Effectiveness of an Intervention Providing Digitally Generated Personalized Feedback and Education on Adherence to Continuous Positive Airway Pressure: Randomized Controlled Trial.

BACKGROUND: Many people worldwide experience obstructive sleep apnea, which is associated with medical and psychological problems. Continuous positive airway pressure (CPAP) is an efficacious therapy for obstructive sleep apnea, but its effect is limited by nonadherence. Studies show that personalized education and feedback can increase CPAP adherence. Moreover, tailoring the style of information to the psychological profile of a patient has been shown to enhance the impact of interventions. OBJECTIVE: This study aimed to assess the effect of an intervention providing digitally generated personalized education and feedback on CPAP adherence and the additional effect of tailoring the style of the education and feedback to an individual's psychological profile. METHODS: This study was a 90-day, multicenter, parallel, single-blinded, and randomized controlled trial with 3 conditions: personalized content in a tailored style (PT) in addition to usual care (UC), personalized content in a nontailored style (PN) in addition to UC, and UC. To test the effect of personalized education and feedback, the PN + PT group was compared with the UC group. To test the additional effect of tailoring the style to psychological profiles, the PN and PT groups were compared. Overall, 169 participants were recruited from 6 US sleep clinics. The primary outcome measures were adherence based on minutes of use per night and on nights of use per week. RESULTS: We found a significant positive effect of personalized education and feedback on both primary adherence outcome measures. The difference in the estimated average adherence based on minutes of use per night between the PT + PN and UC groups on day 90 was 81.3 minutes in favor of the PT + PN group (95% CI -134.00 to -29.10; P=.002). The difference in the average adherence based on nights of use per week between the PT + PN and UC groups at week 12 was 0.9 nights per week in favor of the PT + PN group (difference in odds ratio 0.39, 95% CI 0.21-0.72; P=.003). We did not find an additional effect of tailoring the style of the intervention to psychological profiles on the primary outcomes. The difference in nightly use between the PT and PN groups on day 90 (95% CI -28.20 to 96.50; P=.28) and the difference in nights of use per week between the PT and PN groups at week 12 (difference in odds ratio 0.85, 95% CI 0.51-1.43; P=.054) were both nonsignificant. CONCLUSIONS: The results show that personalized education and feedback can increase CPAP adherence substantially. Tailoring the style of the intervention to the psychological profiles of patients did not further increase adherence. Future research should investigate how the impact of interventions can be enhanced by catering to differences in psychological profiles. TRIAL REGISTRATION: ClinicalTrials.gov NCT02195531; https://clinicaltrials.gov/ct2/show/NCT02195531.

Effectiveness of a Pharmacist-Led Web-Based Medication Adherence Tool With Patient-Centered Communication: Results of a Clustered Randomized Controlled Trial.

BACKGROUND: Growing numbers of people use medication for chronic conditions; nonadherence is common, leading to poor disease control. A web-based tool to identify an increased risk for nonadherence with related potential individual barriers might facilitate tailored interventions and improve adherence. OBJECTIVE: This study aims to assess the effectiveness of a newly developed tool aimed at improving medication adherence. METHODS: We performed a cluster randomized controlled trial in patients initiating cardiovascular or oral blood glucose-lowering medication. Participants were recruited from community pharmacies. They completed an online questionnaire comprising assessments of their risk for medication nonadherence and subsequently of barriers to adherence. In pharmacies belonging to the intervention group, individual barriers displayed in a graphical profile on a tablet were discussed by pharmacists and patients with high nonadherence risk in face-to-face meetings and shared with their general practitioners and practice nurses. Tailored interventions were initiated by pharmacists. Barriers of control patients were not presented nor discussed and these patients received usual care. The primary outcome was the effectiveness of the intervention on medication adherence at 8 months' follow-up between patients with an increased nonadherence risk from the intervention and control groups, calculated from dispensing data. RESULTS: Data from 492 participants in 15 community pharmacies were available for analyses (intervention 253, 7 pharmacies; control 239, 8 pharmacies). The intervention had no effect on medication adherence (B=-0.01; 95% CI -0.59 to 0.57; P=.96), nor in the post hoc per-protocol analysis (B=0.19; 95% CI -0.50 to 0.89; P=.58). CONCLUSIONS: This study showed no effectiveness of a risk stratification and tailored intervention addressing personal barriers for medication adherence. Various potential explanations for lack of effectiveness were identified. These explanations relate, for instance, to high medication adherence in the control group, study power, and fidelity. Process evaluation should elicit possible improvements and inform the redesign of intervention and implementation. TRIAL REGISTRATION: The Netherlands National Trial Register NTR5186; https://tinyurl.com/5d8w99hk.

The Impact of Mindset on Self-Tracking Experience.

Self-tracking technologies aim to offer a better understanding of ourselves through data, create self-awareness, and facilitate healthy behavior change. Despite such promising objectives, very little is known about whether the implicit beliefs users may have about the changeability of their own behavior influence the way they experience self-tracking. These implicit beliefs about the permanence of the abilities are called mindsets; someone with a fixed mindset typically perceives human qualities (e.g., intelligence) as fixed, while someone with a growth mindset perceives them as amenable to change and improvement through learning. This paper investigates the concept of mindset in the context of self-tracking and uses online survey data from individuals wearing a self-tracking device (n = 290) to explore the ways in which users with different mindsets experience self-tracking. A combination of qualitative and quantitative approaches indicates that implicit beliefs about the changeability of behavior influence the extent to which users are self-determined toward self-tracking use. Moreover, differences were found in how users perceive and respond to failure, and how self-judgmental vs. self-compassionate they are toward their own mistakes. Overall, considering that how users respond to the self-tracking data is one of the core dimensions of self-tracking, our results suggest that mindset is one of the important determinants in shaping the self-tracking experience. This paper concludes by presenting design considerations and directions for future research.

Respiratory Adherence Care Enhancer Questionnaire: Identifying Self-Management Barriers of Inhalation Corticosteroids in Asthma.

Introduction: Suboptimal self-management of inhaled corticosteroids (ICS) in asthma patients is frequently observed in clinical practice and associated with poor asthma control. Driving factors for suboptimal self-management are complex and consist of a range of behavioral barriers (cognitive, affective and practical) with a considerable inter-individual variability. Identification of individual barriers facilitates the use of corresponding behavior change techniques and tailored care to improve asthma treatment outcomes. Objective: This study describes the development and validation of the 'Respiratory Adherence Care Enhancer' (RACE) questionnaire to identify individual barriers to self-management of ICS therapy in asthma patients. Methods: The development included: 1) an inventory of self-management barriers based on a literature review, 2) expert assessment on relevance and completeness of this set, linking these barriers to behavioral domains of the Theoretical Domains Framework (TDF) and 3) the formulation of corresponding questions assessing each of the barriers. A cross-sectional study was performed for validation. Primary care asthma patients were invited to fill out the RACE-questionnaire prior to a semi-structured telephonic interview as golden standard. Barriers detected from the questionnaire were compared to those mentioned in the interview. Results: The developed questionnaire is made up of 6 TDF-domains, covering 10 self-management barriers with 23 questions. For the validation 64 patients completed the questionnaire, of whom 61 patients were interviewed. Cronbach's alpha for the consistency of questions within the barriers ranged from 0.58 to 0.90. Optimal cut-off values for the presence of barriers were determined at a specificity between 67 and 92% with a sensitivity between 41 and 83%. Significant Areas Under the Receiver Operating Curves values were observed for 9 barriers with values between 0.69 and 0.86 (p-value <0.05), except for 'Knowledge of ICS medication' with an insignificant value of 0.53. Conclusion: The RACE-questionnaire yields adequate psychometric characteristics to identify individual barriers to self-management of ICS therapy in asthma patients, facilitating tailored care.

A dual-process view on medication adherence: The role of affect.

Medication non-adherence has been recognised as one of the major problems in health care that leads to preventable costs and hospitalisations. This study aimed to assess the role of affect in medication adherence. We propose a dual-process framework of medication adherence based on the reflective-impulsive model, which includes both cognitive and affective processes. We tested this framework in a cross-sectional study (N = 525). The results supported this framework by illustrating the clear role of both cognitive and affective processes.

'A necessary evil': associations with taking medication and their relationship with medication adherence.

Cognitive factors, like beliefs, have been studied extensively as determinants of medication adherence, while affect associated with taking medicines has been studied much less. In the present study (N = 525), we investigated affect by assessing patients' first associations with taking their medicines. Results showed that these associations were related to self-reported medication adherence: Patients who associated taking medicines with negative affect were the least adherent, while those associating taking medicines with the need to take medicines were the most adherent. Our results support the idea that affect should be considered an important determinant of adherence.

The relation of trait and state mindfulness with satisfaction and physical activity: A cross-sectional study in 305 Dutch participants.

Previous research has shown that satisfaction mediates the relationship of state mindfulness (i.e. during physical activity) with physical activity. This study aimed to replicate this finding and to explore the role of trait mindfulness with a cross-sectional design. In all, 305 participants completed measures on trait and state mindfulness, satisfaction with physical activity, and physical activity. Mediation analyses were used. Satisfaction mediated the effect of state mindfulness on physical activity. Trait mindfulness related to physical activity via an indirect path, namely through two consecutive mediators, first state mindfulness and then satisfaction. Our results suggest that to enhance satisfaction, both state and trait mindfulness should be considered.

Effectiveness of a medication-adherence tool: study protocol for a randomized controlled trial.

BACKGROUND: Research shows that more than half of the people taking medication for a chronic condition are non-adherent. Nonadherence hinders disease control with a burden on patient quality of life and healthcare systems. We developed a tool that provides insight into nonadherence risks and barriers for medication-adherence including an intervention strategy to overcome those barriers. This study aims to assess the effectiveness of using this adherence tool in starters with cardiovascular or oral blood glucose-lowering medication to improve medication-adherence. METHODS/DESIGN: In a cluster-randomized controlled trial 25 pharmacies in the Netherlands will be randomized to the intervention or control arm. Patients registered in a general practice participating in a collaborative can be included when they start cardiovascular or oral blood glucose-lowering medication prescribed by their general practitioner. Participants complete an assessment consisting of measuring nonadherence risk and potential barriers to adherence. For patients with an increased nonadherence risk, a graphic barrier profile is created, showing to what extent eight cognitive, emotional, or practical barriers are present. All patients will fill in the medication-adherence assessment twice: between 1 and 2 weeks after the start of the medication and after 8 months. The intervention strategy consists of discussing this barrier profile to overcome barriers. Pharmacists and assistants of the intervention pharmacies are trained in discussing the profile and to offer a tailored intervention to overcome barriers. In the control arm, patients receive care as usual. The primary outcome is medication-adherence of patients with a high risk of nonadherence at 8 months follow-up. Secondary outcomes include the difference in the percentage of patients with an increased nonadherence risk between intervention and control group after 8 months, the predictive values of the baseline questionnaire in the control group in relation to medication-adherence after 8 months, medication-adherence after 1 year follow-up, and barriers and facilitators in the implementation of the tool. DISCUSSION: This manuscript presents the protocol for a cluster-randomized clinical trial on the use of an adherence tool to improve medication-adherence. This study will provide insight into the effectiveness of the tool in starters with cardiovascular or oral blood glucose-lowering medication in improvement of medication-adherence. TRIAL REGISTRATION: The Netherlands National Trial Register, NTR5186 . Registered on 18 May 2015.

Effectiveness of personalised support for self-management in primary care: a cluster randomised controlled trial.

BACKGROUND: Self-management support is an important component of the clinical management of many chronic conditions. The validated Self-Management Screening questionnaire (SeMaS) assesses individual characteristics that influence a patient's ability to self-manage. AIM: To assess the effect of providing personalised self-management support in clinical practice on patients' activation and health-related behaviours. DESIGN AND SETTING: A cluster randomised controlled trial was conducted in 15 primary care group practices in the south of the Netherlands. METHOD: After attending a dedicated self-management support training session, practice nurses in the intervention arm discussed the results of SeMaS with the patient at baseline, and tailored the self-management support. Participants completed a 13-item Patient Activation Measure (PAM-13) and validated lifestyle questionnaires at baseline and after 6 months. Data, including individual care plans, referrals to self-management interventions, self-monitoring, and healthcare use, were extracted from patients' medical records. Multilevel multiple regression was used to assess the effect on outcomes. RESULTS: The PAM-13 score did not differ significantly between the control (n = 348) and intervention (n = 296) arms at 6 months. In the intervention arm, 29.4% of the patients performed self-monitoring, versus 15.2% in the control arm (effect size r = 0.9, P = 0.01). In the per protocol analysis (control n = 348; intervention n = 136), the effect of the intervention was significant on the number of individual care plans (effect size r = 1.3, P = 0.04) and on self-monitoring (effect size r = 1.0, P = 0.01). CONCLUSION: This study showed that discussing SeMaS and offering tailored support did not affect patient activation or lifestyle, but did stimulate patients to self-monitor and use individual care plans.

Mindfulness and satisfaction in physical activity: A cross-sectional study in the Dutch population.

Both satisfaction and mindfulness relate to sustained physical activity. This study explored their relationship. We conducted a cross-sectional study with 398 Dutch participants who completed measures on trait mindfulness, mindfulness and satisfaction with physical activity, physical activity habits, and physical activity. We performed mediation and moderated mediation. Satisfaction mediated the effect of mindfulness on physical activity. Mindfulness was related to physical activity only when one's habit was weak. The relation of mindfulness with satisfaction was stronger for weak compared to strong habit. Understanding the relationship between mindfulness and satisfaction can contribute to the development of interventions to sustain physical activity.

Validation of Self-Management Screening (SeMaS), a tool to facilitate personalised counselling and support of patients with chronic diseases.

BACKGROUND: A rising number of people with chronic conditions is offered interventions to enhance self-management. The responsiveness of individuals to these interventions depends on patient characteristics. We aimed to develop and validate a tool to facilitate personalised counselling and support for self-management in patients with chronic diseases in primary care. METHODS: We drafted a prototype of the tool for Self-Management Screening (SeMaS), comprising 27 questions that were mainly derived from validated questionnaires. To reach high content validity, we performed a literature review and held focus groups with patients and healthcare professionals as input for the tool. The characteristics self-efficacy, locus of control, depression, anxiety, coping, social support, and perceived burden of disease were incorporated into the tool. Three items were added to guide the type of support or intervention, being computer skills, functioning in groups, and willingness to perform self-monitoring. Subsequently, the construct and criterion validity of the tool were investigated in a sample of 204 chronic patients from two primary care practices. Patients filled in the SeMaS and a set of validated questionnaires for evaluation of SeMaS. The Patient Activation Measure (PAM-13), a generic instrument to measure patient health activation, was used to test the convergent construct validity. RESULTS: Patients had a mean age of 66.8 years and 46.6 % was female. 5.9 % did not experience any barrier to self-management, 28.9 % experienced one minor or major barrier, and 30.4 % two minor or major barriers. Compared to the criterion measures, the positive predictive value of the SeMaS characteristics ranged from 41.5 to 77.8 % and the negative predictive value ranged from 53.3 to 99.4 %. Crohnbach's alpha for internal consistency ranged from 0.56 to 0.87, except for locus of control (α = 0.02). The regression model with PAM-13 as a dependent variable showed that the SeMaS explained 31.7 % (r(2) = 0.317) of the variance in the PAM-13 score. CONCLUSIONS: SeMaS is a short validated tool that can signal potential barriers for self-management that need to be addressed in the dialogue with the patient. As such it can be used to facilitate personalised counselling and support to enhance self-management in patients with chronic conditions in primary care.

The development of the ProMAS: a Probabilistic Medication Adherence Scale.

Current self-report medication adherence measures often provide heavily skewed results with limited variance, suggesting that most participants are highly adherent. This contrasts with findings from objective adherence measures. We argue that one of the main limitations of these self-report measures is the limited range covered by the behaviors assessed. That is, the items do not match the adherence behaviors that people perform, resulting in a ceiling effect. In this paper, we present a new self-reported medication adherence scale based on the Rasch model approach (the ProMAS), which covers a wide range of adherence behaviors. The ProMAS was tested with 370 elderly receiving medication for chronic conditions. The results indicated that the ProMAS provided adherence scores with sufficient fit to the Rasch model. Furthermore, the ProMAS covered a wider range of adherence behaviors compared to the widely used Medication Adherence Report Scale (MARS) instrument, resulting in more variance and less skewness in adherence scores. We conclude that the ProMAS is more capable of discriminating between people with different adherence rates than the MARS.

An online survey to study the relationship between patients' health literacy and coping style and their preferences for self-management-related information.

OBJECTIVE: To evaluate patients' preferences for message features and assess their relationships with health literacy, monitor-blunter coping style, and other patient-dependent characteristics. METHODS: Patients with coronary heart disease completed an internet-based survey, which assessed health literacy and monitor-blunter coping style, as well as various other patient characteristics such as sociodemographics, disease history, and explicit information preferences. To assess preferences for message features, nine text sets differing in one of nine message features were composed, and participants were asked to state their preferences. RESULTS: The survey was completed by 213 patients. For three of the nine text sets, a relationship was found between patient preference and health literacy or monitor-blunter coping style. Patients with low health literacy preferred the text based on patient experience. Patients with a monitoring coping style preferred information on short-term effects of their treatment and mentioning of explicit risks. Various other patient characteristics such as marital status, social support, disease history, and age also showed a strong association. CONCLUSION: Individual differences exist in patients' preferences for message features, and these preferences relate to patient characteristics such as health literacy and monitor-blunter coping style.

A qualitative participatory study to identify experiences of coronary heart disease patients to support the development of online self-management services.

OBJECTIVE: Web-based self-management services remain underutilized in current practice. Our aim was to gain insight into disease and self-management experiences of patients in early and progressive stages of coronary heart disease (CHD), to understand moderating effects of daily life experiences on the utilization of web-based self-management services and preconditions for use. METHODS: We applied generative research techniques, which stem from the field of product design and are characterized by the use of creative processes. Three groups of patients with CHD received a sensitizing package to document and reflect on their health, and were subsequently either interviewed or participated in a focus group session. RESULTS: In total, 23 patients participated in this study. Emerging themes were (1) fear for recurrent events, (2) experiences with professional care, (3) the perceived inability to prevent disease progression, (4) the desire to go on living without thinking about the disease every day, (5) the social environment as a barrier to or facilitator for self-management, and (6) the need for information tailored to personal preferences. CONCLUSION: How patients experience their disease varies between stable and post-acute stages, as well as between early and progressive stages of CHD. Patients in post-acute stages of the disease seem to be most amenable to support, while patients in stable stages want to live their life without being reminded of their disease. In the context of self-management, web-based services should be adapted to the variation in needs that occur in the different stages of CHD and new strategies to fit such services to these needs should be developed. Furthermore, they should be tailored to patients' individual health situation and preferences, support patient empowerment, and manage expectations regarding the progression of their disease.

Using personas as an intermediate construct in the development of tailored messages: a case study.

Tailoring health education messages to patients' preferences for message style is believed to increase patients' susceptibility to the given advice. This paper presents a persona-centered approach towards creating tailored health messages for chronically ill patients. A case study of tailoring messages to the preferences of patients with coronary heart disease illustrates the approach and shows the need for patient-centered data collection so that personas reflect patients' preferences. Based on these personas, a manageable set of tailored messages can be created in a step-by-step approach.

Modeling recognition memory using the similarity structure of natural input.

The natural input memory (NIM) model is a new model for recognition memory that operates on natural visual input. A biologically informed perceptual preprocessing method takes local samples (eye fixations) from a natural image and translates these into a feature-vector representation. During recognition, the model compares incoming preprocessed natural input to stored representations. By complementing the recognition memory process with a perceptual front end, the NIM model is able to make predictions about memorability based directly on individual natural stimuli. We demonstrate that the NIM model is able to simulate experimentally obtained similarity ratings and recognition memory for individual stimuli (i.e., face images).