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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:PurposeThe Scleroderma Patient-centered Intervention Network (SPIN) online hand exercise program (SPIN-HAND), is an online self-help program of hand exercises designed to improve hand function for people with scleroderma. The objective of this feasibility trial was to evaluate aspects of feasibility for conducting a full-scale randomized controlled trial of the SPIN-HAND program.Materials and methodsThe feasibility trial was embedded in the SPIN cohort and utilized the cohort multiple randomized controlled trial (cmRCT) design. In the cmRCT design, at the time of cohort enrollment, cohort participants consent to be assessed for trial eligibility and randomized prior to being informed about trials conducted using the cohort. When trials were conducted in the cohort, participants randomized to the intervention were informed and consented to access the intervention. Participants randomized to control were not informed that they have not received an intervention. All participants eligible and randomized to participate in the trial were included in analyses on an intent-to-treat basis. Cohort participants with a Cochin Hand Function Scale score ≥ 3/90 and an interest in using an online hand-exercise intervention were randomized (1:1 ratio) to be offered as usual care plus the SPIN-HAND Program or usual care for 3 months. User satisfaction was assessed with semi-structured interviews.ResultsOf the 40 randomized participants, 24 were allocated to SPIN-HAND and 16 to usual care. Of 24 participants randomized to be offered SPIN-HAND, 15 (63%) consented to use the program. Usage of SPIN-HAND content among the 15 participants who consented to use the program was low; only five (33%) logged in more than twice. Participants found the content relevant and easy to understand (satisfaction rating 8.5/10, N = 6). Automated eligibility and randomization procedures via the SPIN Cohort platform functioned properly. The required technical support was minimal.ConclusionsTrial methodology functioned as designed, and the SPIN-HAND Program was feasibly delivered; however, the acceptance of the offer and use of program content among accepters were low. Adjustments to information provided to potential participants will be implemented in the full-scale SPIN-HAND trial to attempt to increase offer acceptance.

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:BackgroundIndividuals with dementia or mild cognitive impairment frequently have multiple chronic conditions (defined as ≥2 chronic medical conditions) and take multiple medications, increasing their risk for adverse outcomes. Deprescribing (reducing or stopping medications for which potential harms outweigh potential benefits) may decrease their risk of adverse outcomes.ObjectiveTo examine the effectiveness of increasing patient and clinician awareness about the potential to deprescribe unnecessary or risky medications among patients with dementia or mild cognitive impairment.Design, setting, and participantsThis pragmatic, patient-centered, 12-month cluster randomized clinical trial was conducted from April 1, 2019, to March 31, 2020, at 18 primary care clinics in a not-for-profit integrated health care delivery system. The study included 3012 adults aged 65 years or older with dementia or mild cognitive impairment who had 1 or more additional chronic medical conditions and were taking 5 or more long-term medications.InterventionsAn educational brochure and a questionnaire on attitudes toward deprescribing were mailed to patients prior to a primary care visit, clinicians were notified about the mailing, and deprescribing tip sheets were distributed to clinicians at monthly clinic meetings.Main outcomes and measuresThe number of prescribed long-term medications and the percentage of individuals prescribed 1 or more potentially inappropriate medications (PIMs). Analysis was performed on an intention-to-treat basis.ResultsThis study comprised 1433 individuals (806 women [56.2%]; mean [SD] age, 80.1 [7.2] years) in 9 intervention clinics and 1579 individuals (874 women [55.4%]; mean [SD] age, 79.9 [7.5] years) in 9 control clinics who met the eligibility criteria. At baseline, both groups were prescribed a similar mean (SD) number of long-term medications (7.0 [2.1] in the intervention group and 7.0 [2.2] in the control group), and a similar proportion of individuals in both groups were taking 1 or more PIMs (437 of 1433 individuals [30.5%] in the intervention group and 467 of 1579 individuals [29.6%] in the control group). At 6 months, the adjusted mean number of long-term medications was similar in the intervention and control groups (6.4 [95% CI, 6.3-6.5] vs 6.5 [95% CI, 6.4-6.6]; P = .14). The estimated percentages of patients in the intervention and control groups taking 1 or more PIMs were similar (17.8% [95% CI, 15.4%-20.5%] vs 20.9% [95% CI, 18.4%-23.6%]; P = .08). In preplanned subgroup analyses, adjusted differences between the intervention and control groups were -0.16 (95% CI, -0.34 to 0.01) for individuals prescribed 7 or more long-term medications at baseline (n = 1434) and -0.03 (95% CI, -0.20 to 0.13) for those prescribed 5 to 6 medications (n = 1578) (P = .28 for interaction; P = .19 for subgroup interaction for PIMs).Conclusions and relevanceThis large-scale educational deprescribing intervention for older adults with cognitive impairment taking 5 or more long-term medications and their primary care clinicians demonstrated small effect sizes and did not significantly reduce the number of long-term medications and PIMs. Such interventions should target older adults taking relatively more medications.Trial registrationClinicalTrials.gov Identifier: NCT03984396.

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:Introduction: Recently, we developed a home-based, minimal-equipment exercise training program HOMEX for people with chronic obstructive pulmonary disease (COPD) and tested its effectiveness over 1 year in a randomized controlled trial. The aims of the current study were to evaluate the implementation of HOMEX from the perspectives of all involved persons and to optimize the program to ensure its long-term sustainability. Methods: In this mixed-methods study, we used qualitative and quantitative approaches to evaluate the implementation of the intervention on the level of patients with COPD and coaches who provided the intervention and relevant stakeholders. To assess the implementation outcomes dose, reach, fidelity, and adherence, we summarized information recorded in the notes of the coaches and the diaries of patients, complemented with results from qualitative assessments. To assess acceptability and appropriateness, we conducted surveys with patients and coaches, and semistructured interviews with selected patients, coaches, and stakeholders. Results: The coaches delivered the three home visits with one exception according to the protocol (fidelity). Of the 53 intervention group participants, 37 (70%) conducted HOMEX training until the end of the study and 43 (79%) trained for at least 10 months. The exercise behaviors of the participants could be separated into the phases "Starting the training and stabilizing into regular training routine" and "Managing training disruptions" (adherence). Overall, patients, coaches, and stakeholders conveyed a very high "acceptability" of HOMEX, noting the home-based aspect as a particular strength and interaction with other patients as future need. All involved groups perceived the strength-training exercises as appropriate, efficient for people with COPD, and relevant to maintain improvements after pulmonary rehabilitation. The most important facilitators of the patients for long-term motivation were self-perceived improvement in strength, supervision by a coach, and integration of the training in daily routine. Based on these insights, we redesigned and reworded the exercise cards, introduced three new exercises, and refined the training book. Discussion: The results of this study provided insights of the involved persons in the frame of the HOMEX intervention implementation with a particular focus on the long-term training behavior of the participants and their perception and experience with the exercise program. These findings enabled us to optimize the training material and adapt the structure of the program for sustainable further use in clinical and other settings.

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.

Dataset Information

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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