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Effects of a COPD self-management support intervention: a randomized controlled trial.

ABSTRACT: Background:This 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). Methods:In 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). Results:The 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). Conclusion:Better 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.

SUBMITTER: Bringsvor HB

PROVIDER: S-EPMC6231510 | biostudies-literature | 2018

REPOSITORIES: biostudies-literature

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Effects of a COPD self-management support intervention: a randomized controlled trial.

Bringsvor Heidi B HB Langeland Eva E Oftedal Bjørg Frøysland BF Skaug Knut K Assmus Jörg J Bentsen Signe Berit SB

International journal of chronic obstructive pulmonary disease 20181108

<h4>Background</h4>This 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).<h4>Methods</h4>In 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 H ...[more]

PMID: 30510410

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Project description:Background:Atrial fibrillation (AF) is the most common arrhythmia worldwide. Despite effective treatment, it is characterized by frequent recurrences. Optimal therapeutic management of AF requires active participation and self-management from patients. Two major components of self-management are self-monitoring and sign-and-symptom management. Pulse self-palpation (PSP) is a method of self-monitoring; however, not all AF patients are capable of successfully performing PSP. Due to a lack of interventions on this topic, a nurse-led intervention for patients with AF (PSPAF intervention) was developed to foster self-monitoring and to enhance self-management through PSP. The purpose of this pilot study was to test the acceptability, feasibility, and potential effects of this intervention on the capability of patients' PSP and sign-and-symptom management. Moreover, we aimed at gathering data on the feasibility of applied research methods to aid in the design of future studies. Methods:The pilot trial involved 20 adult patients with AF, randomized to an intervention or usual care group. At baseline and during a home visit 3-5?weeks later, we collected data using questionnaires, checklists, field notes, a mobile ECG device, and a diary. Acceptability and feasibility measures were validated through predefined cut-off points. Effect size estimates were expressed as relative risks (RR) and the number needed to treat (NNT). Results:The PSPAF intervention seemed feasible, but only partly acceptable. There were limitations in terms of potential effectiveness, suitability, addressing participants' willingness to implement its content in daily life, and adherence. Estimations of effect sizes suggest a large effect of the intervention on patients' PSP capability (RR = 6.0; 95% CI = [0.83, 43.3]; NNT = 2.4), but almost no effect on sign-and-symptom management (RR = 1.5; 95% CI = [0.7, 3.1]; NNT = 4.0). The feasibility of applied research methods showed minor limitations on recruitment and participant burden. Conclusions:Despite some limitations, the intervention seemed to be applicable and promising. Taking into account the suggestions and amendments we have made, we recommend conducting a full-scale trial to examine the efficacy of the PSPAF intervention. Trial registration:This pilot study was registered in the German Clinical Trials Register at September 4, 2017 (Main ID: DRKS00012808).

Project description:BackgroundPain is a prevalent and distressing symptom in patients with cancer, having an enormous impact on functioning and quality of life. Fragmentation of care, inadequate pain communication, and reluctance towards pain medication contribute to difficulties in optimizing outcomes. Integration of patient self-management and professional care by means of healthcare technology provides new opportunities in the outpatient setting.Methods/designThis study protocol outlines a two-armed multicenter randomized controlled trial that compares a technology based multicomponent self-management support intervention with care as usual and includes an effect, economic and process evaluation. Patients will be recruited consecutively via the outpatient oncology clinics and inpatient oncology wards of one academic hospital and one regional hospital in the south of the Netherlands. Irrespective of the stage of disease, patients are eligible when they are diagnosed with cancer and have uncontrolled moderate to severe cancer (treatment) related pain defined as NRS≥4 for more than two weeks. Randomization (1:1) will assign patients to either the intervention or control group; patients in the intervention group receive self-management support and patients in the control group receive care as usual. The intervention will be delivered by registered nurses specialized in pain and palliative care. Important components include monitoring of pain, adverse effects and medication as well as graphical feedback, education, and nurse support. Effect measurements for both groups will be carried out with questionnaires at baseline (T0), after 4 weeks (T1) and after 12 weeks (T2). Pain intensity and quality of life are the primary outcomes. Secondary outcomes include self-efficacy, knowledge, anxiety, depression and pain medication use. The final questionnaire contains also questions for the economic evaluation that includes both cost-effectiveness and cost-utility analysis. Data for the process evaluation will be gathered continuously over the study period and focus on recruitment, reach, dose delivered and dose received.DiscussionThe proposed study will provide insight into the effectiveness of the self-management support intervention delivered by nurses to outpatients with uncontrolled cancer pain. Study findings will be used to empower patients and health professionals to improve cancer pain control.Trial registrationNCT02333968 December 29, 2014.

Project description:BackgroundThe financial costs associated with asthma care continue to increase while care remains suboptimal. Promoting optimal self-management, including the use of asthma action plans, along with regular health professional review has been shown to be an effective strategy and is recommended in asthma guidelines internationally. Despite evidence of benefit, guided self-management remains underused, however the potential for online resources to promote self-management behaviors is gaining increasing recognition. The aim of this paper is to describe the protocol for a pilot evaluation of a website 'Living well with asthma' which has been developed with the aim of promoting self-management behaviors shown to improve outcomes.Methods/designThe study is a parallel randomized controlled trial, where adults with asthma are randomly assigned to either access to the website for 12 weeks, or usual asthma care for 12 weeks (followed by access to the website if desired). Individuals are included if they are over 16-years-old, have a diagnosis of asthma with an Asthma Control Questionnaire (ACQ) score of greater than, or equal to 1, and have access to the internet. Primary outcomes for this evaluation include recruitment and retention rates, changes at 12 weeks from baseline for both ACQ and Asthma Quality of Life Questionnaire (AQLQ) scores, and quantitative data describing website usage (number of times logged on, length of time logged on, number of times individual pages looked at, and for how long). Secondary outcomes include clinical outcomes (medication use, health services use, lung function) and patient reported outcomes (including adherence, patient activation measures, and health status).DiscussionPiloting of complex interventions is considered best practice and will maximise the potential of any future large-scale randomized controlled trial to successfully recruit and be able to report on necessary outcomes. Here we will provide results across a range of outcomes which will provide estimates of efficacy to inform the design of a future full-scale randomized controlled trial of the 'Living well with asthma' website.Trial registrationThis trial is registered with Current Controlled Trials ISRCTN78556552 on 18/06/13.

Project description:BackgroundThis study evaluated the efficacy of the PASSAGE Program, a structured multicomponent interdisciplinary group intervention for the self-management of FMS.MethodsA mixed-methods randomized controlled trial (intervention (INT) vs. waitlist (WL)) was conducted with patients suffering from FMS. Data were collected at baseline (T0), at the end of the intervention (T1), and 3 months later (T2). The primary outcome was change in pain intensity (0-10). Secondary outcomes were fibromyalgia severity, pain interference, sleep quality, pain coping strategies, depression, health-related quality of life, patient global impression of change (PGIC), and perceived pain relief. Qualitative group interviews with a subset of patients were also conducted. Complete data from T0 to T2 were available for 43 patients.ResultsThe intervention had a statistically significant impact on the three PGIC measures. At the end of the PASSAGE Program, the percentages of patients who perceived overall improvement in their pain levels, functioning and quality of life were significantly higher in the INT Group (73%, 55%, 77% respectively) than in the WL Group (8%, 12%, 20%). The same differences were observed 3 months post-intervention (Intervention group: 62%, 43%, 38% vs Waitlist Group: 13%, 13%, 9%). The proportion of patients who reported ? 50% pain relief was also significantly higher in the INT Group at the end of the intervention (36% vs 12%) and 3 months post-intervention (33% vs 4%). Results of the qualitative analysis were in line with the quantitative findings regarding the efficacy of the intervention. The improvement, however, was not reflected in the primary outcome and other secondary outcome measures.ConclusionThe PASSAGE Program was effective in helping FMS patients gain a sense of control over their symptoms. We suggest including PGIC in future clinical trials on FMS as they appear to capture important aspects of the patients' experience.Trial registrationInternational Standard Randomized Controlled Trial Number Register ISRCTN14526380.

Project description:BACKGROUND:Cardiovascular disease (CVD) is a leading cause of hospitalization and death around the world. The prevalence of CVD is increasing and, therefore, development and investigation of effective programs to help people better self-manage their CVD and prevent secondary complications are needed. OBJECTIVE:In this paper, we report on a protocol to evaluate Healing Circles-an evidence-based and patient-informed peer support mobile health program designed to facilitate self-management and support patients in their recovery from and management of CVD. We hypothesize that individuals with CVD who use Healing Circles will experience greater improvements to their self-management ability than individuals receiving usual care. METHODS:In this single-blinded (assessor) randomized controlled trial, 250 community-living individuals with CVD will be randomized on a 1:1 basis to either Healing Circles or Usual Care. The primary outcome of self-management will be measured using the Health Education Impact Questionnaire version 3.0. Secondary outcomes include self-efficacy with chronic disease management, health-related quality of life, health resource use and costs, and electronic health literacy. Measurements will be taken at the baseline and every 6 months for 24 months. RESULTS:The study started recruitment in September 2017. Individuals are currently being recruited for participation, and existing participants are currently on follow-up. Measurements will be taken every 6 months until the study end, which is anticipated in December 2019. CONCLUSIONS:Healing Circles is a novel program aimed toward improving self-management through peer support. Given our real-world study design, our findings will be readily translatable into practice. If the results support our hypothesis, it will indicate that Healing Circles is an effective intervention for improving self-management and reducing health care use. TRIAL REGISTRATION:ClinicalTrials.gov NCT03159325; https://clinicaltrials.gov/ct2/show/NCT03159325 (Archived by WebCite at http://www.webcitation.org/74DvxVKUd). INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID):DERR1-10.2196/12322.

Project description:BACKGROUND:In patients with severe asthma, high-altitude climate treatment has been shown to improve asthma control. However, asthma symptoms and limitations may increase after finishing inpatient rehabilitation programs and returning to sea level. OBJECTIVE:We assessed the effectiveness of a patient-tailored, internet-based, self-management strategy in addition to usual care after finishing high-altitude climate treatment. METHODS:We performed a randomized controlled trial with a 1-year follow-up in patients from a high-altitude asthma center in Davos, Switzerland. At the end of a 12-week multidisciplinary rehabilitation program, 62 adults with asthma were randomized to receive either internet-based self-management support in addition to usual care (n=33) or usual care only after discharge (n=29). The endpoints were changes in asthma-related quality of life according to the Asthma Quality of Life Questionnaire (AQLQ) (a higher score is better) and asthma control according to the Asthma Control Questionnaire (ACQ) (a lower score is better), with a minimally important difference of 0.5 points for both. RESULTS:Asthma-related quality of life and asthma control declined over time in the usual care strategy group, whereas there was a slower decline in the internet-based strategy group. For both endpoints, mixed-model analysis showed a significant positive effect in favor of internet-based self-management during follow-up (mean AQLQ score difference 0.39, 95% CI 0.092-0.69; P=.01 and ACQ score difference -0.50, 95% CI -0.86 to -0.15; P=.006), which was prominent among patients with uncontrolled asthma at discharge (AQLQ score difference 0.59, 95% CI 0.19-0.99; P=.003 and ACQ score difference -0.73, 95% CI -1.18 to -0.28; P=.002). CONCLUSIONS:Internet-based self-management support was associated with a smaller decline in quality of life and asthma control as compared with usual care, especially in patients with lower asthma control, after completion of high-altitude climate treatment. Internet-based self-management support in adults with severe asthma seems feasible and effective to maintain quality of life and asthma control. TRIAL REGISTRATION:The trial is registered in the Netherlands Trial Register (NTR1995).

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.

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Effects of a COPD self-management support intervention: a randomized controlled trial.

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Effects of a COPD self-management support intervention: a randomized controlled trial.

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