Web-based Training for Nurses on Shared Decision-Making and Prenatal Screening for Down Syndrome: a Controlled Trial (Preprint)

2021 ◽  
Author(s):  
Alex Poulin Herron ◽  
Titilayo Tatiana Agbadje ◽  
Sabrina Guay-Bélanger ◽  
Gérard Ngueta ◽  
Geneviève Roch ◽  
...  
Keyword(s):  
Decision Making ◽  
Down Syndrome ◽  
Pregnant Women ◽  
Training Program ◽  
Prenatal Screening ◽  
Intervention Group ◽  
Control Group ◽  
Intention To Use ◽  
Shared Decision ◽  
Web Based

BACKGROUND Background: Nurses provide maternity care and thus play an important role in supporting pregnant women making decisions about prenatal screening for Down syndrome. We developed a web-based shared decision making (SDM) training program for health professionals focusing on Down syndrome screening decisions. OBJECTIVE Objective: We assessed the impact of a SDM training program on nurses’ intention to use a decision aid with pregnant women deciding about prenatal screening for Down syndrome. METHODS Methods: In this 2-arm parallel controlled trial, French-speaking nurses working with pregnant women in the province of Quebec were recruited online by a private survey firm. They were conveniently allocated either to the intervention group (web-based SDM training program that included prenatal screening) or to the control group (web-based training program focusing on prenatal screening alone, with no SDM content). The primary outcome was intention to use a decision aid. Secondary outcomes were psychosocial variables of intention (e.g. social influence), as well as knowledge, satisfaction, acceptability, perceived usefulness and reaction to the pedagogical approach. All outcomes were self-assessed through online questionnaires including space for written comments. No blinding was performed. We used Student's t test and Fisher's exact test to compare continuous and categorical variables between groups. RESULTS Results: Of 57 participants assessed for eligibility, 40 were allocated to the intervention (n=20) or control group (n=20) and 36 (n=18 in each) completed the training program. Mean age of participants was 41 years (SD 9). Most were women (97.5%), Caucasian (95%), clinical nurses (70%), and had completed a baccalaureate degree (65%). Post-intervention, the mean score of intention was 6.3 (5.9; 6.7) for the intervention group and 6.0 (5.42; 6.64) for the control group. The difference in intention score and other psychosocial variables score between groups was not statistically significant. Knowledge scores about SDM were significantly different (79% in the intervention group, 64% in the control group, p=0.009). There was no significant difference in overall satisfaction [4.4 (SD 0.7) in the intervention group and 4.5 (SD 0.9)] in the control group and perceived usefulness [4.6 (SD 0.4) in the intervention group and 4.4 (SD 0.5)] in the control group. Acceptability of the training program showed a statistically significant difference [4.6 (SD 0.4) in the intervention group and 4.3 (SD 0.4) in the control group; p=0.02] as well as reaction to the pedagogical approach [4.7 (SD 0.4) in the intervention group and 4.4 (SD 0.4) in the control group; p=0.02]. Seventeen participants also gave written comments on the training. CONCLUSIONS Conclusions: Nurses’ intention to use SDM in prenatal care is already high, with training or without, but their knowledge about SDM could be improved with SDM training. Our results will inform future strategies to implement shared decision-making among nurses. CLINICALTRIAL Trial Registration: ClinicalTrials.gov NCT04162288; https://clinicaltrials.gov/ct2/show/NCT04162288?term=NCT04162288&draw=2&rank=1

Evaluating a Web-Based Training Program for Nurses on Shared Decision-Making and Screening for Down Syndrome: Protocol for a Randomized Control Trial (Preprint)

2020 ◽  
Author(s):  
Alex Poulin Herron ◽  
Titilayo Tatiana Agbadjé ◽  
Mélissa Côté ◽  
Codjo-Djignefa Djade ◽  
Geneviève Roch ◽  
...  
Keyword(s):  
Decision Making ◽  
Pregnant Women ◽  
Training Program ◽  
Decision Aid ◽  
Prenatal Screening ◽  
Control Group ◽  
Intention To Use ◽  
Shared Decision ◽  
Web Based ◽  
The Impact

BACKGROUND Pregnant women have difficulty choosing from amongst the wide variety of available prenatal screening options. To help pregnant women and their partners make informed decisions based on their values, needs, and preferences, a decision aid (DA) and a web-based shared decision making (SDM) training program for health professionals have been developed. In Canada, nurses have responsibilities regarding maternity care and thus the potential to do decision coaching on prenatal screening. However, there is a gap of knowledge concerning the effectiveness of SDM interventions in this area of nursing practice. OBJECTIVE This study aims to assess the impact of an SDM training program on nurses’ intention to use a decision aid for prenatal screening as well as their knowledge and overall appreciation of the training. METHODS This is a two-arm parallel randomized trial. Nurses working with pregnant women from the province of Quebec, and speaking in French, will be recruited online by a private survey firm. They will be randomly allocated (1:1 ratio) to either an experimental group, which will complete a web-based SDM training program for prenatal screening, or to a control group, which will complete a web-based training program focusing on prenatal screening alone. The experimental intervention consists of a three hour web-based and fully automated training activity hosted on the University Laval platform and has four modules: 1) SDM; 2) Down syndrome prenatal screening; 3) DA; and 4) Communication between healthcare professionals and the patient. For the control group, the topic of SDM in Module 1 has been replaced with “Context and history of prenatal screening” and the topic of DA in Module 3 has been replaced with “Consent in prenatal screening.” In addition to sociodemographic questions using a self-administered questionnaire with closed ended questions, we will assess 1) intention to use a DA in prenatal screening clinical practice; 2) knowledge; 3) satisfaction with the training; 4) acceptability; and 5) perceived usefulness. The randomization will be done by a predetermined sequence and include 36 nurses. Participants and researchers will be blinded. Intention to use DA will be assessed by a Student t test and bivariate and multivariate analysis will be performed to assess knowledge and overall appreciation of the training. RESULTS This study is ongoing and results will be available at the end of 2020 CONCLUSIONS This study results will inform on the impact of an SDM training program on nurses’ intention to use a decision aid for prenatal screening as well as their knowledge and overall appreciation of the training. It will also provide feedback on ways to upgrade the SDM training program, if needed. CLINICALTRIAL ClinicalTrials.gov ID NCT04162288

scholarly journals Web-Based Training for Nurses on Shared Decision Making and Prenatal Screening for Down Syndrome: Protocol for a Randomized Controlled Trial

10.2196/17878 ◽  
2020 ◽  
Vol 9 (10) ◽  
pp. e17878
Author(s):  
Alex Poulin Herron ◽  
Titilayo Tatiana Agbadje ◽  
Melissa Cote ◽  
Codjo Djignefa Djade ◽  
Geneviève Roch ◽  
...  
Keyword(s):  
Pregnant Women ◽  
Training Program ◽  
Decision Aid ◽  
Prenatal Screening ◽  
Decision Aids ◽  
Control Group ◽  
Intention To Use ◽  
Shared Decision ◽  
Web Based ◽  
The Impact

Background Pregnant women often find it difficult to choose from among the wide variety of available prenatal screening options. To help pregnant women and their partners make informed decisions based on their values, needs, and preferences, a decision aid and a web-based shared decision making (SDM) training program for health professionals have been developed. In Canada, nurses provide maternity care and thus can train as decision coaches for prenatal screening. However, there is a knowledge gap about the effectiveness of SDM interventions in maternity care in nursing practice. Objective This study aims to assess the impact of an SDM training program on nurses’ intentions to use a decision aid for prenatal screening and on their knowledge and to assess their overall impressions of the training. Methods This is a 2-arm parallel randomized trial. French-speaking nurses working with pregnant women in the province of Quebec were recruited online by a private survey firm. They were randomly allocated (1:1 ratio) to either an experimental group, which completed a web-based SDM training program that included prenatal screening, or a control group, which completed a web-based training program focusing on prenatal screening alone. The experimental intervention consisted of a 3-hour web-based training hosted on the Université Laval platform with 4 modules: (1) SDM; (2) Down syndrome prenatal screening; (3) decision aids; and (4) communication between health care professionals and the patient. For the control group, the topic of SDM in Module 1 was replaced with “Context and history of prenatal screening,” and the topic of decision aids in Module 3 was replaced with “Consent in prenatal screening.” Participants completed a self-administered sociodemographic questionnaire with close-ended questions. We also assessed the participants' (1) intention to use a decision aid in prenatal screening clinical practice, (2) knowledge, (3) satisfaction with the training, (4) acceptability, and (5) perceived usefulness of the training. The randomization was done using a predetermined sequence and included 40 nurses. Participants and researchers were blinded. Intention to use a decision aid will be assessed by a t test. Bivariate and multivariate analysis will be performed to assess knowledge and overall impressions of the training. Results This study was funded in 2017 and approved by Genome Canada. Data were collected from September 2019 to late January 2020. This paper was initially submitted before data analysis began. Results are expected to be published in winter 2020. Conclusions Study results will inform us on the impact of an SDM training program on nurses’ intention to use and knowledge of decision aids for prenatal screening and their overall impressions of the training. Participant feedback will also inform an upgrade of the program, if needed. Trial Registration ClinicalTrials.gov NCT04162288; https://clinicaltrials.gov/ct2/show/NCT04162288 International Registered Report Identifier (IRRID) DERR1-10.2196/17878

scholarly journals Web-Based Training for Nurses on Shared Decision Making and Prenatal Screening for Down Syndrome: Protocol for a Randomized Controlled Trial (Preprint)

2020 ◽  
Author(s):  
Alex Poulin Herron ◽  
Titilayo Tatiana Agbadje ◽  
Melissa Cote ◽  
Codjo Djignefa Djade ◽  
Geneviève Roch ◽  
...  
Keyword(s):  
Pregnant Women ◽  
Training Program ◽  
Decision Aid ◽  
Prenatal Screening ◽  
Decision Aids ◽  
Control Group ◽  
Intention To Use ◽  
Shared Decision ◽  
Web Based ◽  
The Impact

BACKGROUND Pregnant women often find it difficult to choose from among the wide variety of available prenatal screening options. To help pregnant women and their partners make informed decisions based on their values, needs, and preferences, a decision aid and a web-based shared decision making (SDM) training program for health professionals have been developed. In Canada, nurses provide maternity care and thus can train as decision coaches for prenatal screening. However, there is a knowledge gap about the effectiveness of SDM interventions in maternity care in nursing practice. OBJECTIVE This study aims to assess the impact of an SDM training program on nurses’ intentions to use a decision aid for prenatal screening and on their knowledge and to assess their overall impressions of the training. METHODS This is a 2-arm parallel randomized trial. French-speaking nurses working with pregnant women in the province of Quebec were recruited online by a private survey firm. They were randomly allocated (1:1 ratio) to either an experimental group, which completed a web-based SDM training program that included prenatal screening, or a control group, which completed a web-based training program focusing on prenatal screening alone. The experimental intervention consisted of a 3-hour web-based training hosted on the Université Laval platform with 4 modules: (1) SDM; (2) Down syndrome prenatal screening; (3) decision aids; and (4) communication between health care professionals and the patient. For the control group, the topic of SDM in Module 1 was replaced with “Context and history of prenatal screening,” and the topic of decision aids in Module 3 was replaced with “Consent in prenatal screening.” Participants completed a self-administered sociodemographic questionnaire with close-ended questions. We also assessed the participants' (1) intention to use a decision aid in prenatal screening clinical practice, (2) knowledge, (3) satisfaction with the training, (4) acceptability, and (5) perceived usefulness of the training. The randomization was done using a predetermined sequence and included 40 nurses. Participants and researchers were blinded. Intention to use a decision aid will be assessed by a t test. Bivariate and multivariate analysis will be performed to assess knowledge and overall impressions of the training. RESULTS This study was funded in 2017 and approved by Genome Canada. Data were collected from September 2019 to late January 2020. This paper was initially submitted before data analysis began. Results are expected to be published in winter 2020. CONCLUSIONS Study results will inform us on the impact of an SDM training program on nurses’ intention to use and knowledge of decision aids for prenatal screening and their overall impressions of the training. Participant feedback will also inform an upgrade of the program, if needed. CLINICALTRIAL ClinicalTrials.gov NCT04162288; https://clinicaltrials.gov/ct2/show/NCT04162288 INTERNATIONAL REGISTERED REPORT DERR1-10.2196/17878

scholarly journals Effect of Shared Decision-making on Anxiety of Women Recommended for Prenatal Screening Tests in Southeast of Iran

2020 ◽  
Author(s):  
Zahra Moudi ◽  
Raheleh Jam ◽  
Hossein Ansari ◽  
Mostafa Montazer Zohour
Keyword(s):  
Decision Making ◽  
Pregnant Women ◽  
Shared Decision Making ◽  
Prenatal Screening ◽  
Intervention Group ◽  
Screening Tests ◽  
Control Group ◽  
Shared Decision ◽  
Level Of Education ◽  
University Level

Objective: To study the effect of shared decision-making (SDM) on the anxiety of women who were recommended for prenatal screening tests. Materials and methods: This quasi-experimental study was conducted on a total of 200 pregnant women who referred to the health centers of Zahedan, Iran, for prenatal care within April 7 to September 7, 2019. The control group received routine care, and the intervention group attended a session based on SDM. The demographic characteristics form and Spielberger Six-item State-Trait Anxiety Inventory were filled out before and immediately after the counseling, as well as before receiving the results of maternal serum biochemical markers. Results: No statistically significant effect of SDM on anxiety was reported between the control and intervention groups immediately after the counseling session (P=0.46). However, the obtained data showed that the mean value of anxiety scores (16.52±3.06) was higher among the women in the intervention group than that reported for the control group (13.80±3.55) on the day before receiving the results of the blood tests (P<0.001). Nevertheless, logistic regression analysis showed only women with a university level of education were likely to have higher anxiety scores than women with lower educational levels (AOR=10.60; 95% CI: 2.07-54.24; P=0.005). Conclusion: Offering prenatal screening can cause a slight increase in the level of anxiety among women with a university level of education. Therefore, it is required to implement supportive strategies to help high-risk pregnant women in coping with anxiety.  

scholarly journals Does a simple web-based intervention facilitate the articulation of patients’ unvoiced agenda for a consultation with their diabetologists? A qualitative study

BMJ Open ◽  
2019 ◽  
Vol 9 (6) ◽  
pp. e026588 ◽  
Author(s):  
Julia Frost ◽  
Andy Gibson ◽  
Obioha Ukoumunne ◽  
Bijay Vaidya ◽  
Nicky Britten
Keyword(s):  
Decision Making ◽  
Qualitative Study ◽  
Shared Decision Making ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Shared Decision ◽  
Structured Interviews ◽  
Web Based ◽  
Patients With Diabetes

ObjectiveTo explore whether a preconsultation web-based intervention enables patients with diabetes to articulate their agenda in a consultation in the hospital outpatient clinic with their diabetologist.Methods and designA qualitative study embedded in a pragmatic pilot randomised controlled trial.SettingTwo city outpatient departments in England.Participants25 patients attending a follow-up consultation and 6 diabetologists.InterventionThe PACE-D, a web-based tool adapted for patients with diabetes to use before their consultation to generate an agenda of topics to discuss with their diabetologist.Data collection25 participants had their consultation with their diabetologist audio-recorded: 12 in the control arm and 13 in the intervention arm; 12 of the latter also had their PACE-D intervention session and a consultation recorded. Semi-structured interviews with 6 diabetologists, and 12 patients (6 in the intervention group and 6 in the control group).AnalysisThematic discourse analysis undertaken with patient representatives trained in qualitative data analysis techniques.ResultsWe identified four consultation types: diabetologist facilitated; patient identified; consultant facilitated and patient initiated and patient ignored. We also identified three critical aspects that explained the production and utilisation of the agenda form: existing consultative style; orientation to the use of the intervention and impact on the consultation. Where patients and diabetologists have a shared preference for a consultant-led or patient-led consultation, the intervention augments effective communication and shared decision making. However, where preferences diverge (eg, there is a mismatch in patients' and diabetologists' preferences and orientations), the intervention does not improve the potential for shared decision making.ConclusionA simple web-based intervention facilitates the articulation of patients’ unvoiced agenda for a consultation with their diabetologist, but only when pre-existing consultation styles and orientations already favour shared decision making. More needs to be done to translate patient empowerment in the consultation setting into genuine self-efficacy.Trial registration numberISRCTN75070242.

scholarly journals Shared decision making and patient-centeredness for patients with poorly controlled type 2 diabetes mellitus in primary care—results of the cluster-randomised controlled DEBATE trial

2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Anja Wollny ◽  
Christin Löffler ◽  
Eva Drewelow ◽  
Attila Altiner ◽  
Christian Helbig ◽  
...  
Keyword(s):  
Diabetes Mellitus ◽  
Type 2 Diabetes ◽  
Decision Making ◽  
Type 2 Diabetes Mellitus ◽  
Shared Decision Making ◽  
Intervention Group ◽  
Control Group ◽  
Shared Decision ◽  
Patient Centeredness

Abstract Background We investigate whether an educational intervention of GPs increases patient-centeredness and perceived shared decision making in the treatment of patients with poorly controlled type 2 diabetes mellitus? Methods We performed a cluster-randomized controlled trial in German primary care. Patients with type 2 diabetes mellitus defined as HbA1c levels ≥ 8.0% (64 mmol/mol) at the time of recruitment (n = 833) from general practitioners (n = 108) were included. Outcome measures included subjective shared decision making (SDM-Q-9; scale from 0 to 45 (high)) and patient-centeredness (PACIC-D; scale from 1 to 5 (high)) as secondary outcomes. Data collection was performed before intervention (baseline, T0), at 6 months (T1), at 12 months (T2), at 18 months (T3), and at 24 months (T4) after baseline. Results Subjective shared decision making decreased in both groups during the course of the study (intervention group: -3.17 between T0 and T4 (95% CI: -4.66, -1.69; p < 0.0001) control group: -2.80 (95% CI: -4.30, -1.30; p = 0.0003)). There were no significant differences between the two groups (-0.37; 95% CI: -2.20, 1.45; p = 0.6847). The intervention's impact on patient-centeredness was minor. Values increased in both groups, but the increase was not statistically significant, nor was the difference between the groups. Conclusions The intervention did not increase patient perceived subjective shared decision making and patient-centeredness in the intervention group as compared to the control group. Effects in both groups might be partially attributed to the Hawthorne-effect. Future trials should focus on patient-based intervention elements to investigate effects on shared decision making and patient-centeredness. Trial registration The trial was registered on March 10th, 2011 at ISRCTN registry under the reference ISRCTN70713571.

scholarly journals Diagnosa Preeklampsia pada Ibu Hamil Menggunakan Sistem Informasi Berbasis Web

2019 ◽  
Vol 2 (2) ◽  
pp. 18-27
Author(s):  
Fajaria Nur Aini ◽  
Melyana Nurul Widyawati ◽  
Bedjo Santoso
Keyword(s):  
Information System ◽  
Information Systems ◽  
Pregnant Women ◽  
Community Health Center ◽  
Intervention Group ◽  
Diagnostic System ◽  
Control Group ◽  
P Value ◽  
Web Based ◽  
Time Required

This study aims to produce a preeclampsia diagnostic system online and to determine the difference in the speed of time required to diagnose preeclampsia using a web-based information system with a manual system. This research method is to arrange a framework with a quasi experimental research design with a post test only with control group. This research was conducted at the Community Health Center. The results showed that the majority of respondents were healthy pregnant women namely in the intervention group of 20 pregnant women (30.30%) and in the control group of 15 pregnant women (22.73%). The smallest number of diagnoses is in the case of superimposed preeclampsia. Web-based information systems are also able to increase diagnostic speeds to 7.21%. Statistical test results using the Independent T-Test obtained a P-value of 0.041 <0.05 (α). Conclusion, there is a difference in the time of diagnosis of preeclampsia using a web-based information system with a manual system.   Keywords: Diagnosis, Preeclampsia, Information Systems, Web

Desirable features in a decision aid for prenatal screening – what do pregnant women and their partners think? A mixed methods pilot study

2020 ◽  
Author(s):  
Titilayo Tatiana Agbadje ◽  
Samira Abbasgholizadeh Rahimi ◽  
Mélissa Côté ◽  
Andrée-Anne Tremblay ◽  
Mariama Penda Diallo ◽  
...  
Keyword(s):  
Decision Making ◽  
Down Syndrome ◽  
Mixed Methods ◽  
Pilot Study ◽  
Pregnant Women ◽  
Technology Acceptance ◽  
Decision Aid ◽  
Prenatal Screening ◽  
Values Clarification ◽  
Quebec City

Abstract Background To help pregnant women and their partners make informed value-congruent decisions about Down syndrome prenatal screening, our team developed two successive versions of a decision aid (DAv2017 and DAv2014). We aimed to assess pregnant women and their partners’ perceptions of the usefulness of the two DAs for preparing for decision making, their relative acceptability and their most desirable features. Methods This is a mixed methods pilot study. We recruited participants of study (women and their partners) when consulting for prenatal care in three clinical sites in Quebec City. To be eligible, women had to: (a) be at least 18 years old; (b) be more than 16 weeks pregnant; or having given birth in the previous year and (c) be able to speak and write in French or English. Both women and partners were invited to give their informed consent. We collected quantitative data on the usefulness of the DAs for preparing for decision making and their relative acceptability. We developed an interview grid based on the Technology Acceptance Model and Acceptability questionnaire to explore their perceptions of the most desirable features. We performed descriptive statistics and deductive analysis. Results Overall, 23 couples and 16 individual women participated in the study. The majority of participants were between 25 and 34 years old (79% of women and 59% of partners) and highly educated (66.7% of women and 54% of partners had a university-level education). DAv2017 scored higher for usefulness for preparing for decision making (86.2 ± 13 out of 100 for DAv2017 and 77.7 ± 14 for DAv2014). For most dimensions, DAv2017 was more acceptable than DAv2014 (e.g. the amount of information was found “just right” by 80% of participants for DAv2017 against 56% for DAv2014). However, participants preferred the presentation and the values clarification exercise of DAv2014. In their opinion, neither DA presented information in a completely balanced manner. They suggested adding more information about raising Down syndrome children, replacing frequencies with percentages, different values clarification methods, and a section for the partner. Conclusions A new user-centered version of the prenatal screening DA will integrate participants’ suggestions to reflect end users’ priorities.

scholarly journals Implementing shared decision-making on acute psychiatric wards: a cluster-randomized trial with inpatients suffering from schizophrenia (SDM-PLUS)

2020 ◽  
Vol 29 ◽  
Author(s):  
J. Hamann ◽  
F. Holzhüter ◽  
S. Blakaj ◽  
S. Becher ◽  
B. Haller ◽  
...  
Keyword(s):  
Decision Making ◽  
Shared Decision Making ◽  
Primary Outcome ◽  
Intervention Group ◽  
Psychiatric Hospitals ◽  
Mental Illnesses ◽  
Control Group ◽  
Shared Decision ◽  
Acute Psychiatric Wards ◽  
Perceived Involvement

Abstract Aims Although shared decision-making (SDM) has the potential to improve health outcomes, psychiatrists often exclude patients with more severe mental illnesses or more acute conditions from participation in treatment decisions. This study examines whether SDM is facilitated by an approach which is specifically adapted to the needs of acutely ill patients (SDM-PLUS). Methods The study is a multi-centre, cluster-randomised, non-blinded, controlled trial of SDM-PLUS in 12 acute psychiatric wards of five psychiatric hospitals addressing inpatients with schizophrenia or schizoaffective disorder. All patients fulfilling the inclusion criteria were consecutively recruited for the trial at the time of their admission to the ward. Treatment teams of intervention wards were trained in the SDM-PLUS approach through participation in two half-day workshops. Patients on intervention wards received group training in SDM. Staff (and patients) of the control wards acted under ‘treatment as usual’ conditions. The primary outcome parameter was the patients' perceived involvement in decision-making at 3 weeks after study enrolment, analysed using a random-effects linear regression model. Results In total, 161 participants each were recruited in the intervention and control group. SDM-PLUS led to higher perceived involvement in decision-making (primary outcome, analysed patients n = 257, mean group difference 16.5, 95% CI 9.0–24.0, p = 0.002, adjusted for baseline differences: β 17.3, 95% CI 10.8–23.6, p = 0.0004). In addition, intervention group patients exhibited better therapeutic alliance, treatment satisfaction and self-rated medication compliance during inpatient stay. There were, however, no significant improvements in adherence and rehospitalisation rates in the 6- and 12-month follow-up. Conclusions Despite limitations in patient recruitment, the SDM-PLUS trial has shown that the adoption of behavioural approaches (e.g. motivational interviewing) for SDM may yield a successful application to mental health. The authors recommend strategies to ensure effects are not lost at the interface between in- and outpatient treatment. Trial registration: The trial was registered at Deutsches Register Klinischer Studien (DRKS00010880).

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