Unravelling effectiveness of a nurse-led behaviour change intervention to enhance physical activity in patients at risk for cardiovascular disease in primary care: study protocol for a cluster randomised controlled trial

BACKGROUND: Self-management interventions are considered effective in patients with chronic disease, but trials have shown inconsistent results, and it is unknown which patients benefit most. Adequate self-management requires behaviour change in both patients and health care providers. Therefore, the Activate intervention was developed with a focus on behaviour change in both patients and nurses. The intervention aims for change in a single self-management behaviour, namely physical activity, in primary care patients at risk for cardiovascular disease. The aim of this study is to evaluate the effectiveness of the Activate intervention. METHODS/DESIGN: A two-arm cluster randomised controlled trial will be conducted to compare the Activate intervention with care as usual at 31 general practices in the Netherlands. Approximately 279 patients at risk for cardiovascular disease will participate. The Activate intervention is developed using the Behaviour Change Wheel and consists of 4 nurse-led consultations in a 3-month period, integrating 17 behaviour change techniques. The Behaviour Change Wheel was also applied to analyse what behaviour change is needed in nurses to deliver the intervention adequately. This resulted in 1-day training and coaching sessions (including 21 behaviour change techniques). The primary outcome is physical activity, measured as the number of minutes of moderate to vigorous physical activity using an accelerometer. Potential effect modifiers are age, body mass index, level of education, social support, depression, patient-provider relationship and baseline number of minutes of physical activity. Data will be collected at baseline and at 3 months and 6 months of follow-up. A process evaluation will be conducted to evaluate the training of nurses, treatment fidelity, and to identify barriers to and facilitators of implementation as well as to assess participants' satisfaction. DISCUSSION: To increase physical activity in patients and to support nurses in delivering the intervention, behaviour change techniques are applied to change behaviours of the patients and nurses. Evaluation of the effectiveness of the intervention, exploration of which patients benefit most, and evaluation of our theory-based training for primary care nurses will enhance understanding of what works and for whom, which is essential for further implementation of self-management in clinical practice. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT02725203 . Registered on 25 March 2016

Development and testing of an instrument to measure contextual factors influencing self-care decisions among adults with chronic illness

BACKGROUND: Decisions about how to manage bothersome symptoms of chronic illness are complex and influenced by factors related to the patient, their illness, and their environment. Naturalistic decision-making describes decision-making when conditions are dynamically evolving, and the decision maker may be uncertain because the situation is ambiguous and missing information. Contextual factors, including time stress, the perception of high stakes, and input from others may facilitate or complicate decisions about the self-care of symptoms. There is no valid instrument to measure these contextual factors. The purpose of this study was to develop and test a self-report instrument measuring the contextual factors that influence self-care decisions about symptoms. METHODS: Items were drafted from the literature and refined with patient input. Content validity of the instrument was evaluated using a Delphi survey of expert clinicians and researchers, and cognitive interviews with adults with chronic illness. Psychometric testing included exploratory factor analysis to test dimensionality, item response theory-based approaches for item recalibration, confirmatory factor analysis to generate factor determinacy scores, and evaluation of construct validity. RESULTS: Ten contextual factors influencing decision-making were identified and multiple items per factor were generated. Items were refined based on cognitive interviews with five adults with chronic illness. After a two round Delphi survey of expert clinicians (n = 12) all items had a content validity index of \u3e 0.78. Five additional adults with chronic illness endorsed the relevance, comprehensiveness, and comprehensibility of the inventory during cognitive interviews. Initial psychometric testing (n = 431) revealed a 6-factor multidimensional structure that was further refined for precision, and high multidimensional reliability (0.864). In construct validity testing, there were modest associations with some scales of the Melbourne Decision Making Questionnaire and the Self-Care of Chronic Illness Inventory. CONCLUSION: The Self-Care Decisions Inventory is a 27-item self-report instrument that measures the extent to which contextual factors influence decisions about symptoms of chronic illness. The six scales (external, urgency, uncertainty, cognitive/affective, waiting/cue competition, and concealment) reflect naturalistic decision making, have excellent content validity, and demonstrate high multidimensional reliability. Additional testing of the instrument is needed to evaluate clinical utility

Self-care management of bothersome symptoms as recommended by clinicians for patients with a chronic condition: A Delphi study

BACKGROUND: Chronically medically ill patients often need clinical assistance with symptom management, as well as self-care interventions that can help to reduce the impact of bothersome symptoms. Experienced clinicians can help to guide the development of more effective self-care interventions. OBJECTIVE: To create a consensus-based list of common bothersome symptoms of chronic conditions and of self-care management behaviors recommended to patients by clinicians to reduce the impact of these symptoms. METHODS: A two-round Delphi study was performed among an international panel of 47 clinicians using online surveys to identify common and bothersome symptoms and related self-care management behaviors recommended to patients with heart failure, chronic obstructive pulmonary disease, asthma, type 2 diabetes, or arthritis. RESULTS: A total of 30 common bothersome symptoms and 158 self-care management behaviors across the five conditions were listed. Each chronic condition has its own bothersome symptoms and self-care management behaviors. Consensus was reached on the vast majority of recommended behaviors. CONCLUSIONS: The list of common bothersome symptoms and self-care management behaviors reflect consensus across four countries on many points but also disagreement on others, and a few recommendations are inconsistent with current guidelines. Efforts to encourage clinicians to recommend effective self-care management behaviors may reduce symptom impact in chronically ill patient populations

Patterns of self-care decision-making and associated factors: A cross-sectional observational study

OBJECTIVE: The aim of this study was to identify for the first time patterns of self-care decision-making (i.e. the extent to which participants viewed contextual factors influencing decisions about symptoms) and associated factors among community-dwelling adults with chronic illness. METHODS: This was a secondary analysis of data collected during the development and psychometric evaluation of the 27-item Self-Care Decisions Inventory that is based on Naturalistic Decision-Making (n = 430, average age = 54.9 ± 16.2 years, 70.2 % female, 87.0 % Caucasian, average number of chronic conditions = 3.6 ± 2.8). Latent class mixture modeling was used to identify patterns among contextual factors that influence self-care decision-making under the domains of external, urgency, uncertainty, cognitive/affective, waiting/cue competition, and concealment. Multivariate multinomial regression was used to identify additional socio-demographic, clinical, and self-care behavior factors that were different across the patterns of self-care decision-making. RESULTS: Three patterns of self-care decision-making were identified in a cohort of 430 adults. A \u27maintainers\u27 pattern (48.1 %) consisted of adults with limited contextual influences on self-care decision-making except for urgency. A \u27highly uncertain\u27 pattern (23.0 %) consisted of adults whose self-care decision-making was largely driven by uncertainty about the cause or meaning of the symptom. A \u27distressed concealers\u27 pattern (28.8 %) consisted of adults whose self-care decision-making was highly influenced by external factors, cognitive/affective factors and concealment. Age, education, financial security and specific symptoms were significantly different across the three patterns in multivariate models. CONCLUSION: Adults living with chronic illness vary in the extent to which contextual factors influence decisions they make about symptoms, and would therefore benefit from different interventions

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

Introduction Self-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 self-management interventions must be assessed in the context of which components are responsible for eliciting the effect and in which subgroups of patients the intervention works best. The aim of the present study is to identify condition-transcending determinants of success of self-management interventions in two parallel individual patient data meta-analyses of self-management trials in patients with congestive heart failure (CHF) and in patients with chronic obstructive pulmonary disease (COPD). Methods and analysis Investigators of 53 randomised trials (32 in CHF and 21 in COPD) will be requested to share their de-identified individual patient data. Data will be analysed using random effects models, taking clustering within studies into account. Effect modification by age, sex, disease severity, symptom status, comorbid conditions and level of education will be assessed. Sensitivity analyses will be conducted to assess the robustness of the findings. Ethics and dissemination The de-identified individual patient data are used only for the purpose for which they were originally collected and for which ethical approval has been obtained by the original investigators. Knowledge on the effective ingredients of self-management programmes and identification of subgroups of patients in which those interventions are most effective will guide the development of evidence-based personalised self-management interventions for patients with CHF and COPD as well as with other chronic diseases

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

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

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

Operational definition of self-care interventions for adults with chronic illness [Editorial]

[Extract] The World Health Organization (WHO) defines self-care as the ability of individuals, families, and communities to promote health, prevent disease, maintain health, and cope with illness and disability with or without the support of a healthcare provider (World Health Organization, 2021). Self-care is especially crucial when someone has a chronic illness. In this context, the middle-range theory of self-care in chronic illness defines self-care as a process of maintaining health through health promoting practices and illness management (Riegel et al., 2012). This definition is consistent with the WHO definition while emphasizing those elements of self-care that are important in chronic illness. Recognition of the importance of self-care has generated numerous studies of self-care interventions worldwide. Yet, the definition of what constitutes a self-care intervention remains unclear