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Web-based support for self-management strategies versus usual care for people with COPD in primary healthcare: a protocol for a randomised, 12-month, parallel-group pragmatic trial.

ABSTRACT: INTRODUCTION:The use of adequate self-management strategies for people with chronic obstructive pulmonary disease (COPD) may increase the level of physical activity (PA), improve health-related quality of life (HRQoL) and reduce healthcare use. Whether web-based support in addition to prompts (email and SMS) could be used to promote self-management strategies to facilitate behaviour change in people with COPD is not clear. This clinical trial aims to generate evidence on the effect of a web-based solution, the COPD Web, in a cohort of people with COPD in a primary healthcare context. METHODS AND ANALYSIS:The overall design is a pragmatic randomised controlled trial with preassessments and postassessments (3 and 12 months) and an implementation and user experience evaluation. People with a diagnosis of COPD, treated in primary healthcare will be eligible for the study. A total of 144 participants will be enrolled by healthcare professionals at included primary healthcare units and, after fulfilled baseline assessments, randomised to either control or intervention group. All participants will receive usual care, a pedometer and a leaflet about the importance of PA. Participants in the intervention will, in addition, get access to the COPD Web, an interactive self-managed website that aims to support people with COPD in self-management strategies. They will also continuously get support from prompts with a focus on behaviour change.The effect on participants' PA, dyspnoea, COPD-related symptoms, HRQoL and health economics will be assessed using accelerometer and questionnaires. To identify enablers and barriers for the use of web-based support to change behaviour, semistructured interviews will be conducted in a subgroup of participants at the 3 months follow-up. ETHICS AND DISSEMINATION:Ethical approval has been received from the Regional Ethical Review Board in Umeå, Sweden. Dnr 2018-274-31. Findings will be presented at conferences, submitted for publication in peer-reviewed journals and presented to the involved healthcare professionals, participants and patient organisations. TRIAL REGISTRATION NUMBER:NCT03746873.

SUBMITTER: Stenlund T

PROVIDER: S-EPMC6797375 | biostudies-literature | 2019 Oct

REPOSITORIES: biostudies-literature

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Web-based support for self-management strategies versus usual care for people with COPD in primary healthcare: a protocol for a randomised, 12-month, parallel-group pragmatic trial.

Stenlund Tobias T Nyberg André A Lundell Sara S Wadell Karin K

BMJ open 20191007 10

<h4>Introduction</h4>The use of adequate self-management strategies for people with chronic obstructive pulmonary disease (COPD) may increase the level of physical activity (PA), improve health-related quality of life (HRQoL) and reduce healthcare use. Whether web-based support in addition to prompts (email and SMS) could be used to promote self-management strategies to facilitate behaviour change in people with COPD is not clear. This clinical trial aims to generate evidence on the effect of a ...[more]

PMID: 31594889

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Project description:OBJECTIVE:Evaluate the feasibility of the COPD Web and its study design and study procedures and to increase the understanding of the potential effect of the tool in order to provide guidance for a future large scale trial. DESIGN:Parallel-group controlled pragmatic pilot trial. SUBJECTS:There was a total of 83 patients with COPD (mean age 70?±?8 years with a forced expiratory volume in first second percent predicted of 60?±?17%). The intervention group (n?=?43) was introduced to and had access to the COPD Web in addition to usual care, while the control group (n?=?40) received usual care alone. MAIN OUTCOME MEASURES:The feasibility of the COPD Web (i.e., if and how the COPD Web was used) was automatically collected through the website, while outcomes on health, conceptual knowledge, and physical activity (PA) were collected through questionnaires at baseline, 3 months and 12 months. RESULTS:At 3 months, 77% of the intervention group was considered users, and the majority of time spent on the site was related to PA and exercises and was spent during the first month (>80%). In addition, the intervention group reported increased PA (odds ratio [OR]?=?4.4, P?<?.001), increased conceptual knowledge in five domains (OR = 2.6-4.2, all P?<?.05), and altered disease management strategies (e.g., increased PA) (OR ? 2.7 P?<?.05) in comparison to the control group. The latter was also different between groups at 12 months (OR = 3.7, P?=?.044). Knowledge of PA was correlated with level of PA (??=?.425-.512, P?<?.05) as well as to the use of PA as a strategy to manage their disease (?2?=?11.2-32.9, P?<?.05). CONCLUSION:Giving patients with COPD access to the COPD Web in addition to their ordinary primary care might be an effective shorter term (3 month) strategy to promote self-management. However, these results needs to be confirmed in a definitive large-scale trial. Key points Even though self-management strategies are an important part of chronic obstructive pulmonary disease (COPD) management, access to support for such strategies are limited for a large part of the COPD-population. Promoting self-management through the COPD Web might increase short-term levels of physical activity, promote conceptual knowledge and alter disease management strategies. The primary care COPD population in this study experienced limited impact of the disease in daily life, limited exertional dyspnea, and high generic quality-of-life, but vastly reduced levels of physical activity. A future large scale study should include strategies to encourage greater exposures to the COPD Web, including an extended analysis of factors associated with using or not using the tool over time and its impact on outcome measures, objective measures of conceptual knowledge, and physical activity, and it should include a large enough sample size to enable sub-group analyses and strategies to enhance recruitment.

Project description:INTRODUCTION:The use of adequate self-management strategies for people with chronic obstructive pulmonary disease (COPD) reduces healthcare use, improves health-related quality of life (HRQoL) and recovery after acute exacerbations. However, not many people with COPD receive support that promotes the use of such strategies and therefore new methods to facilitate and promote the use of self-management strategies are highly warranted. This pilot trial aims to evaluate the feasibility of the study design and study procedures considering effectiveness of the novel intervention, the COPD-web. METHODS AND ANALYSIS: The overall design is a pragmatic controlled pilot trial with preassessments and postassessments and a parallel process evaluation. Patients with the diagnosis of COPD will be eligible for the study. The intervention group will be recruited when visiting one of the six participating primary care units in Sweden. The control group will be identified from the unit's computerised registers. The intervention, the COPD-web, is an interactive web page with two sections; one directed at people with COPD and one at healthcare professionals. The sections aim to support patients' self-management skills-and to facilitate the provision of support for self-management strategies, respectively. Effectiveness with regard to patients' symptoms, HRQoL, knowledge of and readiness for COPD-related self-management, health literacy, self-efficacy for physical activity and time spent in physical activity and time being sedentary, and further, healthcare professionals' knowledge of and readiness to support COPD-related self-management strategies will be assessed using questionnaires at 3 and 12 months. The process evaluation will include observations and interviews. ETHICS AND DISSEMINATION:Ethical approval has been obtained. Findings will be presented at conferences, submitted for publication in peer-reviewed publications and presented to the involved healthcare professionals, patients and to patient organisations. TRIAL REGISTRATION NUMBER:ClinicalTrials.gov: NCT02696187.

Project description:BackgroundPediatric obesity management can be successful, but some families discontinue care prematurely (i.e., attrition), limiting treatment impact. Attrition is often a consequence of barriers and constraints that limit families' access to obesity management. Family Navigation (FN) can improve access, satisfaction with care, and treatment outcomes in diverse areas of healthcare. To help our team prepare for a future effectiveness trial, the objectives of our randomized feasibility study are to (i) explore children's and caregivers' acceptability of FN and (ii) examine attrition, measures of study rigor and conduct, and responses to FN + Usual Care vs Usual Care by collecting clinical, health services, and health economic data.MethodsIn our 2.5-year study, 108 6-17-year-olds with obesity and their caregivers will be randomized (1:1) to FN + Usual Care or Usual Care after they enroll in obesity management clinics in Calgary and Mississauga, Canada. Our Stakeholder Steering Committee and research team will use Experience-Based Co-Design to design and refine our FN intervention to reduce families' barriers to care, maximizing the intervention dose families receive. FN will be delivered by a navigator at each site who will use logistical and relational strategies to enhance access to care, supplementing obesity management. Usual Care will be offered similarly at both clinics, adhering to expert guidelines. At enrollment, families will complete a multidisciplinary assessment, then meet regularly with a multidisciplinary team of clinicians for obesity management. Over 12 months, both FN and Usual Care will be delivered virtually and/or in-person, pandemic permitting. Data will be collected at 0, 3, 6, and 12 months post-baseline. We will explore child and caregiver perceptions of FN acceptability as well as evaluate attrition, recruitment, enrolment, randomization, and protocol integrity against pre-set success thresholds. Data on clinical, health services, and health economic outcomes will be collected using established protocols. Qualitative data analysis will apply thematic analysis; quantitative data analysis will be descriptive.DiscussionOur trial will assess the feasibility of FN to address attrition in managing pediatric obesity. Study data will inform a future effectiveness trial, which will be designed to test whether FN reduces attrition.Trial registrationThis trial was registered prospectively at ClinicalTrials.gov (# NCT05403658 ; first posted: June 3, 2022).

Project description:BackgroundExercise capacity is a strong predictor of survival in patients with coronary artery disease (CAD). Exercise capacity improves after cardiac rehabilitation exercise training, but previous studies have demonstrated a decline in peak oxygen uptake after ending a formal rehabilitation program. There is a lack of knowledge on how long-term exercise adherence can be achieved in CAD patients. We therefore assessed if a 12-month maintenance program following cardiac rehabilitation would lead to increased adherence to exercise and increased exercise capacity compared to usual care.Materials and methodsTwo-centre, open, parallel randomized controlled trial with 12 months follow-up comparing usual care to a maintenance program. The maintenance program consisted of one monthly supervised high intensity interval training session, a written exercise program and exercise diary, and a maximum exercise test every third month during follow-up. Forty-nine patients (15 women) on optimal medical treatment were included following discharge from cardiac rehabilitation. The primary endpoint was change in peak oxygen uptake at follow-up; secondary endpoints were physical activity level, quality of life and blood markers of cardiovascular risk.ResultsThere was no change in peak oxygen uptake from baseline to follow-up in either group (intervention group 27.9 (±4.7) to 28.8 (±5.6) mL·kg (-1) min (-1), control group 32.0 (±6.2) to 32.8 (±5.8) mL·kg (-1) min (-1), with no between-group difference, p = 0.22). Quality of life and blood biomarkers remained essentially unchanged, and both self-reported and measured physical activity levels were similar between groups after 12 months.ConclusionsA maintenance exercise program for 12 months did not improve adherence to exercise or peak oxygen uptake in CAD patients after discharge from cardiac rehabilitation compared to usual care. This suggests that infrequent supervised high intensity interval training sessions are inadequate to improve peak oxygen uptake in this patient group.Trial registrationClinicalTrials.gov NCT01246570.

Project description:IntroductionGiven that polypharmacy and potentially inappropriate prescribing are common in elderly orthopaedic patients, pharmacist interventions to improve medication practices among this population are important. However, past studies have reported mixed results regarding the effectiveness of pharmacist-led interventions in inpatient elderly care. Furthermore, few randomised controlled trials have evaluated patient-relevant outcomes as a primary endpoint. Therefore, we will evaluate whether a pharmacist-led intervention could reduce readmission of hospitalised elderly orthopaedic patients with polypharmacy or potentially inappropriate prescribing.Methods and analysisThis is an ongoing single-centre, prospective, non-blinded, randomised controlled trial designed to evaluate the superiority of a pharmacist-led intervention for hospitalised elderly patients compared with usual care. The trial will include newly admitted orthopaedic patients 70 years of age and older with polypharmacy or at least one potentially inappropriate prescription, as identified by the screening tool of older people's prescriptions (STOPP) criteria. Usual care includes medication reconciliation, patient education and monitoring, as well as providing information about discharge medications. Pharmacist interventions, in addition to usual care, include advising the patient's physician to stop unnecessary or inappropriate medications and start necessary medications. The primary outcome is the 1-year readmission rate. Secondary outcomes are the proportion of patients who undergo emergency department visits and the occurrences of all-cause death, a new fracture, myocardial infarction and ischaemic stroke. The study started in November 2017, and up to approximately 220 patients will be enrolled.Ethics and disseminationThe protocol was approved by the Medical Ethics Committee of the National Hospital Organization Tochigi Medical Center (No. 29-22). The trial was registered at the University Hospital Medical Information Network (UMIN) clinical registry. The results of this trial will be submitted for publication in a peer-reviewed journal.Trial registration numberUMIN000029404.

Project description:BackgroundThe integration of a personal recovery-oriented practice in mental health services is an emerging principle in policy planning. Self-management support (SMS) is an intervention promoting recovery that aims at educating patients on the nature of their mental disorder, improving their strategies to manage their day-to-day symptoms, fostering self-efficacy and empowerment, preventing relapse, and promoting well-being. While SMS is well established for chronic physical conditions, there is a lack of evidence to support the implementation of structured SMS programs for common mental disorders, and particularly for anxiety disorders. This study aims to examine the effectiveness of a group-based self-management support program for anxiety disorders as an add-on to treatment-as-usual in community-based care settings.Methods/designWe will conduct a multicentre pragmatic randomized controlled trial with a pre-treatment, post-treatment (4-month post-randomization), and follow-ups at 8, 12 and 24-months. TREATMENT AND CONTROL GROUPS: a) group self-management support (10 weekly 2.5-h group web-based sessions with 10-15 patients with two trained facilitators); b) treatment-as-usual. Participants will include adults meeting DSM-5 criteria for Panic Disorder, Agoraphobia, Social Anxiety Disorder, and/or Generalized Anxiety Disorder. The primary outcome measure will be the Beck Anxiety Inventory; secondary outcome measures will comprise self-reported instruments for anxiety and depressive symptoms, recovery, self-management, quality of life, and service utilisation.Statistical analysisData will be analysed based on intention-to-treat with a mixed effects regression model accounting for between and within-subject variations in the effects of the intervention.DiscussionThis study will contribute to the limited knowledge base regarding the effectiveness of structured group self-management support for anxiety disorders. It is expected that changes in patients' self-management behaviour will lead to better anxiety management and, consequently, to improved patient outcomes.Trial registrationClinicalTrials.gov: NCT05124639 . Prospectively registered 18 November 2021.

Project description:Early treatment response markers, for example, improvement in forced expiratory volume in 1 second (FEV1) and St George's Respiratory Questionnaire (SGRQ) total score, may help clinicians to better manage patients with chronic obstructive pulmonary disease (COPD). We investigated the prevalence of clinically important improvements in FEV1 and SGRQ scores after 2-month budesonide/formoterol or formoterol treatment and whether such improvements predict subsequent improvements and exacerbation rates.This post hoc analysis is based on data from three double-blind, randomized studies in patients with moderate-to-very-severe COPD receiving twice-daily budesonide/formoterol or formoterol alone for 6 or 12 months. Prebronchodilator FEV1 and SGRQ total score were measured before treatment and at 2 and 12 months; COPD exacerbation rates were measured during months 2-12. Responders were defined by ?100 mL improvement in prebronchodilator FEV1 and ?4-point decrease in SGRQ total score.Overall, 2,331 and 1,799 patients were included in the 0-2- and 0-12-month responder analyses, respectively, and 2,360 patients in the 2-12-month exacerbation rate analysis. At 2 months, 35.1% of patients were FEV1 responders and 44.3% were SGRQ responders. The probability of response was significantly greater with budesonide/formoterol than with formoterol or placebo for both parameters. Two-month responders had a greater chance of 12-month response than 2-month nonresponders for both FEV1 (odds ratio, 5.57; 95% confidence interval, 4.14-7.50) and SGRQ (odds ratio, 3.87; 95% confidence interval, 2.83-5.31). Two-month response in FEV1 (P<0.001), but not SGRQ (P=0.11), was associated with greater reductions in exacerbation risk.Early FEV1 and SGRQ treatment responses relate to their changes at 12 months. FEV1 response, but not SGRQ response, at 2 months predicts the risk of a future COPD exacerbation in some, but not all patients. This is potentially useful in clinical practice, although more sensitive and specific markers of favorable treatment response are required.

Dataset Information

Web-based support for self-management strategies versus usual care for people with COPD in primary healthcare: a protocol for a randomised, 12-month, parallel-group pragmatic trial.

Publications

Web-based support for self-management strategies versus usual care for people with COPD in primary healthcare: a protocol for a randomised, 12-month, parallel-group pragmatic trial.

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