Effectiveness of Pediatric Teleconsultation to Improve Skin Conditions in Infants and to Reduce Parenting Stress in Mothers: Randomized Controlled Trial (Preprint)

BACKGROUND Electronic health (eHealth) for infants and mothers is a current focus of attention, but its effectiveness has rarely been examined in Japan. For infants, skin problems, including atopic dermatitis (AD), which is known to lead to other allergic diseases, is one of the most common conditions. For mothers, parenting stress, which adversely affects mothers’ and children’s well-being, is one of the biggest problems in the postpartum period; this requires a national solution in Japan. OBJECTIVE To evaluate the effectiveness of pediatric teleconsultation for preventing atopic dermatitis in infants and reducing parenting stress in mothers in Japan. METHODS The study was an open-label, randomized, parallel-armed controlled trial. In total, 318 pairs of infants and mothers in Yokohama City Sakae Ward in Japan were recruited when they submitted birth cards to the ward, received the explanation, and completed online informed consent on the website for this trial. Eligible pairs of infant and mother were randomly assigned to the intervention group (n=140) or the control group (n=138). Participants in both the intervention and control groups received routine postnatal care from the local government services. In addition, participants in the intervention group had the option to use combined pediatric services with teleconsultation and email newsletters without any charge from the date of registration until the infant was 4 months of age. Primary outcomes were (i) the prevalence of AD in infants diagnosed based on the United Kingdom Working Party’s criteria; and (ii) parenting stress and mental status in mothers, assessed using the Parenting Stress Index-Short Form (PSI-SF) and General Health Questionnaire-12 (GHQ-12). Data were collected via the ward office staff and researcher at the 4-month checkup. RESULTS The prevalence of AD in infants was significantly lower in the intervention group than in the control group at the 4-month checkup (20% vs. 33%, P=.03; relative risk ratio, 0.614 [95% confidence interval, 0.406 to 0.927]). No significant differences were observed in the PSI-SF and GHQ-12 scores between the two groups. CONCLUSIONS This is the first randomized controlled trial demonstrating that a combined pediatric service with teleconsultation and email newsletters was effective in reducing the prevalence of AD in infants. Pediatric eHealth will become a new strategy for preventing AD. CLINICALTRIAL UMIN000029774; https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034022

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A randomized controlled trial of a specific reminiscence approach to promote the well-being of nursing home residents with dementia

International Psychogeriatrics ◽

10.1017/s1041610204000055 ◽

2004 ◽

Vol 16 (1) ◽

pp. 33-49 ◽

Cited By ~ 80

Author(s):

Claudia K. Y. Lai ◽

Iris Chi ◽

Jeanie Kayser-Jones

Keyword(s):

Randomized Controlled Trial ◽

Nursing Home ◽

Repeated Measures ◽

Comparison Group ◽

Controlled Trial ◽

Intervention Group ◽

Nursing Home Residents ◽

Well Being ◽

Control Group ◽

Randomized Controlled

Background: To date, no firm conclusions can be reached regarding the effectiveness of reminiscence for dementia. Researchers have emphasized that there is an urgent need for more systematic research in the area.Objective and Method: A single-blinded, parallel-groups (one intervention, one comparison, and one no-intervention group) randomized controlled trial (RCT) was adopted to investigate whether a specific reminiscence program leads to higher levels of psychosocial well-being in nursing home residents with dementia. The intervention adopted a life-story approach, while the comparison group provided friendly discussions to control for any changes in outcome as a result of social contacts and attention. The Social Engagement Scale (SES) and Well-being/Ill-being Scale (WIB) were the outcome measures used. The outcomes of the groups were examined with reference to the baseline (T0), immediately (T1), and six weeks (T2) after intervention. The final sample had 101 subjects (control group: n=30; comparison group: n=35; intervention group: n=36). Using multivariate analysis with repeated measures, no significant differences in outcome were found between groups at either T1 or T2. Wilcoxon signed rank tests were performed for each group comparing outcomes between T1 and T0, T2 and T1, and T2 and T0. Significant differences were observed in the intervention group when comparing T1 and T0 WIB (p=.014), but not for the other groups.Conclusion: Although the intervention did not lead to significant differences between the three groups over time, there was a significant improvement in psychosocial well-being for the intervention group.

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Comparing The Effects of Self-Selected Music Versus Predetermined Music On Patient Anxiety Prior To Gynaecological Surgery: The MUANX Randomized Controlled Trial

10.21203/rs.3.rs-274561/v1 ◽

2021 ◽

Author(s):

Danielle Reynaud ◽

Nicolas Bouscaren ◽

Victorine Lenclume ◽

Malik Boukerrou

Keyword(s):

Randomized Controlled Trial ◽

Controlled Trial ◽

Intervention Group ◽

Well Being ◽

Preoperative Anxiety ◽

Control Group ◽

Gynaecological Surgery ◽

Patient Anxiety ◽

Randomized Controlled ◽

Significant Difference

Abstract Background: Anxiety is frequently observed in the preoperative setting. The negative impact of preoperative anxiety is well known. In the context of gynaecological surgery, anxiety is exacerbated by the fact that the intervention can have catastrophic repercussions on a woman’s body image, sexuality, and psycho-affective well-being. Music listening is increasingly used as an alternative therapy for minimizing preoperative anxiety. Personal preferences, familiarity and popularity may be key elements for an optimal relaxation response to music. This study aimed to determine whether listening to self-selected music decreases preoperative anxiety in women scheduled to undergo gynaecologic surgery compared with predetermined music from an application (MUSIC CARE®).Methods: The MUANX study was a single-blind, monocentric, parallel, superiority, randomized controlled trial. A total of 174 women were included and randomized in two groups between August 2017 and September 2018. Patients in the intervention group listened to the personal music playlist that they had created before being hospitalized. Patients in the control group listened to the predetermined playlist on the MUSIC CARE® application. All patients received standard nursing care and listened to 20 minutes of music one hour before surgery. Anxiety scores were assessed before and after the music session using Spielberger’s State-Trait Anxiety Inventory (STAI).Results: The mean age of the 171 evaluated patients was 41.5 years (SD=10.0 years). Before the music session, the STAI state anxiety score was similar in the control group (M=38.8, SD=11.9) and the intervention group (M=39.0, SD=13.1). After the music session, this score had significantly decreased in both the control group (M= -7.2, SD=9.0) and the intervention group (M=-5.5, SD=6.6), with no significant difference in score reduction between groups. Physiological parameters were unchanged after the music session. No significant differences in postoperative measurements (pain intensity, hospitalization duration) were observed between the two groups.Conclusion: Self-selected music is as effective as predetermined music for reducing patient anxiety before gynaecological surgery. As it has no side effects and is easily applicable in gynaecological surgical services, this non-drug intervention may be proposed by healthcare professionals in the management of preoperative anxiety.Trial registration The MUANX trial is registered at the US National Institutes of Health (ClinicalTrials.gov) #NCT03226834. Registered on 24 July 2017. https://clinicaltrials.gov/ct2/show/NCT03226834?term=muanx&draw=2&rank=1

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Improvements in Health-Related Quality of Life, Cardio-Metabolic Health, and Fitness in Postmenopausal Women After an Exercise Plus Health Promotion Intervention: A Randomized Controlled Trial

Journal of Physical Activity and Health ◽

10.1123/jpah.2016-0218 ◽

2017 ◽

Vol 14 (5) ◽

pp. 336-343 ◽

Cited By ~ 8

Author(s):

Mercedes Vélez-Toral ◽

Débora Godoy-Izquierdo ◽

Nicolás Mendoza Ladrón de Guevara ◽

Carlos de Teresa Galván ◽

Alberto Salamanca Ballesteros ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Controlled Trial ◽

Intervention Group ◽

Well Being ◽

Metabolic Health ◽

Metabolic Status ◽

Control Group ◽

Randomized Controlled ◽

Health And Fitness ◽

Mental Well Being

Background:This study explored multidimensional outcomes that were derived from the adherence to regular exercise among previously sedentary postmenopausal 45 to 64 years old women who engaged in a ~20-week exercise program.Methods:A randomized controlled trial with between-group (intervention and control women) and within-subject measures (baseline, postintervention, and 3-month and 12-month follow-ups) was conducted. HRQoL and several indicators of cardio-metabolic status and fitness were assessed.Results:After the intervention, the participants experienced a positive change in their short and long-term physical and mental health, with significant enhancements in several HRQoL dimensions, particularly mental well-being (23.3% of change) and menopause-related health and subdomains (17.0% of change) (P < .01). Improvements were maintained or continued (eg, mental well-being) overtime. These outcomes were accompanied by significant improvements in cardio-metabolic status and fitness, including weight, BMI, cardio-respiratory fitness and flexibility (up to 16.2% of change, P < .05). After the intervention, the intervention group exhibited better HRQoL than the control group at each of the measurement phases. Between-group differences were also observed for some indicators of cardiovascular health and flexibility.Conclusions:Our findings add evidence on the association of positive outcomes on HRQoL with improvements in cardio-metabolic health and fitness status after the adoption of an active lifestyle.

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Effects of Chinese medicine on patients with acute exacerbations of COPD: study protocol for a randomized controlled trial

Trials ◽

10.1186/s13063-019-3772-y ◽

2019 ◽

Vol 20 (1) ◽

Cited By ~ 1

Author(s):

Hailong Zhang ◽

Jiansheng Li ◽

Xueqing Yu ◽

Suyun Li ◽

Haifeng Wang ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Chinese Medicine ◽

Short Form ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Double Blind ◽

Randomized Controlled ◽

Patient Reported ◽

Acute Exacerbations

Abstract Background The incidence, mortality, and prevalence of chronic obstructive pulmonary disease (COPD) are high in China. Acute exacerbations of COPD (AECOPD) are important events in the management of COPD because they negatively impact health status, rates of hospitalization and readmission, and disease progression. AECOPD have been effectively treated with Chinese medicine for a long time. The aim of this proposed trial is to assess the therapeutic effect of Chinese medicine (CM) on AECOPD. Methods/design This proposed study is a multicenter, double-blind, parallel-group randomized controlled trial (RCT). We will randomly assign 378 participants with AECOPD into two groups in a 1:1 ratio. On the basis of health education and conventional treatment, the intervention group will be treated with CM, and the control group is given CM placebo according to CM syndrome. Patients are randomized to either receive CM or placebo, 10 g/packet, twice daily. The double-blind treatment lasts for 2 weeks and is followed up for 4 weeks. The main outcome is the COPD Assessment Test; secondary outcomes are treatment failure rate, treatment success rate, length of hospital stay, AECOPD readmission rate, intubation rate, mortality, dyspnea, the 36-item Short Form Health Survey, and the COPD patient-reported outcome scale. We will document these outcomes faithfully at the beginning of the study, 2 weeks after treatment, and at the 4 weeks follow-up. Discussion This high-quality RCT with strict methodology and few design deficits will help to prove the effectiveness of CM for AECOPD. We hope this trial will provide useful evidence for developing a therapeutic schedule with CM for patients with AECOPD. Trial registration ClinicalTrials.gov, NCT03428412. Registered on 4 February 2018.

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Clinico-biochemical relation of Vitamin D3 with the severity of atopic dermatitis and response to supplementation of Vitamin D3: A randomized controlled trial

Indian Journal of Child Health ◽

10.32677/ijch.v8i12.3227 ◽

2022 ◽

Vol 8 (12) ◽

pp. 412-415

Author(s):

Narayan Prasad Modi ◽

Arun Kumar Dash

Keyword(s):

Randomized Controlled Trial ◽

Atopic Dermatitis ◽

Vitamin D3 ◽

Urban Areas ◽

Controlled Trial ◽

Intervention Group ◽

Serum Vitamin ◽

Control Group ◽

Baseline Serum ◽

Randomized Controlled

Background: Atopic dermatitis (AD), also known as eczema, is one of the most common skin disorders among children and adults, with a steep rise in diagnoses among children. Many studies have investigated the relationship between Vitamin D3 (Vit D3) and AD. Methods: A randomized controlled trial was conducted among 60 children at SCB Medical College, Cuttack from August 2014 to November 2016. Children were randomly assigned to an intervention group that received 60,000 IU of Vit. D3 every week for 6 weeks in addition to regular treatment for AD and a control group that received same treatment of AD except for Vit. D3. Both the groups were followed up at 4 weeks and 8 weeks. Results: In 60 cases of moderate to severe AD, 70% of the patients were male. About 81.7% of patients were from urban areas and 56.7% belonged to a middle socioeconomic class. In 76.6% of cases, family history of atopy was present. At baseline, mean SCORAD was 47.8±7.5 in the intervention group, and 49.2±10.3 in the control group. At baseline, serum Vitamin. D3 level (ng/ml) was 17.6±1.8 in intervention and 17.3±3.5 in control group. After Vitamin. D3 supplementation, the SCORAD improved to 12.8±5.1 (75% reduction) at 4 weeks, and 3.6±2.1 (92% reduction) at 8 weeks in the intervention group. In the control group, the mean SCORAD was 18.8±9.1 (61% reduction) at 4 weeks, and 7.3±4 (85% reduction) at 8 weeks. Discussion: The improvement of serum 25-hydroxy Vit. D3 was 134% and 366% in the intervention group compared to 78% and 121% in the observation group after 4 weeks and 8 weeks respectively. The p-values at both the time points were significant (<0.05) for the intervention group as compared to the control group. Conclusion: Short-term therapeutic supplementation of Vitamin. D3 in children with moderate to severe AD improves the clinical score. There is an inverse relationship between serum Vitamin. D3 level and severity of AD.

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The effect of the emotion regulation training on the resilience of caregivers of patients with schizophrenia: a parallel randomized controlled trial

BMC Psychology ◽

10.1186/s40359-021-00542-5 ◽

2021 ◽

Vol 9 (1) ◽

Author(s):

Maryam Behrouian ◽

Tahereh Ramezani ◽

Mahlagha Dehghan ◽

Abdoreza Sabahi ◽

Batool Ebrahimnejad Zarandi

Keyword(s):

Randomized Controlled Trial ◽

Emotion Regulation ◽

Controlled Trial ◽

Intervention Group ◽

Well Being ◽

Control Group ◽

Psychological Traits ◽

Randomized Controlled ◽

Significant Difference ◽

The Mean

Abstract Background Schizophrenia is the most severe mental chronic disabling disease that the majority of the patients need constant care in a variety of aspects. Regarding the role of family caregivers in taking care of these patients, caregivers need to be resilient, in addition to other psychological traits, to adapt to the circumstance. This study aimed to investigate the effect of the emotion regulation training on the resilience of caregivers of patients with schizophrenia in southeastern Iran. Methods The study was a parallel randomized controlled trial. Seventy caregivers of patients with schizophrenia were selected by convenience sampling method and randomly assigned to an emotion regulation training group and a control group. The intervention group received eight 90-min training sessions (one session weekly) about emotion regulation. The participants completed the Conner–Davidson resilience scale before and one month after the intervention. Results The mean scores of the resilience increased in the control and intervention groups at the end of the study. A significant difference was found between the two groups (p < 0.001). At the beginning of the study, the mean score of the resilience was 59.94 in the control group and 51.97 in the intervention group. However, the mean score of the resilience in the control group was 61.28 after the intervention, which was not significant, but it was 69.08 in the intervention group, which was significant. A significant difference was observed between two groups in the mean scores (p = 0.01). Conclusions According to the results of this study, cognitive and metacognitive skills of emotion regulation can be suggested as one of the methods for increasing the psychological well-being of schizophrenia patients’ caregivers. The increase of mental well-being and resilience of caregivers can help them better manage a patient with schizophrenia. Trial registration IRCT registration number: IRCT2017061733997N2, Registration date: 2017-08-16, 1396/05/25, Registration timing: prospective, https://en.irct.ir/trial/26116

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BRAIN FITNESS INTERVENTION ON KNOWLEDGE AND WORRIES ABOUT ALZHEIMER’S: A RANDOMIZED CONTROLLED TRIAL

Innovation in Aging ◽

10.1093/geroni/igz038.000 ◽

2019 ◽

Vol 3 (Supplement_1) ◽

pp. S1-S1

Author(s):

Kaipeng Wang ◽

Fei Sun ◽

Qiuling An ◽

Yanfei Han ◽

Yi Zhou

Keyword(s):

Older Adults ◽

Randomized Controlled Trial ◽

Treatment Group ◽

Tai Chi ◽

Controlled Trial ◽

Intervention Group ◽

Well Being ◽

Control Group ◽

Randomized Controlled ◽

Brain Fitness

Abstract As one of the world’s fastest aging countries, China’s growing prevalence of Alzheimer’s and related dementias (ADRD) poses concerns among older adults. Lack of knowledge about ADRD and excessive worries about ADRD can cause cumulative stress and threaten physical and psychological well-being of older adults. We conducted a randomized controlled trial to examine the effectiveness of a Brain Fitness Intervention (BFI) on the knowledge and worries about Alzheimer’s at three senior residential care facilities in China. Ninety older adults aged 60 and above underwent randomization. Fifty participants in the intervention group received eight weekly BFI sessions, including Tai Chi exercise, experiential learning, and group discussions. The primary outcomes were the changes from baseline to Week 8 in the scores on the ADRD knowledge scale (ranging 5–50) and worry scale (ranging 5–45). Twenty-seven participants withdrew from the study. Intent-to-treat analysis showed that the estimated mean change in knowledge on ADRD was 4.26 in the treatment group and -1.52 in the control group (p < 0.001). The estimated mean change in worries about ADRD was -10.25 in the treatment group and -2.9 in the control group (p < 0.001). Results remained robust in sensitivity analysis adjusting for study sites and baseline characteristics. Heterogeneity analysis showed that the treatment effect became stronger with the increase of age. Findings support the effectiveness of BFI in increasing ADRD knowledge and reducing worries among Chinese older adults. Future trials with larger sample sizes will be needed for more conclusive results.

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Effectiveness of a psycho-educational intervention for expecting parents to prevent postpartum parenting stress, depression and anxiety: a randomized controlled trial

BMC Pregnancy and Childbirth ◽

10.1186/s12884-020-03341-9 ◽

2020 ◽

Vol 20 (1) ◽

Author(s):

Marjolein Missler ◽

Annemieke van Straten ◽

Jaap Denissen ◽

Tara Donker ◽

Roseriet Beijers

Keyword(s):

Randomized Controlled Trial ◽

Parenting Stress ◽

Controlled Trial ◽

Well Being ◽

Added Value ◽

Control Group ◽

Depression And Anxiety ◽

Randomized Controlled ◽

Secondary Outcomes ◽

Caregiving Quality

Abstract Background The first months postpartum can be challenging for parents, leading to elevated symptoms of parenting stress, depression and anxiety. In turn, distressed parents are at higher risk for providing suboptimal quality of caregiving. As psychoeducational interventions can be effective in reducing psychological distress, the goal of this randomized controlled trial was to examine the effectiveness of low-intensity universal psychoeducational program to prevent postpartum parenting stress, and to enhance parental well-being and caregiving quality. Method Between 26 and 34 weeks of pregnancy, 138 pregnant women and 96 partners were randomized to the intervention or a waitlist control group. The intervention consisted of a booklet, a video, a home visit, and a telephone call. Information was provided on (1) sensitive responsiveness, adapting to the parental role, and attending to own needs; (2) crying patterns; (3) feeding (arrangements); and (4) sleeping (arrangements). The primary outcome was parenting stress postpartum. Secondary outcomes were additional measures of distress (depression and anxiety), parental well-being, and caregiving quality. Results Both groups showed a rise in distress after birth. No between-group differences were observed on parenting stress, nor on the secondary outcomes. The intervention was rated as useful and of added value by the parents. Conclusion This study offered no evidence that our universal prevention program was effective in decreasing parental distress or in increasing caregiving quality. However, parents found aspects of the intervention useful. More research is needed, including a longer period of follow-up as well as observational measures of parents’ responsiveness. Trial registration This trial has been registered on 15 September 2016 in the Netherlands National Trial Register, ID: NTR6065, https://www.trialregister.nl/trial/5782.

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Effectiveness of an Energy Management Training Course on Employee Well-Being: A Randomized Controlled Trial

American Journal of Health Promotion ◽

10.1177/0890117118776875 ◽

2018 ◽

Vol 33 (1) ◽

pp. 118-130 ◽

Cited By ~ 2

Author(s):

Sai Krupa Das ◽

Shawn T. Mason ◽

Taylor A. Vail ◽

Gail V. Rogers ◽

Kara A. Livingston ◽

...

Keyword(s):

Physical Activity ◽

Randomized Controlled Trial ◽

Cardiometabolic Risk ◽

Short Form ◽

Controlled Trial ◽

Purpose In Life ◽

Well Being ◽

Control Group ◽

Randomized Controlled ◽

Sf 36

Purpose: Programs focused on employee well-being have gained momentum in recent years, but few have been rigorously evaluated. This study evaluates the effectiveness of an intervention designed to enhance vitality and purpose in life by assessing changes in employee quality of life (QoL) and health-related behaviors. Design: A worksite-based randomized controlled trial. Setting: Twelve eligible worksites (8 randomized to the intervention group [IG] and 4 to the wait-listed control group [CG]). Participants: Employees (n = 240) at the randomized worksites. Intervention: A 2.5-day group-based behavioral intervention. Measures: Rand Medical Outcomes Survey (MOS) 36-item Short-Form (SF-36) vitality and QoL measures, Ryff Purpose in Life Scale, Center for Epidemiologic Studies questionnaire for depression, MOS sleep, body weight, physical activity, diet quality, and blood measures for glucose and lipids (which were used to calculate a cardiometabolic risk score) obtained at baseline and 6 months. Analysis: General linear mixed models were used to compare least squares means or prevalence differences in outcomes between IG and CG participants. Results: As compared to CG, IG had a significantly higher mean 6-month change on the SF-36 vitality scale ( P = .003) and scored in the highest categories for 5 of the remaining 7 SF-36 domains: general health ( P = .014), mental health ( P = .027), absence of role limitations due to physical problems ( P = .026), and social functioning ( P = .007). The IG also had greater improvements in purpose in life ( P < .001) and sleep quality (index I, P = .024; index II, P = .021). No statistically significant changes were observed for weight, diet, physical activity, or cardiometabolic risk factors. Conclusion: An intensive 2.5-day intervention showed improvement in employee QoL and well-being over 6 months.

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Effectiveness of a web-based medication adherence tool with patient centered communication: Results of a clustered randomized controlled trial (Preprint)

10.2196/preprints.16141 ◽

2019 ◽

Author(s):

Jan van Lieshout ◽

Joyca Lacroix ◽

Aart van Halteren ◽

Martina Teichert

Keyword(s):

Randomized Controlled Trial ◽

Medication Adherence ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Community Pharmacies ◽

Web Based ◽

Randomized Controlled ◽

Tailored Interventions ◽

Increased Risk

BACKGROUND Growing numbers of people use medication for chronic conditions; non-adherence is common, leading to poor disease control. A newly developed web-based tool to identify an increased risk for non-adherence with related potential individual barriers might facilitate tailored interventions and improve adherence. OBJECTIVE To assess the effectiveness of the newly developed tool to improve medication adherence. METHODS A cluster randomized controlled trial assessed the effectiveness of this adherence tool in patients initiating cardiovascular or oral blood glucose lowering medication. Participants were included in community pharmacies. They completed an online questionnaire comprising an assessments of their risk for medication non-adherence and subsequently of barriers to adherence. In pharmacies belonging to the intervention group, individual barriers displayed in a graphical profile on a tablet were discussed by pharmacists and patients at high non-adherence risk in face to face meetings and shared with their general practitioners and practice nurses. Tailored interventions were initiated by the healthcare providers. Barriers of control patients were not presented or discussed and these patients received usual care. The primary outcome was the difference in medication adherence at 8 months follow-up between patients with an increased non-adherence risk from intervention and control group, calculated from dispensing data. RESULTS Data from 492 participants in 15 community pharmacies were available for analyses (intervention 253, 7 pharmacies; control 239, 8 pharmacies). The intervention had no effect on medication adherence (-0.01; 95%CI -0.59 – 0.57; P= .96), neither in the post hoc per protocol analysis (0.19; 95%CI -0.50 – 0.89; P=.58). CONCLUSIONS This study showed no effectiveness of a risk stratification and tailored intervention addressing personal barriers for medication adherence. Various potential explanations for lack of effect were identified. These explanations relate for instance to high medication adherence in the control group, study power and fidelity. Process evaluation should elicit possible improvements and inform the redesign of intervention and implementation. CLINICALTRIAL The Netherlands National Trial Register: NTR5186. Date: May 18, 2015 (http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=5186)

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