Self-management Trials Research Articles

Evaluation of Exacerbation and Symptom-Free Time in Patients with COPD

In clinical practice, clinicians mainly focus on Chronic Obstructive Pulmonary Disease (COPD) exacerbations and symptoms, while patients may prefer to evaluate periods free of COPD exacerbations and deteriorated symptoms. The latter would suit the positive health approach that centralizes people and their beliefs. We aimed to identify patient characteristics and health outcomes relating to: 1) COPD exacerbation-free days; 2) days with no more symptoms than usual; and 3) combined COPD exacerbation and comorbid flare-up-free days (i.e. chronic heart failure, anxiety, depression flare-ups) using negative binomial regression analyzes. Data were obtained from two self-management intervention trials including COPD patients with and without comorbidities. 313 patients (mean age 66.0 years, 63.6% male, 68.7% comorbidity) were included. Better baseline chronic respiratory questionnaire (CRQ) fatigue (incidence rate ratio (IRR) = 1.03 (95% CI 1.01–1.05), p = 0.02) and mastery scores (IRR = 1.03 (95% CI 1.00–1.06), p = 0.04) and fewer courses of antibiotics (IRR = 0.95 (95% CI 0.94–0.96), p < 0.01) were related to more COPD exacerbation-free days. Additionally, better baseline CRQ fatigue (IRR = 1.05 (95% CI 1.00–1.10), p = 0.04) and mastery scores (IRR = 1.06 (95% CI 1.00–1.12), p = 0.04), fewer courses of antibiotics (IRR = 0.94 (95% CI 0.91–0.96), p < 0.01), and improved CRQ dyspnea scores over 12 months of follow-up (IRR = 1.07 (95% CI 1.01–1.12), p < 0.01) were correlated to more days free of deteriorated symptoms. Less baseline dyspnea (modified Medical Research Council score) (IRR = 0.95 (95% CI 0.92–0.98), p < 0.01) and fewer courses of antibiotics (IRR = 0.94 (95% CI 0.93–0.95), p < 0.01) were associated with more combined COPD exacerbation and comorbid flare-up-free days. Healthcare professionals should be aware that less fatigue and better mastering of COPD relate to more exacerbation and symptom-free time in COPD patients.

Predictors of patient adherence to COPD self-management exacerbation action plans

ObjectiveIdentifying patient characteristics predicting categories of patient adherence to Chronic Obstructive Pulmonary Disease (COPD) exacerbation action plans. MethodsData were obtained from self-treatment intervention groups of two COPD self-management trials. Patients with ≥1 exacerbation and/or ≥1 self-initiated prednisolone course during one-year follow-up were included. Optimal treatment was defined as ‘self-initiating prednisolone treatment ≤2 days from the onset of a COPD exacerbation’. Predictors of adherence categories were identified by multinomial logistic regression analysis using patient characteristics. Results145 COPD patients were included and allocated to four adherence categories: ‘optimal treatment’ (26.2 %), ‘sub optimal treatment’ (11.7 %), ‘significant delay or no treatment’ (31.7 %), or ‘treatment outside the actual exacerbation period’ (30.3 %). One unit increase in baseline dyspnoea score (mMRC scale 0–4) increased the risk of ‘significant delay or no treatment’ (OR 1.64 (95 % CI 1.07−2.50)). Cardiac comorbidity showed a borderline significant increased risk of ‘treatment outside the actual exacerbation period’ (OR 2.40 (95 % CI 0.98−5.85)). ConclusionMore severe dyspnoea and cardiac comorbidity may lower adherence to COPD exacerbation action plans. Practice implicationsTailored self-management support with more focus on dyspnoea and cardiac disease symptoms may help patients to better act upon increased exacerbation symptoms and improve adherence to COPD exacerbation action plans.

Effectiveness of chronic obstructive pulmonary disease self-management interventions in primary care settings: a systematic review.

Chronic obstructive pulmonary disease (COPD) is one of the more disabling diseases and the third cause of mortality worldwide. Self-management is considered an effective strategy for controlling and managing COPD. This review aims to summarise the available evidence on the effectiveness of COPD self-management in primary care settings. Social Sciences, Citation Index, MEDLINE, CINAHL, Academic Search Complete and Scopus were searched for randomised controlled trials of COPD self-management in general practice between 2001 and 2018. Ten randomised controlled trials of COPD self-management trials conducted in primary care settings were included in this review. The identified trials have recruited stable patients; a majority having mild to moderate COPD. The trials implemented different types of interventions and measured improvements in knowledge, skills and behaviours of self-management, mental health, self-efficacy and endpoint outcomes such as hospitalisation and quality of life. The findings showed that COPD self-management trials had positive effects on COPD knowledge and improved self-management behaviours such as adherence to medication, physical activities and smoking cessation in some cases; however, the effect of trials on hospitalisation rate, quality of life and healthcare utilisation were not conclusive. There was also not enough evidence to suggest that the trials were efficient in improving self-efficacy, a major driver of self-management behaviours. Primary care COPD self-management trials are efficient in improving surrogate outcomes such as knowledge of and adherence to self-management behaviours; however, such improvements are less likely to be sustainable in the absence of self-efficacy. Future studies should also focus on improving endpoint self-management outcomes like hospitalisation rate and quality of life to benefit both patient and healthcare system.

Systematic review of the effectiveness of community-based self-management interventions among primary care COPD patients

COPD self-management reduces hospital admissions and improves health-related quality of life (HRQoL). However, whilst most patients are managed in primary care, the majority of self-management trials have recruited participants with more severe disease from secondary care. We report the findings of a systematic review of the effectiveness of community-based self-management interventions in primary care patients with COPD. We systematically searched eleven electronic databases and identified 12 eligible randomised controlled trials with seven included in meta-analyses for HRQoL, anxiety and depression. We report no difference in HRQoL at final follow-up (St George’s Respiratory Questionnaire total score −0.29; 95%CI −2.09, 1.51; I2 0%), nor any difference in anxiety or depression. In conclusion, supported self-management interventions delivered in the community to patients from primary care do not appear to be effective. Further research is recommended to identify effective self-management interventions suitable for primary care populations, particularly those with milder disease.

One-to-one oral hygiene advice provided in a dental setting for oral health.

Effective oral hygiene measures carried out on a regular basis are vital to maintain good oral health. One-to-one oral hygiene advice (OHA) within the dental setting is often provided as a means to motivate individuals and to help achieve improved levels of oral health. However, it is unclear if one-to-one OHA in a dental setting is effective in improving oral health and what method(s) might be most effective and efficient. To assess the effects of one-to-one OHA, provided by a member of the dental team within the dental setting, on patients' oral health, hygiene, behaviour, and attitudes compared to no advice or advice in a different format. Cochrane Oral Health's Information Specialist searched the following databases: Cochrane Oral Health's Trials Register (to 10 November 2017); the Cochrane Central Register of Controlled Trials (CENTRAL; 2017, Issue 10) in the Cochrane Library (searched 10 November 2017); MEDLINE Ovid (1946 to 10 November 2017); and Embase Ovid (1980 to 10 November 2017). The US National Institutes of Health Ongoing Trials Register (ClinicalTrials.gov) and the World Health Organization International Clinical Trials Registry Platform were also searched for ongoing trials (10 November 2017). No restrictions were placed on the language or date of publication when searching the electronic databases. Reference lists of relevant articles and previously published systematic reviews were handsearched. The authors of eligible trials were contacted, where feasible, to identify any unpublished work. We included randomised controlled trials assessing the effects of one-to-one OHA delivered by a dental care professional in a dental care setting with a minimum of 8 weeks follow-up. We included healthy participants or participants who had a well-defined medical condition. At least two review authors carried out selection of studies, data extraction and risk of bias independently and in duplicate. Consensus was achieved by discussion, or involvement of a third review author if required. Nineteen studies met the criteria for inclusion in the review with data available for a total of 4232 participants. The included studies reported a wide variety of interventions, study populations, clinical outcomes and outcome measures. There was substantial clinical heterogeneity amongst the studies and it was not deemed appropriate to pool data in a meta-analysis. We summarised data by categorising similar interventions into comparison groups.Comparison 1: Any form of one-to-one OHA versus no OHAFour studies compared any form of one-to-one OHA versus no OHA.Two studies reported the outcome of gingivitis. Although one small study had contradictory results at 3 months and 6 months, the other study showed very low-quality evidence of a benefit for OHA at all time points (very low-quality evidence).The same two studies reported the outcome of plaque. There was low-quality evidence that these interventions showed a benefit for OHA in plaque reduction at all time points.Two studies reported the outcome of dental caries at 6 months and 12 months respectively. There was very low-quality evidence of a benefit for OHA at 12 months.Comparison 2: Personalised one-to-one OHA versus routine one-to-one OHAFour studies compared personalised OHA versus routine OHA.There was little evidence available that any of these interventions demonstrated a difference on the outcomes of gingivitis, plaque or dental caries (very low quality).Comparison 3: Self-management versus professional OHAFive trials compared some form of self-management with some form of professional OHA.There was little evidence available that any of these interventions demonstrated a difference on the outcomes of gingivitis or plaque (very low quality). None of the studies measured dental caries.Comparison 4: Enhanced one-to-one OHA versus one-to-one OHASeven trials compared some form of enhanced OHA with some form of routine OHA.There was little evidence available that any of these interventions demonstrated a difference on the outcomes of gingivitis, plaque or dental caries (very low quality). There was insufficient high-quality evidence to recommend any specific one-to-one OHA method as being effective in improving oral health or being more effective than any other method. Further high-quality randomised controlled trials are required to determine the most effective, efficient method of one-to-one OHA for oral health maintenance and improvement. The design of such trials should be cognisant of the limitations of the available evidence presented in this Cochrane Review.

Assessing depression severity with a self-rated vs. rater-administered instrument in patients with epilepsy

RationaleUp to 30–50% of individuals with epilepsy have depressive symptoms, which often complicate seizure management and reduce overall quality of life. To identify and manage depressive symptoms appropriately, clinicians need standardized instruments that can accurately identify and monitor those with clinically significant depression. The self-reported 9-item Patient Health Questionnaire (PHQ-9) has been used relatively widely to screen and monitor depression in epilepsy. The rater-administered Montgomery–Asberg Depression Rating Scale (MADRS) is a rater-administered instrument widely used in depression treatment trials but less widely applied in epilepsy. This secondary analysis from 2 epilepsy self-management clinical trials compared depression severity ratings using the PHQ-9 and the MADRS instruments. MethodsData for this analysis were derived from pooled baseline and longitudinal data from 2 prospective epilepsy self-management randomized controlled trials (RCTs). Both RCTs assessed depression with the PHQ-9 and the MADRS. For this analysis, total depression severity scores and case classification of individuals with no/minimal, mild, moderate/moderately severe, and severe depression were assessed using both PHQ-9 and MADRS. ResultsThe sample contained 164 individuals with epilepsy. Demographic and clinical variables between the 2 studies were generally similar. There were 107 women (64.8%), 106 African-Americans (64.2%), and 51 Whites (30.9%). Individuals had epilepsy for an average of 22.1 (SD: 15.5). Mean past 30-day seizure frequency at baseline was 3.1 (SD: 11.6). Baseline mean PHQ-9 was 10.7 (SD: 6.80) with depression severity of 32 (19.6%) not or minimally depressed, 47 (28.8%) mildly depressed, 37 (22.7%) moderately depressed, 27 (16.6%) moderately severely depressed, and 20 (12.3%) severely depressed. Baseline mean MADRS severity was 18.5 (SD: 11.3) with 30 (18.8%) not or minimally depressed, 27 (16.9%) mildly depressed, 92 (56.1%) moderately depressed, and 11 (6.9%) severely depressed. The correlation between total PHQ-9 and total MADRS was 0.843 (p < .01) although case classification by depression severity varied somewhat between the two instruments. ConclusionsStandardized measures to evaluate depression severity in people with epilepsy can help identify cases and monitor treatment. The PHQ-9 and MADRS both perform well in assessing depression in people with epilepsy although administration burden is less with PHQ-9 thus making it likely preferable for settings where time and epilepsy specialty resources are limited.

Comparison of Self-Efficacy for Managing Chronic Disease between patients with systemic sclerosis and other chronic conditions: a systematic review.

The complexity and burden of systemic sclerosis (SSc) pose challenges to developing and sustaining disease management self-efficacy. The objective of this systematic review was to compare scores on a commonly used self-efficacy measure, the Self-Efficacy for Managing Chronic Disease (SEMCD) Scale, between SSc and other diseases. Data sources included the CINAHL, EMBASE, MEDLINE, and Scopus databases, searched through January 25, 2016, and reference lists of included articles and relevant reviews. Studies in any language that reported total SEMCD scores or individual item scores in adult non-psychiatric medical patients were eligible. We identified one eligible non-intervention study of SSc patients (n=553), 13 other non-intervention studies, and 21 studies with pre-intervention data for patients enrolled in a self-management program or a trial of a program. Of 13 non-intervention studies with published total score means in cancer, cardiovascular disease, Parkinson's disease, spinal cord injuries, organ transplant candidates and recipients, dialysis, and lupus, SEMCD scores were statistically significantly lower (poorer self-efficacy) in SSc than 6 other disease samples, not significantly different from 6, and significantly higher than lupus patients. Compared to 18 studies of patients in self-management programs or trials with published total score means, SSc patients were similar or lower than 9 samples and significantly higher than 9 samples. Compared to patients with other diseases not enrolled in programs to improve self-efficacy, SSc patients report lower self-efficacy scores than most patient groups. Rigorously tested self-care interventions designed to meet the unique needs of patients with SSc are needed.

Patient self-management in primary care patients with mild COPD – protocol of a randomised controlled trial of telephone health coaching

BackgroundThe prevalence of diagnosed chronic obstructive pulmonary disease (COPD) in the UK is 1.8%, although it is estimated that this represents less than half of the total disease in the population as much remains undiagnosed. Case finding initiatives in primary care will identify people with mild disease and symptoms. The majority of self-management trials have identified patients from secondary care clinics or following a hospital admission for exacerbation of their condition. This trial will recruit a primary care population with mild symptoms of COPD and use telephone health coaching to encourage self-management.Methods/DesignIn this study, using a multi-centred randomised controlled trial (RCT) across at least 70 general practices in England, we plan to establish the effectiveness of nurse-led telephone health coaching to support self-management in primary care for people who report only mild symptoms of their COPD (MRC grade 1 and 2) compared to usual care. The intervention focuses on taking up smoking cessation services, increasing physical activity, medication management and action planning and is underpinned by behavioural change theory. In total, we aim to recruit 556 patients with COPD confirmed by spirometry with follow up at six and 12 months. The primary outcome is health related quality of life using the St Georges Respiratory Questionnaire (SGRQ). Spirometry and BMI are measured at baseline. Secondary outcomes include self-reported health behaviours (smoking and physical activity), physical activity measured by accelerometery (at 12 months), psychological morbidity, self-efficacy and cost-effectiveness of the intervention. Longitudinal qualitative interviews will explore how engaged participants were with the intervention and how embedded behaviour change was in every day practices.DiscussionThis trial will provide robust evidence about the effectiveness of a novel telephone health coaching intervention to promote behaviour change and prevent disease progression in patients with mild symptoms of dyspnoea in primary care.Trial registrationCurrent controlled trials ISRCTN06710391.

Towards tailoring of self-management for patients with chronic heart failure or chronic obstructive pulmonary disease: a protocol for an individual patient data meta-analysis

IntroductionSelf-management interventions in patients with chronic conditions have received increasing attention over the past few years, yet the meta-analyses encountered considerable heterogeneity in results. This suggests that the effectiveness of...

AB1437-HPR Measurement issues in the evaluation of arthritis self-management interventions

BackgroundInterventions aimed at delivering self-management support and education for people with chronic conditions have long been recognized as an important aspect of chronic disease management. However, current evidence regarding program...

Measurement issues in the evaluation of chronic disease self-management programs

To provide an in-depth analysis of outcome measures used in the evaluation of chronic disease self-management programs consistent with the Stanford curricula. Based on a systematic review on self-management programs, effect sizes derived from reported outcome measures are categorized according to the quality of life appraisal model developed by Schwartz and Rapkin which classifies outcomes from performance-based measures (e.g., clinical outcomes) to evaluation-based measures (e.g., emotional well-being). The majority of outcomes assessed in self-management trials are based on evaluation-based methods. Overall, effects on knowledge--the only performance-based measure observed in selected trials--are generally medium to large. In contrast, substantially more inconsistent results are found for both perception- and evaluation-based measures that mostly range between nil and small positive effects. Effectiveness of self-management interventions and resulting recommendations for health policy makers are most frequently derived from highly variable evaluation-based measures, that is, types of outcomes that potentially carry a substantial amount of measurement error and/or bias such as response shift. Therefore, decisions regarding the value and efficacy of chronic disease self-management programs need to be interpreted with care. More research, especially qualitative studies, is needed to unravel cognitive processes and the role of response shift bias in the measurement of change.

Action Plan to enhance self-management and early detection of exacerbations in COPD patients; a multicenter RCT

BackgroundEarly detection of exacerbations by COPD patients initiating prompt interventions has shown to be clinically relevant. Until now, research failed to identify the effectiveness of a written individualized Action Plan (AP) to achieve this.Methods/DesignThe current multicenter, single-blind RCT with a follow-up period of 6 months, evaluates the hypothesis that individualized AP's reduce exacerbation recovery time. Patients are included from regular respiratory nurse clinics and allocated to either usual care or the AP intervention. The AP provides individualized treatment prescriptions (pharmaceutical and non-pharmaceutical) related to a color coded symptom status (reinforcement at 1 and 4 months). Although usually not possible in self-management trials, we ensured blinding of patients, using a modified informed consent procedure in which patients give consent to postponed information. Exacerbations in both study arms are defined using the Anthonisen symptom diary-card algorithm. The Clinical COPD Questionnaire (CCQ) is assessed every 3-days. CCQ-recovery time of an exacerbation is the primary study outcome. Additionally, healthcare utilization, anxiety, depression, treatment delay, and self-efficacy are assessed at baseline and 6 months. We aim at including 245 COPD patients from 7 hospitals and 5 general practices to capture the a-priori sample size of at least 73 exacerbations per study arm.DiscussionThis RCT identifies if an AP is an effective component of self-management in patients with COPD and clearly differentiates from existing studies in its design, outcome measures and generalizability of the results considering that the study is carried out in multiple sites including general practices.Trial RegistrationNCT00879281