User-Centered Design of a Mobile Health Intervention to Enhance Exacerbation-Related Self-Management in Patients With Chronic Obstructive Pulmonary Disease (Copilot): Mixed Methods Study.

BACKGROUND: Adequate self-management skills are of great importance for patients with chronic obstructive pulmonary disease (COPD) to reduce the impact of COPD exacerbations. Using mobile health (mHealth) to support exacerbation-related self-management could be promising in engaging patients in their own health and changing health behaviors. However, there is limited knowledge on how to design mHealth interventions that are effective, meet the needs of end users, and are perceived as useful. By following an iterative user-centered design (UCD) process, an evidence-driven and usable mHealth intervention was developed to enhance exacerbation-related self-management in patients with COPD. OBJECTIVE: This study aimed to describe in detail the full UCD and development process of an evidence-driven and usable mHealth intervention to enhance exacerbation-related self-management in patients with COPD. METHODS: The UCD process consisted of four iterative phases: (1) background analysis and design conceptualization, (2) alpha usability testing, (3) iterative software development, and (4) field usability testing. Patients with COPD, health care providers, COPD experts, designers, software developers, and a behavioral scientist were involved throughout the design and development process. The intervention was developed using the behavior change wheel (BCW), a theoretically based approach for designing behavior change interventions, and logic modeling was used to map out the potential working mechanism of the intervention. Furthermore, the principles of design thinking were used for the creative design of the intervention. Qualitative and quantitative research methods were used throughout the design and development process. RESULTS: The background analysis and design conceptualization phase resulted in final guiding principles for the intervention, a logic model to underpin the working mechanism of the intervention, and design requirements. Usability requirements were obtained from the usability testing phases. The iterative software development resulted in an evidence-driven and usable mHealth intervention-Copilot, a mobile app consisting of a symptom-monitoring module, and a personalized COPD action plan. CONCLUSIONS: By following a UCD process, an mHealth intervention was developed that meets the needs and preferences of patients with COPD, is likely to be used by patients with COPD, and has a high potential to be effective in reducing exacerbation impact. This extensive report of the intervention development process contributes to more transparency in the development of complex interventions in health care and can be used by researchers and designers as guidance for the development of future mHealth interventions.

Nurses' perceptions towards the delivery and feasibility of a behaviour change intervention to enhance physical activity in patients at risk for cardiovascular disease in primary care: a qualitative study.

BACKGROUND: Self-management support is widely accepted for the management of chronic conditions. Self-management often requires behaviour change in patients, in which primary care nurses play a pivotal role. To support patients in changing their behaviour, the structured behaviour change Activate intervention was developed. This intervention aims to enhance physical activity in patients at risk for cardiovascular disease in primary care as well as to enhance nurses' role in supporting these patients. This study aimed to evaluate nurses' perceptions towards the delivery and feasibility of the Activate intervention. METHODS: A qualitative study nested within a cluster-randomised controlled trial using semistructured interviews was conducted and thematically analysed. Fourteen nurses who delivered the Activate intervention participated. RESULTS: Three key themes emerged concerning nurses' perceptions of delivering the intervention: nurses' engagement towards delivering the intervention; acquiring knowledge and skills; and dealing with adherence to the consultation structure. Three key themes were identified concerning the feasibility of the intervention: expectations towards the use of the intervention in routine practice; perceptions towards the feasibility of the training programme; and enabling personal development. CONCLUSIONS: Delivering a behaviour change intervention is challenged by the complexity of changing nurses' consultation style, including acquiring corresponding knowledge and skills. The findings have increased the understanding of the effectiveness of the Activate trial and will guide the development and evaluation of future behaviour change interventions delivered by nurses in primary care. TRIAL REGISTRATION: ClinicalTrials.gov NCT02725203 .

Do Self-Management Interventions Work in Patients With Heart Failure? An Individual Patient Data Meta-Analysis.

BACKGROUND: Self-management interventions are widely implemented in the care for patients with heart failure (HF). However, trials show inconsistent results, and whether specific patient groups respond differently is unknown. This individual patient data meta-analysis assessed the effectiveness of self-management interventions in patients with HF and whether subgroups of patients respond differently. METHODS AND RESULTS: A systematic literature search identified randomized trials of self-management interventions. Data from 20 studies, representing 5624 patients, were included and analyzed with the use of mixed-effects models and Cox proportional-hazard models, including interaction terms. Self-management interventions reduced the risk of time to the combined end point of HF-related hospitalization or all-cause death (hazard ratio, 0.80; 95% confidence interval [CI], 0.71-0.89), time to HF-related hospitalization (hazard ratio, 0.80; 95% CI, 0.69-0.92), and improved 12-month HF-related quality of life (standardized mean difference, 0.15; 95% CI, 0.00-0.30). Subgroup analysis revealed a protective effect of self-management on the number of HF-related hospital days in patients <65 years of age (mean, 0.70 versus 5.35 days; interaction P=0.03). Patients without depression did not show an effect of self-management on survival (hazard ratio for all-cause mortality, 0.86; 95% CI, 0.69-1.06), whereas in patients with moderate/severe depression, self-management reduced survival (hazard ratio, 1.39; 95% CI, 1.06-1.83, interaction P=0.01). CONCLUSIONS: This study shows that self-management interventions had a beneficial effect on time to HF-related hospitalization or all-cause death and HF-related hospitalization alone and elicited a small increase in HF-related quality of life. The findings do not endorse limiting self-management interventions to subgroups of patients with HF, but increased mortality in depressed patients warrants caution in applying self-management strategies in these patients.

Characteristics of effective self-management interventions in patients with COPD: individual patient data meta-analysis.

It is unknown whether heterogeneity in effects of self-management interventions in patients with chronic obstructive pulmonary disease (COPD) can be explained by differences in programme characteristics. This study aimed to identify which characteristics of COPD self-management interventions are most effective.Systematic search in electronic databases identified randomised trials on self-management interventions conducted between 1985 and 2013. Individual patient data were requested for meta-analysis by generalised mixed effects models.14 randomised trials were included (67% of eligible), representing 3282 patients (75% of eligible). Univariable analyses showed favourable effects on some outcomes for more planned contacts and longer duration of interventions, interventions with peer contact, without log keeping, without problem solving, and without support allocation. After adjusting for other programme characteristics in multivariable analyses, only the effects of duration on all-cause hospitalisation remained. Each month increase in intervention duration reduced risk of all-cause hospitalisation (time to event hazard ratios 0.98, 95% CI 0.97-0.99; risk ratio (RR) after 6 months follow-up 0.96, 95% CI 0.92-0.99; RR after 12 months follow-up 0.98, 95% CI 0.96-1.00).Our results showed that longer duration of self-management interventions conferred a reduction in all-cause hospitalisations in COPD patients. Other characteristics are not consistently associated with differential effects of self-management interventions across clinically relevant outcomes.

What Are Effective Program Characteristics of Self-Management Interventions in Patients With Heart Failure? An Individual Patient Data Meta-analysis.

BACKGROUND: To identify those characteristics of self-management interventions in patients with heart failure (HF) that are effective in influencing health-related quality of life, mortality, and hospitalizations. METHODS AND RESULTS: Randomized trials on self-management interventions conducted between January 1985 and June 2013 were identified and individual patient data were requested for meta-analysis. Generalized mixed effects models and Cox proportional hazard models including frailty terms were used to assess the relation between characteristics of interventions and health-related outcomes. Twenty randomized trials (5624 patients) were included. Longer intervention duration reduced mortality risk (hazard ratio 0.99, 95% confidence interval [CI] 0.97-0.999 per month increase in duration), risk of HF-related hospitalization (hazard ratio 0.98, 95% CI 0.96-0.99), and HF-related hospitalization at 6 months (risk ratio 0.96, 95% CI 0.92-0.995). Although results were not consistent across outcomes, interventions comprising standardized training of interventionists, peer contact, log keeping, or goal-setting skills appeared less effective than interventions without these characteristics. CONCLUSION: No specific program characteristics were consistently associated with better effects of self-management interventions, but longer duration seemed to improve the effect of self-management interventions on several outcomes. Future research using factorial trial designs and process evaluations is needed to understand the working mechanism of specific program characteristics of self-management interventions in HF patients.

Feasibility of Exercise Training in Cancer Patients Scheduled for Elective Gastrointestinal Surgery.

BACKGROUND/AIMS: This study examines the feasibility of a preoperative exercise program to improve the physical fitness of a patient before gastrointestinal surgery. METHODS: An outpatient exercise program was developed to increase preoperative aerobic capacity, peripheral muscle endurance and respiratory muscle function in patients with pancreatic, liver, intestinal, gastric or esophageal cancer. During a consult at the outpatient clinic, patients were invited to participate in the exercise program when their surgery was not scheduled within 2 weeks. RESULTS: The 115 participants followed on average 5.7 (3.5) training sessions. Adherence to the exercise program was high: 82% of the planned training sessions were attended, and no adverse events occurred. Mixed model analyses showed a significant increase of maximal inspiratory muscle strength (84.1-104.7 cm H2O; p = 0.00) and inspiratory muscle endurance (35.0-39.5 cm H2O; p = 0.00). No significant changes were found in aerobic capacity and peripheral muscle strength. CONCLUSION: This exercise program in patients awaiting oncological surgery is feasible in terms of participation and adherence. Inspiratory muscle function improved significantly as a result of inspiratory muscle training. The exercise program however failed to result in improved aerobic capacity and peripheral muscle strength, probably due to the limited number of training sessions as a result of the restricted time interval between screening and surgery.

RELEASE-HF study: a protocol for an observational, registry-based study on the effectiveness of telemedicine in heart failure in the Netherlands.

INTRODUCTION: Meta-analyses show postive effects of telemedicine in heart failure (HF) management on hospitalisation, mortality and costs. However, these effects are heterogeneous due to variation in the included HF population, the telemedicine components and the quality of the comparator usual care. Still, telemedicine is gaining acceptance in HF management. The current nationwide study aims to identify (1) in which subgroup(s) of patients with HF telemedicine is (cost-)effective and (2) which components of telemedicine are most (cost-)effective. METHODS AND ANALYSIS: The RELEASE-HF ('REsponsible roLl-out of E-heAlth through Systematic Evaluation - Heart Failure') study is a multicentre, observational, registry-based cohort study that plans to enrol 6480 patients with HF using data from the HF registry facilitated by the Netherlands Heart Registration. Collected data include patient characteristics, treatment information and clinical outcomes, and are measured at HF diagnosis and at 6 and 12 months afterwards. The components of telemedicine are described at the hospital level based on closed-ended interviews with clinicians and at the patient level based on additional data extracted from electronic health records and telemedicine-generated data. The costs of telemedicine are calculated using registration data and interviews with clinicians and finance department staff. To overcome missing data, additional national databases will be linked to the HF registry if feasible. Heterogeneity of the effects of offering telemedicine compared with not offering on days alive without unplanned hospitalisations in 1 year is assessed across predefined patient characteristics using exploratory stratified analyses. The effects of telemedicine components are assessed by fitting separate models for component contrasts. ETHICS AND DISSEMINATION: The study has been approved by the Medical Ethics Committee 2021 of the University Medical Center Utrecht (the Netherlands). Results will be published in peer-reviewed journals and presented at (inter)national conferences. Effective telemedicine scenarios will be proposed among hospitals throughout the country and abroad, if applicable and feasible. TRIAL REGISTRATION NUMBER: NCT05654961.

Effect of an action plan with ongoing support by a case manager on exacerbation-related outcome in patients with COPD: a multicentre randomised controlled trial.

BACKGROUND: An individualised action plan (AP) is a potentially effective method of helping patients with chronic obstructive pulmonary disease (COPD) to recognise and anticipate early exacerbation symptoms. This multicentre randomised controlled trial evaluates the hypothesis that individualised APs reduce exacerbation recovery time. METHODS: Two hundred and thirty-three patients with COPD (age 65±10 years, forced expiratory volume in 1 s 56±21% predicted) were randomised to receive either an individualised AP (n=111) or care as usual (n=122). The AP provides individualised treatment prescriptions (pharmaceutical and non-pharmaceutical) related to a colour-coded symptom status to enhance an adequate response to periods of symptom deterioration (reinforced at 1 and 4 months). Exacerbation onset was defined using the Anthonisen symptom diary card algorithm. Every 3 days the Clinical COPD Questionnaire (CCQ) was assessed to evaluate the longitudinal course of health status. The primary outcome was health status recovery in the event of an exacerbation. RESULTS: During the 6-month follow-up period there was no difference in exacerbation rates and healthcare utilisation between the two groups. Cox-adjusted survival analysis including frailty showed enhanced health status recovery (HR 1.58; 95% CI 0.96 to 2.60) and reduced length of the exacerbation (HR 1.30; 95% CI 0.92 to 1.84). The mean difference in symptom recovery time was -3.68 days (95% CI -7.32 to -0.04). Mixed model repeated measure analysis showed that an AP decreased the impact of exacerbations on health status both in the prodromal and early post-onset periods. Between-group differences in CCQ scores were above the minimal clinically relevant difference of 0.4 points (3.0±0.7 vs. 3.4±0.9; p≤0.01). CONCLUSION: This study shows that an individualised AP, including ongoing support by a case manager, decreases the impact of exacerbations on health status and tends to accelerate recovery. APs can be considered a key component of self-management programmes in patients with COPD.

How do COPD patients respond to exacerbations?

BACKGROUND: Although timely treatment of COPD exacerbations seems clinically important, nearly half of these exacerbations remain unreported and subsequently untreated. Recent studies have investigated incidence and impact of failure to seek medical treatment during exacerbations. Yet, little is known about type and timing of other self-management actions in periods of symptom deterioration. The current prospective study aims at determining the relative incidence, timing and determinants of three types of patient responses. METHODS: In a multicentre observational study, 121 patients (age 67 ± 11 years, FEV1pred. 48 ± 19) were followed for 6 weeks by daily diary symptom recording. Three types of action were assessed daily: planning periods of rest, breathing techniques and/or sputum clearing (type-A), increased bronchodilator use (type-B) and contacting a healthcare provider (type-C). RESULTS: Type-A action was taken in 70.7%, type-B in 62.7% and type C in 17.3% of exacerbations (n = 75). Smokers were less likely to take type-A and B actions. Type-C actions were associated with more severe airflow limitation and increased number of hospital admissions in the last year. CONCLUSIONS: Our study shows that most patients are willing to take timely self-management actions during exacerbations. Future research is needed to determine whether the low incidence of contacting a healthcare provider is due to a lack of self-management or healthcare accessibility.

Fidelity of primary care nurses' delivery of a behavioural change intervention enhancing physical activity in patients at risk of cardiovascular disease: an observational study.

OBJECTIVE: To evaluate the fidelity of delivery of a nurse-led intervention to enhance physical activity in patients at risk for cardiovascular diseases, the Activate intervention, by assessing: (1) self-reported fidelity of delivery; (2) observed fidelity of delivery; (3) quality of delivery of the Activate intervention and (4) nurses' beliefs about their capability, motivation, confidence and effectiveness towards delivering the Activate intervention, including behavioural change techniques. DESIGN: An observational study. SETTING: General practices in the Netherlands. PARTICIPANTS: Primary care nurses (n=20) from 16 general practices. PRIMARY AND SECONDARY OUTCOME MEASURES: Nurses' self-reported fidelity was evaluated using checklists (n=282), and the observed fidelity and quality of delivery were examined using audiorecordings of consultations of the delivery of the Activate intervention (n=42). Nurses' beliefs towards delivering the intervention were assessed using questionnaires (n=72). RESULTS: The self-reported fidelity was 88.1% and observed fidelity was 85.4%, representing high fidelity. The observed fidelity of applied behavioural change techniques was moderate (75.0%). The observed quality of delivery was sufficient and varied among nurses (mean 2.9; SD 4.4; range 0-4). Nurses' beliefs about their capability, motivation, confidence and effectiveness towards delivering the intervention increased over time. CONCLUSIONS: Nurses delivered most intervention components as intended with sufficient quality. Nurses believed they were capable, motivated and confident to deliver the intervention. They believed the intervention was effective to increase patients' physical activity level. Despite the high fidelity and moderate fidelity of applied behavioural change techniques, the varying quality of delivery within and across nurses might have diluted the effectiveness of the Activate intervention. TRIAL REGISTRATION NUMBER: NCT02725203.

Characteristics of self-care interventions for patients with a chronic condition: A scoping review.

BACKGROUND: Self-care is a fundamental element of treatment for patients with a chronic condition and a major focus of many interventions. A large body of research exists describing different types of self-care interventions, but these studies have never been compared across conditions. Examination of heterogeneous interventions could provide insights into effective approaches that should be used in diverse patient populations. OBJECTIVES: To provide a comprehensive and standardized cross-condition overview of interventions to enhance self-care in patients with a chronic condition. Specific aims were to: 1) identify what self-care concepts and behaviors are evaluated in self-care interventions; 2) classify and quantify heterogeneity in mode and type of delivery; 3) quantify the behavior change techniques used to enhance self-care behavior; and 4) assess the dose of self-care interventions delivered. DESIGN: Scoping review DATA SOURCES: Four electronic databases - PubMed, EMBASE, PsychINFO and CINAHL - were searched from January 2008 through January 2019. ELIGIBILITY CRITERIA FOR STUDY SELECTION: Randomized controlled trials (RCTs) with concealed allocation to the intervention were included if they compared a behavioral or educational self- care intervention to usual care or another self-care intervention and were conducted in adults. Nine common chronic conditions were included: hypertension, coronary artery disease, arthritis, chronic kidney disease, heart failure, stroke, asthma, chronic obstructive lung disease, and type 2 diabetes mellitus. Diagnoses that are psychiatric (e.g. schizophrenia), acute rather than chronic, or benefitting little from self-care (e.g. dementia) were excluded. Studies had to be reported in English with full-text available. RESULTS: 9309 citations were considered and 233 studies were included in the final review. Most studies addressed type 2 diabetes mellitus (n = 85; 36%), hypertension (n = 32; 14%) or heart failure (n = 27; 12%). The majority (97%) focused on healthy behaviors like physical activity (70%), dietary intake (59%), and medication management (52%). Major deficits found in self-care interventions included a lack of attention to the psychological consequences of chronic illness, technology and behavior change techniques were rarely used, few studies focused on helping patients manage signs and symptoms, and the interventions were rarely innovative. Research reporting was generally poor. CONCLUSIONS: Major gaps in targeted areas of self-care were identified. Opportunities exist to improve the quality and reporting of future self-care intervention research. Registration: The study was registered in the PROSPERO database (#123,719).

Detecting exacerbations using the Clinical COPD Questionnaire.

BACKGROUND: Early treatment of COPD exacerbations has shown to be important. Despite a non-negligible negative impact on health related quality of life, a large proportion of these episodes is not reported (no change in treatment). Little is known whether (low burden) strategies are able to capture these unreported exacerbations. METHODS: The Clinical COPD Questionnaire (CCQ) is a short questionnaire with great evaluative properties in measuring health status. The current explorative study evaluates the discriminative properties of weekly CCQ assessment in detecting exacerbations. RESULTS: In a multicentre prospective cohort study, 121 patients, age 67.4 ± 10.5 years, FEV1 47.7 ± 18.5% pred were followed for 6 weeks by daily diary card recording and weekly CCQ assessment. Weeks were retrospectively labeled as stable or exacerbation (onset) weeks using the Anthonisen symptom diary-card algorithm. Change in CCQ total scores are significantly higher in exacerbation-onset weeks, 0.35 ± 0.69 compared to -0.04 ± 0.37 in stable weeks (p < 0.001). Performance of the Δ CCQ total score discriminating between stable and exacerbation onset weeks was sufficient (area under the ROC curve 0.75). At a cut off point of 0.2, sensitivity was 62.5 (50.3-73.4), specificity 82.0 (79.3-84.4), and a positive and negative predictive value of 43.5 (35.0-51.0) and 90.8 (87.8-93.5), respectively. Using this cut off point, 22 (out of 38) unreported exacerbations were detected while 39 stable patients would have been false positively 'contacted'. CONCLUSIONS: Weekly CCQ assessment is a promising, low burden method to detect unreported exacerbations. Further research is needed to validate discriminative performance and practical implications of the CCQ in detecting exacerbations in daily care.

SAFE@HOME: Digital health platform facilitating a new care path for women at increased risk of preeclampsia - A case-control study.

OBJECTIVE: In women at risk of developing preeclampsia, we evaluated the use of a digital health platform for telemonitoring blood pressure and symptoms combined with a minimal antenatal visit schedule. STUDY DESIGN: A case-control study for women with chronic hypertension, history of preeclampsia, or maternal cardiac or kidney disease. A care path was designed with reduced visits enhanced with a digital platform (SAFE@HOME) for daily blood pressure and symptom monitoring starting from 16 weeks of gestation. Home-measurements were monitored in-hospital by obstetric professionals, taking actions upon alarming results. This prospective SAFE@HOME group was compared to a retrospective control group managed without self-monitoring. MAIN OUTCOME MEASURES: Primary: healthcare consumption (number of antenatal visits, ultrasounds, admissions and diagnostics), user experiences of the platform. Secondary: maternal and perinatal outcomes. RESULTS: Baseline characteristics of the SAFE@HOME (n = 103) and control group (n = 133) were comparable. In the SAFE@HOME group, antenatal visits (mean 13.7 vs 16.0, p < 0.001) and ultrasounds (6.3 vs 7.4, p = 0.005) were lower compared to the control group. Admissions for hypertension or suspected preeclampsia were significantly fewer in the SAFE@HOME group (2.9% versus 13.5%, p = 0.004). Telemonitoring participants were highly satisfied using the platform. No differences were observed for maternal and perinatal outcomes. CONCLUSIONS: Our care path including blood pressure telemonitoring for women at risk of preeclampsia allows fewer antenatal visits, ultrasounds and hypertension-related admissions. We observed no differences in perinatal outcomes. These results suggest that telemonitoring of blood pressure is feasible in a high-risk pregnant population and has the potential to profoundly change antenatal care.

Status of Theory Use in Self-Care Research.

BACKGROUND: Theories can provide a foundation to explain behavior, investigate relationships, and to predict the effect of interventions. The aim of the study was to clarify the use of theories in studies testing interventions to promote self-care. METHOD: A scoping review. PubMed, EMBASE, PsychINFO, and CINAHL were searched from January 2008 through January 2019. Nine common chronic conditions were included. We included studies testing a self-care intervention if they used a randomized controlled trial design. The study was registered in PROSPERO (#123719). RESULTS: The search retrieved 9309 potential studies, of which 233 were included in the review. In total, 76 (33%) of the 233 studies used a theory and 24 different theories were used. Bandura's social cognitive theory was the most frequently used (48 studies), but 22 other theories were used in a minority of studies. Most studies used theories minimally to justify or provide a rationale for the study, to develop the intervention, to select outcomes, and/or to explain the results. Only eight studies fully used a theory in the rationale, intervention development, choice of outcomes, and discussion. CONCLUSION: The use of theories to guide self-care research is limited, which may pose a barrier in accumulating knowledge underlying self-care interventions.

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

BACKGROUND: Early 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/DESIGN: The 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. DISCUSSION: This 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.

Patients' experiences with a behaviour change intervention to enhance physical activity in primary care: A mixed methods study.

OBJECTIVE: To explore the experiences of patients at risk for cardiovascular disease in primary care with the Activate intervention in relation to their success in increasing their physical activity. METHODS: A convergent mixed methods study was conducted, parallel to a cluster-randomised controlled trial in primary care, using a questionnaire and semi-structured interviews. Questionnaires from 67 patients were analysed, and semi-structured interviews of 22 patients were thematically analysed. Experiences of patients who had objectively increased their physical activity (responders) were compared to those who had not (non-responders). Objective success was analysed in relation to self-perceived success. RESULTS: The questionnaire and interview data corresponded, and no substantial differences among responders and non-responders emerged. Participating in the intervention increased patients' awareness of their physical activity and their physical activity level. Key components of the intervention were the subsequent support of nurses with whom patients' have a trustful relationship and the use of self-monitoring tools. Patients highly valued jointly setting goals, planning actions, receiving feedback and review on their goal attainment and jointly solving problems. Nurses' support, the use of self-monitoring tools, and involving others incentivised patients to increase their physical activity. Internal circumstances and external circumstances challenged patients' engagement in increasing and maintaining their physical activity. CONCLUSION: Patients experienced the Activate intervention as valuable to increase and maintain their physical activity, irrespective of their objective change in physical activity. The findings enable the understanding of the effectiveness of the intervention and implementation in primary care. TRIAL REGISTRATION: ClinicalTrials.gov NCT02725203.

Effects of telemonitoring in patients with chronic obstructive pulmonary disease.

The objective of this study was to determine the effects of a homebased telemonitoring device, The Health Buddy (HB), on health consumption and health-related quality of life (HRQoL) in patients with moderate to severe chronic obstructive pulmonary disease (COPD). The HB provides daily symptom-surveillance by a case manager and education to enhance disease knowledge and self-management. A nonrandomized controlled multicenter study was established comparing the effectiveness of telemonitoring as an add-on to care as usual with a follow-up of 6 months. Four hospitals took part in the experimental group and 2 hospitals formed an equivalent control group with 59 and 56 patients, respectively. HRQoL was measured by the Clinical COPD Questionnaire. Healthcare consumption was assessed using medical records in the 6 months preceding study entry and during the study. Compared with the control group, the HB group showed a significant decrease in hospital admission rates (HB -0.11 +/- 1.16 vs. control +0.27 +/- 1.0, p = 0.02) and in the total number of exacerbations (HB -0.35 +/- 1.4 vs. control +0.32 +/- 1.2, p = 0.004). There was a tendency toward decreased hospital days and outpatient visits. No significant changes in HRQoL were observed at follow-up between both study groups. Despite inherent limitations of the study, these findings suggest that adopting telemonitoring in everyday clinical practice is feasible and can substantially improve care and decrease healthcare utilization of patients with moderate to severe COPD.

Self-management support in routine primary care by nurses.

OBJECTIVES: To examine how and to what extent self-management support, including behaviour change support, is provided by primary care nurses in routine consultations with chronically ill patients. DESIGN: Observational study design. METHODS: Routine consultations of primary care nurses in the Netherlands with chronically ill patients were audio-taped and analysed. The analysis identified health topics addressed according to health care standards, self-management topics addressed using a validated set of topics, and behaviour change techniques (BCTs) using the Behaviour Change Techniques Taxonomy v1. RESULTS: Seventy-eight routine consultations of 17 primary care nurses with chronically ill patients were included in the analysis. Nurses addressed both health topics and self-management topics in brief, fragmented, and often inconsistent manners. Dietary intake and physical activity were the most frequently addressed topics. Nurses applied 21 BCTs to target behaviour change, but the use of these techniques was mainly inconsistent and implicit. The most consistently used BCTs were review behaviour goal(s) (56.4%) and feedback on behaviour (51.3%). CONCLUSIONS: Nurses addressed both health topics and self-management topics in their routine consultations. The duration, frequency, and number of addressed topics differed throughout the consultations. Nurses tended to prioritize the monitoring and optimization of patients' medical treatment and provided limited self-management support. Nurses seldom deepened their focus on behaviour change and infrequently used effective techniques to support this change. Adoption of self-management in primary care, including behaviour change, might be enhanced if nurses consistently and explicitly use effective BCTs in their consultations. Statement of contribution What is already known on this subject? Primary care nurses play a pivotal role in self-management support for patients with a chronic condition. Adequate self-management support requires nurses to activate patients and enhance behaviour change. Little is known regarding to what extent nurses provide self-management support in routine primary care. What does this study add? Self-management support is brief, fragmented, and inconsistently provided by nurses. Nurses tend to prioritize medical treatment optimization and seldom focus on behavioural change. Nurses' use of effective behaviour change techniques is low and should be enhanced.

Increasing value and reducing waste by optimizing the development of complex interventions: Enriching the development phase of the Medical Research Council (MRC) Framework.

BACKGROUND: In recent years there has been much emphasis on 'research waste' caused by poor question selection, insufficient attention to previous research results, and avoidable weakness in research design, conduct and analysis. Little attention has been paid to the effect of inadequate development of interventions before proceeding to a full clinical trial. OBJECTIVE: We therefore propose to enrich the development phase of the MRC Framework by adding crucial elements to improve the likelihood of success and enhance the fit with clinical practice METHODS: Based on existing intervention development guidance and synthesis, a comprehensive iterative intervention development approach is proposed. Examples from published reports are presented to illustrate the methodology that can be applied within each element to enhance the intervention design. RESULTS: A comprehensive iterative approach is presented by combining the elements of the MRC Framework development phase with essential elements from existing guidance including: problem identification, the systematic identification of evidence, identification or development of theory, determination of needs, the examination of current practice and context, modelling the process and expected outcomes leading to final element: the intervention design. All elements are drawn from existing models to provide intervention developers with a greater chance of producing an intervention that is well adopted, effective and fitted to the context. CONCLUSION: This comprehensive approach of developing interventions will strengthen the internal and external validity, minimize research waste and add value to health care research. In complex interventions in health care research, flaws in the development process immediately impact the chances of success. Knowledge regarding the causal mechanisms and interactions within the intended clinical context is needed to develop interventions that fit daily practice and are beneficial for the end-user.

Complex self-management interventions in chronic disease unravelled: a review of lessons learned from an individual patient data meta-analysis.

OBJECTIVES: Meta-analyses using individual patient data (IPD) rather than aggregated data are increasingly applied to analyze sources of heterogeneity between trials and have only recently been applied to unravel multicomponent, complex interventions. This study reflects on methodological challenges encountered in two IPD meta-analyses on self-management interventions in patients with heart failure or chronic obstructive pulmonary disease. STUDY DESIGN AND SETTING: Critical reflection on prior IPD meta-analyses and discussion of literature. RESULTS: Experience from two IPD meta-analyses illustrates methodological challenges. Despite close collaboration with principal investigators, assessing the effect of characteristics of complex interventions on the outcomes of trials is compromised by lack of sufficient details on intervention characteristics and limited data on fidelity and adherence. Furthermore, trials collected baseline variables in a highly diverse way, limiting the possibilities to study subgroups of patients in a consistent manner. Possible solutions are proposed based on lessons learnt from the methodological challenges. CONCLUSION: Future researchers of complex interventions should pay considerable attention to the causal mechanism underlying the intervention and conducting process evaluations. Future researchers on IPD meta-analyses of complex interventions should carefully consider their own causal assumptions and availability of required data in eligible trials before undertaking such resource-intensive IPD meta-analysis.