scholarly journals The effect of solution-focused counseling on violence rate and quality of life of pregnant women at risk of domestic violence: a randomized controlled trial

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Sepideh Dinmohammadi ◽  
Mohsen Dadashi ◽  
Elahe Ahmadnia ◽  
Leila Janani ◽  
Roghieh Kharaghani
Keyword(s):  
Quality Of Life ◽  
Domestic Violence ◽  
Randomized Controlled Trial ◽  
Pregnant Women ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Randomized Controlled ◽  
Solution Focused

Abstract Background Domestic violence during pregnancy as one of the most common social problems and major challenges of health systems can affect the health of the mother and fetus. The study aimed to compare the two groups of intervention based on solution-focused counseling and control in terms of violence and quality of life amounts in women who had experienced domestic violence. Methods A randomized controlled trial on 90 pregnant women was blocked into two intervention groups (n = 45) and a control (n = 45). The intervention group received six counseling sessions with a solution-focused approach. Study tool included conflict tactics scale (CTS- 2) and short form health survey (SF-36). The tools were completed once before the intervention and again 6 weeks after the end of the counseling sessions by the participants of both groups. The P-value less than 0.05 was considered statistically significant. Results A total of 82/90 pregnant women were analyzed. The results showed that median and interquartile range (IQR) of physical, psychological and sexual violence significantly decreased in the intervention group than the control group (Ps = 0.001). Moreover, quality of life scores significantly improved in the intervention group compared to the control group (P = 0.001). Conclusion Solution-focused counseling could be an effective approach to reduce the amount of violence and increase the quality of life in women exposed to domestic violence. Trial registration Iranian Registry of Clinical Trials IRCT2017040628352N4. Date of registration: August 20th 2017.

scholarly journals The effect of solution-focused counseling on violence rate and quality of life of pregnant women at risk of domestic violence: A randomized controlled trial

2021 ◽  
Author(s):  
Sepideh Din Mohammadi ◽  
Mohsen Dadashi ◽  
Elahe Ahmadnia ◽  
leila Janani ◽  
Roghieh Kharaghani
Keyword(s):  
Quality Of Life ◽  
Domestic Violence ◽  
Pregnant Women ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Randomized Controlled ◽  
Solution Focused ◽  
And Control

Abstract Background: Domestic violence during pregnancy as one of the most common social problems and major challenges of health systems can affect the health of the mother and fetus. The study aimed to compare the two groups of intervention based on solution-focused counseling and control in terms of violence and quality of life amounts in women who had experienced domestic violence.Methods: This study was a randomized controlled trial on 90 pregnant women who were selected from one maternity ward in Zanjan city. A convenience sampling of 90 women was blocked randomized into two groups of intervention (n=45) and control (n=45). Study tool included conflict tactics scale (CTS- 2) and short form health survey (SF-36). The intervention group received six counseling sessions with a solution-focused approach. The tools were completed once before the intervention and again six weeks after the end of the counseling sessions by the participants of both groups. The P-value less than 0.05 was considered statistically significant.Results: A total of 82/90 pregnant women were analyzed. The results showed that median and interquartile range (IQR) of physical, psychological and sexual violence significantly decreased in the intervention group than the control group (Ps=0.001). Moreover, quality of life scores significantly improved in the intervention group compared to the control group (P=0.001).Conclusion: solution-focused counseling could be an effective approach to reduce the amount of violence and increase the quality of life in women exposed to domestic violence.

scholarly journals The Effect of Solution-Focused Counseling on Violence Rate and Quality of Life of Pregnant Women at Risk of Domestic Violence: A randomized Controlled Trial

2020 ◽  
Author(s):  
Sepideh Din Mohammadi ◽  
Mohsen Dadashi ◽  
Elahe Ahmadnia ◽  
leila Janani ◽  
Roghieh Kharaghani
Keyword(s):  
Quality Of Life ◽  
At Risk ◽  
Domestic Violence ◽  
Pregnant Women ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Solution Focused

Abstract Background: Domestic violence is considered as one of the most common social problems, which can affect the quality of life of women. The problem of preventing and controlling this problem, especially during pregnancy, is one of the basic challenges of health systems. The aim of this study was to determine the effect of counseling based on conflict solution on the rate of violence and quality of life of pregnant women at risk of domestic violence. Methods: This study was a randomized controlled trial on 90 pregnant women, who were selected from maternity wards in health center number three in Zanjan city. Women who had inclusion criteria based on the domestic violence conflict tactics scale (CTS-2) selected with convenience sampling and randomly divided into two groups of intervention (45 people) and control (45 people) with a blocked randomization method. The intervention group received six counseling sessions with a solution-focused approach and the control group received no intervention. Study tool included demographic and reproductive questionnaires CTS- 2 and short form health survey (SF-36); which completed at baseline and six weeks follow-up in both groups. The results were analyzed by nonparametric ANCOVA using SPSS and R soft wares.Results: The results showed that there was a significant difference in the physical violence (P=0.001), psychological violence (P=0.001), and sexual violence (P=0.001) in the intervention group compared to the control group at six weeks follow- up. There were significant improvements in negotiation scores in the intervention group (P˂0.001). Moreover, there were significant differences in the quality of life scores (P=0.001), vitality (p=0.003), psychological health (p=0.004), bodily pain (p=0.014), physical functioning (p=0.023), and social functioning (p=0.019) between the two groups at the follow- up period.Conclusion: According to the result, individual counseling based on a solution-based approach reduces the amount of domestic violence and increases the quality of life of pregnant women at risk of violence.Trial registration: Iranian Registry of Clinical Trials IRCT2017040628352N4. Date of registration: August 20th 2017.

scholarly journals The effect of solution-focused counseling on violence rate and quality of life of pregnant women at risk of domestic violence: A randomized controlled trial

2020 ◽  
Author(s):  
Sepideh Din Mohammadi ◽  
Mohsen Dadashi ◽  
Elahe Ahmadnia ◽  
leila Janani ◽  
Roghieh Kharaghani
Keyword(s):  
Quality Of Life ◽  
At Risk ◽  
Domestic Violence ◽  
Pregnant Women ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Solution Focused

Abstract Background: Domestic violence is considered as one of the most common social problems, which can affect the quality of life of women. The problem of preventing and controlling this problem, especially during pregnancy, is one of the basic challenges of health systems. The aim of this study was to determine the effect of counseling based on conflict solution on the rate of violence and quality of life of pregnant women at risk of domestic violence. Methods: This study was a randomized controlled trial on 90 pregnant women, who were selected from maternity wards in health center number three in Zanjan city. Women who had inclusion criteria based on the domestic violence conflict tactics scale (CTS-2) selected using convenience sampling and randomly divided into two groups of intervention (45 people) and control (45 people) with a blocked randomization method. The intervention group received six counseling sessions with a solution-focused approach and the control group received no intervention. Study tool included demographic and reproductive questionnaires CTS- 2 and short form health survey (SF-36); which completed at baseline and six weeks follow-up in both groups. The results were analyzed by nonparametric ANCOVA using SPSS and R soft wares.Results: The results showed that there was a significant difference in the physical violence (P=0.001), psychological violence (P=0.001), and sexual violence (P=0.001) in the intervention group compared to the control group at six weeks follow- up. There were significant improvements in negotiation scores in the intervention group (P˂0.001). Moreover, there were significant differences in the quality of life scores (P=0.001), vitality (p=0.003), psychological health (p=0.004), bodily pain (p=0.014), physical functioning (p=0.023), and social functioning (p=0.019) between the two groups at the follow- up period.Conclusion: According to the result, individual counseling based on a solution-based approach reduces the amount of domestic violence and increases the quality of life of pregnant women at risk of violence.Trial registration: Iranian Registry of Clinical Trials IRCT2017040628352N4. Date of registration: August 20th 2017.

scholarly journals Asthma in Adolescents: A Randomized, Controlled Trial of an Asthma Program for Adolescents and Young Adults with Severe Asthma

2002 ◽  
Vol 9 (4) ◽  
pp. 253-259 ◽  
Author(s):  
Robert L Cowie ◽  
Margot F Underwood ◽  
Cinde B Little ◽  
Ian Mitchell ◽  
Sheldon Spier ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Emergency Department ◽  
Randomized Controlled Trial ◽  
Asthma Control ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Randomized Controlled ◽  
Disease Specific

BACKGROUND: Asthma is common and is often poorly controlled in adolescent subjects.OBJECTIVE: To determine the impact of an age-specific asthma program on asthma control, particularly on exacerbations of asthma requiring emergency department treatment, and on the quality of life of adolescents with asthma.METHODS: The present randomized, controlled trial included patients who were 15 to 20 years of age and had visited emergency departments for management of their asthma. The interventional group attended an age-specific asthma program that included assessment, education and management by a team of asthma educators, respiratory therapists and respiratory physicians. In the control group, spirometry was performed, and the patients continued to receive usual care from their regular physicians. The outcomes were assessed by a questionnaire six months after entry into the study.RESULTS: Ninety-three subjects entered the study and were randomly assigned to the intervention or control group. Of these, only 62 patients were available for review after six months. Subjects in both the control and the intervention groups showed a marked improvement in their level of asthma control, reflected primarily by a 73% reduction in the rate of emergency department attendance for asthma. Other indexes of disease control, including disease-specific quality of life, as assessed by questionnaires, were improved. There was, however, no discernible difference between the subjects in the two groups, with the exception of an improvement in favour of the intervention group in the symptom (actual difference 0.7, P=0.048) and emotional (actual difference 0.8, P=0.028) domains of the asthma quality of life questionnaire. The overall quality of life score favoured the intervention group by a clinically relevant difference of 0.6, but this difference did not reach statistical significance (P=0.06).CONCLUSIONS: Although all subjects demonstrated a significant improvement in asthma control and quality of life, the improvement attributable to this intervention was limited to two domains in disease-specific quality of life.

scholarly journals Health Education Through a Campaign and mHealth to Enhance Knowledge and Quality of Life Among Patients With Chronic Kidney Disease in Bangladesh: Protocol for a Randomized Controlled Trial (Preprint)

2021 ◽  
Author(s):  
Mohammad Habibur Rahman Sarker ◽  
Michiko Moriyama ◽  
Harun Ur Rashid ◽  
Md Moshiur Rahman ◽  
Mohammod Jobayer Chisti ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Chronic Kidney Disease ◽  
Randomized Controlled Trial ◽  
Kidney Disease ◽  
Health Education ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Randomized Controlled

BACKGROUND Despite the growing burden of chronic kidney disease (CKD), disease knowledge and understanding are still lacking, especially in Bangladesh. OBJECTIVE The aim of this study was to evaluate the outcome of a health education intervention in order to enhance knowledge, health-related quality of life (QOL), and motivation regarding healthy lifestyles among rural and periurban adults suffering from CKD. METHODS A parallel-group (1:1) randomized controlled trial is ongoing in the Mirzapur subdistrict, Bangladesh, where two groups of patients with CKD are being compared. Patients aged 18 years and over with CKD (stages 1-3) were enrolled in November 2020. Patients were randomly allocated into either the intervention group (n=63) or the control group (n=63). The control group received usual treatment, while the intervention group received health education through a CKD campaign facilitated by a nephrologist and via mHealth (ie, periodic mobile phone calls) from community health workers. Both groups were followed up for a period of 6 months. The primary endpoint is patients’ increased knowledge measured using the Chronic Kidney Disease Knowledge Questionnaire. The secondary endpoints are improved QOL measured using the standardized EuroQol 5-Dimension 5-Level (EQ-5D-5L) questionnaire as well as improvements in the levels of blood pressure, BMI, serum creatinine, fasting blood sugar, hemoglobin, cholesterol, high-density lipoprotein cholesterol, triglyceride, serum uric acid, blood urea nitrogen, and albumin to creatinine ratio. RESULTS Enrollment of participants began in November 2020; the intervention and follow-up were completed in May 2021. We enrolled 126 patients in the study. Patients’ mean ages were 57.97 (SD 15.03) years in the control group and 57.32 (SD 14.37) years in the intervention group. There were 45 out of 63 (71%) females in the control group and 38 out of 63 (60%) females in the intervention group. In addition, there were 38 out of 63 (60%) literate patients in the control group and 33 out of 63 (52%) literate patients in the intervention group. CONCLUSIONS It is expected that a combined approach, incorporating both a CKD campaign and mHealth, for health education may be an effective tool for increasing knowledge and improving QOL among patients with CKD. CLINICALTRIAL ClinicalTrials.gov NCT04094831; https://clinicaltrials.gov/ct2/show/NCT04094831 INTERNATIONAL REGISTERED REPORT DERR1-10.2196/30191

scholarly journals Walking in pregnancy and prevention of insomnia in third trimester using pedometers: study protocol of Walking_Preg project (WPP). A randomized controlled trial

2020 ◽  
Vol 20 (1) ◽  
Author(s):  
C. Amezcua-Prieto ◽  
M. Naveiro-Fuentes ◽  
N. Arco-Jiménez ◽  
R. Olmedo-Requena ◽  
R. Barrios-Rodríguez ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Randomized Controlled Trial ◽  
Sleep Quality ◽  
Pregnant Women ◽  
Controlled Trial ◽  
Intervention Group ◽  
Third Trimester ◽  
Randomized Controlled ◽  
In Pregnancy

Abstract Background Previous studies in pregnancy have not focused in evaluating the effect of walking during pregnancy and prevention of insomnia. Our general objective is to determine the effect of a walking program in preventing the appearance of insomnia in the third trimester of pregnancy, increasing sleep quality and improving quality of life throughout pregnancy. Methods Randomized Controlled trial in parallel in healthy sedentary pregnant women (n = 265), Walking_Preg Project (WPP), from university hospital in Granada, Spain. At 12th gestational week (GW), they will be invited to participate and randomly assigned to one of the three arms of study: the intervention group I1 (pedometer, goal of 11,000 steps/day), intervention group I2 (pedometer, no goal) and control (no pedometer). Duration of intervention: 13–32 GW. At 12th, 19th and 31st GW the average steps/day will be measured in groups I1 and I2. At 13th, 20th and 32nd GW, Athens Insomnia Scale (AIS), Pittsburgh Sleep Quality Index (PSQI), Adherence to Mediterranean Diet (AMD), physical activity (short IPAQ), quality of life (PSI), and consumption of toxic substances (caffeine, illegal drugs, alcohol and tobacco) will be collected. Student t test or Mann-Whitney U will be used to compare 19th and 31st GW mean of daily steps between I1 and I2 groups. To compare differences between groups in terms of frequency of insomnia/quality of life for each trimester of pregnancy, Pearson’s Chi-square test or Fisher’s exact test will be used. To determine differences in hours of sleep and quality of sleep throughout each trimester of pregnancy, analysis of variance or Friedman test will be used. McNemar-Bowker test will be used to assess differences in life quality in pre-post analyses in the 3 arms. We will use Stata 15 statistical software. Discussion promoting walking in second half of pregnancy through use of pedometer and health pre-registration of a goal to be achieved –'10,000–11,000 steps a day’– should prevent appearance of insomnia in third trimester, will increase sleep quality and quality of life in pregnant women. Trial registration ClinicalTrials.gov Identifier: NCT03735381. Registered 8th November, 2018.

scholarly journals Efficacy and cost-utility of the eHealth application ‘Oncokompas’, supporting patients with incurable cancer in finding optimal palliative care, tailored to their quality of life and personal preferences: a study protocol of a randomized controlled trial

2019 ◽  
Vol 18 (1) ◽  
Author(s):  
Anouk S. Schuit ◽  
Karen Holtmaat ◽  
Nienke Hooghiemstra ◽  
Femke Jansen ◽  
Birgit I. Lissenberg-Witte ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Palliative Care ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Intervention Group ◽  
Cost Utility ◽  
Control Group ◽  
Incurable Cancer ◽  
Randomized Controlled

Abstract Background Patients with incurable cancer have to deal with a wide range of symptoms due to their disease and treatment, influencing their quality of life. Nowadays, patients are expected to adopt an active role in managing their own health and healthcare. Oncokompas is an eHealth self-management application developed to support patients in finding optimal palliative care, tailored to their quality of life and personal preferences. A randomized controlled trial will be carried out to determine the efficacy and cost-utility of Oncokompas compared to care as usual. Methods 136 adult patients with incurable lung, breast, colorectal and head and neck cancer, lymphoma and glioma, will be included. Eligible patients have no curative treatment options and a prognosis of at least three months. Patients will be randomly assigned to the intervention group or the control group. The intervention group directly has access to Oncokompas alongside care as usual, while the waiting list control group receives care as usual and will have access to Oncokompas after three months. The primary outcome measure is patient activation, which can be described as a patient’s knowledge, skills and confidence to manage his or her own health and healthcare. Secondary outcome measures comprise self-efficacy, health-related quality of life, and costs. Measures will be assessed at baseline, two weeks after randomization, and three months after the baseline measurement. Discussion This study will result in knowledge on the efficacy and cost-utility of Oncokompas among patients with incurable cancer. Also, more knowledge will be generated into the need for and costs of palliative care from a societal and healthcare perspective. Trial registration Netherlands Trial Register identifier: NTR 7494. Registered on 24 September 2018.

scholarly journals Effectiveness of self-help workbook intervention on quality of life in cancer patients receiving chemotherapy: results of a randomized controlled trial

2020 ◽  
Author(s):  
Toshimi Takano ◽  
Ayako Matsuda ◽  
Noriko Ishizuka ◽  
Yukinori Ozaki ◽  
Koichi Suyama ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Randomized Controlled Trial ◽  
Cancer Patients ◽  
Emotional Functioning ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Randomized Controlled ◽  
Self Help

Abstract Background: A self-help workbook is expected to support cancer patients to cope with physical and psychosocial distress, to facilitate communication with medical staff, and to improve quality of life (QOL). We conducted a randomized controlled trial to evaluate the effectiveness of a self-help workbook intervention on QOL and survival. Methods: From June 2014 to March 2015, patients with breast, colorectal, gastric, and lung cancer receiving outpatient chemotherapy were randomized into an intervention group (n = 100) or control group (n = 100). Intervention group participants received workbooks originally made for this study, read advice on how to cope with distress, and filled out questionnaires on the workbooks periodically. EORTC QLQ-C30 was evaluated at baseline, at 12 weeks, and at 24 weeks. The primary endpoint was Global Health Status / QOL scale (GQOL). Results: No significant interaction was observed between the intervention and time in terms of GQOL or any of the functional scales. Among the 69 patients who continued cytotoxic chemotherapy at 24 weeks, the intervention was significantly associated with improved emotional functioning scores (P = 0.0007). Overall survival was not significantly different between the two groups. Conclusions: Self-help workbook intervention was feasible in cancer patients receiving chemotherapy. Although the effect of the intervention was limited, the intervention may improve emotional functioning among patients who receive long-term cytotoxic chemotherapy.Trial registration: UMIN Clinical Trials Registry, UMIN000012842. Registered 14 January 2014, https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015002

scholarly journals Improving Adherence and Quality of Life of CPAP for Obstructive Sleep Apnea With An Intervention Based On Stratification and Personalization of Care Plans: A Randomized Controlled Trial

2021 ◽  
Author(s):  
David Rudilla ◽  
Salvador Perelló ◽  
Pedro Landete ◽  
Enrique Zamora ◽  
María Vázquez ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Care Plans ◽  
Randomized Controlled ◽  
Individualized Care ◽  
Health Related

Abstract Purpose The aim was to determine adherence to CPAP and health-related outcomes in patients with OSA via a comprehensive program based on stratification and individualized care plans, including motivational interview. Methods A multicentre, randomized controlled trial (RCT) design was used in 3 hospitals. The control group followed the usual treatment. Intervention group (PIMA) followed the treatment with an adapted care plan (home visits, telephone, care-center) depending on socio-demographic, clinical and psychological variables, using motivational interviews in all the interventions. The main outcome was adherence, and secondary were quality of life, emotional state, activities, social relationships, perceived competence, and motivation. The clinical trial was registered with www.clinicaltrials.gov (NCT 04691479). Results 213 patients (68.1% men, 58.7% between 51–69 years old, 45.5% upper-secondary school education) were randomized: 108 were in the intervention group and 105 were in the control group. The result showed a statistically significant difference in adherence at 90 and 180 days respectively: 129.24 (IC 95% 77.25-181.22) p < 0.0001 and 288.30 (IC95% 187.146–389.47) p < 0.0001. The adherence (hours/day) showed favourable results for the PIMA group compared to the control group at 90 days with a difference of 1.74 hours/day (IC95% 1.18–2.30) p < 0.0001 and at 180 days with a difference of 2.31 (IC95% 1.72–2.91) p < 0.001. The results for secondary outcomes also showed statistically significant differences in favour of the PIMA group. Conclusions This study found evidence that a program based on stratification and personalized care plans, through motivational interviewing, improves adherence to CPAP treatment and health-related outcomes than traditional care.

scholarly journals Health Education Through a Campaign and mHealth to Enhance Knowledge and Quality of Life Among Patients With Chronic Kidney Disease in Bangladesh: Protocol for a Randomized Controlled Trial

10.2196/30191 ◽  
2021 ◽  
Vol 10 (11) ◽  
pp. e30191
Author(s):  
Mohammad Habibur Rahman Sarker ◽  
Michiko Moriyama ◽  
Harun Ur Rashid ◽  
Md Moshiur Rahman ◽  
Mohammod Jobayer Chisti ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Chronic Kidney Disease ◽  
Randomized Controlled Trial ◽  
Kidney Disease ◽  
Health Education ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Randomized Controlled

Background Despite the growing burden of chronic kidney disease (CKD), disease knowledge and understanding are still lacking, especially in Bangladesh. Objective The aim of this study was to evaluate the outcome of a health education intervention in order to enhance knowledge, health-related quality of life (QOL), and motivation regarding healthy lifestyles among rural and periurban adults suffering from CKD. Methods A parallel-group (1:1) randomized controlled trial is ongoing in the Mirzapur subdistrict, Bangladesh, where two groups of patients with CKD are being compared. Patients aged 18 years and over with CKD (stages 1-3) were enrolled in November 2020. Patients were randomly allocated into either the intervention group (n=63) or the control group (n=63). The control group received usual treatment, while the intervention group received health education through a CKD campaign facilitated by a nephrologist and via mHealth (ie, periodic mobile phone calls) from community health workers. Both groups were followed up for a period of 6 months. The primary endpoint is patients’ increased knowledge measured using the Chronic Kidney Disease Knowledge Questionnaire. The secondary endpoints are improved QOL measured using the standardized EuroQol 5-Dimension 5-Level (EQ-5D-5L) questionnaire as well as improvements in the levels of blood pressure, BMI, serum creatinine, fasting blood sugar, hemoglobin, cholesterol, high-density lipoprotein cholesterol, triglyceride, serum uric acid, blood urea nitrogen, and albumin to creatinine ratio. Results Enrollment of participants began in November 2020; the intervention and follow-up were completed in May 2021. We enrolled 126 patients in the study. Patients’ mean ages were 57.97 (SD 15.03) years in the control group and 57.32 (SD 14.37) years in the intervention group. There were 45 out of 63 (71%) females in the control group and 38 out of 63 (60%) females in the intervention group. In addition, there were 38 out of 63 (60%) literate patients in the control group and 33 out of 63 (52%) literate patients in the intervention group. Conclusions It is expected that a combined approach, incorporating both a CKD campaign and mHealth, for health education may be an effective tool for increasing knowledge and improving QOL among patients with CKD. Trial Registration ClinicalTrials.gov NCT04094831; https://clinicaltrials.gov/ct2/show/NCT04094831 International Registered Report Identifier (IRRID) DERR1-10.2196/30191

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