to medical services, has clear potential to influence survival. Clinical trial information: ACTRN12606000233527; 12609000809235.

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Effect of Artificial Intelligence on Nutritional Status of children post cardiac surgery; A Randomized Controlled Trial (Preprint)

10.2196/preprints.36480 ◽

2022 ◽

Author(s):

Maryam Zahid ◽

Ume Sughra

Keyword(s):

Nutritional Status ◽

Usual Care ◽

Usual Care Group ◽

Mobile Application ◽

Controlled Trial ◽

Intervention Group ◽

Care Group ◽

Randomized Controlled ◽

Nutritional Status Of Children ◽

Post Cardiac Surgery

BACKGROUND Malnutrition is the most common problem in congenital heart diseases patients. Health based mobile applications play an important role in planning and tracking of diet for better nutritional status OBJECTIVE To assess the effect of artificial intelligence on nutritional status of children post cardiac surgery in comparison to usual care group. To assess usefulness of diet related mobile application in comparison to usual care group. METHODS This is a two arm randomized controlled trial that was conducted at a Tertiary Care Hospital, Rawalpindi. The study duration was 6 months from February 2021 till July 2021. Sample size was calculated to be 88. Intervention group was given a diet related mobile application and usual care group was handed a pamphlet with diet instructions on discharge. RESULTS Mean weight of all participants was 15 ± 5.7 kg at the time of discharge whereas at the end of 8th week mean weight of the participants in usual care group was 16.5 ± 7.2 kg and intervention group was 17.1 ± 5 kg. Average calories consumed by usual care group was 972 ± 252 kcal and 1000.75 ± 210 kcal by intervention group after 8 weeks of discharge. Average proteins consumed by the usual care group was 34.3 ± 12.5 grams and 39± 6.4 grams by intervention group after 8 weeks of discharge. At the end of intervention preferred diet planning tool for 79% of the participants was mobile application. At 8th week 93% of the participants considered the visual cues useful, 80% think that the mobile application language was understandable, 79% of the participants think nutritional goal setting is a useful feature in mobile application and 55% of the participants think the recipes in the application were useful. CONCLUSIONS The study showed strength for the future of scalable modern technology for self-nutrition monitoring. There was slight increase in the weight and nutritional intake of both groups as interventions period was limited. CLINICALTRIAL Study was registered on clinicaltrial.gov website with trial identity number NCT04782635.

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The Natural History of Back Pain after a Randomised Controlled Trial of Acupuncture Vs Usual Care – Long Term Outcomes

Acupuncture in Medicine ◽

10.1136/aim.25.4.121 ◽

2007 ◽

Vol 25 (4) ◽

pp. 121-129 ◽

Cited By ~ 6

Author(s):

Stephanie L Prady ◽

Kate Thomas ◽

Lisa Esmonde ◽

Simon Crouch ◽

Hugh MacPherson

Keyword(s):

Back Pain ◽

Randomised Controlled Trial ◽

Usual Care ◽

Controlled Trial ◽

Bodily Pain ◽

Care Group ◽

Long Term Outcomes ◽

Short Term Treatment ◽

Randomised Controlled

Introduction There is growing evidence about the effectiveness of acupuncture in the short term treatment of chronic low back pain but little is known about long term outcomes. To address this question we followed up participants of a past randomised controlled trial of acupuncture to assess outcomes after 5.5 to 7 years. Methods A postal questionnaire assessing pain, quality of life, disability, experience with back pain and healthcare resource use was sent to all 239 participants of the York Acupuncture for Back Pain trial. Results Response to the survey was low at 43.9%. Pain measured by the SF-36 Bodily Pain dimension was maintained in the acupuncture group since the last follow up 3.5 to 5 years previously. The usual care group had improved over the intervening years and there was now no evidence of a difference between the groups (difference −0.4 points, 95% confidence interval −10.1 to 9.7). The results were unchanged on sensitivity analysis using multiple imputation. In both groups back pain had not completely resolved and worry about back health was moderate. Physiotherapy and acupuncture were used at similar rates for continuing treatment. Discussion We theorise that exposure to a short course of acupuncture speeds natural recovery from a back pain episode, but improvements plateau after two years. Acupuncture is often accessed privately for long term management of back pain but is rarely available within the health service. While our study methods were robust, the low response rate means that our findings should be interpreted with caution.

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Using Moxibustion in Primary Healthcare to Correct Non-Vertex Presentation: A Multicentre Randomised Controlled Trial

Acupuncture in Medicine ◽

10.1136/acupmed-2012-010261 ◽

2013 ◽

Vol 31 (1) ◽

pp. 31-38 ◽

Cited By ~ 36

Author(s):

Jorge Vas ◽

José Manuel Aranda-Regules ◽

Manuela Modesto ◽

María Ramos-Monserrat ◽

Mercedes Barón ◽

...

Keyword(s):

Randomised Controlled Trial ◽

Usual Care ◽

Primary Healthcare ◽

Primary Outcome ◽

Controlled Trial ◽

Acupuncture Point ◽

Care Group ◽

Moxibustion Group ◽

Vertex Presentation ◽

Randomised Controlled

Objective To compare the effectiveness of additional moxibustion at point BL67 with moxibustion at a non-specific acupuncture point and with usual care alone to correct non-vertex presentation. Methods This was a multicentre randomised controlled trial in which 406 low-risk pregnant women with a fetus in ultrasound breech presentation, with a gestational age of 33–35 weeks, were assigned to (1) true moxibustion at point BL67 plus usual care; (2) moxibustion at SP1, a non-specific acupuncture point (sham moxibustion) plus usual care; or (3) usual care alone. The primary outcome was cephalic presentation at birth. Women were recruited at health centres in primary healthcare. Results In the true moxibustion group, 58.1% of the full-term presentations were cephalic compared with 43.4% in the sham moxibustion group (RR 1.34, 95% CI 1.05 to 1.70) and 44.8% of those in the usual care group (RR 1.29, 95% CI 1.02 to 1.64). The reduction in RR of the primary outcome in women allocated to the true moxibustion group compared with the usual care group was 29.7% (95% CI 3.1% to 55.2%) and the number needed to treat was 8 (95% CI 4 to 72). There were no severe adverse effects during the treatment. Conclusions Moxibustion at acupuncture point BL67 is effective and safe to correct non-vertex presentation when used between 33 and 35 weeks of gestation. We believe that moxibustion represents a treatment option that should be considered to achieve version of the non-vertex fetus. Trial Registration Current Controlled Trials ISRCTN10634508.

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Impact of pharmacist-led care on glycaemic control of patients with uncontrolled type 2 diabetes: a randomised controlled trial in Nigeria

Pharmacy Practice ◽

10.18549/pharmpract.2021.3.2402 ◽

2021 ◽

Vol 19 (3) ◽

pp. 2402

Author(s):

Emmanuel A. David ◽

Rebecca O. Soremekun ◽

Isaac O. Abah ◽

Roseline I. Aderemi-Williams

Keyword(s):

Type 2 Diabetes ◽

Glycaemic Control ◽

Usual Care ◽

Usual Care Group ◽

Intervention Group ◽

Glycated Haemoglobin ◽

Care Group ◽

Laboratory Parameters ◽

Randomised Controlled

Background: Diabetes mellitus is a chronic, degenerative disease, requiring a multi-dimensional, multi-professional care by healthcare providers and substantial self-care by the patients, to achieve treatment goals. Objective: To evaluate the impact of pharmacist-led care on glycaemic control in patients with uncontrolled Type 2 Diabetes Methods: In a parallel group, single-blind randomised controlled study; type 2 diabetic patients, with greater than 7% glycated haemoglobin (A1C) were randomised into intervention and usual care groups and followed for six months. Glycated haemoglobin analyzer, lipid analyzer and blood pressure monitor/apparatus were used to measure patients’ laboratory parameters at baseline and six months. Intervention group patients received pharmacist-structured care, made up of patient education and phone calls, in addition to usual care. In an intention to treat analysis, Mann-Whitney U test was used to compare median change at six months in the primary (A1C) and secondary outcome measures. Effect size was computed and proportion of patients that reached target laboratory parameters were compared in both arms. Results: All enrolled participants (108) completed the study, 54 in each arm. Mean age was 51 (SD 11.75) and majority were females (68.5%). Participants in the intervention group had significant reduction in A1C of -0.75%, compared with an increase of 0.15% in the usual care group (p<0.001; eta-square= 0.144). The proportion of those that achieved target A1C of <7% at 6 months in the intervention and usual care group was 42.6% vs 20.8% (p=0.02). Furthermore, intervention patients were about 3 times more likely to have better glucose control; A1C<7% (aOR 2.72, 95%CI: 1.14-6.46) compared to usual care group, adjusted for sex, age, and duration of diabetes. Conclusions: Pharmacist-led care significantly improved glycaemic control in patients with uncontrolled T2DM.

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Opportunistic screening versus usual care for detection of atrial fibrillation in primary care: cluster randomised controlled trial

BMJ ◽

10.1136/bmj.m3208 ◽

2020 ◽

pp. m3208

Author(s):

Steven B Uittenbogaart ◽

Nicole Verbiest-van Gurp ◽

Wim A M Lucassen ◽

Bjorn Winkens ◽

Mark Nielen ◽

...

Keyword(s):

Atrial Fibrillation ◽

Primary Care ◽

Usual Care ◽

Controlled Trial ◽

Cluster Randomised Controlled Trial ◽

Care Group ◽

Opportunistic Screening ◽

Cluster Randomised ◽

Care Practices ◽

Randomised Controlled

AbstractObjectiveTo investigate whether opportunistic screening in primary care increases the detection of atrial fibrillation compared with usual care.DesignCluster randomised controlled trial.Setting47 intention-to-screen and 49 usual care primary care practices in the Netherlands, not blinded for allocation; the study was carried out from September 2015 to August 2018.ParticipantsIn each practice, a fixed sample of 200 eligible patients, aged 65 or older, with no known history of atrial fibrillation in the electronic medical record system, were randomly selected. In the intention-to-screen group, 9218 patients eligible for screening were included, 55.0% women, mean age 75.2 years. In the usual care group, 9526 patients were eligible for screening, 54.3% women, mean age 75.0 years.InterventionsOpportunistic screening (that is, screening in patients visiting their general practice) consisted of three index tests: pulse palpation, electronic blood pressure measurement with an atrial fibrillation algorithm, and electrocardiography (ECG) with a handheld single lead electrocardiographic device. The reference standard was 12 lead ECG, performed in patients with at least one positive index test and in a sample of patients (10%) with three negative tests. If 12 lead ECG showed no atrial fibrillation, patients were invited for more screening by continuous monitoring with a Holter electrocardiograph for two weeks.Main outcome measuresDifference in the detection rate of newly diagnosed atrial fibrillation over one year in intention-to-screen versus usual care practices.ResultsFollow-up was complete for 8874 patients in the intention-to-screen practices and for 9102 patients in the usual care practices. 144 (1.62%) new diagnoses of atrial fibrillation in the intention-to-screen group versus 139 (1.53%) in the usual care group were found (adjusted odds ratio 1.06 (95% confidence interval 0.84 to 1.35)). Of 9218 eligible patients in the intention-to-screen group, 4106 (44.5%) participated in the screening protocol. In these patients, 12 lead ECG detected newly diagnosed atrial fibrillation in 26 patients (0.63%). In the 266 patients who continued with Holter monitoring, four more diagnoses of atrial fibrillation were found.ConclusionsOpportunistic screening for atrial fibrillation in primary care patients, aged 65 and over, did not increase the detection rate of atrial fibrillation, which implies that opportunistic screening for atrial fibrillation is not useful in this setting.Trial registrationNetherlands Trial Register No NL4776 (old NTR4914).

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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

BMJ ◽

10.1136/bmj-2021-066952 ◽

2021 ◽

pp. e066952

Author(s):

Annette Mollerup ◽

Marius Henriksen ◽

Sofus Christian Larsen ◽

Anita Selmer Bennetzen ◽

Mette Kildevæld Simonsen ◽

...

Keyword(s):

Randomised Controlled Trial ◽

Usual Care ◽

Symptom Severity ◽

Controlled Trial ◽

Self Care ◽

Community Dwelling ◽

Care Group ◽

Open Label ◽

Secondary Outcomes ◽

Randomised Controlled

Abstract 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 .

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