The COVID-OR Study: 1 year Observation of Recovery from critical illness following COVID-19 and feasibility of smartwatch assisted rehabilitation. (Preprint)

2021 ◽  
Author(s):  
Alex Hunter ◽  
Todd Leckie ◽  
Oliver Coe ◽  
Benjamin Hardy ◽  
Daniel Fitzpatrick ◽  
...  
Keyword(s):  
Critical Care ◽  
Critical Illness ◽  
Controlled Trial ◽  
Step Count ◽  
Control Group ◽  
Feedback Questionnaire ◽  
Critical Care Admission ◽  
Steps Per Day ◽  
One Year ◽  
Randomised Controlled

BACKGROUND As a sequelae of the COVID-19 pandemic, a large cohort of critical illness survivors have had to recover in the context of ongoing societal restrictions. OBJECTIVE To observe the recovery of survivors of critical care admission with COVID-19 using smartwatches, evaluate how these devices enabled a remote multidisciplinary team (MDT) to support patient recovery, and assess the usability of these devices. METHODS A prospective multi-centre observational trial in eight UK critical care units. 50 participants with moderate or severe lung injury as a result of confirmed COVID-19 disease were recruited at discharge from critical care and given a smartwatch (Fitbit Charge 3). Data collected included step count and daily resting heart rate (HR). A subgroup, the ‘MDT site’ (n=19), had their smartwatch data used to inform a regular MDT meeting. Devices were evaluated by use of a patient feedback questionnaire and direct feedback from the MDT. Participants that did not upload smartwatch data were excluded from analysis. RESULTS From the overall cohort, 35 (70%) participants used and uploaded data from their smartwatch during the 1 year period. 14 users uploaded data from the MDT site. The overall cohort recorded a mean increase of 4359 (±3488) steps per day in the first month following discharge, to 7914(±4146) steps at 1 year (p<0.01). HR reduced from a mean of 79 (7) beats per minute in the first month to 69 (4) at one year following discharge (p<0.01)). The MDT subgroup increased mean step count by more than the control group (176 vs 42%, p=0.04) over the 1 year. 94% of fitbit users found their smartwatch easy to use and 80% felt that the technology helped and motivated them to recover. CONCLUSIONS This is the first study to report 1-year recovery of patients who survived COVID-19 critical illness using smartwatch technology. Future work could explore the role of smartwatches as part of a randomised controlled trial to assess clinical and economic effectiveness. INTERNATIONAL REGISTERED REPORT RR2-https://doi.org/10.12968/ijtr.2020.0102

scholarly journals Steps that count! A feasibility study of a pedometer-based, health-promotion intervention in an employed, South African population

2014 ◽  
Vol 26 (1) ◽  
pp. 15
Author(s):  
Julian David Pillay ◽  
Tracy Lynn Kolbe-Alexander ◽  
Karin I Proper ◽  
Willem Van Mechelen ◽  
Estelle Victoria Lambert
Keyword(s):  
Controlled Trial ◽  
Intervention Group ◽  
Sitting Time ◽  
Control Group ◽  
Daily Routine ◽  
Loss To Follow Up ◽  
Motivational Messages ◽  
Feedback Questionnaire ◽  
Steps Per Day ◽  
Randomised Controlled

Background. The emergence of the pedometer as a useful motivational aid for increasing physical activity (PA) has supported its use in PA interventions. Objectives. To examine the feasibility of a 10-week pedometer-based intervention complemented by regular motivational messages, to increase ambulatory PA; and to determine the minimum sample size required for a randomised, controlled trial (RCT). Methods. Participants, sourced by convenience sampling of employees from an academic institution, were randomly assigned to either an intervention group (IG) (n=11) or control group (CG) (n=11), following baseline health measurements and blinded pedometer wear (week 1). Participants in the IG subsequently wore an unblinded pedometer (10 weeks) to self-monitor daily steps. Individualised messages using pedometer data (IG) and general motivational messages (IG and CG) were provided bi-weekly. Blinded pedometer wear (IG and CG) and a feedback questionnaire (IG) were completed at week 12. Pedometer data were compared between the IG and CG at week 12. Results. Participants’ perceptions of the intervention supported the benefit of the pedometer as a useful motivational aid and a reminder to increase steps per day. Occupational sitting time and inability to incorporate PA into daily routine emerged as the main barrier to adherence. Steps per day increased more in the IG (mean ± standard deviation (SD) 996±1 748) than in the CG (mean±SD 97±750). Modest improvements were noted in all clinical measures (IG). Conclusion. Based on the improvement of 1 000 steps/day (IG), a minimum of 85 participants in the IG and CG, respectively, is required for a future RCT (80% power; p<0.05). We recommend a minimum of 150 participants in each group to account for loss to follow-up and to allow for subgroup analyses.

A Controlled Trial of Home-Based Acute Psychiatric Services

1993 ◽  
Vol 163 (1) ◽  
pp. 49-54 ◽  
Author(s):  
Tom Burns ◽  
Alan Beadsmoore ◽  
Ashok V. Bhat ◽  
Andrew Oliver ◽  
Carola Mathers
Keyword(s):  
Controlled Trial ◽  
Controlled Study ◽  
Control Group ◽  
Community Based ◽  
Home Based ◽  
Randomised Controlled Study ◽  
One Year ◽  
Randomised Controlled ◽  
Clinical Measures ◽  
Experimental Group

While research has shown community-based psychiatric care to be as good as, or better than, hospital-based care, generalisation to clinical practice has been difficult. This prospective, randomised controlled study examined a community-based approach feasible within NHS conditions. Ninety-four patients were randomly allocated to experimental and 78 to control treatments and followed for one year. The groups were well matched apart from an excess of psychotic control patients. No differences in clinical or social functioning outcome were found. Both groups improved substantially on clinical measures in the first six weeks, with some slow consolidation thereafter. There were three suicides in the control group and one in the experimental group. Access to care was better in the experimental group (93% attended assessment) than in the control group (75% attended assessment).

scholarly journals Twelve month follow-up on a randomised controlled trial of relaxation training for post-stroke anxiety

2016 ◽  
Vol 31 (9) ◽  
pp. 1164-1167 ◽  
Author(s):  
Katherine Golding ◽  
Chris Fife-Schaw ◽  
Ian Kneebone
Keyword(s):  
Randomised Controlled Trial ◽  
Relaxation Training ◽  
Controlled Trial ◽  
Depression Scale ◽  
Control Group ◽  
Autogenic Relaxation ◽  
One Year ◽  
Randomised Controlled ◽  
Anxiety Subscale

Objective: To follow up participants in a randomised controlled trial of relaxation training for anxiety after stroke at 12 months. Design: Twelve month follow-up to a randomised controlled trial, in which the control group also received treatment. Setting: Community. Participants: Fifteen of twenty one original participants with post-stroke anxiety participated in a one year follow-up study. Interventions: A self-help autogenic relaxation CD listened to five times a week for one month, immediately in the intervention group and after three months in the control group. Main measures: Hospital Anxiety and Depression Scale-Anxiety subscale and the Telephone Interview of Cognitive Status for inclusion. Hospital Anxiety and Depression Scale-Anxiety subscale for outcome. All measures were administered by phone. Results: Anxiety ratings reduced significantly between pre and post-intervention, and between pre-intervention and one year follow-up ( χ2(2) = 22.29, p < 0.001). Conclusions: Reductions in anxiety in stroke survivors who received a self-help autogenic relaxation CD appear to be maintained after one year.

Comparing audiometric parameters between crushed and intact cartilage tympanoplasty: a double-blinded, randomised, controlled trial study

2020 ◽  
pp. 1-5
Author(s):  
A Tajdini ◽  
N Hatami ◽  
B Rahmaty ◽  
A Kouhi ◽  
S Dabiri ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Hearing Results ◽  
Cartilage Tympanoplasty ◽  
One Year ◽  
Randomised Controlled ◽  
Double Blinded

Abstract Objective To investigate hearing and the take rate of crushed cartilage grafts in tympanoplasty. Methods In this double-blinded, randomised, controlled trial, 46 patients with tympanic membrane perforation were enrolled. A conchal cartilage graft was used for reconstruction in both intervention and control groups. In the intervention group, crushed cartilage was used. The success rate and hearing results were ascertained every four months over a one-year follow-up period. Results A total of 36 patients – 20 in the intervention group and 16 in the control group – completed one year of follow up. There were no statistically significant differences between the two groups in mean air–bone gap, bone conduction threshold, speech discrimination score or speech reception threshold. Conclusion The reduction in living cells after crushed cartilage tympanoplasty may decrease the rigidity and the volume of the graft, but may not necessarily improve the hearing results.

A Randomised Controlled Trial of Psychotherapy in Patients with Refractory Irritable Bowel Syndrome

1993 ◽  
Vol 163 (3) ◽  
pp. 315-321 ◽  
Author(s):  
Elspeth Guthrie ◽  
Francis Creed ◽  
David Dawson ◽  
Barbara Tomenson
Keyword(s):  
Irritable Bowel Syndrome ◽  
Randomised Controlled Trial ◽  
Psychological Symptoms ◽  
Controlled Trial ◽  
Control Group ◽  
Psychological Assessments ◽  
Irritable Bowel ◽  
One Year ◽  
Randomised Controlled

Patients with chronic, refractory irritable bowel syndrome (n =102) were entered into a randomised controlled trial of psychotherapy versus supportive listening. Independent physical and psychological assessments were carried out at the beginning and end of the 12-week trial. For women, psychotherapy was found to be superior to supportive listening, in terms of an improvement in both physical and psychological symptoms. There was a similar trend for men, but this did not reach significance. Following completion of the trial, patients in the control group were offered psychotherapy; 33 accepted and following treatment experienced a marked improvement in their symptoms; ten declined. At follow-up one year later, those patients who had received psychotherapy remained well, patients who had dropped out of the trial were unwell with severe symptoms, and most of the controls who declined psychotherapy had relapsed. This study shows that psychotherapy is feasible and effective in the majority of irritable bowel syndrome patients with chronic symptoms unresponsive to medical treatment.

Effectiveness of Child to Parent Communication Using Information Package on Food Hygiene

2018 ◽  
Vol 3 (07) ◽  
Author(s):  
Ms. Sonam Yangchen Bhutia ◽  
Dr. Sushma Kumari Saini ◽  
Dr. Manmeet Kaur ◽  
Dr. Sandhya Ghai
Keyword(s):  
School Children ◽  
Home Visit ◽  
Controlled Trial ◽  
Family Members ◽  
Sampling Technique ◽  
Control Group ◽  
Food Hygiene ◽  
Parent Communication ◽  
Post Test ◽  
Randomised Controlled

School children can act as change agent not only for families but for community. The study aimed to assess effectiveness of information package on knowledge and practices of parents/family members of school children studying in Govt. Sr. Sec. School on food hygiene in Dhanas and Daddu Majra Colony, UT, Chandigarh. A non-randomised controlled trial was conducted on 201 school children studying in VIIth standard and their parents/family members. Purposive sampling technique was utilised to enrol 101 in case and 100 participants in control group. Interview schedule for knowledge assessment and observation checklist for assessing the practices of parents/ family members was used. Pre assessment of both the groups was done by a home visit. Experimental group school children were educated on food hygiene as per the protocol. Pre and post-test knowledge of school children on food hygiene was assessed and were asked to disseminate the information to their parents/family members.  After 15 days, second time home visit was done to the parents/family members of both the groups for the post assessment of knowledge and practices. Significant improvement in knowledge and practices of parents/family members related to food hygiene was observed. Hence, school children can be an effective tool in health related knowledge dissemination which can further promote healthy practices.

scholarly journals Anti-adhesion Gel versus No gel following Operative Hysteroscopy prior to Subsequent fertility Treatment or timed InterCourse (AGNOHSTIC), a randomised controlled trial: protocol

2021 ◽  
Vol 2021 (1) ◽  
Author(s):  
S van Wessel ◽  
T Hamerlynck ◽  
V Schutyser ◽  
C Tomassetti ◽  
C Wyns ◽  
...  
Keyword(s):  
Live Birth ◽  
Financial Support ◽  
Controlled Trial ◽  
Reproductive Age ◽  
Fertility Treatment ◽  
Control Group ◽  
Women Of Reproductive Age ◽  
Operative Hysteroscopy ◽  
Randomised Controlled

Abstract STUDY QUESTIONS Does the application of anti-adhesion gel, compared to no gel, following operative hysteroscopy to treat intrauterine pathology in women wishing to conceive increase the chance of conception leading to live birth? WHAT IS KNOWN ALREADY Intrauterine adhesions (IUAs) following operative hysteroscopy may impair reproductive success in women of reproductive age. Anti-adhesion barrier gels may decrease the occurrence of IUAs, but the evidence on their effectiveness to improve reproductive outcomes is sparse and of low quality. STUDY DESIGN, SIZE, DURATION This multicentre, parallel group, superiority, blinded and pragmatic randomised controlled trial is being carried out in seven participating centres in Belgium. Recruitment started in April 2019. Women will be randomly allocated to treatment with anti-adhesion gel (intervention group) or no gel (control group). Sterile ultrasound gel will be applied into the vagina as a mock-procedure in both treatment arms. The patient, fertility physician and gynaecologist performing the second-look hysteroscopy are unaware of the allocated treatment. Power analysis, based on a target improvement of 15% in conception leading to live birth using anti-adhesion gel, a power of 85%, a significance level of 5%, and a drop-out rate of 10%, yielded a number of 444 patients to be randomised. The baseline rate of conception leading to live birth in the control group is expected to be 45%. PARTICIPANTS/MATERIALS, SETTING, METHODS Women of reproductive age (18–47 years), wishing to conceive (spontaneously or by fertility treatment) and scheduled for operative hysteroscopy to treat intrauterine pathology (endometrial polyps, myomas with uterine cavity deformation, uterine septa, IUAs or retained products of conception) are eligible for recruitment. Women may try to conceive from 3 to 6 weeks after receiving allocated treatment with follow-up ending at 30 weeks after treatment. If the woman fails to conceive within this timeframe, a second-look hysteroscopy will be scheduled within 2–6 weeks to check for IUAs. The primary endpoint is conception leading to live birth, measured at 30 weeks after randomisation. The secondary endpoints are time to conception, clinical pregnancy, miscarriage and ectopic pregnancy rates, measured at 30 weeks after receiving allocated treatment. The long-term follow-up starts when the patient is pregnant and she will be contacted every trimester. STUDY FUNDING/COMPETING INTEREST(S) This work is funded by the Belgian Healthcare Knowledge Centre (KCE). The anti-adhesion gel is supplied at no cost by Nordic Pharma and without conditions. Dr. Tomassetti reports grants and non-financial support from Merck SA, non-financial support from Ferring SA, personal fees and non-financial support from Gedeon-Richter, outside the submitted work. None of the other authors have a conflict of interest.

scholarly journals Supported progressive resistance exercise training to counter the adverse side effects of robot-assisted radical prostatectomy: a randomised controlled trial

2021 ◽  
Author(s):  
Ruth E. Ashton ◽  
Jonathan J. Aning ◽  
Garry A. Tew ◽  
Wendy A Robson ◽  
John M Saxton
Keyword(s):  
Randomised Controlled Trial ◽  
Radical Prostatectomy ◽  
Muscular Strength ◽  
Controlled Trial ◽  
Control Group ◽  
Robot Assisted ◽  
Resistance Exercise Training ◽  
Home Based ◽  
Aerobic Exercise Capacity ◽  
Randomised Controlled

Abstract Purpose To investigate the effects of a supported home-based progressive resistance exercise training (RET) programme on indices of cardiovascular health, muscular strength and health-related quality of life (HR-QoL) in prostate cancer (PCa) patients after treatment with robot-assisted radical prostatectomy (RARP). Methods This study was a single-site, two-arm randomised controlled trial, with 40 participants randomised to either the intervention or control group over a 10-month period. In addition to receiving usual care, the intervention group completed three weekly RET sessions using resistance bands for 6 months. Participants performed 3 sets of 12–15 repetitions for each exercise, targeting each major muscle group. The control group received usual care only. Brachial artery flow-mediated dilatation (FMD) was the primary outcome and assessed at baseline, 3 and 6 months. Secondary outcomes included body weight, body fat, aerobic fitness, strength and blood-borne biomarkers associated with cardiometabolic risk. Results There was no significant difference between the groups in FMD at 3 or 6 months. However, there were improvements in aerobic exercise capacity (P < 0.01) and upper- (P < 0.01) and lower-limb (P = 0.01) strength in favour of the RET group at 6 months, accompanied by greater weight loss (P = 0.04) and a reduction in body fat (P = 0.02). Improvements in HRQoL were evident in the RET group at 3 and 6 months via the PCa-specific component of the FACT-P questionnaire (both P < 0.01). Five adverse events and one serious adverse event were reported throughout the trial duration. Conclusion This study demonstrates that home-based RET is an effective and safe mode of exercise that elicits beneficial effects on aerobic exercise capacity, muscular strength and HR-QoL in men who have undergone RARP. Trial registration ISRCTN10490647.

scholarly journals Nurse-based secondary preventive follow-up by telephone reduced recurrence of cardiovascular events: a randomised controlled trial

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Anna-Lotta Irewall ◽  
Anders Ulvenstam ◽  
Anna Graipe ◽  
Joachim Ögren ◽  
Thomas Mooe
Keyword(s):  
Randomised Controlled Trial ◽  
Primary Endpoint ◽  
Cardiovascular Events ◽  
Controlled Trial ◽  
Control Group ◽  
Coronary Syndrome ◽  
Secondary Endpoints ◽  
Randomised Controlled

AbstractEnhanced follow-up is needed to improve the results of secondary preventive care in patients with established cardiovascular disease. We examined the effect of long-term, nurse-based, secondary preventive follow-up by telephone on the recurrence of cardiovascular events. Open, randomised, controlled trial with two parallel groups. Between 1 January 2010 and 31 December 2014, consecutive patients (n = 1890) admitted to hospital due to stroke, transient ischaemic attack (TIA), or acute coronary syndrome (ACS) were included. Participants were randomised (1:1) to nurse-based telephone follow-up (intervention, n = 944) or usual care (control, n = 946) and followed until 31 December 2017. The primary endpoint was a composite of stroke, myocardial infarction, cardiac revascularisation, and cardiovascular death. The individual components of the primary endpoint, TIA, and all-cause mortality were analysed as secondary endpoints. The assessment of outcome events was blinded to study group assignment. After a mean follow-up of 4.5 years, 22.7% (n = 214) of patients in the intervention group and 27.1% (n = 256) in the control group reached the primary composite endpoint (HR 0.81, 95% CI 0.68–0.97; ARR 4.4%, 95% CI 0.5–8.3). Secondary endpoints did not differ significantly between groups. Nurse-based secondary preventive follow-up by telephone reduced the recurrence of cardiovascular events during long-term follow-up.

scholarly journals A Short Mindfulness Retreat for Students to Reduce Stress and Promote Self-Compassion: Pilot Randomised Controlled Trial Exploring Both an Indoor and a Natural Outdoor Retreat Setting

Healthcare ◽  
2021 ◽  
Vol 9 (7) ◽  
pp. 910
Author(s):  
Dorthe Djernis ◽  
Mia S. O’Toole ◽  
Lone O. Fjorback ◽  
Helle Svenningsen ◽  
Mimi Y. Mehlsen ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Effect Sizes ◽  
Medium Effect ◽  
Control Group ◽  
Post Intervention ◽  
Pilot Randomised Controlled Trial ◽  
Self Compassion ◽  
Randomised Controlled

Here, we developed and examined a new way of disseminating mindfulness in nature to people without meditation experience, based on the finding that mindfulness conducted in natural settings may have added benefits. We evaluated a 5-day residential programme aiming to reduce stress and improve mental health outcomes. We compared an indoor and an outdoor version of the programme to a control group in a pilot randomised controlled trial (RCT). Sixty Danish university students experiencing moderate to high levels of stress were randomised into a residential mindfulness programme indoors (n = 20), in nature (n = 22), or a control group (n = 18). Participants completed the Perceived Stress Scale and the Self-Compassion Scale (primary outcomes) along with additional secondary outcome measures at the start and end of the program and 3 months after. Stress was decreased with small to medium effect sizes post-intervention, although not statistically significant. Self-compassion increased post-intervention, but effect sizes were small and not significant. At follow-up, changes in stress were not significant, however self-compassion increased for both interventions with medium-sized effects. For the intervention groups, medium- to large-sized positive effects on trait mindfulness after a behavioural task were found post-intervention, and small- to medium-sized effects in self-reported mindfulness were seen at follow-up. Connectedness to Nature was the only outcome measure with an incremental effect in nature, exceeding the control with a medium-sized effect at follow-up. All participants in the nature arm completed the intervention, and so did 97% of the participants in all three arms. Overall, the results encourage the conduct of a larger-scale RCT, but only after adjusting some elements of the programme to better fit and take advantage of the potential benefits of the natural environment.

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