Use Intention and User Expectations of Human-Supported and Self-Help eHealth Interventions: Internet-Based Randomized Controlled Trial.

BACKGROUND: Self-help eHealth interventions provide automated support to change health behaviors without any further human assistance. The main advantage of self-help eHealth interventions is that they have the potential to lower the workload of health care professionals. However, one disadvantage is that they generally have a lower uptake. Possibly, the absence of a relationship with a health care professional (referred to as the working alliance) could lead to negative expectations that hinder the uptake of self-help interventions. The Unified Theory of Acceptance and Use of Technology (UTAUT) identifies which expectations predict use intention. As there has been no previous research exploring how expectations affect the adoption of both self-help and human-supported eHealth interventions, this study is the first to investigate the impact of expectations on the uptake of both kinds of eHealth interventions. OBJECTIVE: This study investigated the intention to use a self-help eHealth intervention compared to a human-supported eHealth intervention and the expectations that moderate this relationship. METHODS: A total of 146 participants were randomly assigned to 1 of 2 conditions (human-supported or self-help eHealth interventions). Participants evaluated screenshots of a human-supported or self-help app-based stress intervention. We measured intention to use the intervention-expected working alliance and the UTAUT constructs: performance expectancy, effort expectancy, and social influence. RESULTS: Use intention did not differ significantly between the 2 conditions (t142=-1.133; P=.26). Performance expectancy (F1,140=69.269; P<.001), effort expectancy (F1,140=3.961; P=.049), social influence (F1,140=90.025; P<.001), and expected working alliance (F1,140=26.435; P<.001) were positively related to use intention regardless of condition. The interaction analysis showed that performance expectancy (F1,140=4.363; P=.04) and effort expectancy (F1,140=4.102; P=.045) more strongly influenced use intention in the self-help condition compared to the human-supported condition. CONCLUSIONS: As we found no difference in use intention, our results suggest that we could expect an equal uptake of self-help eHealth interventions and human-supported ones. However, attention should be paid to people who have doubts about the intervention's helpfulness or ease of use. For those people, providing additional human support would be beneficial to ensure uptake. Screening user expectations could help health care professionals optimize self-help eHealth intervention uptake in practice. TRIAL REGISTRATION: OSF Registries osf.io/n47cz; https://osf.io/n47cz.

Conditioning of the Cortisol Awakening Response in Healthy Men: Study Protocol for a Randomized Controlled Trial.

BACKGROUND: The hormone cortisol plays important roles in human circadian and stress physiology and is an interesting target for interventions. Cortisol varies not only in response to stress but also as part of a diurnal rhythm. It shows a particularly sharp increase immediately after awakening, the cortisol awakening response (CAR). Cortisol can be affected by medication, but it is less clear whether it can also be affected by learning. Animal studies have consistently shown that cortisol can be affected by pharmacological conditioning, but the results in humans have been mixed. Other studies have suggested that conditioning is also possible during sleep and that the diurnal rhythm can be conditioned, but these findings have not yet been applied to cortisol conditioning. OBJECTIVE: The objective of our study was to introduce a novel avenue for conditioning cortisol: by using the CAR as an unconditioned response and using scent conditioning while the participant is asleep. This study investigates an innovative way to study the effects of conditioning on cortisol and the diurnal rhythm, using a variety of devices and measures to make measurement possible at a distance and at unusual moments. METHODS: The study protocol takes 2 weeks and is performed from the participant's home. Measures in week 1 are taken to reflect the CAR and waking under baseline conditions. For the first 3 nights of week 2, participants are exposed to a scent from 30 minutes before awakening until their normal time of awakening to allow the scent to become associated with the CAR. On the final night, participants are forced to wake 4 hours earlier, when cortisol levels are normally low, and either the same (conditioned group) or a different (control group) scent is presented half an hour before this new time. This allows us to test whether cortisol levels are higher after the same scent is presented. The primary outcome is the CAR, assessed by saliva cortisol levels, 0, 15, 30, and 45 minutes after awakening. The secondary outcomes are heart rate variability, actigraphy measures taken during sleep, and self-reported mood after awakening. To perform manipulations and measurements, this study uses wearable devices, 2 smartphone apps, web-based questionnaires, and a programmed scent device. RESULTS: We completed data collection as of December 24, 2021. CONCLUSIONS: This study can provide new insights into learning effects on cortisol and the diurnal rhythm. If the procedure does affect the CAR and associated measures, it also has potential clinical implications in the treatment of sleep and stress disorders. TRIAL REGISTRATION: Netherlands Trial Register NL58792.058.16; https://trialsearch.who.int/Trial2.aspx?TrialID=NL7791. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/38087.

Early identification of persistent somatic symptoms in primary care: data-driven and theory-driven predictive modelling based on electronic medical records of Dutch general practices.

OBJECTIVE: The present study aimed to early identify patients with persistent somatic symptoms (PSS) in primary care by exploring routine care data-based approaches. DESIGN/SETTING: A cohort study based on routine primary care data from 76 general practices in the Netherlands was executed for predictive modelling. PARTICIPANTS: Inclusion of 94 440 adult patients was based on: at least 7-year general practice enrolment, having more than one symptom/disease registration and >10 consultations. METHODS: Cases were selected based on the first PSS registration in 2017-2018. Candidate predictors were selected 2-5 years prior to PSS and categorised into data-driven approaches: symptoms/diseases, medications, referrals, sequential patterns and changing lab results; and theory-driven approaches: constructed factors based on literature and terminology in free text. Of these, 12 candidate predictor categories were formed and used to develop prediction models by cross-validated least absolute shrinkage and selection operator regression on 80% of the dataset. Derived models were internally validated on the remaining 20% of the dataset. RESULTS: All models had comparable predictive values (area under the receiver operating characteristic curves=0.70 to 0.72). Predictors are related to genital complaints, specific symptoms (eg, digestive, fatigue and mood), healthcare utilisation, and number of complaints. Most fruitful predictor categories are literature-based and medications. Predictors often had overlapping constructs, such as digestive symptoms (symptom/disease codes) and drugs for anti-constipation (medication codes), indicating that registration is inconsistent between general practitioners (GPs). CONCLUSIONS: The findings indicate low to moderate diagnostic accuracy for early identification of PSS based on routine primary care data. Nonetheless, simple clinical decision rules based on structured symptom/disease or medication codes could possibly be an efficient way to support GPs in identifying patients at risk of PSS. A full data-based prediction currently appears to be hampered by inconsistent and missing registrations. Future research on predictive modelling of PSS using routine care data should focus on data enrichment or free-text mining to overcome inconsistent registrations and improve predictive accuracy.

Values of Importance to Patients With Cardiovascular Disease as a Foundation for eHealth Design and Evaluation: Mixed Methods Study.

BACKGROUND: eHealth interventions are developed to support and facilitate patients with lifestyle changes and self-care tasks after being diagnosed with a cardiovascular disease (CVD). Creating long-lasting effects on lifestyle change and health outcomes with eHealth interventions is challenging and requires good understanding of patient values. OBJECTIVE: The aim of the study was to identify values of importance to patients with CVD to aid in designing a technological lifestyle platform. METHODS: A mixed method design was applied, combining data from usability testing with an additional online survey study, to validate the outcomes of the usability tests. RESULTS: A total of 11 relevant patient values were identified, including the need for security, support, not wanting to feel anxious, tailoring of treatment, and personalized, accessible care. The validation survey shows that all values but one (value 9: To have extrinsic motivation to accomplish goals or activities [related to health/lifestyle]) were regarded as important/very important. A rating of very unimportant or unimportant was given by less than 2% of the respondents (value 1: 4/641, 0.6%; value 2: 10/641, 1.6%; value 3: 9/641, 1.4%; value 4: 5/641, 0.8%; value 5: 10/641, 1.6%; value 6: 4/641, 0.6%; value 7: 10/639, 1.6%; value 8: 4/639, 0.6%; value 10: 3/636, 0.5%; value 11: 4/636, 0.6%) to all values except but one (value 9: 56/636, 8.8%). CONCLUSIONS: There is a high consensus among patients regarding the identified values reflecting goals and themes central to their lives, while living with or managing their CVD. The identified values can serve as a foundation for future research to translate and integrate these values into the design of the eHealth technology. This may call for prioritization of values, as not all values can be met equally.

Identifying persistent somatic symptoms in electronic health records: exploring multiple theory-driven methods of identification.

OBJECTIVE: Persistent somatic symptoms (PSSs) are defined as symptoms not fully explained by well-established pathophysiological mechanisms and are prevalent in up to 10% of patients in primary care. The present study aimed to explore methods to identify patients with a recognisable risk of having PSS in routine primary care data. DESIGN: A cross-sectional study to explore four identification methods that each cover part of the broad spectrum of PSS was performed. Cases were selected based on (1) PSS-related syndrome codes, (2) PSS-related symptom codes, (3) PSS-related terminology and (4) Four-Dimensional Symptom Questionnaire scores and all methods combined. SETTING: Coded electronic health record data were extracted from 76 general practices in the Netherlands. PARTICIPANTS: Patients who were registered for at least 1 year during 2014-2018, were included (n=169 138). OUTCOME MEASURES: Identification methods were explored based on (1) PSS sample sizes and demographics, (2) presence of chronic conditions and (3) healthcare utilisation (HCU) variables. Overlap between methods and practice specific differences were examined. RESULTS: The percentage of cases identified varied between 0.3% and 7.0% across the methods. Over 58.1% of cases had chronic physical condition(s) and over 33.8% had chronic mental condition(s). HCU was generally higher for cases selected by any method compared with the total cohort. HCU was higher for method B compared with the other methods. In 26.7% of cases, cases were selected by multiple methods. Overlap between methods was low. CONCLUSIONS: Different methods yielded different patient samples which were general practice specific. Therefore, for the most comprehensive data-based selection of PSS cases, a combination of methods A, C and D would be recommended. Advanced (data-driven) methods are needed to create a more sensitive algorithm for identifying the full spectrum of PSS. For clinical purposes, method B could possibly support screening of patients who are currently missed in daily practice.

Measuring daily functioning in older persons using a frailty index: a cohort study based on routine primary care data.

BACKGROUND: Electronic health records (EHRs) are increasingly used for research; however, multicomponent outcome measures such as daily functioning cannot yet be readily extracted. AIM: To evaluate whether an electronic frailty index based on routine primary care data can be used as a measure for daily functioning in research with community-dwelling older persons (aged ≥75 years). DESIGN AND SETTING: Cohort study among participants of the Integrated Systemic Care for Older People (ISCOPE) trial (11 476 eligible; 7285 in observational cohort; 3141 in trial; over-representation of frail people). METHOD: At baseline (T0) and after 12 months (T12), daily functioning was measured with the Groningen Activities Restriction Scale (GARS, range 18-72). Electronic frailty index scores (range 0-1) at T0 and T12 were computed from the EHRs. The electronic frailty index (electronic Frailty Index - Utrecht) was tested for responsiveness and compared with the GARS as a gold standard for daily functioning. RESULTS: In total, 1390 participants with complete EHR and follow-up data were selected (31.4% male; median age = 81 years, interquartile range = 78-85). The electronic frailty index increased with age, was higher for females, and lower for participants living with a partner. It was responsive after an acute major medical event; however, the correlation between the electronic frailty index and GARS at T0 and over time was limited. CONCLUSION: Because the electronic frailty index does not reflect daily functioning, further research on new methods to measure daily functioning with routine care data (for example, other proxies) is needed before EHRs can be a useful data source for research with older persons.

Psychosocial well-being in young adults with chronic illness since childhood: the role of illness cognitions.

BACKGROUND: More and more pediatric patients reach adulthood. Some of them are successfully integrating in adult life, but many others are not. Possibly Illness cognitions (IC) - the way people give meaning to their illness/disability - may play a role in individual differences on long-term adjustment. This study explored the association of IC with disease-characteristics and Health Related Quality of Life (HRQoL), anxiety and depression in young adults with a disability benefit due to childhood-onset chronic condition. METHODS: In a cross-sectional study, young adults (22-31 years, N = 377) who claimed a disability benefit because of a somatic condition since childhood, completed the Illness Cognition Questionnaire (acceptance-helplessness-benefits), RAND-36 (HRQoL) and HADS (anxiety and depression) online. Besides descriptive statistics, linear regression analyses were conducted to predict (1) illness cognitions by age, gender and disease-characteristics, and (2) HRQoL (Mental and Physical Component Scale), Anxiety and Depression by illness cognitions, controlling for disease-characteristics, age and gender. RESULTS: Respectively 90.2%, 83.8% and 53.3% of the young adults with a disability benefit experienced feelings of acceptance, benefits and helplessness. Several disease-characteristics were associated with IC. More acceptance and less helplessness were associated with better mental (ß = 0.31; ß = -0.32) and physical (ß = 0.16; ß = -0.15) HRQoL and with less anxiety (ß = -0.27; ß = 0.28) and depression (ß = -0.29; ß = 0.31). CONCLUSIONS: IC of young adult beneficiaries were associated with their HRQoL and feelings of anxiety and depression. Early recognition of psychological distress and negative IC might be a key to the identification of pediatric patients at risk for long-term dysfunction. Identification of maladaptive illness cognitions enables the development of psychosocial interventions to optimise their well-being and adaptation to society.

Internet-based cognitive behavioral therapy for patients with chronic somatic conditions: a meta-analytic review.

BACKGROUND: Patients with chronic somatic conditions face unique challenges accessing mental health care outside of their homes due to symptoms and physical limitations. Internet-based cognitive behavioral therapy (ICBT) has shown to be effective for various psychological conditions. The increasing number of recent trials need to be systematically evaluated and quantitatively analyzed to determine whether ICBT is also effective for chronic somatic conditions and to gain insight into the types of problems that could be targeted. OBJECTIVE: Our goal was to describe and evaluate the effectiveness of guided ICBT interventions for chronic somatic conditions on general psychological outcomes, disease-related physical outcomes, and disease-related impact on daily life outcomes. The role of treatment length was also examined. METHODS: PubMed, PsycINFO, and Embase were searched from inception until February 2012, by combining search terms indicative of effect studies, Internet, and cognitive behavioral therapy. Studies were included if they fulfilled the following six criteria: (1) randomized controlled trial, (2) Internet-based interventions, (3) based on cognitive behavioral therapy, (4) therapist-guided, (5) adult (≥18 years old) patients with an existing chronic somatic condition, and (6) published in English. 23 randomized controlled trials of guided ICBT were selected by 2 independent raters after reviewing 4848 abstracts. Demographic, clinical, and methodological variables were extracted. Standardized mean differences were calculated between intervention and control conditions for each outcome and pooled using random effects models when appropriate. RESULTS: Guided ICBT was shown to improve all outcome categories with small effect sizes for generic psychological outcomes (effect size range 0.17-0.21) and occasionally larger effects for disease-specific physical outcomes (effect size range 0.07 to 1.19) and disease-related impact outcomes (effect size range 0.17-1.11). Interventions with a longer treatment duration (>6 weeks) led to more consistent effects on depression. CONCLUSIONS: Guided ICBT appears to be a promising and effective treatment for chronic somatic conditions to improve psychological and physical functioning and disease-related impact. The most consistent improvements were found for disease-specific outcomes, which supports the possible relevance of tailoring interventions to specific patient groups. Explorative analyses revealed that longer treatment length holds the promise of larger treatment effects for the specific outcome of depression. While the current meta-analysis focused on several chronic somatic conditions, future meta-analyses for separate chronic somatic conditions can further consolidate these results, also in terms of cost-effectiveness.

Whiplash patients with cervicogenic headache after lateral atlanto-axial joint pulsed radiofrequency treatment.

BACKGROUND: Whiplash patients regard cervicogenic headache (CEH) as the most burdensome symptom of their condition. Sufferers experience a significant degree of disability from headache, associated neck pain and disability, and sleep disturbance. Lateral C1/2 joint pulsed radiofrequency (PRF) treatment has been shown to produce significant relief from headache in patients with CEH. OBJECTIVES: The objective of this retrospective questionnaire study of 45 consecutive whiplash patients with CEH who had undergone antero-lateral atlantoaxial joint pulsed radiofrequency treatment (AA PRF) was to evaluate the treatment's long-term effects on pain-related disability and health-related quality of life. PATIENTS AND METHODS: Four questionnaires were sent to all 45 patients who had undergone AA PRF: 1) The short form-36 (SF-36); 2) The neck disability index (NDI); 3) The medical outcome scale-sleep scale (MOS-SS); 4) The headache impact test-6 (HIT-6). All 45 patients received AA PRF under fluoroscopic guidance. PRF treatment was conducted at 45 V with a pulsed frequency of 4 Hz and a pulsed width of 10 ms for 4 minutes . RESULTS: Patients who responded to the procedure reported lower pain scores at 2, 6, and 12 months of follow-up compared to nonresponders. More important, patients reported marked improvements in headache impact (P < 0.01), neck-disability scores (P < 0.01), awakening due to headache (P < 0.01), and sleep problems (9-item; P < 0.05) on the MOS-SS. Responders to the procedure also reported a significantly higher health-related quality of life in terms of bodily pain (P < 0.05) and health change (P < 0.01) on the SF-36. CONCLUSIONS: In light of the inherent limitations of our retrospective study, AA PRF treatment can only be tentatively viewed as a promising treatment modality for whiplash patients with CEH and is subject to validation in future studies.