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A prospective pilot study of home monitoring in adults with cystic fibrosis (HOME-CF): protocol for a randomised controlled trial.

ABSTRACT: Home monitoring has the potential to detect early pulmonary exacerbations in people with cystic fibrosis (CF), with consequent improvements in health outcomes and healthcare associated costs. This study aims to assess the effects of home monitoring on hospital admissions, quality of life, antibiotic requirements, exacerbation frequency, lung function, nutritional outcomes, anxiety, depression, costs and health outcomes, as well as the qualitative effects on the patient experience.This randomised controlled mixed-methods trial aims to recruit 100 adults with CF cared for in one large regional CF centre. Participants are randomly allocated 1:1 to the intervention group (twice-weekly home monitoring of symptoms measured by the Cystic Fibrosis Respiratory Symptom Diary - Chronic Respiratory Infection Symptom Score (CFRSD-CRISS) and Forced Expiratory Volume in one second (FEV1)) or a control group (routine clinical care) for the 12-month study period. Measurements are recorded at study visits at baseline, 3, 6, 9 and 12 months. Spirometry, body weight, co-morbidities, medications, hospital inpatient days, courses of antibiotics (oral and intravenous), pulmonary exacerbations (defined by the modified Fuchs criteria) are recorded at each study visit. Health status, capability and health economics are measured at each study visit by the Hospital Anxiety and Depression Scale (HADS), the ICEpop CAPability measure for Adults (ICECAP-A), EuroQol 5 dimensions (EQ-5D-5L) questionnaire and an adapted resource use questionnaire. The patient experience is assessed by semi-structured qualitative interviews at baseline and 12 months.Results from this study will help to determine the effect of home monitoring on inpatient bed days and quality of life in adults with CF, as well as other relevant health and health economic outcomes.This study protocol is registered with Clinicaltrials.gov ( NCT02994706 ), date registered 16th July 2014.

SUBMITTER: Choyce J

PROVIDER: S-EPMC5256574 | biostudies-literature | 2017 Jan

REPOSITORIES: biostudies-literature

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A prospective pilot study of home monitoring in adults with cystic fibrosis (HOME-CF): protocol for a randomised controlled trial.

Choyce Jocelyn J Shaw Karen L KL Sitch Alice J AJ Mistry Hema H Whitehouse Joanna L JL Nash Edward F EF

BMC pulmonary medicine 20170123 1

<h4>Background</h4>Home monitoring has the potential to detect early pulmonary exacerbations in people with cystic fibrosis (CF), with consequent improvements in health outcomes and healthcare associated costs. This study aims to assess the effects of home monitoring on hospital admissions, quality of life, antibiotic requirements, exacerbation frequency, lung function, nutritional outcomes, anxiety, depression, costs and health outcomes, as well as the qualitative effects on the patient experie ...[more]

PMID: 28114922

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Project description:BackgroundDespite evidence of exercise benefits to lung function, adherence to routine exercise in adults with cystic fibrosis (CF) is low. The incorporation of interactive virtual reality video exergame activities in home-based programs as an incentive may help improve motivation and adherence to exercise. This proposed study will attempt to improve the physical fitness and respiratory function of sedentary adults with CF by engaging them in a Nintendo Wii Fit Plus™ home-based exercise program.MethodsA single group pretest-posttest design will be used to examine the immediate (12-weeks) and long-term effect (24-weeks) of a home-based exergame program on improving pulmonary-related function (physical fitness and respiratory function) in sedentary adults with CF. Participants will receive a one-time orientation to the Wii Fit Plus, and will be requested to use it to exercise according to the recommended guidelines 3 times a week for 30 min in the following 24 weeks. Monthly phone monitoring will be conducted during the first 12 weeks. Besides evaluating the efficacy of a home-based exergame program on improving aerobic capacity, physical activity, and respiratory-related symptoms, we will examine the impact of the exergame on airway ion transport as measured by nasal potential difference, which will be collected at baseline and at the end of 12-weeks only.DiscussionThis is the first study to evaluate the feasibility, acceptability and potential effectiveness of a low-cost exercise avenue (i.e., exergames) for adults with CF to improve their pulmonary-related function, which is important for CF disease management and prevention of complications. In addition, the proposed study will be the first to investigate the therapeutic efficacy of home-based exergames on airway ion transport among adults with CF. Through an increase in physical activity, it is expected that participants will improve their physical fitness and respiratory function at the end of the study.Trial registrationClinicalTrials.gov ID: NCT02277860.

Project description:BackgroundLung disease as major cause for morbidity in patients with cystic fibrosis (CF) starts early in life. Its large phenotypic heterogeneity is partially explained by the genotype but other contributing factors are not well delineated. The close relationship between mucus, inflammation and infection, drives morpho-functional alterations already early in pediatric CF disease, The TRACK-CF cohort has been established to gain insight to disease onset and progression, assessed by lung function testing and imaging to capture morpho-functional changes and to associate these with risk and protective factors, which contribute to the variation of the CF lung disease progression.Methods and designTRACK-CF is a prospective, longitudinal, observational cohort study following patients with CF from newborn screening or clinical diagnosis throughout childhood. The study protocol includes monthly telephone interviews, quarterly visits with microbiological sampling and multiple-breath washout and as well as a yearly chest magnetic resonance imaging. A parallel biobank has been set up to enable the translation from the deeply phenotyped cohort to the validation of relevant biomarkers. The main goal is to determine influencing factors by the combined analysis of clinical information and biomaterials. Primary endpoints are the lung clearance index by multiple breath washout and semi-quantitative magnetic resonance imaging scores. The frequency of pulmonary exacerbations, infection with pro-inflammatory pathogens and anthropometric data are defined as secondary endpoints.DiscussionThis extensive cohort includes children after diagnosis with comprehensive monitoring throughout childhood. The unique composition and the use of validated, sensitive methods with the attached biobank bears the potential to decisively advance the understanding of early CF lung disease.Ethics and trial registrationThe study protocol was approved by the Ethics Committees of the University of Heidelberg (approval S-211/2011) and each participating site and is registered at clinicaltrials.gov (NCT02270476).

Project description:Background: Physical activity (PA) and exercise are widely documented as key components in the management of cystic fibrosis (CF). In recent years there have been significant improvements in telehealth, in particular; wearable technology, smartphone use and remote monitoring, all of which may have potential to impact on PA in adults with CF. The objective of this pilot randomised trial is to explore the effect of wearable technology, which is remotely monitored, combined with personalised text message feedback and goal setting, on PA in adults with CF. Secondary endpoints include lung function, aerobic capacity, quality of life, body composition, wellbeing and sleep. Methods: This is a pilot randomised trial which will be conducted at the University Hospital Limerick, Ireland. Participants will be randomised to the intervention or active comparator after their baseline assessment. The 12-week intervention will consist of wearable technology (Fitbit Charge 2) which is linked to an online monitoring system (Fitabase) that enables the physiotherapist to remotely monitor participant data. The CF physiotherapist will set individualised PA goals with each participant at baseline and will send text message feedback each week. The text messages will be personalised, one-way texts with positive reinforcement on step count attained by the participant. The active comparator group will receive this wearable technology which is also linked to Fitabase; however, no feedback will be provided to participants in this group. Both groups will be re-assessed at 12 weeks. After this point, both groups will continue with the Fitbit alone for a further 12 weeks. Both groups will be re-assessed at 24 weeks. A semi structured interview will assess satisfaction and acceptability of the intervention. Discussion: This is a novel concept which utilises modern technology, remote monitoring and personalised feedback to investigate the effect on PA in adults with CF. Trial registration: ClinicalTrials.gov NCT03672058 (14/09/2018).

Project description:BACKGROUND:Physical activity (PA) and exercise have become an accepted and valued component of cystic fibrosis (CF) care. Regular PA and exercise can positively impact pulmonary function, improve physical fitness, and enhance health-related quality of life (HRQoL). However, motivating people to be more active is challenging. Supervised exercise programs are expensive and labour intensive, and adherence falls off significantly once supervision ends. Unsupervised or partially supervised programs are less costly and more flexible, but compliance can be more problematic. The primary objective of this study is to evaluate the effects of a partially supervised exercise intervention along with regular motivation on forced expiratory volume in 1 s (FEV1) at 6 months in a large international group of CF patients. Secondary endpoints include patient reported HRQoL, as well as levels of anxiety and depression, and control of blood sugar. METHODS/DESIGN:It is planned that a total of 292 patients with CF 12 years and older with a FEV1 ≥ 35% predicted shall be randomised. Following baseline assessments (2 visits) patients are randomised into an intervention and a control group. Thereafter, they will be seen every 3 months for assessments in their centre for one year (4 follow-up visits). Along with individual counselling to increase vigorous PA by at least 3 h per week on each clinic visit, the intervention group documents daily PA and inactivity time and receives a step counter to record their progress within a web-based diary. They also receive monthly phone calls from the study staff during the first 6 months of the study. After 6 months, they continue with the step counter and web-based programme for a further 6 months. The control group receives standard care and keeps their PA level constant during the study period. Thereafter, they receive the intervention as well. DISCUSSION:This is the first large, international multi-centre study to investigate the effects of a PA intervention in CF with motivational feedback on several health outcomes using modern technology. Should this relatively simple programme prove successful, it will be made available on a wider scale internationally. TRIAL REGISTRATION:ClinicalTrials.gov Identifier: NCT01744561 ; Registration date: December 6, 2012.

Project description:IntroductionIn people with cystic fibrosis (CF), exacerbations have been shown to have profound and prolonged negative effects such as reducing physical activity and health-related quality of life, increasing the rate of decline of lung function and healthcare costs, and ultimately increasing the risk of mortality. Delayed initiation of treatment following the signs of an exacerbation has been shown to be associated with failure to recover to baseline. Therefore, the late identification and treatment of an exacerbation due to delayed presentation will potentially worsen short-term and long-term outcomes. We have developed a smartphone application, containing questions which require yes or no responses relating to symptoms suggestive of a respiratory exacerbation. Its use is intended to facilitate the early identification of symptoms suggestive of a respiratory exacerbation, and allow the CF team to initiate treatment sooner, thereby potentially reducing the risk of severe exacerbations which require intravenous antibiotics (IVAB) and often a hospital admission.MethodsWe will undertake a randomised controlled trial. 60 adults with CF will be recruited and randomised to either the intervention or control group. The intervention group will use the smartphone application weekly for 12 months, or earlier than the next weekly reporting time if they feel their symptoms have worsened. The control group will continue to receive usual care, involving regular (approximately 3 monthly) CF outpatient clinic appointments. The primary outcome measure will be courses and days of IVAB.Ethics and disseminationApproval was obtained from the Sir Charles Gairdner Group Human Research Ethics Committee for WA Health (2015-030) and Curtin University Human Research Ethics Committee (HR212/2015), and has been registered with the Australian and New Zealand Clinical Trials Registry. Results of this study will be presented at international conferences and published in peer-reviewed journals in accordance with the Consolidated Standards of Reporting Trials statement.Trial registration numberACTRN12615000599572.

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A prospective pilot study of home monitoring in adults with cystic fibrosis (HOME-CF): protocol for a randomised controlled trial.

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A prospective pilot study of home monitoring in adults with cystic fibrosis (HOME-CF): protocol for a randomised controlled trial.

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