Interviewing people on sensitive topics: challenges and strategies.

Interviewing participants on sensitive topics is challenging and requires carefully planned and executed strategies throughout the research process. Sensitive topics have the potential to cause distress to participants or researchers. In this methods paper, strategies for conducting interviews on sensitive topics are described, including choosing the appropriate interview approach, creating a safe and comfortable environment, building rapport, utilizing sensitive and open questioning, reflexivity of the researcher, and awareness of the potential therapeutic effect of the interviews on participants. The strategies are illustrated with experiences from research on sensitive topics.

Lessons learned from the MOMENT study on how to recruit and retain a target population online, across borders, and with automated remote data collection.

Increasingly, studies use social media to recruit, enroll, and collect data from participants. This introduces a threat to data integrity: efforts to produce fraudulent data to receive participant compensation, e.g., gift cards. MOMENT is an online symptom-monitoring and self-care study that implemented safeguards to protect data integrity. Facebook, Twitter, and patient organizations were used to recruit participants with chronic health conditions in four countries (USA, Italy, The Netherlands, Sweden). Links to the REDCap baseline survey were posted to social media accounts. The initial study launch, where participants completed the baseline survey and were automatically re-directed to the LifeData ecological momentary assessment app, was overwhelmed with fraudulent responses. In response, safeguards (e.g., reCAPTCHA, attention checks) were implemented and baseline data was manually inspected prior to LifeData enrollment. The initial launch resulted in 411 responses in 48 hours, 265 of which (64.5%) successfully registered for the LifeData app and were considered enrolled. Ninety-nine percent of these were determined to be fraudulent. Following implementation of safeguards, the re-launch yielded 147 completed baselines in 3.5 months. Eighteen cases (12.2%) were found fraudulent and not invited to enroll. Most fraudulent cases in the re-launch (15 of 18) were identified by a single attention check question. In total, 96.1% of fraudulent responses were to the USA-based survey. Data integrity safeguards are necessary for research studies that recruit online and should be reported in manuscripts. Three safeguard strategies were effective in preventing and removing most of the fraudulent data in the MOMENT study. Additional strategies were also used and may be necessary in other contexts.

Use of virtual reality in preoperative education of cardiac surgery patients - A feasibility study.

OBJECTIVE: A Virtual Patient Tour (VPT) was developed to inform cardiac surgery patients about their hospitalization from the admission to their postoperative stay on the ward. The objective of our study was to assess the feasibility and acceptability of this VPT following the framework of the Virtual Reality Clinical Outcomes Research Experts Committee. METHODS: In this single-centre cross-sectional study, adult patients admitted to the hospital for elective cardiac surgery were included. Acceptability, usability, and tolerability were measured by the validated questionnaires Unified Theory of Acceptance and Use of Technology (acceptability), System Usability Scale (usability), and Virtual Reality Sickness Questionnaire (tolerability). Descriptive statistics were used for the analysis. RESULTS: Twenty-eight participants used the VPT. Results showed high acceptability (mean 16.7 ± 1.5), acceptable usability (mean 86.7 ± 9.3), and high tolerability (sickness score, median 7.1 % [0-17.1 %]). CONCLUSION: The use of the VPT is a feasible and promising technique. The next step is to optimize the content and technique of the VPT based on the suggestions of the participants. PRACTICE IMPLICATIONS: We recommend incorporating the VPT into preoperative patient education in addition to the routine information in cardiac surgery patients.

'What Happened?': Perceptions of Patients with Hypertension of Conflicting Results between Self-Reported Medication Adherence and Chemical Adherence Testing: A Qualitative Study.

AIM: To explore the perceptions of outpatients with hypertension regarding the conflicting results between their self-reported medication adherence and chemical adherence testing. METHODS AND RESULTS: An exploratory generic qualitative study design with semi-structured interviews was conducted. Thirteen adult patients being treated with antihypertensives were interviewed. Patients had a negative chemical adherence test for at least one prescribed antihypertensive, while they reported to adhere to their medication. Audio-recorded interviews were thematically analyzed. Six themes emerged: (1) becoming frustrated with medication intake, (2) being uncomfortable with addressing medication nonadherence, (3) feeling ashamed and angry about their nonadherence, (4) feeling falsely accused of nonadherence, (5) experiencing results as a wakeup call and (6) wanting to be heard and listened to. Participants reacted differently to the adherence test results. Two distinct groups were identified among the participants: the first group felt shameful, disappointed, and angry at themselves for being nonadherent; the second group felt falsely accused and rejected the adherence test results. No differences between both groups were found in their reasons for becoming frustrated with medication intake and their behavior after the adherence test results. Patients felt that communication with clinicians is key in the treatment support of patients with hypertension. CONCLUSIONS: Clinicians need to consider the reasons for nonadherence and the different responses of patients to the chemical adherence test results in their support to optimize treatment for patients with hypertension.

Barriers and facilitators for the implementation of co-created nursing innovations in a Dutch university hospital.

INTRODUCTION: Escalating global nursing shortages require solutions for efficient care, fewer injuries and lost workdays. When commercial solutions are lacking, innovations developed through co-creation can be a viable alternative. However, many co-created nursing innovations are ineffectively implemented. Understanding the barriers and facilitators for the successful implementation of co-created nursing innovations is crucial. OBJECTIVE: This study explored nurses' perceived determinants influencing the implementation of co-created nursing innovations. METHODS: We conducted a qualitative study using semi-structured interviews with nurses at a Dutch university hospital who were working with co-created nursing innovations. The Theoretical Domains Framework (TDF) was employed to identify the barriers and facilitators. Data analysis followed a deductive theoretical thematic analysis approach based on the 14 TDF domains. Determinants were labeled as a barrier, facilitator, or both. RESULTS: Of the 14 TDF domains, 9 appeared relevant, including Intention, Professional Role and Identify, and Knowledge. The absence of a "superuser," lack of storage space, and negative experiences during use were perceived as barriers to the implementation of nursing innovations. The importance of time-saving features, user-friendliness, reminders to use the innovation, and team enthusiasm were perceived as facilitators. CONCLUSIONS: Participants confirmed that the Social Influences domain, combined with Behavioral Regulation and Knowledge, were barriers to implementation, while Intentions and Reinforcements and Rewards were seen as facilitators. SPANISH ABSTRACT: http://links.lww.com/IJEBH/A235.

Optimizing support before and after Cardiac Resynchronization Therapy implantation in co-creation with patients with heart failure, informal caregivers and healthcare professionals.

AIM: To optimize support by healthcare professionals to enhance physical activity, HF-related symptom monitoring and management in patients with heart failure before and after cardiac resynchronization therapy (CRT) implantation in co-creation with patients, informal caregivers, and healthcare professionals. METHODS AND RESULTS: A qualitative and co-design approach was used to develop support strategies collaboratively with end-users. Seventeen semi-structured interviews were conducted to explore patients' expectations and factors influencing physical activity and symptom management. The qualitatively obtained insights informed the development of support strategies using an ideas group with patients, informal caregivers, and healthcare professionals.Four themes emerged from the interviews: 1. Expecting and hoping to regain energy and fitness; 2. Difficulties and opportunities to become more active; 3. Impact of CRT on sense of safety; and 4. Dealing with continuing bothersome symptoms. Several strategies were brainstormed, prioritized and prototyped, including optimization of CRT information, a peer contact list, expansion of the post-CRT implantation consultation to ask questions and share concerns, and a group meeting with peer patients, partners, and healthcare professionals. CONCLUSION: Patients expected and hoped to have positive effects from CRT, but not all patients experienced improvement after CRT. To improve patients' physical activity, feelings of insecurity, symptom monitoring, and thoughtful response to symptoms, support must include providing information and support to increase their knowledge and discuss experiences and physical and mental concerns.

Rheumatoid arthritis patients' perspective on the use of prediction models in clinical decision-making.

OBJECTIVES: A rapidly expanding number of prediction models is being developed aiming to improve rheumatoid arthritis (RA) diagnosis and treatment. However, few are actually implemented in clinical practice. This study explores factors influencing the acceptance of prediction models in clinical decision-making by RA patients. METHODS: A qualitative study design was used with thematic analysis of semi-structured interviews. Purposive sampling was applied to capture a complete overview of influencing factors. The interview topic list was based on pilot data. RESULTS: Data saturation was reached after 12 interviews. Patients were generally positive about the use of prediction models in clinical decision-making. Six key themes were identified from the interviews. First, patients have the need for information on prediction models. Second, factors influencing trust in model-supported treatment are described. Third, patients envision the model to have a supportive role in clinical decision-making. Fourth, patients hope to personally benefit from model-supported treatment in various ways. Fifth, patients are willing to contribute time and effort to contribute to model input. And lastly, we discuss the theme on effects of the relationship with the caregiver in model-supported treatment. CONCLUSION: Within this study RA patients were generally positive about the use of prediction models in their treatment given some conditions were met and concerns addressed. The results of this study can be used during the development and implementation in RA care of prediction models in order to enhance patient acceptability.

Symptom characteristics, perceived causal attributions, and contextual factors influencing self-care behaviors: An ecological daily assessment study of adults with chronic illness.

OBJECTIVE: Insights into how symptoms influence self-care can guide patient education and improve symptom control. This study examined symptom characteristics, causal attributions, and contextual factors influencing self-care of adults with arthritis, asthma, chronic obstructive pulmonary disease, diabetes, or heart failure. METHODS: Adults (n = 81) with a symptomatic chronic illness participated in a longitudinal observational study. Using Ecological Daily Assessment, participants described one symptom twice daily for two weeks, rating its frequency, severity, bothersomeness, duration, causes, and self-care. RESULTS: The most frequent symptoms were fatigue and shortness of breath. Pain, fatigue, and joint stiffness were the most severe and bothersome. Most participants engaged in active self-care, but those with fatigue and pain engaged in passive self-care (i.e., rest or do nothing), especially when symptoms were infrequent, mild, somewhat bothersome, and fleeting. In people using passive self-care, thoughts, feelings, and the desire to conceal symptoms from others interfered with self-care. CONCLUSION: Most adults with a chronic illness take an active role in managing their symptoms but some conceal or ignore symptoms until the frequency, severity, bothersomeness, or duration increases. PRACTICE IMPLICATIONS: When patients report symptoms, asking about self-care behaviors may reveal inaction or ineffective approaches. A discussion of active self-care options may improve symptom control.

How do patients with rheumatoid arthritis perceive their self-care and self-care support? A mixed-method study.

AIM: To explore self-care and needs and preferences towards tailored self-care support of patients with rheumatoid arthritis at the outpatient clinic. DESIGN: A sequential explanatory mixed method design. METHODS: The Self-Care of Chronic Illness Inventory questionnaire, two focus groups and six semi-structured interviews were conducted between November 2021 and April 2023. Questionnaires of 107 patients were descriptively analysed. Subsequently, 11 patients and 2 healthcare professionals participated in the focus groups and 6 patients in the interviews, which were thematically analysed. RESULTS: Quantitative and qualitative data corresponded and showed that patients perform various self-care activities at an adequate level and have strategies to exert control and reduce symptoms. One key theme emerged: 'Not only being the person with rheumatoid arthritis' (RA) as patients primarily aim to get on with their lives. Nine subthemes covered self-care activities for maintaining health including staying physically active, finding the right medication and dose and adapting their diet. Patients differed in how they self-monitored their symptoms. Recognizing symptoms and finding strategies to manage symptoms included the process of body listening in which patient seek and try different strategies to find what works for them and incorporate routines. Patients experienced positive effects of a warm or cold environment. Patients felt the need for practical and emotional support from others and preferred having credible information. CONCLUSION: Patients perform adequate self-care including a diversity of self-care activities to get on with their lives and have strategies to reduce and control the symptoms and impact of RA. IMPLICATIONS: Tailoring self-care support to patients' individual needs and preferences is necessary to help patients cope with the erratic nature of the disease and maintain their quality of life. Healthcare providers need to provide practical and emotional support and use credible information to allow patients to make self-care decisions to manage their lives. REPORTING METHODS: Quantitative finding are reported according to the STROBE guidelines and qualitative finding are reported according to the COREQ guidelines. WHAT DOES THIS PAPER ADD: Patients perform various self-care activities at an adequate level and have strategies to exert control and reduce symptoms. Patients primarily aim to continue their lives and not being seen as the person with rheumatoid arthritis. Healthcare professionals need to provide practical and emotional support and use credible information to inform patients' self-care decision-making. PATIENT OR PUBLIC CONTRIBUTION: No patient or public contribution.

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 ±â€¯16.2 years, 70.2 % female, 87.0 % Caucasian, average number of chronic conditions = 3.6 ±â€¯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 'maintainers' pattern (48.1 %) consisted of adults with limited contextual influences on self-care decision-making except for urgency. A 'highly uncertain' 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 'distressed concealers' 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.

Factors That Influence the Use of eHealth in Home Care: Scoping Review and Cross-sectional Survey.

BACKGROUND: In home care, eHealth implementation requires health care professionals and home care clients to change their behavior because they have to incorporate the use of eHealth into their daily routines. Knowledge of factors that influence the use of eHealth in home care is needed to optimize implementation strategies. However, a comprehensive overview of such factors is lacking. OBJECTIVE: The aims of this study were to (1) provide insight into the types of eHealth that are used and preferred in home care and (2) identify factors that influence the use of eHealth in home care according to health care professionals and home care clients. METHODS: A scoping review and online, cross-sectional survey were conducted sequentially. The survey was conducted among Dutch health care professionals with a nursing background who were working for a home care organization at the time. The capability, opportunity, motivation, behavior (COM-B) model, which posits that for any behavior (B) to occur, a person must have the capability (C), opportunity (O), and motivation (M) to perform the behavior, was used to identify influencing factors. The use of a theoretical model may contribute to a better understanding of how to achieve and sustain behavior change in clinical practice. RESULTS: We included 30 studies in the scoping review. The most frequently studied type of eHealth was a telecommunication/telemonitoring system. The survey was completed by 102 participants. The most frequently used types of eHealth were electronic health records, social alarms, and online client portals. A health app was the most frequently preferred type of eHealth. We identified 22 factors that influence the use of eHealth in home care according to health care professionals and home care clients. Influencing factors were organized into the components of the COM-B model, namely capability (n=6), opportunity (n=10), and motivation (n=6). We found that there is no single influencing factor that is key to the complexity of eHealth implementation. CONCLUSIONS: Different types of eHealth are used, and many types of eHealth are preferred by health care professionals. The identified factors that influence the use of eHealth in home care relate to all components of the COM-B model. These factors need to be addressed and embedded in implementation strategies of eHealth to optimize the use of eHealth in home care.

The effectiveness of self-care interventions in chronic illness: A meta-analysis of randomized controlled trials.

OBJECTIVE: To characterize and explain variation in the comparative effectiveness of self-care interventions on relevant outcomes of chronic illness compared with controls. DESIGN: Meta-analysis and meta-regression. METHODS: Data extraction was framed within the context of a previously-published scoping review of randomized trials designed to enhance self-care in type 2 diabetes mellitus, heart failure, hypertension, asthma, coronary artery disease, and chronic obstructive pulmonary disease (published between 2008 and 2019). Data were pooled using random-effects meta-analyses. Meta-regression was used to test the effect of potential moderators on trial effectiveness. RESULTS: 145 trials involving 36,853 participants were included. Overall, the effect size of self-care interventions on improving outcomes was small (Hedges' g = 0.29 (95% CI = 0.25-0.33), p < 0.001) with statistically significant heterogeneity across trials (Q = 514.85, p < 0.001, I2 = 72.0%). A majority of trials (n = 83, 57.2%) were rated as having a high risk of bias. There was no statistically significant difference in trial effectiveness based on the use of theory, specific components of self-care addressed, the number of modes of delivery, the number of behavioral change techniques, specific modes of delivery, specific behavioral change techniques, intervention duration, total number of hours of intervention, or either participant age or gender. CONCLUSIONS: Self-care interventions are modestly effective in improving outcomes. Poor trial quality limits the strength of conclusions in this area of science. There is much to be done to enhance the design, conduct and reporting of self-care trials in order to gain more insight into the effectiveness of self-care interventions. TWEETABLE ABSTRACT: New review highlights poor trial design as major impediment to understanding the contribution of self -care to outcomes in chronic illness.

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.

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 > 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.

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).

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.

Effectiveness of the nurse-led Activate intervention in patients at risk of cardiovascular disease in primary care: a cluster-randomised controlled trial.

BACKGROUND: To understand better the success of self-management interventions and to enable tailoring of such interventions at specific subgroups of patients, the nurse-led Activate intervention is developed targeting one component of self-management (physical activity) in a heterogeneous subgroup (patients at risk of cardiovascular disease) in Dutch primary care. AIM: The aim of this study was to evaluate the effectiveness of the Activate intervention and identifying which patient-related characteristics modify the effect. METHODS: A two-armed cluster-randomised controlled trial was conducted comparing the intervention with care as usual. The intervention consisted of four nurse-led behaviour change consultations within a 3-month period. Data were collected at baseline, 3 months and 6 months. Primary outcome was the daily amount of moderate to vigorous physical activity at 6 months. Secondary outcomes included sedentary behaviour, self-efficacy for physical activity, patient activation for self-management and health status. Prespecified effect modifiers were age, body mass index, level of education, social support, depression, patient provider relationship and baseline physical activity. RESULTS: Thirty-one general practices (n = 195 patients) were included (intervention group n = 93; control group n = 102). No significant between-group difference was found for physical activity (mean difference 2.49 minutes; 95% confidence interval -2.1; 7.1; P = 0.28) and secondary outcomes. Patients with low perceived social support (P = 0.01) and patients with a low baseline activity level (P = 0.02) benefitted more from the intervention. CONCLUSION: The Activate intervention did not improve patients' physical activity and secondary outcomes in primary care patients at risk of cardiovascular disease. To understand the results, the intervention fidelity and active components for effective self-management require further investigation.Trial registration: ClinicalTrials.gov NCT02725203.

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.