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  • 1
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    Online Resource
    Mental Health Specialist Video Consultations Versus Treatment-as-Usual for Patients With Depression or Anxiety Disorders in Primary Care: Randomized Controlled Feasibility Trial
    JMIR Publications Inc. ; 2021
    In:  JMIR Mental Health Vol. 8, No. 3 ( 2021-3-12), p. e22569-
    Details
    In: JMIR Mental Health, JMIR Publications Inc., Vol. 8, No. 3 ( 2021-3-12), p. e22569-
    Abstract: Most people affected by depression or anxiety disorders are treated solely by their primary care physician. Access to specialized mental health care is impeded by patients’ comorbidity and immobility in aging societies and long waiting times at the providers’ end. Video-based integrated care models may leverage limited resources more efficiently and provide timely specialized care in primary care settings. Objective The study aims to evaluate the feasibility of mental health specialist video consultations with primary care patients with depression or anxiety disorders. Methods Participants were recruited by their primary care physicians during regular practice visits. Patients who had experienced at least moderate symptoms of depression and/or anxiety disorders were considered eligible for the study. Patients were randomized into 2 groups receiving either treatment-as-usual as provided by their general practitioner or up to 5 video consultations conducted by a mental health specialist. Video consultations focused on systematic diagnosis and proactive monitoring using validated clinical rating scales, the establishment of an effective working alliance, and a stepped-care algorithm within integrated care adjusting treatments based on clinical outcomes. Feasibility outcomes were recruitment, rate of loss to follow-up, acceptability of treatment, and attendance at sessions. Effectiveness outcomes included depression (Patient Health Questionnaire-9), anxiety (Generalized Anxiety Disorder-7), burden of specific somatic complaints (Somatic Symptom Disorder-B Criteria Scale-12), recovery (Recovery Assessment Scale-German [RAS-G] ), and perception of chronic illness care (Patient Assessment of Chronic Illness Care), which were measured at baseline and 16 weeks postallocation by assessors blinded to the group allocation. Results A total of 50 patients with depression and/or anxiety disorders were randomized, 23 in the intervention group and 27 in the treatment-as-usual group. The recruitment yield (number randomized per number screened) and the consent rate (number randomized per number eligible) were 69% (50/73) and 86% (50/58), respectively. Regarding acceptability, 87% (20/23) of the participants in the intervention group completed the intervention. Of the 108 planned video consultations, 102 (94.4%) were delivered. Follow-up rates were 96% (22/23) and 85% (23/27) for the intervention and control groups, respectively. The change from baseline scores at postmeasurement for the No Domination by Symptoms domain of recovery (RAS-G) was somewhat higher in the intervention group than in the control group (Mann-Whitney U test: rank-biserial r=0.19; 95% CI −0.09 to 0.46; P=.18). We did not detect any notable differences between the intervention and control groups in terms of other effectiveness outcomes. We did not observe any serious adverse events related to the trial. Conclusions The intervention and study procedures were found to be feasible for patients, primary care practice staff, and mental health specialists. A sufficiently powered pragmatic trial on mental health specialist video consultations should be conducted to investigate their effectiveness in routine care. Trial Registration German Clinical Trials Register DRKS00015812; https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML & TRIAL_ID=DRKS00015812.
    Type of Medium: Online Resource
    ISSN: 2368-7959
    URL: Article
    DOI: 10.2196/22569
    Language: English
    Publisher: JMIR Publications Inc.
    Publication Date: 2021
    detail.hit.zdb_id: 2798262-2
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  • 2
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    Study protocol for a randomised controlled trial of a web-based behavioural lifestyle programme for emPOWERment in early Multiple Sclerosis (POWER@MS1)
    BMJ ; 2021
    In:  BMJ Open Vol. 11, No. 2 ( 2021-02), p. e041720-
    Details
    In: BMJ Open, BMJ, Vol. 11, No. 2 ( 2021-02), p. e041720-
    Abstract: Multiple sclerosis (MS) is an inflammatory and degenerative disease of the central nervous system that mainly affects young adults. Uncertainty is a major psychological burden of the disease from diagnosis to prognosis, enhanced by the pressure to make early decisions on a diverse set of immunotherapies. Watchful waiting for 1–2 years while adapting goals and lifestyle habits to life with a chronic disease represents another reasonable option for persons with MS (PwMS). A behaviour change programme based on evidence-based patient information (EBPI) is not available in standard care. This randomised controlled trial (RCT) with an embedded process evaluation investigates the efficacy and cost-effectiveness of a web-based behavioural lifestyle programme to change lifestyle behaviour and reduce inflammatory disease activity in PwMS. Methods and analysis A web-based behavioural intervention will be evaluated in an RCT aiming to recruit 328 persons with clinically isolated syndrome, suspected MS or confirmed MS for less than 1 year, who have not yet started immunotherapy. Moreover, a mixed-methods process evaluation and a health economic evaluation will be carried out. Participants will be recruited in at least 16 MS centres across Germany and randomised to an intervention group with 12 months of access to EBPI about lifestyle factors in MS, combined with a complex behaviour change programme or to a control group (optimised standard care). The combined primary endpoint is the incidence of new T2 lesions on MRI or confirmed relapses. Ethics and dissemination The study has been approved by the Ethics Committee of the Hamburg Chamber of Physicians (PV6015). Trial results will be communicated at scientific conferences and meetings and presented on relevant patient websites and in patient education seminars. Trial registration number ClinicalTrials.gov Registry ( NCT03968172 ); Pre-results.
    Type of Medium: Online Resource
    ISSN: 2044-6055 , 2044-6055
    URL: Article
    DOI: 10.1136/bmjopen-2020-041720
    Language: English
    Publisher: BMJ
    Publication Date: 2021
    detail.hit.zdb_id: 2599832-8
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  • 3
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    Mental health specialist video consultations versus treatment as usual in patients with depression or anxiety disorders in primary care: study protocol for an individually randomised superiority trial (the PROVIDE-C trial)
    Springer Science and Business Media LLC ; 2021
    In:  Trials Vol. 22, No. 1 ( 2021-12)
    Details
    In: Trials, Springer Science and Business Media LLC, Vol. 22, No. 1 ( 2021-12)
    Abstract: Most people with mental disorders, including those with severe and chronic disorders, are treated solely by their general practitioner (GP). Nevertheless, specialised mental health care may be required for specific patients. Notably, the accessibility of mental health specialist care is mainly complicated by (a) long waiting times for an appointment with specialists, (b) long travel distances to specialists, particularly in rural and remote areas, and (c) patients’ reservations about mental health specialist care (including fear of being stigmatised by seeking such care). To mitigate those barriers, technology-based integrated care models have been proposed. The purpose of this study is to examine the effectiveness and cost-effectiveness of a mental health specialist video consultations model versus treatment as usual in patients with depression or anxiety disorders in primary care. Methods In an individually randomised, prospective, two-arm superiority trial with parallel group design, N = 320 patients with anxiety and/or depressive disorder will be recruited in general practices in Germany. The intervention includes a newly developed treatment model based on video consultations with focus on diagnostics, treatment planning, and short-term intervention by mental health specialists. We will systematically compare the effectiveness, cost-effectiveness, and adverse effects of this new model with usual care by the GP: the primary outcome is the absolute change in the mean depressive and anxiety symptom severity measured on the Patient Health Questionnaire Anxiety and Depression Scale (PHQ-ADS) from baseline to 6 months after baseline assessment. Follow-up in both groups will be conducted by blinded outcome assessors at 6 months and 12 months after baseline. The main analysis will be based on the intention-to-treat principle. We will optimise the likelihood of treatment effectiveness by strict inclusion criteria for patients, enhanced intervention integrity, and conducting a process evaluation. Discussion To the best of our knowledge, this is the first confirmatory study on a video-based, integrated care model for the treatment of anxiety and depressive disorders in GP patients in Germany. Trial registration ClinicalTrials.gov, United States National Institutes of Health NCT04316572 . Prospectively registered on 20 March 2020.
    Type of Medium: Online Resource
    ISSN: 1745-6215
    URL: Article
    DOI: 10.1186/s13063-021-05289-3
    Language: English
    Publisher: Springer Science and Business Media LLC
    Publication Date: 2021
    detail.hit.zdb_id: 2040523-6
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  • 4
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    Model of integrated mental health video consultations for people with depression or anxiety in primary care (PROVIDE-C): assessor masked, multicentre, randomised controlled trial
    BMJ ; 2024
    In:  BMJ
    Details
    In: BMJ, BMJ
    Abstract: To evaluate whether an integrated mental health video consultation approach (PROVIDE model) can improve symptoms compared with usual care in adults with depression and anxiety disorders attending primary care. Design Assessor masked, multicentre, randomised controlled trial (PROVIDE-C). Setting In 29 primary care practices in Germany, working remotely online from one trial hub. Participants 376 adults (18-81 years) who presented to their general practitioner (GP) with depression or anxiety, or both. Intervention Participants were randomised (1:1) to receive the PROVIDE model (n=187) or usual care (n=189). Usual care was provided by GPs through interventions such as brief counselling and psychotropic medication prescriptions and may or may not have included referrals to mental health specialists. The PROVIDE model comprised transdiagnostic treatment provided through five real-time video sessions between the patient at the primary care practice and a mental health specialist at an offsite location. Main outcome measures The primary outcome was the absolute change in the mean severity of depressive and anxiety symptoms measured using the patient health questionnaire anxiety and depression scale (PHQ-ADS) at six months, in the intention-to-treat population. Secondary outcomes, measured at six and 12 months, included PHQ-ADS subscores, psychological distress related to somatic symptoms, recovery, health related quality of life, quality and patient centredness of chronic illness care, and adverse events. Results Between 24 March 2020 and 23 November 2021, 376 patients were randomised into treatment groups. Mean age was 45 years (standard deviation (SD) 14), 63% of the participants were female, and mean PHQ-ADS-score was 26 points (SD 7.6). Compared with usual care, the PROVIDE intervention led to improvements in severity of depressive and anxiety symptom (adjusted mean change difference in the PHQ-ADS score −2.4 points (95% confidence interval −4.5 to −0.4), P=0.02) at six months. The effects were sustained at 12 months (−2.9 (−5.0 to −0.7), P 〈 0.01). No serious adverse events were reported in either group. Conclusions Through relatively low intensity treatment, the PROVIDE model led to a decrease in depressive and anxiety symptoms with small effects in the short and long term. Depression and anxiety disorders are prevalent and therefore the small effect might cumulatively impact on population health in this population. Trial registration ClinicalTrials.gov NCT04316572 .
    Type of Medium: Online Resource
    ISSN: 1756-1833
    URL: Article
    DOI: 10.1136/bmj-2024-079921
    Language: English
    Publisher: BMJ
    Publication Date: 2024
    detail.hit.zdb_id: 1479799-9
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  • 5
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    Preferences of people with type 2 diabetes for telemedical lifestyle programmes in Germany: protocol of a discrete choice experiment
    BMJ ; 2020
    In:  BMJ Open Vol. 10, No. 9 ( 2020-09), p. e036995-
    Details
    In: BMJ Open, BMJ, Vol. 10, No. 9 ( 2020-09), p. e036995-
    Abstract: Telemedical lifestyle programmes for people with type 2 diabetes mellitus (T2DM) provide an opportunity to develop a healthier lifestyle and consequently to improve health outcomes. When implementing new programmes into standard care, considering patients’ preferences may increase the success of the participants. This study aims to examine the preferences of people with T2DM with respect to telemedical lifestyle programmes, to analyse whether these preferences predict programme success and to explore the changes that may occur during a telemedical lifestyle intervention. Methods and analysis We outline the protocol of the development and assessment of a discrete choice experiment (DCE) to examine patient preferences in a telemedical lifestyle programme with regard to the functions of the online portal, communication, responsibilities, group activities and time requirements. To develop the design of the DCE, we conducted pilot work involving healthcare experts and in particular people with T2DM using cognitive pretesting. The final DCE is being implemented within a randomised controlled trial for investigating whether participation in a telemedical lifestyle intervention programme sustainably improves the HbA 1c values in 850 members of a large German statutory health insurance with T2DM. Preferences are being assessed before and after participants complete the programme. The DCE data will be analysed using regression and latent class analyses. Ethics and dissemination The DCE study has been approved by the ethics committee of the medical faculty of the Heinrich Heine University Duesseldorf, registration number 2018-242-ProspDEuA, registered on 6 December 2018. The TeLIPro trial is registered at the US National Library of Medicine, registration number NCT03675919 , registered on 15 September 2018. We aim to disseminate our results in peer-reviewed journals, at national and international conferences and among interested patient groups and the public.
    Type of Medium: Online Resource
    ISSN: 2044-6055 , 2044-6055
    URL: Article
    DOI: 10.1136/bmjopen-2020-036995
    Language: English
    Publisher: BMJ
    Publication Date: 2020
    detail.hit.zdb_id: 2599832-8
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  • 6
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    Preferences of women in difficult life situations for a physical activity programme: protocol of a discrete choice experiment in the German NU-BIG project
    BMJ ; 2023
    In:  BMJ Open Vol. 13, No. 7 ( 2023-07), p. e067235-
    Details
    In: BMJ Open, BMJ, Vol. 13, No. 7 ( 2023-07), p. e067235-
    Abstract: The BIG project (‘Bewegung als Investition in die Gesundheit’, ie, ‘Movement as Investment in Health’) was developed in 2005 as a community-based participatory research programme to offer accessible opportunities for physical activity to women in difficult life situations. Since then, the programme has been expanded to eight sites in Germany. A systematic evaluation of BIG is currently being conducted. As part of this effort, we strive to understand the preferences of participating women for different aspects of the programme, and to analyse their willingness to pay. Methods and analysis In this protocol, we describe the development and analysis plan of a discrete choice experiment (DCE) to investigate participants’ preferences for a physical activity programme for women in difficult life situations. The experiment will be embedded in a questionnaire covering several aspects of participation in the programme (eg, reach, efficacy and further effects) and the socioeconomic characteristics of all active participants. After a thorough search of the literature, BIG documents review and expert interviews, we identified five important attributes of the programme: course times, travel time to the course venue, additional social activities organised by BIG, consideration of wishes and interests for the further planning of courses and costs per course unit. Thereafter, we piloted the experiment with a sample of participants from the target group. After data collection, the experiment will be analysed using a conditional logit model and a latent class analysis to assess eventual heterogeneity in preferences. Ethics and dissemination Understanding women’s preferences will provide useful insights for the further development of the programme and ultimately increase participation and retention. The questionnaire, the included DCE and the pretest on participants received ethical approval (application no. 20-247_1-B). We plan to disseminate the results of the DCE in peer-reviewed journals, national conferences and among participants and programme coordinators and organisers.
    Type of Medium: Online Resource
    ISSN: 2044-6055 , 2044-6055
    URL: Article
    URL: Article
    DOI: 10.1136/bmjopen-2022-067235
    DOI: 10.1136/bmjopen-2022-067235.supp1
    Language: English
    Publisher: BMJ
    Publication Date: 2023
    detail.hit.zdb_id: 2599832-8
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  • 7
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    Effectiveness of real-time continuous glucose monitoring to improve glycaemic control and pregnancy outcome in patients with gestational diabetes mellitus: a study protocol for a randomised controlled trial
    BMJ ; 2020
    In:  BMJ Open Vol. 10, No. 11 ( 2020-11), p. e040498-
    Details
    In: BMJ Open, BMJ, Vol. 10, No. 11 ( 2020-11), p. e040498-
    Abstract: Real-time continuous glucose monitoring (rt-CGM) informs users about current interstitial glucose levels and allows early detection of glycaemic excursions and timely adaptation by behavioural change or pharmacological intervention. Randomised controlled studies adequately powered to evaluate the impact of long-term application of rt-CGM systems on the reduction of adverse obstetric outcomes in women with gestational diabetes (GDM) are missing. We aim to assess differences in the proportion of large for gestational age newborns in women using rt-CGM as compared with women with self-monitored blood glucose (primary outcome). Rates of neonatal hypoglycaemia, caesarean section and shoulder dystocia are secondary outcomes. A comparison of glucose metabolism and quality of life during and after pregnancy completes the scope of this study. Methods and analysis Open-label multicentre randomised controlled trial with two parallel groups including 372 female patients with a recent diagnosis of GDM (between 24+0 until 31+6 weeks of gestation): 186 with rt-CGM (Dexcom G6) and 186 with self-monitored blood glucose (SMBG). Women with GDM will be consecutively recruited and randomised to rt-CGM or control (SMBG) group after a run-in period of 6–8 days. The third visit will be scheduled 8–10 days later and then every 2 weeks. At every visit, glucose measurements will be evaluated and all patients will be treated according to the standard care. The control group will receive a blinded CGM for 10 days between the second and third visit and between week 36+0 and 38+6. Cord blood will be sampled immediately after delivery. 48 hours after delivery neonatal biometry and maternal glycosylated haemoglobin A1c (HbA1c) will be assessed, and between weeks 8 and 16 after delivery all patients receive a re-examination of glucose metabolism including blinded CGM for 8–10 days. Ethics and dissemination This study received ethical approval from the main ethic committee in Vienna. Data will be presented at international conferences and published in peer-reviewed journals. Trial registration number NCT03981328 ; Pre-results.
    Type of Medium: Online Resource
    ISSN: 2044-6055 , 2044-6055
    URL: Article
    DOI: 10.1136/bmjopen-2020-040498
    Language: English
    Publisher: BMJ
    Publication Date: 2020
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  • 8
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    Effectiveness of a complex intervention to improve participation and activities in nursing home residents with joint contractures (JointConEval): study protocol of a multicentre cluster-randomised controlled trial [DRKS-ID:DRKS00015185]
    Springer Science and Business Media LLC ; 2019
    In:  Trials Vol. 20, No. 1 ( 2019-12)
    Details
    In: Trials, Springer Science and Business Media LLC, Vol. 20, No. 1 ( 2019-12)
    Type of Medium: Online Resource
    ISSN: 1745-6215
    URL: Article
    DOI: 10.1186/s13063-019-3384-6
    Language: English
    Publisher: Springer Science and Business Media LLC
    Publication Date: 2019
    detail.hit.zdb_id: 2040523-6
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  • 9
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    Heterogeneity in Health Insurance Choice: An Experimental Investigation of Consumer Choice and Feature Preferences
    Elsevier BV ; 2023
    In:  SSRN Electronic Journal
    Details
    In: SSRN Electronic Journal, Elsevier BV
    Type of Medium: Online Resource
    ISSN: 1556-5068
    URL: Article
    DOI: 10.2139/ssrn.4429303
    Language: English
    Publisher: Elsevier BV
    Publication Date: 2023
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  • 10
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    Development and evaluation of an interactive web-based decision-making programme on relapse management for people with multiple sclerosis (POWER@MS2)—study protocol for a randomised controlled trial
    Springer Science and Business Media LLC ; 2021
    In:  Trials Vol. 22, No. 1 ( 2021-02-14)
    Details
    In: Trials, Springer Science and Business Media LLC, Vol. 22, No. 1 ( 2021-02-14)
    Abstract: Multiple sclerosis is a chronic inflammatory, degenerative disease of the central nervous system manifesting at first with relapses in about 85% of cases. In Germany, intravenous therapy with high-dose corticosteroids is the treatment standard of acute relapses. The treatment leads to a faster reduction of symptoms in about 25 of 100 treated patients but has no proven long-term benefits over placebo treatment. Intravenous treatment is not superior to oral treatment. Therefore, informed decisions on relapse management are required. An earlier randomised controlled trial showed that evidence-based patient information and education on relapse management leads to more informed decisions and more relapses not treated or treated with oral corticosteroids. This study aims to evaluate whether a web-based relapse management programme will positively change relapse management and strengthen autonomy in people with multiple sclerosis. Methods The pragmatic double-blind randomised controlled trial is accompanied by a mixed-methods process evaluation and a health economic evaluation and follows the UK Medical Research Council guidance on developing and evaluating complex interventions. A total of 188 people with possible or relapsing-remitting multiple sclerosis with ≥ 1 relapse within the last year and/or ≥ 2 relapses within the last 2 years will be recruited and randomised using blocks. The intervention group receives a web- and dialogue-based decision aid on relapse management, a nurse-led webinar and access to a monitored chat forum. The control group receives standard information, which will be made available via the same online platform as the intervention. The primary endpoint is the proportion of relapses not treated or treated with oral corticosteroids. Key secondary endpoints are the annualised relapse rate, decision-making, empowerment, quality of life and cost-effectiveness. Facilitators and barriers will be assessed by mixed-methods process evaluation measures. The study ends when 81 relapses have been documented or after 24 months of observation per individual patient. Analyses will follow the intention-to-treat principle. Discussion We hypothesise that the intervention will enhance patient empowerment and have a positive impact on patients’ relapse management. Trial registration ClinicalTrials.gov NCT04233970 . Registered on 18 January 2020
    Type of Medium: Online Resource
    ISSN: 1745-6215
    URL: Article
    DOI: 10.1186/s13063-021-05059-1
    Language: English
    Publisher: Springer Science and Business Media LLC
    Publication Date: 2021
    detail.hit.zdb_id: 2040523-6
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