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A feasibility pragmatic clinical trial of a primary care network exercise and education program for people with COPD.

ABSTRACT: Background:Pulmonary rehabilitation is an important component of chronic disease management in chronic obstructive pulmonary disease (COPD) and has been shown to improve shortness of breath, exercise capacity, quality of life, and decrease hospitalizations. However, pulmonary rehabilitation capacity is low. Primary care may be an effective method for delivering disease management services to this population. The objective of this feasibility pragmatic clinical trial was to evaluate enrollment and completion of a primary care network exercise and education program for people with COPD. Methods:COPD patients (N = 23; mean age = 65 ± 9?years; FEV1 = 68 ± 20% predicted) were recruited after referral to a primary care network exercise program in Edmonton, Alberta. Participants self-selected either an 8-week 16-session supervised exercise program or an 8-week unsupervised exercise program where they received three visits with an exercise specialist. Both groups self-selected education sessions with clinicians for disease management support. Referrals, completion, and program outcomes (physical activity, exercise capacity and health status) were measured before (T1), immediately after (T2), and 8?weeks following the program (T3). Results:Forty-three referrals were received in 10?months, where a minimum of 50 was required in order for the program to be considered feasible. Twenty-three participants provided baseline data, and twenty participants started the exercise program (10 in each exercise group), 16 of which completed the exercise program (80%). On average, 48% of the recommended education sessions were completed by participants. Conclusions:Enrollment into a COPD exercise and education program in a primary care network was low indicating the need for improved referral processes from physicians. Completion rates by participants were adequate for exercise but not education. The low referral rate and the lack of enrollment in COPD education by the patients indicate that a large-scale trial of the program as designed is not feasible.

SUBMITTER: Hurley KMT

PROVIDER: S-EPMC7590448 | biostudies-literature | 2020

REPOSITORIES: biostudies-literature

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A feasibility pragmatic clinical trial of a primary care network exercise and education program for people with COPD.

Hurley Kelsey M T KMT Selzler Anne-Marie AM Rodgers Wendy M WM Stickland Michael K MK

Pilot and feasibility studies 20201026

<h4>Background</h4>Pulmonary rehabilitation is an important component of chronic disease management in chronic obstructive pulmonary disease (COPD) and has been shown to improve shortness of breath, exercise capacity, quality of life, and decrease hospitalizations. However, pulmonary rehabilitation capacity is low. Primary care may be an effective method for delivering disease management services to this population. The objective of this feasibility pragmatic clinical trial was to evaluate enrol ...[more]

PMID: 33117559

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Project description:National guidance for chronic obstructive pulmonary disease (COPD) suggests that self-management support be provided for patients. Our institution has developed a standardised, manual-based, supported self-management programme: Self-Management Programme of Activity Coping and Education (SPACE for COPD(C)). SPACE was previously piloted on a 1-2-1 basis, delivered by researchers, to individuals with COPD. Discussions with stakeholders highlighted considerable interest in delivering the SPACE for COPD(C) intervention as a group-based self-management programme facilitated by healthcare professionals (HCPs) in primary care settings. The study aims are to explore the feasibility, acceptability and efficacy for the intervention to be delivered and supported by HCPs and to examine whether group-based delivery of SPACE for COPD(C), with sustained support, improves patient outcomes following the SPACE for COPD(C) intervention.A prospective, multi-site, single-blinded randomised controlled trial (RCT) will be conducted, with follow-up at 6 and 9 months. Participants will be randomly assigned to either the control group (usual care) or intervention group (a six-session, group-based SPACE for COPD(C)self-management programme delivered over 5 months). The primary outcome is change in COPD assessment test at 6?months.A discussion session will be conducted with HCPs who deliver the intervention to discuss and gain insight into any potential facilitators/barriers to implementing the intervention in practice. Furthermore, we will conduct semi-structured focus groups with intervention participants to understand feasibility and acceptability. All qualitative data will be analysed thematically.The project has received a favourable opinion from South Hampshire B Research Ethics Committee, REC reference: 14/SC/1169 and full R&D approval from the University Hospitals of Leicester NHS Trust: 152408.Study results will be disseminated through appropriate peer-reviewed journals, national and international respiratory/physiotherapy conferences, via the Collaboration and Leadership in Applied Health Research and Care and through social media.ISRCTN17942821; pre-results.

Project description:PurposeOlder adults with chronic obstructive pulmonary disease (COPD) have a high risk and rate of falls. Home-based fall prevention exercise programs reduce falls in older adults and may be an alternative approach for people with COPD without access to hospital-based rehabilitation. Therefore, we aimed to determine the feasibility of a home-based fall prevention exercise program in older adults with COPD and to examine the effect of the program on fall-related outcomes at baseline, 3 and 6 months.Patients and methodsAdults ≥60 years with COPD at risk for falls participated in a single group study. The intervention was a 6-month home-based fall prevention program which included 40 minutes of independent exercise three times per week, four physiotherapist home visits, bimonthly phone calls, and an optional booster session post-exacerbation. An independent assessor collected outcome measures at home at baseline, 3- and 6-months. Primary feasibility criteria were recruitment and retention rates (≥70%) and exercise adherence (≥60%). Functional outcomes included the Berg Balance Scale (BBS), the Balance Evaluation Systems Test (BESTest), the Activities-Specific Balance Confidence (ABC) scale, the repeated chair-stand test, self-reported function, and fall history.ResultsThirty-six patients (female 63.8%, mean age 74.4 ± 6.1 years; mean FEV1 45.0 ± 13.8% predicted) were enrolled. The recruitment rate was 46.8%, participant retention rate was 69.4%, and exercise adherence rate was 73.6%. Repeated measures ANOVA showed improvements at 3- and 6-months compared to baseline in the BBS (p=0.001) and the BESTest total scores and sub-scores (p=0.001).ConclusionThe home-based fall prevention exercise program met one of the three pre-specified feasibility criteria (exercise adherence), and improved balance-related measures of fall risk in older adults with COPD. Our findings highlight important opportunities for refinement of the study design prior to undertaking a full-scale trial.

Project description:A well-organized education program improved the patients' knowledge about their disease, inhaler technique and quality of life in asthma and chronic obstructive pulmonary disease (COPD) patients. The effectiveness of the education program can be evaluated by assessing patients' satisfaction with the education program as well. In this study, we compared the patients' satisfaction with education program between COPD and asthma patients.A total of 284 asthma and COPD patients were enrolled. Three educational visits were conducted at 2-week intervals. On the first visit, we taught the patients about their diseases and the proper inhaler technique. On the second visit, non-pharmacologic treatments and action plans for acute exacerbation were introduced. On the final appointment, we summarized the educational concepts covered in the two prior visits. After the education program, the patients were assessed for their quality of life, knowledge of chronic airways disease, and satisfaction with the education program, using a structured questionnaire.After the education program, 99.3% of the asthma patients knew much more about their disease and 96.8% agreed that education from the hospital is needed. For COPD patients, 94.8% felt more informed about their disease and 95.7% agreed that education from the hospital is needed. However, 17.1% of asthma patients and 13.5% of COPD patients disagreed to paying an additional fee for the education program. Finally, the knowledge improvement was linked to patient satisfaction with the education program.The improvement in self-knowledge about their disease was linked to their satisfaction with the education program. However, costs associated with the program could limit its accessibility to the patients. The patient education program is a self-management intervention to improve the lives of patients with asthma and COPD. Thus, a policy to reduce the economic burden of the patients should be considered to disseminate the education program in primary care clinics.

Project description:ObjectiveTo examine the impact of a 1-year pragmatic obesity trial on primary care providers' (PCPs) perspectives of treatment.MethodsPCPs from four intervention clinics (PCP-I) and five control clinics (PCP-C) completed pre- and postintervention surveys on weight-loss counseling, comfort discussing obesity treatments, and perceived effectiveness of interventions; questions were rated on 0 to 10 Likert scales. Only PCP-I received patient updates and education about obesity management.ResultsEighty PCPs completed preintervention surveys (pre: 71% female, 71% physicians); 82 PCPs completed postintervention surveys (post: 66% female, 70% physicians). PCPs were most comfortable discussing exercise before and after the trial (pre PCP-C: 8.22 [1.44], mean [standard deviation (SD)]; post PCP-C: 8.37 [1.24]; P = 0.8; pre/post PCP-I: 7.88 [1.51] vs. 7.80 [1.71]; P = 0.3). PCPs were initially least comfortable discussing phentermine/topiramate extended release (ER) but developed significantly more comfort after the trial, to a greater degree among PCP-I (pre/post PCP-C: 2.86 [2.66] vs. 3.73 [2.72], P < 0.001; pre/post PCP-I: 4.00 [2.57] vs. 6.17 [2.27], P < 0.001). After the trial, both PCPs rated exercise significantly less effective for weight loss, with a greater decrease in effectiveness rations among PCP-I (pre/post PCP-C: 7.73 [1.94] vs. 6.93 [2.35], P = 0.017; pre/post PCP-I: 6.27 [2.69] vs. 5.15 [2.31], P = 0.001). Both PCPs rated phentermine (pre/post PCP-C: 5.03 [2.05] vs. 5.50 [2.12], P = 0.002; pre/post PCP-I: 5.70 [1.64] vs. 6.83 [1.18], P = 0.001) and phentermine/topiramate ER (pre/post PCP-C: 3.91 [2.33] vs. 5.47 [2.54], P < 0.001; pre/post PCP-I: 5.58 [2.21] vs. 7.02 [1.47], P < 0.001) significantly more effective after the trial, though ratings were higher among PCP-I.ConclusionsPCPs initially overvalued exercise and undervalued weight-loss medications. PCPs exposed to education and experience gave higher comfort and effectiveness ratings to weight-loss medications.

Project description:IntroductionThe 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 analysisThe 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 through advertisment or by healthcare professionals at included primary healthcare units and, after fulfilled baseline assessment, 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 disseminationEthical approval has been received from the Regional Ethical Review Board in Umeå, Sweden. Dnr 2018-274 and dnr 2019-05572. 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 numberNCT03746873.

Project description:OBJECTIVES:The Scleroderma Patient-centered Intervention Network-Scleroderma Support group Leader EDucation (SPIN-SSLED) Programme was designed to improve confidence and self-efficacy and to reduce burden for support group leaders. Objectives were to (1) evaluate feasibility of programme delivery, including required resources, management issues and scientific aspects (eg, performance of outcome measures) and (2) assess user satisfaction and identify any modifications needed to improve programme content or delivery based on participant feedback. DESIGN:Non-randomised feasibility trial. SETTING:North American patient organisations. PARTICIPANTS:Current support group leaders or potential new leaders referred by patient organisations. INTERVENTION:The programme included 13 modules delivered live via videoconference over 3 months (April to July 2018) in 60 to 90?min sessions. OUTCOME MEASURES:(1) Elements of feasibility, including enrolment and consent procedures, percentage of referred group leaders who consented to participate, session attendance and technical support requirements; (2) programme usability, understandability, organisation and clarity; (3) leader satisfaction with the programme and (4) planned trial outcome measures, including support group leader self-efficacy, burnout, emotional distress and physical function. RESULTS:All 12 referred potential participants consented to enrol, and 10 were included in two training groups of five participants each. Participants attended 95% of sessions. Required technical support was minimal, and videoconferencing technology functioned well. Overall programme satisfaction rating was 9.4/10. Mean item rating on the eight items of the Client Satisfaction Questionnaire-8 was 3.83 (1=low satisfaction; 4=high satisfaction). Pre-post scores on the Scleroderma Support Group Leader Self-efficacy Scale increased by 1.7 SDs (large effect); scores on burnout, emotional distress and physical function improved by 0.44, 0.38 and 0.45 SDs (moderate effects). CONCLUSION:The SPIN-SSLED Programme was feasibly delivered, including management, resource and scientific aspects. Participant satisfaction was high. The programme is ready to be tested in a full-scale randomised controlled trial. TRIAL REGISTRATION NUMBER:NCT03508661.

Project description:BackgroundMany people with clinically significant chronic obstructive pulmonary disease (COPD) remain undiagnosed worldwide. There are a number of small studies which have examined possible methods of case finding through primary care, but no large RCTs that have adequately assessed the most cost-effective approach.Methods/designIn this study, using a cluster randomised controlled trial (RCT) in 56 general practices in the West Midlands, we plan to investigate the effectiveness and cost-effectiveness of a Targeted approach to case finding for COPD compared with routine practice. Using an individual patient RCT nested in the Targeted arm, we plan also to compare the effectiveness and cost-effectiveness of Active case finding using a postal questionnaire (with supplementary opportunistic questionnaires), and Opportunistic-only case finding during routine surgery consultations.All ever-smoking patients aged 40-79 years, without a current diagnosis of COPD and registered with participating practices will be eligible. Patients in the Targeted arm who report positive respiratory symptoms (chronic cough or phlegm, wheeze or dyspnoea) using a brief questionnaire will be invited for further spirometric assessment to ascertain whether they have COPD or not. Post-bronchodilator spirometry will be conducted to ATS standards using an Easy One spirometer by trained research assistants.The primary outcomes will be new cases of COPD and cost per new case identified, comparing targeted case finding with routine care, and two types of targeted case finding (active versus opportunistic). A multilevel logistic regression model will be used to model the probability of detecting a new case of COPD for each treatment arm, with clustering of patients (by practice and household) accounted for using a multi-level structure.A trial-based analysis will be undertaken using costs and outcomes collected during the trial. Secondary outcomes include the feasibility, efficiency, long-term cost-effectiveness, patient and primary care staff views of each approach.DiscussionThis will be the largest RCT of its kind, and should inform how best to identify undiagnosed patients with COPD in the UK and other similar healthcare systems. Sensitivity analyses will help local policy-makers decide which sub-groups of the population to target first.Trial registrationCurrent controlled trials ISRCTN14930255.

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A feasibility pragmatic clinical trial of a primary care network exercise and education program for people with COPD.

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A feasibility pragmatic clinical trial of a primary care network exercise and education program for people with COPD.

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