[Efficiency-Focussed Assessment of Internet-Based Interventions: a Study Protocol]. / Wirksamkeitsfokussierte Bewertung von internetbasierten Interventionen: ein Studienprotokoll.

BACKGROUND: The availability of internet-based interventions for the treatment of mental disorder is steadily growing and is also included in the German health care system. However, there is still room for improvement in terms of the information available to users and practitioners, particularly with regard to the effectiveness of internet-based interventions. OBJECTIVES: To identify and evaluate internet-based interventions for the treatment of mental disorder, listed in the DiGA-Verzeichnis. A user-friendly description of positively evaluated interventions will be made available for interested people at psychenet.de. METHODS: By means of predefined criteria for intervention identification, evaluation and subsequent publication on psychenet.de, a methodological sound and transparent procedure will be established and put into practice. ETHICS AND DISSEMINATION: Ethics approval is not required for this study, as research on secondary data was conducted. Relevant professional, stakeholder and patient associations will be informed about the information offered at psychenet.de.

Patient-centeredness in the multimorbid elderly: a focus group study.

BACKGROUND: Patient-centeredness (PC) aims to adapt health care to the individual needs and preferences of patients. An existing integrative model of PC comprises several dimensions of PC which have not yet been investigated from the patients' perspective. Older patients with multimorbidity represent a target group for patient-centered care, as their care needs are particularly complex and should be addressed individually. We aimed to assess the perspective that older patients with multimorbidity have of patient-centered care and to examine the transferability of the integrative model of PC to this specific population. METHOD: We performed 4 guided focus group interviews with a total of 20 older individuals with multimorbidity. The focus group interviews were audio-recorded and transcribed verbatim. Patients' statements were content-analyzed applying an a priori designed system of categories that included the dimensions of PC from the integrative model and the additional category 'prognosis and life expectancy', which had emerged from an initial literature search on aspects of PC specific to the multimorbid elderly. RESULTS: The new category 'prognosis and life expectancy' was confirmed and expanded to 'individual care needs related to aging and chronic disesase'. All dimensions of our integrative PC model were confirmed for older patients with multimorbidity. Among these, we found that eight dimensions (individual care needs related to aging and chronic disease, biopsychosocial perspective, clinician-patient communication, essential characteristics of the clinician, clinician-patient-relationship, involvement of family and friends, coordination and continuity of care, access to care) were complemented by aspects specific to this target population. CONCLUSIONS: The integrative PC model is applicable to the population of older patients with multimorbidity. For a population-specific adaptation, it might be complemented by the dimension 'individual care needs in aging and chronic disease', in conjunction with age-specific aspects within existing dimensions. Together with corresponding results from a Delphi survey, our adapted PC model will serve as the basis for a subsequent systematic review of instruments measuring PC in older patients with multimorbidity. TRIAL REGISTRATION: PROSPERO ( https://www.crd.york.ac.uk/prospero; CRD42018084057; 2018/02/01), German Clinical Trials Register ( www.drks.de ; DRKS00013309; 2018/01/23).

Engagement With a Web-Based Intervention to Reduce Harmful Drinking: Secondary Analysis of a Randomized Controlled Trial.

BACKGROUND: Engagement with digital behavior change interventions (DBCIs) is considered a prerequisite for intervention efficacy. However, in many trials on DBCIs, participants use the intervention either only little or not at all. OBJECTIVE: To analyze engagement with a web-based intervention to reduce harmful drinking, we explored (1) whether engagement with a web-based alcohol intervention is related to drinking outcomes, (2) which user characteristics are associated with measures of engagement, and (3) whether reported outcomes are associated with data captured by voluntary intervention questionnaires. METHODS: We analyzed data of the intervention arm of a randomized controlled trial on a DBCI to reduce risky alcohol consumption. Data were collected at baseline (T0), after 90 days (T1), and at the end of the 180-day usage period (T2). Engagement with the intervention was measured via system usage data as well as self-reported usage. Drinking behavior was measured as average daily alcohol consumption as well as the number of binge drinking days. User characteristics included demographics, baseline drinking behavior, readiness to change, alcohol-related outcome expectancies, and alcohol abstinence self-efficacy. Following a bivariate approach, we performed two-tailed Welch's t tests and Wilcoxon signed rank/Mann-Whitney U tests or calculated correlation coefficients. RESULTS: The data of 306 users were analyzed. Time spent engaging with the intervention as measured by system usage did not match self-reported usage. Higher self-reported usage was associated with higher reductions in average daily alcohol consumption (T1: ρ=0.39, P<.001; T2: ρ=0.29, P=.015) and in binge drinking days (T1: ρ=0.62, P<.001; T2: ρ=0.3, P=.006). Higher usage was reported from users who were single (T1: P<.001; T2: P<.001), users without children (T1: P<.001; T2: P<.001), users who did not start or finish secondary education (T1: P<.001; T2: P<.001), users without academic education (T1: P<.001; T2: P<.001), and those who worked (T1: P=.001; T2: P=.004). Relationships between self-reported usage and clinical or psychological baseline characteristics were complex. For system usage, the findings were mixed. Reductions in drinking captured by intervention questionnaires were associated with reported outcomes. CONCLUSIONS: Though self-reported usage could be consistently linked to better outcomes and multiple user characteristics, our findings add to the overall inconclusive evidence that can be found throughout the literature. Our findings indicate potential benefits of self-reports as measures of engagement and intervention questionnaires as a basis for tailoring of intervention content. Future studies should adopt a theory-driven approach to engagement research utilizing psychometrically sound self-report questionnaires and include short ecological momentary assessments within the DBCIs. TRIAL REGISTRATION: German Clinical Trials Register DRKS00006104; https://tinyurl.com/y22oc5jo.

Development and evaluation of e-mental health interventions to reduce stigmatization of suicidality - a study protocol.

BACKGROUND: Worldwide, approximately 800,000 persons die by suicide every year; with rates of suicide attempts estimated to be much higher. Suicidal persons often suffer from a mental disorder but stigma, lack of available and suitable support, and insufficient information on mental health limit help seeking. The use of internet-based applications can help individuals inform themselves about mental disorders, assess the extent of their own concerns, find local treatment options, and prepare for contact with health care professionals. This project aims to develop and evaluate e-mental health interventions to improve knowledge about suicidality and to reduce stigmatization of those affected. In developing these interventions, a representative telephone survey was conducted to detect knowledge gaps and stigmatizing attitudes in the general population. METHODS: First, a national representative telephone survey with N = 2000 participants in Germany was conducted. Second, e-mental health interventions are developed to address knowledge gaps and public stigma detected in the survey. These comprise an evidence-based health information package about suicidality, information on regional support services, a self-administered depression test-including suicidality-and an interactive online intervention including personal stories. The development is based on a trialogical exchange of experience between persons affected by suicidality, relatives of affected persons, and clinical experts. Australian researchers who developed an e-mental health intervention for individuals affected by rural suicide were invited to a workshop in order to contribute their knowledge and expertise. Third, the online intervention will be evaluated by a mixed methods design. DISCUSSION: From representative telephone survey data, content can be developed to address specific attitudes and knowledge via the e-mental health interventions. These interventions will be easily accessed and provide an opportunity to reach people who tend not to seek professional services, prefer to inform themselves in advance and/or wish to remain anonymous. Evaluation of the online intervention will provide information on any changes in participants' self-stigma and perceived-stigma of suicidality, and any increase in participants' knowledge on suicidality or self-efficacy expectations. TRIAL REGISTRATION: German Clinical Trial Register DRKS00015071 on August 6, 2018.

[Reasons for Long-Term Use of Benzodiazepines and Z-Drugs in Older Patients]. / Ursachen und Hintergründe der Langzeiteinnahme von Benzodiazepinen und Z-Substanzen bei älteren Patienten.

BACKGROUND: Long-term use of benzodiazepines (BZD) and Z-drugs is associated with the risk of developing dependency. Many older patients use these drugs for long durations, which is often associated with low-dose dependency without an increase in dose. AIM: The aim of this study is to investigate the reasons, symptoms, and side effects, as well as the prescription conditions among older patients who were prescribed BZD or Z-drugs within the last 12 months. METHODS: A 9-page questionnaire was sent to 4,000 patients of the AOK-NordWest, stratified according to age group (50-56 years;>65 years) and intake behavior (long-term use/ guideline incompatible; short-term use/ guideline compatible). Patients provided demographic data and indicated on a comprehensive list of BZD and Z-drugs, which substances they had used or were currently using. In addition, patients were asked about the reasons and underlying symptoms for taking these medications, possible side effects, and previous attempts to discontinue the medications. RESULTS: A total of 466 patients returned completed questionnaires (11.7%). A further 43 privately insured patients were recruited through pharmacies. 169 patients, mainly from the group with guideline-compatible prescriptions, indicated that they had never taken these medications. The remaining 340 patients were 68.5% female and the average age was 72.1 years. Compared to patients with guideline-compatible prescriptions, a greater proportion of patients with guideline-incompatible prescriptions were taking Z-drugs. The average daily dose (DDD) consumed was significantly higher than in those with guideline-compatible prescriptions, although on average both patient groups took low doses (<1 DDD) of the medication. In both groups, the main reason for taking BZD and Z-drugs was sleeping problems. CONCLUSIONS: Considering the recommendation that BZD and Z-drugs are to be taken only short-term for sleeping problems, the extent of insomnia indications is high. The low doses suggest a careful and controlled prescription behavior in both groups, with the majority of long-term consumers likely to have developed low-dose dependency. This is associated with only a limited need for intervention, since only few medication-dependent people underwent addiction treatment.

[Potentials and Challenges of E-Mental Health Interventions in Mental Health Care]. / Potenziale und Herausforderungen von E-Mental-Health-Interventionen in der Versorgung psychischer Störungen.

Mental disorders are common and impairing for both affected individuals and society. Despite the great burden of mental disorders and a comparably well-developed mental health care system in Germany, mental disorders are still treated insufficiently. Additionally, access barriers such as long waiting times for outpatient treatment impede utilization of mental health care services. E-mental health interventions are considered as promising options to reduce access barriers and to overcome gaps in the mental health care system. Such interventions can be delivered flexibly (i. e. independent of time and / or space), so that people living in rural and underserved areas, or people with mobility constraints (e. g. because of physical illness or impairment) can be reached adequately. However, the e-(mental) health sector is facing numerous challenges, as there is ambiguity regarding terminological, conceptual and evaluative aspects hindering the implementation process in routine care and affecting acceptance of e-mental health interventions for users and health care providers. Thus, this contribution describes and discusses potentials, challenges and needs for specification (e. g. terminologically) of e-mental health interventions in the context of mental health care.

[Clinical trial of a stepped and collaborative care model for mental illnesses and comorbidities in the Hamburg Network for Health Services Research]. / Erprobung eines integrierten und gestuften Behandlungsmodells für psychische Störungen und Komorbiditäten im Hamburger Netzwerk für Versorgungsforschung.

Healthcare for mental disorders is a big challenge for the German healthcare system. In cases of comorbid mental diseases, patients suffer from an especially high burden of disease. So far, innovative care models for collaborative and stepped care have only been investigated with respect to their effectiveness for single mental disorders.The project "Collaborative and Stepped Care in Mental Health by Overcoming Treatment Sector Barriers" (COMET), which is being carried out by the Hamburg Network for Health Services Research (HAM-NET) from 2017 until 2020, examines an innovative, guideline-based healthcare model for the improvement of healthcare for patients with mental illnesses and their potential comorbidities. In this article this new stepped and collaborative care model for patients in primary care that integrates general practitioners, psychiatrists, psychotherapists, and hospitals is presented. For the implementation and facilitation of the model, guideline-based treatment pathways, a tablet-based computer program for screening, diagnostic and guideline-based treatment recommendations, as well as a web-based transferal platform were developed.The results of this project on the effectiveness and efficacy of the model can help determine if the model can be implemented in routine healthcare. This could represent a major step towards more integrated and cross-sectoral healthcare for patients with mental illnesses.

[On the Way to Culture-Sensitive Patient Information Materials: Results of a Focus Group Study]. / Auf dem Weg zu kultursensitiven Patienteninformationsmaterialien: Ergebnisse einer Fokusgruppenuntersuchung.

AIM: This study was part of a double-blind randomised controlled trial aimed to evaluate the effects of culture-sensitive patient information materials (PIM) compared with standard translated material. The study aimed to obtain the data for the development of culture sensitive PIM about unipolar depression for the 4 largest migrant groups in Germany (Turkish, Polish, Russian and Italian migration background). METHOD: A qualitative study using 4 manual-based focus groups (FG), one for each migrant group, with 29 participants (9 with a Turkish (TüG), 8 with a Polish (PoG), 5 with a Russian (RuG) and 7 with an Italian (ItG) migration background) was conducted. The discussions were recorded, transcribed and analyzed using qualitative content analysis. RESULTS: 7 categories were identified. For the (1.) development of a good culture-sensitive PIM an easy language, a clear structure, an assessable extent of information and the avoidance of stereotypes were highlighted cross-culturally in all four FG. RuG and PoG had the largest (2.) lack of information about the German health care system. Concerning the (3.) illness perception RuG named problems with recognizing and understanding depression. PoG, RuG and TüG thematized (4.) feared consequences of the illness and of professional helpseeking. ItG, PoG, RuG had fears concerning (5.) psychotropic drugs as a result from insufficient knowledge about medication. For (6.) doctor-patient relationship cultural specifics were identified in RuG and TüG and for (7.) migration or culture specific reasons for depression in RuG, ItG and TüG. CONCLUSION: Although the identified categories were relevant for all or for the majority of migrant groups, for most categories specific cultural aspects were discovered. These findings show the importance of a culture sensitive adaptation of PIM.

Vorvida: study protocol of a randomized controlled trial testing the effectiveness of Internet-based self-help program for the reduction of alcohol consumption for adults.

BACKGROUND: Problem drinking is an important global health concern, causing premature mortality and morbidity. Only few problem drinkers seek professional care, unfortunately, because of multiple barriers such as insufficient change motivation, fear of stigmatization or limited access to care. The aim of this study will be to examine the effectiveness of a novel Internet intervention termed Vorvida, which was developed based on established cognitive-behavioral therapy techniques with the aim of reducing problematic alcohol consumption. METHODS/DESIGN: A two-arm randomized control trial (RCT) will be conducted to determine whether using Vorvida results in greater reductions in self-reported problem drinking, compared with a care-as-usual/waitlist (CAU/WL) control group. There will be a baseline assessment (t0) and follow-up assessments after three (t1) and six months (t2). Inclusion criteria will be: minimum age of 18, an average consumption of alcohol >24/12 g (men/women) per day and an AUDIT-C score ≥ 3, as well as informed consent. Participants will be randomly assigned to the intervention or control condition at a ratio of 1:1. Recruitment, informed consent, randomization and assessment will be Internet-based. Primary outcome will be change in self-reported alcohol consumption between t0 and t1. Secondary outcomes will be self-reported drinking behavior, expectancies of effects of alcohol use, abstinence and relapse tendencies, self-efficacy and motivation to change. DISCUSSION: This study is expected to establish the extent to which a novel Internet intervention could contribute to reducing problem drinking among adults with mild to severe alcohol use disorders who may or may not seek or access a traditional treatments. Potentially, this program could be an effective and efficient tool to help reduce problem drinking on a population level because a great number of users can be reached simultaneously without adding burden to treating clinicians. TRIAL REGISTRATION: German Clinical Trial Registration (DRKS): DRKS00006104. Registered 14 April 2014.

Translation and validation of a multidimensional instrument to assess health literacy.

BACKGROUND: The patients' task to find, evaluate and transfer health information to one's individual condition and life requires competences that are summarized by the term 'health literacy'. Poor health literacy is associated with poorer health outcomes, like a higher rate of rehospitalization, lower receipt of screenings and a higher frequency of doctor visits. OBJECTIVE: Three levels of health literacy are distinguished: functional, communicative and critical health literacy. Aim of this study was to translate and adapt the 'Functional Communicative Critical Health Literacy' (FCCHL) questionnaire to German, and assess its psychometric properties. METHODS/DESIGN: The FCCHL was sent to 9075 participants enrolled in a RCT on health coaching. 4040 participants responded. Besides descriptive and reliability analysis, confirmatory factor analysis was performed to test the questionnaire's postulated scale structure in a calibration (N = 3000) and a validation sample (N = 1040) for cross-validation. RESULTS: The instrument was well accepted (missing values ≤2.1% per item) and showed acceptable or good internal consistency for the entire scale (α = 0.77) and the subscales (α = 0.75-0.80). The proposed three-factor model did not fit the German data sufficiently. As the scales 'communicative health literacy' and 'critical health literacy' showed high intercorrelation (0.98), they were combined to a new scale called 'processing health literacy'. The fit indices for the amended two-factor model were satisfying in both subgroups. CONCLUSIONS: Reliability and acceptance of the German FCCHL are satisfying. An amended two-factor structure showed better validity than the original factor structure. Further research regarding the FCCHL and the underlying construct is needed.

Comparing the nine-item Shared Decision-Making Questionnaire to the OPTION Scale - an attempt to establish convergent validity.

BACKGROUND: While there has been a clear move towards shared decision-making (SDM) in the last few years, the measurement of SDM-related constructs remains challenging. There has been a call for further psychometric testing of known scales, especially regarding validity aspects. OBJECTIVE: To test convergent validity of the nine-item Shared Decision-Making Questionnaire (SDM-Q-9) by comparing it to the OPTION Scale. DESIGN: Cross-sectional study. SETTING AND PARTICIPANTS: Data were collected in outpatient care practices. Patients suffering from chronic diseases and facing a medical decision were included in the study. METHODS: Consultations were evaluated using the OPTION Scale. Patients completed the SDM-Q-9 after the consultation. First, the internal consistency of both scales and the inter-rater reliability of the OPTION Scale were calculated. To analyse the convergent validity of the SDM-Q-9, correlation between the patient (SDM-Q-9) and expert ratings (OPTION Scale) was calculated. RESULTS: A total of 21 physicians provided analysable data of consultations with 63 patients. Analyses revealed good internal consistency of the SDM-Q-9 and limited internal consistency of the OPTION Scale. Inter-rater reliability of the latter was less than optimal. Association between the total scores of both instruments was weak with a Spearman correlation of r = 0.19 and did not reach statistical significance. DISCUSSION: By the use of the OPTION Scale convergent validity of the SDM-Q-9 could not be established. Several possible explanations for this result are discussed. CONCLUSION: This study shows that the measurement of SDM remains challenging.

Information and decision-making needs among people with mental disorders: a systematic review of the literature.

BACKGROUND: Assessment of users' information and decision-making needs is one key step in the development of decision-support interventions. OBJECTIVE: To identify patients' information and decision-making needs as a pre-requisite for the development of high-quality web-based patient decision aids (PtDAs) for common mental disorders. SEARCH STRATEGY: A systematic MEDLINE search for papers published until December 2012 was conducted, and reference lists of included articles and relevant reviews were searched. INCLUSION CRITERIA: Original studies containing data on information or decision-making needs of adults with depression, anxiety disorders, somatoform disorders, alcohol-related disorders and schizophrenia were included. DATA EXTRACTION AND SYNTHESIS: Data extraction was performed using a standardized form, and data synthesis was conducted using a theory-based deductive approach by two independent reviewers. Studies were quality assessed using the Mixed Methods Appraisal Tool. MAIN RESULTS: Twelve studies were included focusing on information needs or the identification of decisions patients with depression and schizophrenia were facing. No studies were found for the other mental disorders. Overall, seven information needs categories were identified with the topics 'basic facts', 'treatment' and 'coping' being of major relevance. Six decision categories were identified of which decisions on 'medication' and 'treatment setting' were most often classified. CONCLUSIONS: This review reveals that patients with schizophrenia and depression show extensive information and decision-making needs. The identified needs can initially inform the design of PtDAs for schizophrenia and depression. However, there is an urgent need to investigate information and decision-making needs among patients with other mental disorders.

Effectiveness of a Web-based tailored interactive health communication application for patients with type 2 diabetes or chronic low back pain: randomized controlled trial.

BACKGROUND: The prevalence of chronic diseases such as type 2 diabetes and chronic low back pain is rising. Patient empowerment is a key strategy in the management of chronic diseases. Patient empowerment can be fostered by Web-based interactive health communication applications (IHCAs) that combine health information with decision support, social support, and/or behavioral change support. Tailoring the content and tone of IHCAs to the needs of individual patients might improve their effectiveness. OBJECTIVE: The main objective was to test the effectiveness of a Web-based, tailored, fully automated IHCA for patients with type 2 diabetes or chronic low back pain against a standard website with identical content without tailoring (control condition) on patients' knowledge and empowerment. METHODS: We performed a blinded randomized trial with a parallel design. In the intervention group, the content was delivered in dialogue form, tailored to relevant patient characteristics. In the control group, the sections of the text were presented in a content tree without any tailoring. Participants were recruited online and offline and were blinded to their group assignments. Measurements were taken at baseline (t0), directly after the first visit (t1), and at 3-month follow-up (t2). The primary hypothesis was that the tailored IHCA would have larger effects on knowledge and patient empowerment (primary outcomes) than the control website. The secondary outcomes were decisional conflict and preparation for decision making. All measurements were conducted by online self-report questionnaires. Intention-to-treat (ITT) and available cases (AC) analyses were performed for all outcomes. RESULTS: A total of 561 users agreed to participate in the study. Of these, 179 (31.9%) had type 2 diabetes and 382 (68.1%) had chronic low back pain. Usage was significantly higher in the tailored system (mean 51.2 minutes) than in the control system (mean 37.6 minutes; P<.001). Three months after system use, 52.4% of the sample was retained. There was no significant intervention effect in the ITT analysis. In the AC analysis, participants using the tailored system displayed significantly more knowledge at t1 (P=.02) and more emotional well-being (subscale of empowerment) at t2 (P=.009). The estimated mean difference between the groups was 3.9 (95% CI 0.5-7.3) points for knowledge and 25.4 (95% CI 6.3-44.5) points for emotional well-being on a 0-100 points scale. CONCLUSIONS: The primary analysis did not support the study hypothesis. However, content tailoring and interactivity may increase knowledge and reduce health-related negative effects in persons who use IHCAs. There were no main effects of the intervention on other dimensions of patient empowerment or decision-related outcomes. This might be due to our tailored IHCA being, at its core, an educational intervention offering health information in a personalized, empathic fashion that merely additionally provides decision support. Tailoring and interactivity may not make a difference with regard to these outcomes. TRIAL REGISTRATION: International Clinical Trials Registry: DRKS00003322; http://apps.who.int/trialsearch/Trial2.aspx?TrialID=DRKS00003322 (Archived by WebCite at http://www.webcitation.org/6WPO0lJwE).

Usefulness scale for patient information material (USE) - development and psychometric properties.

BACKGROUND: One economical way to inform patients about their illness and medical procedures is to provide written health information material. So far, a generic and psychometrically sound scale to evaluate cognitive, emotional, and behavioral aspects of the subjectively experienced usefulness of patient information material from the patient's perspective is lacking. The aim of our study was to develop and psychometrically test such a scale. METHODS: The Usefulness Scale for Patient Information Material (USE) was developed using a multistep approach. Ultimately, three items for each subscale (cognitive, emotional, and behavioral) were selected under consideration of face validity, discrimination, difficulty, and item content. The final version of the USE was subjected to reliability analysis. Structural validity was tested using confirmatory factor analysis, and convergent and divergent validity were tested using correlation analysis. The criterion validity of the USE was tested in an experimental design. To this aim, patients were randomly allocated to one of two groups. One group received a full version of an information brochure on depression or chronic low back pain depending on the respective primary diagnosis. Patients in the second group received a reduced version with a lower design quality, smaller font size and less information. Patients were recruited in six hospitals in Germany. After reading the brochure, they were asked to fill in a questionnaire. RESULTS: Analyzable data were obtained from 120 questionnaires. The confirmatory factor analysis supported the structural validity of the scale. Reliability analysis of the total scale and its subscales showed Cronbach's α values between .84 and .94. Convergent and divergent validity were supported. Criterion validity was confirmed in the experimental condition. Significant differences between the groups receiving full and reduced information were found for the total score (p<.001) and its three subscales (cognitive p<.001, emotional p=.001, and behavioral p<.001), supporting criterion validity. CONCLUSIONS: We developed a generic scale to measure the subjective usefulness of written patient information material from a patient perspective. Our construct is defined in line with current theoretical models for the evaluation of written patient information material. The USE was shown to be a short, reliable and valid psychometric scale.

Quality of online information on type 2 diabetes: a cross-sectional study.

Evidence-based health information is a prerequisite for patients with type 2 diabetes to engage in self-management and to make informed medical decisions. The Internet is an important source of health information. In the present study, we systematically assessed formal quality, quality of decision support and usability of German and English language websites on type 2 diabetes. The search term 'type 2 diabetes' was entered in the two most popular search engines. Descriptive data on website quality are presented. Additionally, associations between website quality and affiliation (commercial vs. non-commercial), presence of the HON code quality seal and website traffic were explored. Forty-six websites were included. Most websites provided basic information necessary for decision-making, while only one website also provided decision support. Websites with a HON code had significantly better formal quality than websites without HON code. We found a highly significant correlation between usability and website traffic and a significant correlation between formal quality and website traffic. Most websites do not provide sufficient information to support patients in medical decision-making. Our finding that usability and website traffic are tightly associated is consistent with previous research indicating that design is the most important cue for users assessing website credibility.

Telephone Health Coaching and Remote Exercise Monitoring (TeGeCoach) in Peripheral Arterial Occlusive Disease.

BACKGROUND: Supervised exercise programs are used to treat intermittent claudication (IC). Home-based exercise programs have been developed to lower barriers to participation. We studied the effects of one such exercise program (TeGeCoach) on self-reported walking ability in patients with IC. METHODS: In a pragmatic multicenter randomized controlled trial (registration number NCT03496948), 1982 patients with symp - tomatic IC insured by one of three German statutory health insurance funds received either telephone health coaching with remote exercise monitoring (TeGeCoach; n = 994) or routine care (n = 988). The primary outcome was the change in Walking Impairment Questionnaire (WIQ) scores after 12 and 24 months in the intention-to-treat population. The secondary outcomes were healthrelated quality of life, symptoms of depression or anxiety, health competence, patient activation, alcohol use, and nicotine depen - dence. RESULTS: There was a significant group difference in WIQ score in favor of TeGeCoach (p < 0.0001), amounting to 6.30 points at 12 months (Bonferroni-corrected 95% CI [4.02; 8.59], Cohen's d = 0.26) and 4.55 points at 24 months ([2.20; 6.91], d = 0.19). Some of the secondary outcomes also showed positive results in favor of TeGeCoach at 12 months with small effect sizes (d ≥ 0.20), including physical health-related quality of life and patient activation. The average daily step count was not higher in the TeGeCoach group. CONCLUSION: Significant improvements regarding symptom burden demonstrate the benefit of a home-based exercise program and thus expand the opportunities for guideline-oriented treatment of IC. Future studies should additionally address the effect of home-based exercise programs on clinical variables by means of, for example, the 6-minute walk test.

Psychometric evaluation of the German version of the Patient Activation Measure (PAM13).

BACKGROUND: The Patient Activation Measure (PAM) consists of 13 items and assesses patient (or consumer) self-reported knowledge, skills, and confidence for self-management of one's health or chronic condition. The aim of this study was to translate the original American version of the PAM13 into German and to test the psychometric properties of the German version in an elderly, multimorbid population with various chronic conditions. METHODS: Translation was performed by a standardized forward-backward translation process. The PAM13 was sent to 9.075 participants enrolled in a randomized controlled study. 4.306 participants responded to the questionnaire. Descriptive and reliability analyses were carried out. To examine scale properties, Andrich's Rasch Rating Scale Model was fitted. RESULTS: The internal consistency is good (α = 0.88) and the item-rest-correlations were found as strong to moderate. The unidimensionality of the construct was confirmed, with a variance explanation of 40.9% and good model-fits for the Rasch model. However, the lowest response options were very rarely used across all items (below 5%) and ranking order of items according to their difficulty was substantially different from that of the American version. Differential item functioning (DIF) was found in subgroups (sex, age, health status), but differences were small. CONCLUSION: The German version of the PAM13 showed acceptable reliability and the model-fit statistics confirmed the Rasch model. The different ranking order of the items and the unfair distribution of the response options suggest further research on validation and revision of the construct.

A tailored, interactive health communication application for patients with type 2 diabetes: study protocol of a randomised controlled trial.

BACKGROUND: Type 2 diabetes is an increasingly common chronic condition whose prognosis can be improved by patient involvement and self-management. Patient involvement can be fostered by web-based Interactive Health Communication Applications (IHCAs) combining health information with decision support, social support and/or behaviour change support. They reach great numbers of patients at low cost and provide high-quality information and support at the time, place and learning speed patients prefer. Still, online tools often suffer from high attrition. Tailoring content and tone of IHCAs to the individual patient´s needs might improve their effectiveness. This study aims to test the effectiveness and usage of a tailored IHCA combining health information with decision support and behaviour change support for patients with type 2 diabetes. METHODS/DESIGN: The effectiveness and usage of the tailored IHCA will be tested against a standard website with identical content in a single-blinded randomized trial with a parallel design. The content covers information on type 2 diabetes, its complications and sequelae, and its treatment options including health behaviour. In the intervention group the content is delivered in dialogue form, tailored to relevant patient characteristics (health literacy, attitudes towards self-care, and barriers to insulin treatment). In the control group the different sections are presented in a content tree, without any tailoring. Participants are blinded to group assignment. Eligibility criteria are age ≥ 18 years, self-reported type 2 diabetes, and Internet access. The study aims to include 414 participants in order to detect the expected small effect (Cohen's d=0.2), with measurements at baseline, directly after the first visit, and at 3-month follow-up. The primary hypothesis is that the tailored IHCA has larger effects on diabetes knowledge and patient empowerment (primary outcomes) than the standard website. Secondary outcomes are website usage as well as decisional conflict and preparation for decision making. All measurements are online self-report questionnaires. DISCUSSION: IHCAs are a promising way to foster diabetes knowledge and self-management competencies. The present trial tries to increase the knowledge on how to develop more effective IHCAs for patients with type 2 diabetes. TRIAL REGISTRATION: International Clinical Trials Registry DRKS00003322.

A tailored, dialogue-based health communication application for patients with chronic low back pain: study protocol of a randomised controlled trial.

BACKGROUND: Chronic low back pain is a common chronic condition whose treatment success can be improved by active involvement of patients. Patient involvement can be fostered by web-based applications combining health information with decision support or behaviour change support. These so-called Interactive Health Communication Applications (IHCAs) can reach great numbers of patients at low financial cost and provide information and support at the time, place and learning speed patients prefer. However, high attrition often seems to decrease the effects of web-based interventions. Tailoring content and tone of IHCAs to the individual patient ́s needs might improve usage and therefore effectiveness. This study aims to evaluate a tailored IHCA for people with chronic low back pain combining health information with decision support and behaviour change support. METHODS/DESIGN: The tailored IHCA will be tested regarding effectiveness and usage against a standard website with identical content in a single-blinded randomized trial with a parallel design. The IHCA contains information on chronic low back pain and its treatment options including health behaviour change recommendations. In the intervention group the content is delivered in dialogue form, tailored to relevant patient characteristics (health literacy, coping style). In the control group there is no tailoring, a standard web-page is used for presenting the content. Participants are unaware of group assignment. Eligibility criteria are age ≥ 18 years , self- reported chronic low back pain, and Internet access. To detect the expected small effect (Cohen's d = 0.2), the sample aims to include 414 patients, with assessments at baseline, directly after the first on-page visit, and at 3-month follow-up using online self-report questionnaires. It is expected that the tailored IHCA has larger effects on knowledge and patient empowerment (primary outcomes) compared to a standard website. Secondary outcomes are website usage, preparation for decision making, and decisional conflict. DISCUSSION: IHCAs can be a suitable way to promote knowledge about chronic low back pain and self-management competencies. Results of the study can increase the knowledge on how to develop IHCAs which are more useful and effective for people suffering from chronic low back pain. TRIAL REGISTRATION: International Clinical Trials Registry DRKS00003322.

[Identification of Information Needs for Prevention of the Problematic Use of Benzodiazepines and Z-Drugs - A Focus Group Study]. / Identifikation von Informationsbedürfnissen zur Prävention des problematischen Konsums von Z-Substanzen und Benzodiazepinen ­ eine Fokusgruppenstudie.

OBJECTIVE: In order to develop demand-driven health information about z-drugs and benzodiazepines, we aimed to identify information needs of people at risk of dependency. METHODS: We conducted three focus groups with different target groups: Younger people with sleep disorders (N=7), middle-aged women with occasional/regular intake of z-drugs or benzodiazepines (N=6) and older people with regular drug intake. RESULTS: The information needs primarily refer to the areas "sleep disorders" (esp. alternative treatment options), "z-drugs and benzodiazepines" (esp. risks of intake) and "offers of assistance" (esp. contact points). CONCLUSION: The thematic overlaps indicate that all affected groups can profit from general information about sleep disorders, different treatment options and risks. Additionally, information services should also focus on guidance and referral in the help system.