Feasibility Trial of a Comprehensive, Highly Patient-Centered COPD Self-Management Support Program.
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ABSTRACT: Purpose
To test the feasibility of a novel self-management support intervention for people with chronic obstructive pulmonary disease (COPD).Methods
We conducted a feasibility randomized controlled trial involving patients ≥40 years with severe or very severe COPD in New York, New York (n=59). Community health workers screened patients and addressed barriers to COPD self-management. Patients were also offered home-based pulmonary rehabilitation (HBPR) and an antibiotic and steroid rescue pack. Control patients received general COPD education. Clinical outcomes for intervention and control were compared by difference-in-differences (DiD) at baseline and 6 months. The study was not powered for statistically significant differences for any measure. Feasibility measures were collected at 6 months.Results
There were high rates of completion of intervention activities, including 75% of patients undergoing evaluation for and participating in HBPR. Most (92%) intervention patients said the program was very or extremely helpful and 96% said they would participate again. Clinical outcomes generally favored the intervention: COPD assessment test, DiD -1.1 (95% confidence interval [CI] -5.9 to 3.6); 6-minute walk test distance, DiD 7.4 meters (95% CI -45.1 to 59.8); self-reported hospitalizations, DiD -9.8% (95% CI -42.3% to 22.8%); medication adherence, DiD 7.7% (-29.6%, 45.0%), and Physical Activity Adult Questionnaire, DiD 86 (95% CI -283 to 455). Intervention patients reported more emergency department visits, DiD 10.6% (95% CI 17.7% to 38.8%).Conclusions
A highly patient-centered, self-management support intervention for people with COPD was well received by patients and associated with potential improvements in clinical and self-management outcomes. A fully powered study of the intervention is warranted.
SUBMITTER: Federman AD
PROVIDER: S-EPMC10913921 | biostudies-literature | 2024 Jan
REPOSITORIES: biostudies-literature
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Feasibility Trial of a Comprehensive, Highly Patient-Centered COPD Self-Management Support Program.
Federman Alex D AD O'Conor Rachel R Nnemnbeng Jeannys J Ankam Jyoti J McDermott Danielle D Lindenauer Peter K PK Wolf Michael S MS Wisnivesky Juan P JP
Chronic obstructive pulmonary diseases (Miami, Fla.) 20240101 1
<h4>Purpose</h4>To test the feasibility of a novel self-management support intervention for people with chronic obstructive pulmonary disease (COPD).<h4>Methods</h4>We conducted a feasibility randomized controlled trial involving patients ≥40 years with severe or very severe COPD in New York, New York (n=59). Community health workers screened patients and addressed barriers to COPD self-management. Patients were also offered home-based pulmonary rehabilitation (HBPR) and an antibiotic and steroi ...[more]
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Project description:BackgroundThe Scleroderma Patient-centered Intervention Network (SPIN) developed an online self-management program (SPIN-SELF) designed to improve disease-management self-efficacy in people with systemic sclerosis (SSc, or scleroderma). The aim of this study was to evaluate feasibility aspects for conducting a full-scale randomized controlled trial (RCT) of the SPIN-SELF Program.MethodsThis feasibility trial was embedded in the SPIN Cohort and utilized the cohort multiple RCT design. In this design, at the time of cohort enrollment, cohort participants consent to be assessed for trial eligibility and randomized prior to being informed about the trial. Participants in the intervention arm are informed and provide consent, but not the control group. Forty English-speaking SPIN Cohort participants from Canada, the USA, or the UK with low disease-management self-efficacy (Self-Efficacy for Managing Chronic Disease Scale [SEMCD] score ≤ 7) who were interested in using an online self-management program were randomized (3:2 ratio) to be offered the SPIN-SELF Program or usual care for 3 months. Program usage was examined via automated usage logs. User satisfaction was assessed with semi-structured interviews. Trial personnel time requirements and implementation challenges were logged.ResultsOf 40 SPIN Cohort participants randomized, 26 were allocated to SPIN-SELF and 14 to usual care. Automated eligibility and randomization procedures via the SPIN Cohort platform functioned properly, except that two participants with SEMCD scores > 7 (scores of 7.2 and 7.3, respectively) were included, which was caused by a system programming error that rounded SEMCD scores. Of 26 SPIN Cohort participants offered the SPIN-SELF Program, only 9 (35%) consented to use the program. Usage logs showed that use of the SPIN-SELF Program was low: 2 of 9 users (22%) logged into the program only once (median = 3), and 4 of 9 (44%) accessed none or only 1 of the 9 program's modules (median = 2).ConclusionsThe results of this study will lead to substantial changes for the planned full-scale RCT of the SPIN-SELF Program that we will incorporate into a planned additional feasibility trial with progression to a full-scale trial. These changes include transitioning to a conventional RCT design with pre-randomization consent and supplementing the online self-help with peer-facilitated videoconference-based groups to enhance engagement.Trial registrationclinicaltrials.gov , NCT03914781 . Registered 16 April 2019.
| S-EPMC8881754 | biostudies-literature
Project description:BACKGROUND:Systemic sclerosis (SSc), or scleroderma, is a rare disease that often results in significant disruptions to activities of daily living and can negatively affect physical and psychological well-being. Because there is no known cure, SSc treatment focuses on reducing symptoms and disability and improving health-related quality of life (HRQoL). Self-management programs are known to increase self-efficacy for disease management in many chronic diseases. The Scleroderma Patient-centered Intervention Network (SPIN) developed a Web-based self-management program (SPIN self-management; SPIN-SELF) to increase self-efficacy for disease management and to improve HRQoL for patients with SSc. OBJECTIVE:The proposed study aims to assess the feasibility of conducting a full-scale randomized controlled trial (RCT) of the SPIN-SELF program by evaluating the trial implementation processes, required resources and management, scientific aspects, and participant acceptability and usage of the SPIN-SELF program. METHODS:The SPIN-SELF feasibility trial will be conducted via the SPIN Cohort. The SPIN Cohort was developed as a framework for embedded pragmatic trials using the cohort multiple RCT design. In total, 40 English-speaking SPIN Cohort participants with low disease management self-efficacy (Self-Efficacy for Managing Chronic Disease Scale score ?7), who have indicated interest in using a Web-based self-management program, will be randomized with a 3:2 ratio into the SPIN-SELF program or usual care for 3 months. Feasibility outcomes include trial implementation processes, required resources and management, scientific aspects, and patient acceptability and usage of the SPIN-SELF program. RESULTS:Enrollment of the 40 participants occurred between July 5, 2019, and July 27, 2019. By November 25, 2019, data collection of trial outcomes was completed. Data analysis is underway, and results are expected to be published in 2020. CONCLUSIONS:The SPIN-SELF program is a self-help tool that may improve disease-management self-efficacy and improve HRQoL in patients with SSc. The SPIN-SELF feasibility trial will ensure that trial methodology is robust, feasible, and consistent with trial participant expectations. The results will guide adjustments that need to be implemented before undertaking a full-scale RCT of the SPIN-SELF program. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID):DERR1-10.2196/16799.
| S-EPMC7210498 | biostudies-literature
Project description:Background: Pulmonary rehabilitation programs improve dyspnea and health status associated with chronic obstructive pulmonary disease (COPD), but benefits wane when patients return to a sedentary lifestyle. This study tested a simple, low-resource, low-cost home walking program. Methods: In this single center, 3-month study, 115 COPD patients were randomized to a control cohort or a goal setting cohort. Each patient met with study staff and received 5 telephone calls at 2-week intervals. During these contacts, the Goal group was assisted by a wellness coach who helped them set personal activity goals. All patients wore a pedometer to record daily steps, the primary study outcome. Results: Over the 12-week interval, the average step-per-days was 36% higher for the Goal cohort patients (Week 12 mean = 4390) than for Control patients (mean = 3790). No group differences emerged on the modified Medical Research Council (mMRC) dyspnea scale, the COPD Assessment Test, or the St. George's Respiratory Questionnaire. Secondary analyses indicated that even patients with greater disease severity, including those with an mMRC score >2 or forced expiratory volume in 1 second (FEV1) % predicted below 50%, increased their walking relative to Control patients. Almost half (48%) of Goal patients successfully reached at least one personal goal such as increasing stamina and activity, or decreasing shortness of breath or weight. Conclusions: A relatively low-resource wellness coaching, goal-setting intervention resulted in a small improvement in the activity level of COPD patients over a 12-week period including those with marked pulmonary impairment. Further investigation should be directed at understanding the optimal blend of in person and remote coaching needed to produce the greatest cost-to-benefit ratio.
| S-EPMC5556960 | biostudies-literature
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.
| S-EPMC6858260 | biostudies-literature
Project description:BackgroundIn addition to medical intervention and counseling, patients with cardiovascular disease (CVD) need to manage their disease and its consequences by themselves in daily life.ObjectiveThe aim of this paper is to describe the development of "Vascular View," a comprehensive, multi-component, tailored, Web-based, self-management support program for patients with CVD, and how this program will be tested in an early randomized controlled trial (RCT).MethodsThe Vascular View program was systematically developed in collaboration with an expert group of 6 patients, and separately with a group of 6 health professionals (medical, nursing, and allied health care professionals), according to the following steps of the intervention mapping (IM) framework: (1) conducting a needs assessment; (2) creating matrices of change objectives; (3) selecting theory-based intervention methods and practical applications; (4) organizing methods and applications into an intervention program; (5) planning the adaption, implementation, and sustainability of the program, and (6) generating an evaluation plan.ResultsThe needs assessment (Step 1) identified 9 general health problems and 8 determinants (knowledge, awareness, attitude, self-efficacy, subjective norm, intention, risk perception, and habits) of self-managing CVD. By defining performance and change objectives (Step 2), 6 topics were distinguished and incorporated into the courses included in Vascular View (Steps 3 and 4): (1) Coping With CVD and its Consequences; (2) Setting Boundaries in Daily Life; (3) Lifestyle (general and tobacco and harmful alcohol use); (4) Healthy Nutrition; (5) Being Physically Active in a Healthy Way; and (6) Interaction With Health Professionals. These courses were based on behavioral change techniques (BCTs) (eg, self-monitoring of behavior, modeling, re-evaluation of outcomes), which were incorporated in the courses through general written information: quotes from and videos of patients with CVD as role models and personalized feedback, diaries, and exercises. The adoption and implementation plan (Step 5) was set up in collaboration with the members of the two expert groups and consisted of a written and digital instruction manual, a flyer, bimonthly newsletters, and reminders by email and telephone to (re-)visit the program. The potential effectiveness of Vascular View will be evaluated (Step 6) in an early RCT to gain insight into relevant outcome variables and related effect sizes, and a process evaluation to identify intervention fidelity, potential working mechanisms, user statistics, and/or satisfaction.ConclusionA comprehensive, multi-component, tailored, Web-based, self-management support program and an early RCT were developed in order to empower patients to self-manage their CVD.Trial registrationNederlands Trial Register NTR5412; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=5412 (Archived by WebCite at http://www.webcitation.org/6jeUFVj40).
| S-EPMC5322199 | biostudies-literature
Project description:BackgroundSystemic sclerosis (scleroderma; SSc) is a rare autoimmune connective tissue disease. We completed an initial feasibility trial of an online self-administered version of the Scleroderma Patient-centered Intervention Network Self-Management (SPIN-SELF) Program using the cohort multiple randomized controlled trial (RCT) design. Due to low intervention offer uptake, we will conduct a new feasibility trial with progression to full-scale trial, using a two-arm parallel, partially nested RCT design. The SPIN-SELF Program has also been revised to include facilitator-led videoconference group sessions in addition to online material. We will test the group-based intervention delivery format, then evaluate the effect of the SPIN-SELF Program on disease management self-efficacy (primary) and patient activation, social appearance anxiety, and functional health outcomes (secondary).MethodsThis study is a feasibility trial with progression to full-scale RCT, pending meeting pre-defined criteria, of the SPIN-SELF Program. Participants will be recruited from the ongoing SPIN Cohort ( http://www.spinsclero.com/en/cohort ) and via social media and partner patient organizations. Eligible participants must have SSc and low to moderate disease management self-efficacy (Self-Efficacy for Managing Chronic Disease (SEMCD) Scale score ≤ 7.0). Participants will be randomized (1:1 allocation) to the group-based SPIN-SELF Program or usual care for 3 months. The primary outcome in the full-scale trial will be disease management self-efficacy based on SEMCD Scale scores at 3 months post-randomization. Secondary outcomes include SEMCD scores 6 months post-randomization plus patient activation, social appearance anxiety, and functional health outcomes at 3 and 6 months post-randomization. We will include 40 participants to assess feasibility. At the end of the feasibility portion, stoppage criteria will be used to determine if the trial procedures or SPIN-SELF Program need important modifications, thereby requiring a re-set for the full-scale trial. Otherwise, the full-scale RCT will proceed, and outcome data from the feasibility portion will be utilized in the full-scale trial. In the full-scale RCT, 524 participants will be recruited.DiscussionThe SPIN-SELF Program may improve disease management self-efficacy, patient activation, social appearance anxiety, and functional health outcomes in people with SSc. SPIN works with partner patient organizations around the world to disseminate its programs free-of-charge.Trial registrationClinicalTrials.gov NCT04246528 . Registered on 27 January 2020.
| S-EPMC8626736 | biostudies-literature
Project description:ImportanceAs the number of patients with diabetes continues to increase in the United States, novel approaches to clinical care access should be considered to meet the care needs for this population, including support for diabetes-related technology.ObjectiveTo evaluate a virtual clinic to facilitate comprehensive diabetes care, support continuous glucose monitoring (CGM) integration into diabetes self-management, and provide behavioral health support for diabetes-related issues.Design, setting, and participantsThis cohort study was a prospective, single-arm, remote study involving adult participants with type 1 or type 2 diabetes who were referred through community resources. The study was conducted virtually from August 24, 2020, to May 26, 2022; analysis was conducted at the clinical coordinating center.InterventionTraining and education led by a Certified Diabetes Care and Education Specialist for CGM use through a virtual endocrinology clinic structure, which included endocrinologists and behavioral health team members.Main outcomes and measuresMain outcomes included CGM-measured mean glucose level, coefficient of variation, and time in range (TIR) of 70 to 180 mg/dL, time with values greater than 180 mg/dL or 250 mg/dL, and time with values less than 70 mg/dL or 54 mg/dL. Hemoglobin A1c was measured at baseline and at 12 and 24 weeks.ResultsAmong the 234 participants, 160 had type 1 diabetes and 74 had type 2 diabetes. The mean (SD) age was 47 (14) years, 123 (53%) were female, and median diabetes duration was 20 years. Median (IQR) CGM use over 6 months was 96% (91%-98%) for participants with type 1 diabetes and 94% (85%-97%) for those with type 2 diabetes. Mean (SD) hemoglobin A1c (HbA1c) in those with type 1 diabetes decreased from 7.8% (1.6%) at baseline to 7.1% (1.0%) at 3 months and 7.1% (1.0%) at 6 months (mean change from baseline to 6 months, -0.6%, 95% CI, -0.8% to -0.5%; P < .001), with an 11% mean TIR increase over 6 months (95% CI, 9% to 14%; P < .001). Mean HbA1c in participants with type 2 diabetes decreased from 8.1% (1.7%) at baseline to 7.1% (1.0%) at 3 months and 7.1% (0.9%) at 6 months (mean change from baseline to 6 months, -1.0%; 95% CI, -1.4% to -0.7%; P < .001), with an 18% TIR increase over 6 months (95% CI, 13% to 24%; P < .001). In participants with type 1 diabetes, mean percentage of time with values less than 70 mg/dL and less than 54 mg/dL decreased over 6 months by 0.8% (95% CI, -1.2% to -0.4%; P = .001) and by 0.3% (95% CI, -0.5% to -0.2%, P < .001), respectively. In the type 2 diabetes group, hypoglycemia was rare (mean [SD] percentage of time <70 mg/dL, 0.5% [0.6%]; and <54 mg/dL, 0.07% [0.14%], over 6 months).Conclusions and relevanceResults from this cohort study demonstrated clinical benefits associated with implementation of a comprehensive care model that included diabetes education. This model of care has potential to reach a large portion of patients with diabetes, facilitate diabetes technology adoption, and improve glucose control.
| S-EPMC10551767 | biostudies-literature
Project description:ObjectiveTo evaluate feasibility of System Support Mapping (MAP), a systems thinking activity that involves creating a diagram of existing self-management activities (e.g. symptom management, health behaviors) to facilitate autonomous engagement in optimal self-management.DesignOne-arm pilot study of MAP in colorectal cancer survivors (NCT03520283).Main outcome measuresFeasibility of recruitment and retention (primary outcome), acceptability, and outcome variability over time.ResultsWe enrolled 24 of 66 cancer survivors approached (36%) and 20 completed follow-up (83%). Key reasons for declining participation included: not interested (n = 18), did not perceive a need (n = 9), and emotional distress/overwhelmed (n = 7). Most participants reported that MAP was acceptable (e.g. 80% liked MAP quite a bit/very much). Exploratory analyses revealed a -4.68 point reduction in fatigue from before to 2 weeks after MAP exceeding a minimally important difference (d = -0.68). There were also improvements in patient autonomy (d = 0.63), self-efficacy (for managing symptoms: d = 0.56, for managing chronic disease: d = 0.44), psychological stress (d = -0.45), anxiety (d = -0.34), sleep disturbance (d = -0.29) and pain (d = -0.32). Qualitative feedback enhanced interpretation of results.ConclusionsMAP feasibility in colorectal cancer survivors was mixed, predominantly because many patients did not perceive a need for this approach. MAP was acceptable among participants and showed promise for improving health outcomes.
| S-EPMC8957632 | biostudies-literature
Project description:BackgroundThis study examines the effects of the COPD-specific health promoting self-management intervention "Better living with COPD" on different self-management-related domains, self-efficacy, and sense of coherence (SOC).MethodsIn a randomized controlled design, 182 people with COPD were allocated to either an intervention group (offered Better living with COPD in addition to usual care) or a control group (usual care). Self-management-related domains were measured by the Health Education Impact Questionnaire (heiQ) before and after intervention. Self-efficacy was measured by the General Self-Efficacy Scale (GSE) and SOC was measured by the 13-item Sense of Coherence Scale (SOC-13). Effects were assessed by ANCOVA, using intention-to-treat (ITT) analysis and per-protocol analysis (PPA).ResultsThe PPA and the ITT analysis showed significant positive changes on Constructive attitudes and approaches (heiQ) (ITT: P=0.0069; PPA: P=0.0021) and Skill and technique acquisition (heiQ) (ITT: P=0.0405; PPA: P=0.0356). Self-monitoring and insight (heiQ) showed significant positive change in the PPA (P=0.0494). No significant changes were found on the other self-management domains (heiQ), self-efficacy (GSE), or SOC (SOC-13).ConclusionBetter living with COPD had a significant positive short-term effect on some self-management-related domains, and could be an intervention contributing to the support of self-management in people with COPD. However, further work is needed to establish the clinical relevance of the findings and to evaluate the long-term effects.
| S-EPMC6231510 | biostudies-literature
Project description:IntroductionChronic obstructive pulmonary disease (COPD) is associated with substantial functional morbidity, including activity-limiting symptoms such as dyspnea and fatigue. Self-management interventions aid in symptomatic management of COPD and have been shown to produce positive outcomes on quality of life (QOL) and reduce hospital admissions.PurposeThe purpose of this randomized controlled longitudinal pilot study was to assess feasibility of the combined Respiratory Fitness (RESP-FIT) + Smartphone Airway Management System (SAMS) program, a 6-week, self-management, technology-enhanced respiratory muscle strength training (RMST) mHealth intervention.Patients and methodsFeasibility was assessed by evaluating recruitment, retention, acceptability, adherence, and safety data. Data were collected from 30 participants (15 in intervention group, 15 in control) at 3 time points (baseline, 6 weeks, and 14 weeks). The intervention group was requested to perform RMST at regular intervals during the week (5 breaths, 5 times a day, 5 days a week). Bluetooth enabled tracking was used to track training sessions. Data were analyzed using descriptive statistics.ResultsRecruitment was staggered for device usage and was completed in 57 weeks, with near 90% retention from baseline to end-of-intervention. Mobile application rating scale scores and interview data indicated moderate satisfaction. Participants completed 14,388 actions in the app. The most commonly used features were recording of daily symptoms via ecological momentary assessment (EMA) and tracking RMST if assigned to training sessions. Training days were successfully captured using EMA, but Bluetooth enabled training tracking was found to be not feasible. Overall, participants reported satisfaction with the RESP-FIT + SAMS mHealth intervention and found it acceptable.ConclusionRESP-FIT is feasible and enables real-time COPD symptom assessment in the home environment, but additional work is needed to integrate Bluetooth technology into the platform. Ongoing investigations focus on the accuracy of symptom perception, self-efficacy, and momentary factors that impact adherence behaviors.
| S-EPMC8650775 | biostudies-literature