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Protocol for a feasibility randomized trial of self-management support for people with chronic obstructive pulmonary disease using lay health coaches.

ABSTRACT: Challenges with self-management are a major contributor to poor outcomes among adults with chronic obstructive pulmonary disease (COPD). The causes of poor self-management in COPD are manifold, and they arise from physical, cognitive, socioeconomic, environmental and societal sources. To address this complexity, we developed the Supporting self-Management Behaviors in Adults with COPD (SaMBA-COPD) model, which uses lay health coaches to identify a patient's barriers to effective COPD self-management and provide tailored support to help them overcome those barriers, reduce their symptoms and need for urgent care and improve their quality of life. The 6-month intervention includes referral of patients to a pharmacist for prescription of antibiotic and oral steroid "rescue packs" and support for a structured home exercise routine. All interactions of coaches and patients will take place by telephone or video call. We will test the feasibility and preliminary efficacy of SaMBA-COPD in a trial of 58 patients randomized 1:1 to the intervention or a COPD education control. Outcomes will be assessed at 6 and 9 months. Data from the trial will be used to inform the design of a fully powered, multi-site randomized trial of the intervention.

SUBMITTER: Federman AD

PROVIDER: S-EPMC8595863 | biostudies-literature | 2021 Nov

REPOSITORIES: biostudies-literature

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Protocol for a feasibility randomized trial of self-management support for people with chronic obstructive pulmonary disease using lay health coaches.

Federman Alex D AD Barry Michele M Moas Esther E Davenport Claire C McGeough Christina C Tejeda Marisilis M Rivera Leny L Gutierrez Stacie S Mejias Hilda H Belton Destini D Mathew Cathleen C Lindenauer Peter K PK McDermott Danielle D O'Conor Rachel R Wolf Michael S MS Wisnivesky Juan P JP

Contemporary clinical trials 20210921

Challenges with self-management are a major contributor to poor outcomes among adults with chronic obstructive pulmonary disease (COPD). The causes of poor self-management in COPD are manifold, and they arise from physical, cognitive, socioeconomic, environmental and societal sources. To address this complexity, we developed the Supporting self-Management Behaviors in Adults with COPD (SaMBA-COPD) model, which uses lay health coaches to identify a patient's barriers to effective COPD self-manage ...[more]

PMID: 34560265

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Project description:BackgroundExercise therapy is safe and effective in people with single conditions, but the feasibility in people with two or more conditions is unclear. Therefore, the aim was to evaluate the feasibility of exercise therapy and self-management in people with multimorbidity prior to a randomised, controlled trial (RCT).MethodsThis was a mixed-methods feasibility study performed in two general hospitals and one psychiatric hospital. 20 adult patients (8 females; mean age (SD) 67 (6.9)) with at least two long-term conditions and a score of ≥ 3 on Disease Burden Impact Scale for at least one condition (at least moderate limitations of daily activities) and of ≥ 2 for at least one other condition. Patients with unstable health conditions, at risk of serious adverse events (SAE) or with terminal conditions were excluded. Participants received 12 weeks of exercise (18 60-min group-based and 6 home-based sessions) and self-management support (6 90-min group-based sessions) supervised by physiotherapists. Pre-defined progression to RCT criteria were the primary outcomes and included recruitment rate (acceptable 20 participants in 3 months), retention through follow-up (75% retention), compliance (75% complete > 9 of exercise and > 3 self-management sessions), outcome burden (80% do not find outcomes too burdensome), improvement in quality of life (EQ-5D-5L) and function (6-min walk test; ≥ 50% experience clinically relevant improvements) and intervention-related SAEs (No SAEs). Furthermore, a purposeful sample including eleven participants and two facilitators were interviewed about their experiences of participating/facilitating. Qualitative data was analysed using thematic analysis.ResultsRecruitment rate (20 in 49 days), retention (85%), outcome burden (95%), and SAEs (0 related to intervention) were acceptable, while compliance (70%) and improvements (35% in quality of life, 46% in function) were not (amendment needed before proceeding to RCT). The intervention was found acceptable by both participants and physiotherapists with some barriers among participants relating to managing multiple chronic conditions while caring for others or maintaining a job. Physiotherapists expressed a need for additional training.ConclusionsExercise therapy and self-management are feasible in people with multimorbidity. The subsequent RCT, amending the intervention according to progression criteria and feedback, will determine whether the intervention is superior to usual care alone.Trial registrationClinicalTrials.gov registration: NCT04645732 Open Science Framework https://osf.io/qk6yg/.

Project description:BackgroundLong Covid is recognised as a complex condition characterised by multiple, interacting and fluctuating symptoms which impact everyday life in diverse ways. The extent of symptom clusters and variability supports interventions that can accommodate heterogeneity, such as personalised self-management support. This approach is also advocated by people living with long Covid and guidelines published by the UK's National Institute for Health and Care Excellence. Long Covid Personalised Self-managemenT support co-design and EvaluatioN (LISTEN) is one of 15 research projects funded by the UK's National Institute of Health Research long Covid research programme. LISTEN aims to work with people living with or recovered from long Covid to co-design self-management resources, and a training programme for rehabilitation practitioners to deliver personalised support. The intervention will focus on people not hospitalised for Covid. The protocol presented here details the co-design of the LISTEN intervention which, on completion, will be evaluated in a randomised controlled trial.MethodsThe study will utilise an Accelerated Experience-Based Co-Design approach, and involve 30 people from England and Wales with lived experience of long Covid, and 15 rehabilitation practitioners living with, or supporting people with, long Covid. Through online meetings, participants will share their stories of long Covid, their challenges and strategies to live better with or recover from long Covid, their priorities for self-management resources and the practitioner training andcreate, review and refine these resources and the training. Throughout, LISTEN will draw upon the UK standards of public involvement in research.DiscussionIf effective and cost-effective, the intervention will be available across the UK's National Health Service. The first of its kind, this study could make a difference to the lives of people with long Covid. To ensure impact, we have developed strategies to involve people from diverse backgrounds and mitigate potential barriers to involvement.

Project description:There is evidence to support the use of supplementation with long-chain omega-3 polyunsaturated fatty acids (LCn-3PUFA) from oily fish or fish oil for the treatment of various inflammatory diseases such as rheumatoid arthritis. Chronic obstructive pulmonary disease (COPD) is a progressive, terminal disease characterized by persistent airflow limitation, lung and systemic inflammation. To date, one randomized controlled trial has been published that assessed the efficacy of LCn-3PUFA in people with this condition. The aim of this article is to discuss the feasibility of conducting a trial to evaluate fish oil supplementation as adjunct therapy in people with COPD.A 16-week parallel, double-blind, randomized, placebo-controlled dietary supplementation trial will be evaluated. Forty participants meeting spirometric and clinical criteria for COPD will be recruited from metropolitan Adelaide, South Australia. Participants will be randomized by minimization, based on a score derived from the modified Medical Research Council Scale for breathlessness, to receive 6 g/day of fish oil (approximately 3.6 g/day of LCn-3PUFA), or placebo (6 g/day of corn oil) capsules. Feasibility outcomes (recruitment, retention, supplement adherence, and time lost to exacerbation) and scientific outcomes (effect size and estimates of variance for inflammatory biomarkers, incorporation of LCn-3PUFA into erythrocytes, small airways function, dyspnea and functional exercise capacity) will be assessed pre- and post-intervention. Key feasibility criteria include recruitment of 40 participants in 52 weeks, 75% participant retention rate, 2% increase in the proportion of long-chain omega-3 fatty acids in erythrocytes, and a positive moderate effect size in at least three efficacy measures.There are a number of challenges in designing supplementation intervention studies with this population. These include the lack of prior data from which to select appropriate primary outcomes or to estimate effect sizes, and the feasibility of continuous supplementation in a population characterized by multiple comorbidities and a high likelihood of exacerbations, potentially requiring hospitalization or change in medication. Upon completion of this protocol, feasibility outcomes will guide the direction of future multicentre dietary interventions in this population.Australia and New Zealand Clinical Trials Register (ANZCTR): ACTRN12612000158864.

Project description:IntroductionThe potential for telehealth-based interventions to provide remote support, education and improve self-management for long-term conditions is increasingly recognised. This trial aims to determine whether an intervention delivered through an easy-to-use tablet computer can improve the quality of life of patients with chronic obstructive pulmonary disease (COPD) by providing personalised self-management information and education.Methods and analysisThe EDGE (sElf management anD support proGrammE) for COPD is a multicentre, randomised controlled trial designed to assess the efficacy of an Internet-linked tablet computer-based intervention (the EDGE platform) in improving quality of life in patients with moderate to very severe COPD compared with usual care. Eligible patients are randomly allocated to receive the tablet computer-based intervention or usual care in a 2:1 ratio using a web-based randomisation system. Participants are recruited from respiratory outpatient clinics and pulmonary rehabilitation courses as well as from those recently discharged from hospital with a COPD-related admission and from primary care clinics. Participants allocated to the tablet computer-based intervention complete a daily symptom diary and record clinical symptoms using a Bluetooth-linked pulse oximeter. Participants allocated to receive usual care are provided with all the information given to those allocated to the intervention but without the use of the tablet computer or the facility to monitor their symptoms or physiological variables. The primary outcome of quality of life is measured using the St George's Respiratory Questionnaire for COPD patients (SGRQ-C) baseline, 6 and 12 months. Secondary outcome measures are recorded at these intervals in addition to 3 months.Ethics and disseminationThe Research Ethics Committee for Berkshire-South Central has provided ethical approval for the conduct of the study in the recruiting regions. The results of the study will be disseminated through peer review publications and conference presentations.Trial registrationCurrent controlled trials ISRCTN40367841.

Project description:BackgroundHome blood pressure monitoring (HBPM) is one component of effective supported self-management, which may potentially be mediated by mobile apps.ObjectiveThe aim of this study was to identify the self-management features (HBPM and broader support strategies) offered by currently available apps and to determine the features associated with download frequency and user ratings.MethodsWe searched Google Play store, Apple App store, National Health Services Apps Library and myhealthapps.net (first search on February 1, 2018; updated August 18, 2018). We included high blood pressure apps available in the United Kingdom and extracted their features, number of downloads, and the average users' rating from the app stores. We mapped the features to the holistic Practical Reviews In Self-Management Support (PRISMS) taxonomy of self-management support. We employed a regression analysis to determine if any features were associated with download frequency or user rating.ResultsWe included 151 apps. The 3 most common features were as follows: monitoring blood pressure (BP) and charting logs; lifestyle (exercise or dietary) advice; and providing information about hypertension. The other 11 components of the PRISMS taxonomy were rarely featured. There was little evidence to support associations between specific features and the download statistics and rating scores, with only 2 uncommon features achieving borderline significant associations. The presence of social support features, such as a forum, was weakly but significantly (R2=.04, P=.02) correlated with the number of downloads. Apps designed specifically for particular BP monitors/smart watches were weakly associated with a higher rating score (R2=.05, P<.001). Apps with more ratings were associated with more downloads (R2=.91, P<.001).ConclusionsThe functionality of currently available apps is limited to logging BP, offering lifestyle advice, and providing information about hypertension. Future app development should consider broadening the remit to produce a system that can respond flexibly to the diversity of support that enables people to self-manage their hypertension.

Dataset Information

Protocol for a feasibility randomized trial of self-management support for people with chronic obstructive pulmonary disease using lay health coaches.

Publications

Protocol for a feasibility randomized trial of self-management support for people with chronic obstructive pulmonary disease using lay health coaches.

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