scholarly journals Impact of a Face-To-Face Versus Smartphone App Versus Combined Breastfeeding Intervention Targeting Fathers: Randomized Controlled Trial (Preprint)

2020 ◽  
Author(s):  
Jane Anne Scott ◽  
Sharyn K Burns ◽  
Yvonne L Hauck ◽  
Roslyn C Giglia ◽  
Anita M Jorgensen ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Infant Feeding ◽  
Self Efficacy ◽  
Controlled Trial ◽  
Smartphone App ◽  
Face To Face ◽  
Baseline Questionnaire ◽  
Randomized Controlled ◽  
Antenatal Classes

BACKGROUND Despite the recognized health and economic benefits of exclusive breastfeeding, few Australian infants are exclusively breastfed beyond 5 months of age. Social support for breastfeeding, in particular the support of an infant’s father, has been identified as a crucial element for successful breastfeeding. OBJECTIVE The objective of this study was to determine the effectiveness of various father-focused breastfeeding interventions in terms of key infant feeding outcomes. METHODS The study was a 4-arm, factorial, randomized controlled trial conducted in Perth, Australia. The trial arms included a control group and 3 interventions, consisting of a face-to-face father-focused antenatal breastfeeding class facilitated by a male peer facilitator; Milk Man, a breastfeeding smartphone app designed specifically for fathers; and a combination of both interventions. Expecting couples were recruited from hospital-based antenatal classes and block randomized to 1 of the 4 arms. Each partner completed surveys at recruitment and at 6 weeks and 26 weeks postpartum. Primary outcomes were duration of exclusive and any breastfeeding. Secondary outcomes included age of introduction of formula and complementary foods, maternal breastfeeding self-efficacy, and partner postpartum support. RESULTS A total of 1426 couples were recruited from public (443/1426, 31.1%) and private (983/1426, 68.9%) hospitals. Of these, 76.6% (1092/1426) of fathers completed the baseline questionnaire, 58.6% (836/1426) completed the 6-week follow-up questionnaire, and 49.2% (702/1426) completed the 26-week follow-up questionnaire. The average age of fathers who completed the baseline questionnaire was 33.6 (SD 5.2) years; the majority were born in Australia (76.4%) and had attended university (61.8%). There were no significant differences between the control and any of the intervention groups in any of the infant feeding outcomes or level of breastfeeding self-efficacy and postpartum partner support reported by mothers. CONCLUSIONS This study did not demonstrate that any intervention was superior to another or that any intervention was inferior to the standard care delivered in routine antenatal classes. Further studies are needed to test the effectiveness of these interventions in more socioeconomically diverse populations that are likely to benefit most from additional partner supports. CLINICALTRIAL Australian New Zealand Clinical Trials Registry ACTRN12614000605695; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12614000605695 INTERNATIONAL REGISTERED REPORT RR2-10.1186/s12884-015-0601-5

scholarly journals Impact of a Face-To-Face Versus Smartphone App Versus Combined Breastfeeding Intervention Targeting Fathers: Randomized Controlled Trial

10.2196/24579 ◽  
2021 ◽  
Vol 4 (2) ◽  
pp. e24579
Author(s):  
Jane Anne Scott ◽  
Sharyn K Burns ◽  
Yvonne L Hauck ◽  
Roslyn C Giglia ◽  
Anita M Jorgensen ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Infant Feeding ◽  
Controlled Trial ◽  
Trial Registration ◽  
Smartphone App ◽  
Face To Face ◽  
Baseline Questionnaire ◽  
Randomized Controlled ◽  
Antenatal Classes

Background Despite the recognized health and economic benefits of exclusive breastfeeding, few Australian infants are exclusively breastfed beyond 5 months of age. Social support for breastfeeding, in particular the support of an infant’s father, has been identified as a crucial element for successful breastfeeding. Objective The objective of this study was to determine the effectiveness of various father-focused breastfeeding interventions in terms of key infant feeding outcomes. Methods The study was a 4-arm, factorial, randomized controlled trial conducted in Perth, Australia. The trial arms included a control group and 3 interventions, consisting of a face-to-face father-focused antenatal breastfeeding class facilitated by a male peer facilitator; Milk Man, a breastfeeding smartphone app designed specifically for fathers; and a combination of both interventions. Expecting couples were recruited from hospital-based antenatal classes and block randomized to 1 of the 4 arms. Each partner completed surveys at recruitment and at 6 weeks and 26 weeks postpartum. Primary outcomes were duration of exclusive and any breastfeeding. Secondary outcomes included age of introduction of formula and complementary foods, maternal breastfeeding self-efficacy, and partner postpartum support. Results A total of 1426 couples were recruited from public (443/1426, 31.1%) and private (983/1426, 68.9%) hospitals. Of these, 76.6% (1092/1426) of fathers completed the baseline questionnaire, 58.6% (836/1426) completed the 6-week follow-up questionnaire, and 49.2% (702/1426) completed the 26-week follow-up questionnaire. The average age of fathers who completed the baseline questionnaire was 33.6 (SD 5.2) years; the majority were born in Australia (76.4%) and had attended university (61.8%). There were no significant differences between the control and any of the intervention groups in any of the infant feeding outcomes or level of breastfeeding self-efficacy and postpartum partner support reported by mothers. Conclusions This study did not demonstrate that any intervention was superior to another or that any intervention was inferior to the standard care delivered in routine antenatal classes. Further studies are needed to test the effectiveness of these interventions in more socioeconomically diverse populations that are likely to benefit most from additional partner supports. Trial Registration Australian New Zealand Clinical Trials Registry ACTRN12614000605695; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12614000605695 International Registered Report Identifier (IRRID) RR2-10.1186/s12884-015-0601-5

scholarly journals A mobile app using therapeutic exercise and education for self-management in patients with hand rheumatoid arthritis: a randomized controlled trial protocol

Trials ◽  
2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Pablo Rodríguez-Sánchez-Laulhé ◽  
Luis Gabriel Luque-Romero ◽  
Jesús Blanquero ◽  
Alejandro Suero-Pineda ◽  
Ángela Biscarri-Carbonero ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Self Management ◽  
Pinch Strength ◽  
Smartphone App ◽  
Therapeutic Exercise ◽  
Randomized Controlled ◽  
Experimental Group

Abstract Background Therapeutic exercise is a safe and cost-effective approach to alleviate hand rheumatoid arthritis (RA)-related symptoms. This study aims to investigate the differences in self-management between a smartphone app (CareHand), using hand exercises and educational advices, compared with a standard approach, on hand overall function, pain intensity, stiffness, and grip and pinch strength in patients with hand RA. Methods The project is a prospective, longitudinal, superiority, randomized controlled trial. Fifty-eight participants with hand RA will be randomly assigned into an experimental group (CareHand app) or a control group (conventional treatment). Control intervention involves a paper sheet with exercises and recommendations, and the experimental group includes the use of a smartphone app, which provides individualized exercise programs, self-management, and educational strategies to promote adherence to treatment. Both intervention protocols will last for 3 months. The principal investigator will conduct an educational session at baseline for all participants. Primary outcome comprises the overall hand function, assessed with the Michigan Hand Outcome Questionnaire (MHQ). Secondary outcomes include self-reported functional ability with the Quick DASH questionnaire, self-reported pain intensity and morning stiffness using a Visual Analogue Scale (VAS), and hand grip and pinch strength (dynamometer). Outcome measures will be collected at baseline, and at 1 month and 3-month follow-up. Discussion This study will evaluate the effectiveness of a tele-rehabilitation tool, which uses exercise and self-management strategies, compared to a conventional approach, in patients with hand RA. The smartphone app will allow to monitor the patient’s status and to enhance patient-therapist communication. Some limitations may be related to the short follow-up duration and the lack of evaluation of psychosocial factors. Overall, this new way of promoting long-term effects in patients with a chronic rheumatic disease could be feasible and easy to implement in daily life clinical practice and current musculoskeletal care. Trial registration ClinicalTrials.gov NCT04263974. Registered on 7 March 2020. Date of last update 15 April 2020. Ethics committee code: PI_RH_2018.

scholarly journals A mobile app using therapeutic exercise and education for self-management in patients with hand rheumatoid arthritis. A randomized controlled trial protocol.

2020 ◽  
Author(s):  
Pablo for the Management of Health Research of Seville F Rodríguez-Sánchez-Laulhé ◽  
Luis Gabriel Luque-Romero ◽  
Jesús Blanquero ◽  
Alejandro Suero-Pineda ◽  
Ángela Biscarri-Carbonero ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Self Management ◽  
Pinch Strength ◽  
Smartphone App ◽  
Therapeutic Exercise ◽  
Randomized Controlled ◽  
Experimental Group

Abstract Background: Therapeutic exercise is a safe and cost-effective approach to alleviate hand rheumatoid arthritis (RA) related symptoms. This study aims to investigate the differences in self-management between a smartphone app (CareHand), using hand exercises and educational advices, compared with a standard approach, on hand overall function, pain intensity, stiffness, and grip and pinch strength in patients with hand RA. Methods: The project is a prospective, longitudinal, superiority, randomized controlled trial. Fifty-eight participants with hand RA will be randomly assigned into an experimental group (CareHand app) or a control group (conventional treatment). Control intervention involves a paper sheet with exercises and recommendations, and the experimental group includes the use of a smartphone app, which provides individualized exercise programmes, self-management and educational strategies to promote adherence to treatment. Both intervention protocols will last for 3 months. The principal investigator will conduct an educational session at baseline for all participants. Primary outcome comprises the overall hand function, assessed with the Michigan Hand Outcome Questionnaire (MHQ). Secondary outcomes include self-reported functional ability with the Quick DASH questionnaire, self-reported pain intensity and morning stiffness using a Visual Analogue Scale (VAS), and hand grip and pinch strength (dynamometer). Outcome measures will be collected at baseline, and at 1 month and 3-month follow-up. Discussion: This study will evaluate the effectiveness of a telerehabilitation tool, which uses exercise and self-management strategies, compared to a conventional approach, in patients with hand RA. The smartphone app will allow to monitor the patient´s status, and to enhance patient-therapist communication. Some limitations may be related to the short follow-up duration and the lack of evaluation of psychosocial factors. Overall, this new way of promoting long-term effects in patients with a chronic rheumatic disease could be feasible and easy to implement in daily life clinical practice and current musculoskeletal care.

Effects of an Intervention App on Problematic Smartphone Use: Randomized Controlled Trial (Preprint)

2020 ◽  
Author(s):  
Jan Keller ◽  
Christina Roitzheim ◽  
Theda Radtke ◽  
Konstantin Schenkel ◽  
Ralf Schwarzer
Keyword(s):  
Randomized Controlled Trial ◽  
Active Control ◽  
Self Efficacy ◽  
Controlled Trial ◽  
Psychological Resources ◽  
Problematic Smartphone Use ◽  
Randomized Controlled ◽  
Smartphone Use ◽  
Digital Detox

BACKGROUND People spend large parts of their everyday life using their smartphone. Despite various advantages of the smartphone for daily life, problematic forms of smartphone use exist which are related to negative psychological and physiological consequences. To reduce problematic smartphone use, existing interventions are oftentimes app-based and include components, that help users to monitor and restrict their smartphone use by setting timers and blockers. Such digital detox interventions lack to address psychological resources such as promoting a self-efficacious and goal-directed smartphone use. OBJECTIVE Evaluation of the theory-based smartphone app “not less but better” that was developed to make people aware of psychological processes while using the smartphone and to support them in using their smartphone in accordance with their goals and values. METHODS In a randomized controlled trial with 232 participants, effects of a 20-day intervention app consisting of five 4-days training modules to foster a goal-directed smartphone use were evaluated. In the active control condition (treatment-as-usual), participants received a digital detox treatment and planned daily timeouts of at least one hour per day. Up to a 3-weeks follow-up, self-reported problematic smartphone use, objectively measured daily smartphone unlocks, time of smartphone use, self-efficacy, and planning towards goal-directed smartphone use were assessed repeatedly. Linear two-level models tested intervention effects. Mediation models were used to analyse mechanisms of the intervention. RESULTS Both conditions manifested substantial reductions in their problematic smartphone use as well as in the amount of time spent with the smartphone. These reductions were documented at postintervention and remained stable at the 3-weeks follow-up. The number of daily unlocks did not change over time. Further, modelling changes in self-efficacy as a mediator between the intervention and problematic smartphone use at follow-up fitted well to the data and showed an indirect effect (b=-0.09 (CIBC 95% [-0.26, -0.01]), indicating that self-efficacy was an important intervention mechanism. Another mediation model revealed an indirect effect from changes in planning via smartphone unlocks at postintervention on problematic smartphone use at follow-up (b=-0.029, CIBC 95% [-0.078, -0.003]). CONCLUSIONS An innovative, theory-based intervention app on goal-directed smartphone use has been found useful in lowering problematic smartphone use as well as time spent with the smartphone. As the active control condition (planning of daily timeouts) experienced similar reductions in these two outcomes, a combined version of both experimental conditions could be used in future interventions on smartphone behaviours. Moreover, present findings highlight the importance to promote psychological resources such as self-efficacy and planning of goal-directed smartphone use to achieve improvements in problematic smartphone use. CLINICALTRIAL German Clinical Trials Register; https://drks.de/drks_web/setLocale_EN.do; identifier: DRKS00017606

Randomized Controlled Trial: Self-Care Traumatic Episode Protocol (STEP), Computerized EMDR Treatment of COVID-19 Related Stress

2021 ◽  
pp. EMDR-D-20-00047
Author(s):  
Judy Moench ◽  
Olivia Billsten
Keyword(s):  
Mental Health ◽  
Randomized Controlled Trial ◽  
Self Efficacy ◽  
Controlled Trial ◽  
Mental Health Clinicians ◽  
Delayed Treatment ◽  
Randomized Controlled ◽  
Traumatic Episode ◽  
General Self Efficacy

Healthcare workers and Mental Health clinicians are at heightened risk for mental health issues while they support their communities during the COVID-19 pandemic, and early psychological intervention is crucial to protect them. The Self-Care Traumatic Episode Protocol (STEP) is a computerized intervention adapted from the Eye Movement Desensitization and Reprocessing Group Traumatic Episode Protocol (EMDR G-TEP). This study evaluated the effectiveness of STEP for Mental Health clinicians in the context of COVID-19. Thirty-four Mental Health clinicians were randomly allocated to treatment (n = 17) or waitlist (n = 17). The Generalized Self-Efficacy Scale (GSE) and Depression and Anxiety Stress Scale (DASS- 21) were completed by the treatment group at baseline and 1-week follow-up postintervention and by the waitlist group at baseline, preintervention, and 1-week follow-up postwaitlist. Pre–post comparisons showed a significant decrease in depression, anxiety, and stress for Immediate Treatment, t(15) = −3.64, p < .01, d = .73, and for Delayed Treatment, t(15) = −3.53, p < .01, d = .68, There was also a significant increase in general self-efficacy for Immediate Treatment, t(15) = 2.87, p < .05, d = .46, and Delayed Treatment, t(15) = 3.72, p < .01, d = .56. The randomized controlled trial (RCT) indicated that STEP may be effective in increasing general self-efficacy and reducing symptoms of depression, anxiety, and stress among Mental Health clinicians in the context of COVID-19. Further research investigating the potential of utilizing the STEP intervention on a larger scale and with other populations is needed.

The Effect of Mobile Instant Messaging versus Face-to-Face Counseling on the Primiparous Mothers’ Breastfeeding Self-efficacy: A Pilot Randomized Controlled Trial

2020 ◽  
Author(s):  
Manoosh Mehrabi ◽  
Shoale Zarei ◽  
Leila Bazrafkan ◽  
Ali Reza Safarpour
Keyword(s):  
Randomized Controlled Trial ◽  
Self Efficacy ◽  
Instant Messaging ◽  
Controlled Trial ◽  
World Health ◽  
Face To Face ◽  
Randomized Controlled ◽  
The World ◽  
The Impact ◽  
Pilot Randomized Controlled Trial

Abstract Background Increasing breastfeeding rates around the world is one of the most important goals of the World Health Organization. Self-efficacy is a modifying and predictive factor for initiation and continuation of breastfeeding. This study was conducted to investigate the impact of mobile-based education and regular delivery of designed messages on breastfeeding self-efficacy in primiparous mothers. Methods This study was a double blind pilot randomized controlled trial, in which a hundred and twenty primiparous breastfeeding mothers were randomly allocated into two groups using permuted block randomization. The standard method conseling arm received routine counseling interventions and the intervention arm received a mobile instant messaging program in addition to the usual counseling. The main objective of this study was to compare self-efficacy in face-to-face counseling group and mobile instant messaging group. Self-efficacy levels were compared in the two groups before and after the study procedures. Results In this study, 60 mothers were studied in each group, and then the collected data were analyzed. The mean post-test scores in the intervention group (60.40 ± 4.92) and the control group (50.10 ± 7.60) were compared in the main analysis. The results indicated a statistically significant difference (p <0.001). Given the amount of effect size ( d= 0.99; 95% CI=1.19-2.02 ) it appears that there is a high level correlation between the applied intervention and level of self-efficacy among the study participants, especially those with higher levels of education. Secondary findings of the study involved evaluating the effects of education, occupation, family income, lactation duration and spouse support for breastfeeding self-efficacy. Except for the maternal education level, which had a significant relationship with the level of breastfeeding self-efficacy (p= 0.02), the other factors did not show any correlation with self-efficacy in breastfeeding. Conclusion The pilot study provided valuable information for feasibility assessment of randomized controlled trials in future studies with larger sample sizes and more participant diversity.

scholarly journals Video consultation as an adequate alternative to face-to-face consultations in CPAP use for patients with obstructive sleep apnea: a Randomized Controlled Trial. (Preprint)

2020 ◽  
Author(s):  
L. Kooij ◽  
P. J. E. Vos ◽  
A. Dijkstra ◽  
E. A. Roovers ◽  
W. H. van Harten
Keyword(s):  
Randomized Controlled Trial ◽  
Self Efficacy ◽  
Controlled Trial ◽  
Outcome Expectancies ◽  
Self Management ◽  
Face To Face ◽  
Randomized Controlled ◽  
Cognitive Components ◽  
Video Consultation ◽  
Over Time

BACKGROUND The effectiveness of Continuous Positive Airway Pressure (CPAP) is dependent on the degree of use, so adherence is essential. Cognitive components (e.g. self-efficacy) are found to be important in predicting CPAP use. Telemedicine interventions are increasingly used to support self-management in different chronic diseases. Especially video consultation is a promising way of supporting OSA patients, and may be beneficial during treatment. So far video consultation is seldom evaluated through thorough controlled research, with only a limited number of outcomes assessed. OBJECTIVE To evaluate the effects of video consultation versus face-to-face consultation for patients with OSA on patients’ CPAP use (minutes/per night), self-efficacy, risk outcomes, outcome expectancies, experiences with technology and, patients’ and professionals’ satisfaction. METHODS A Randomized Controlled Trial was conducted with an intervention- (video consultations) and a usual care group (face-to-face consultations) with CPAP use assessments after 4, 12 and 24 weeks. Patients with confirmed OSA (AHI > 15), requiring CPAP treatment, no history of CPAP treatment, having access to a tablet/smartphone and proficiency of the Dutch language were included in the study. Patients completed questionnaires at baseline and after one month on self-efficacy, risk perception, outcome expectancies (using Self-Efficacy Measure for Sleep Apnea), expectations and experiences with video consultations (covering constructs of the Unified Theory of Acceptance and Use of Technology) and satisfaction. RESULTS In both groups CPAP use decreased over time (P=.01) similarly. No significant difference in change over time (week 4, 12 and 24) between groups was found for CPAP use (P interaction term P=.54). Self-efficacy appeared to have a statistically significant effect on CPAP use in both groups (P=.001), regardless of the intervention arm (P=.27). Patients in both groups were satisfied with the consultations and rated these respectively with an 8.4 and 8.3. The experiences with video consultation were positive, e.g. it did not cost patients effort (92%), they reported to have skills to use it (95%) and they intended to keep using it (95%). All nurses were satisfied with the quality of the sound, video and privacy and security. However, they recommended to use video consultation only in follow-up. CONCLUSIONS To our knowledge, this is the first Randomized Controlled Trial that examined the effects of video consultation on CPAP use over time for newly diagnosed OSA patients in combination with cognitive components and technology acceptance. The findings of this research suggest that, for patients starting CPAP, video consultation can preferably be used in combination with an initial face-to-face consultation and especially for patients with high levels of self-efficacy. Future research should focus on blended care approaches in which self-management and especially self-efficacy is receiving greater emphasis.

scholarly journals A Cross-Provider Health Care Management Program for Musculoskeletal Disorders: Results of a Randomized Controlled Trial in 22 German Companies

2021 ◽  
Vol 18 (22) ◽  
pp. 11844
Author(s):  
Kyung-Eun (Anna) Choi ◽  
Lara Lindert ◽  
Lara Schlomann ◽  
Christina Samel ◽  
Martin Hellmich ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Case Management ◽  
Sick Leave ◽  
Musculoskeletal Disorders ◽  
Self Efficacy ◽  
Controlled Trial ◽  
Self Management ◽  
Randomized Controlled ◽  
Management Group

Musculoskeletal disorders (MSDs) are among the most common cause for reduced work capacity and sick leave. Workplace health promotion programs are often neither tailored to the workplace nor the individual needs of the employees. To counteract lacking intersectional care, this four-year randomized controlled trial (RCT) aimed to investigate the effects of modular coordinating case management (treatment group) compared to supported self-management (control group) on MSD specific sick leave days (routine data), workability (WAI), self-efficacy (self-efficacy scale), and pain (German pain questionnaire, GPQ). The study network comprised 22 companies, 15 company health insurance funds, and 12 pension funds in Germany. Overall, 852 participants (Module A/early intervention: n = 651, Module B/rehabilitation: n = 190, Module C/reintegration: n = 10) participated. Both groups achieved fewer sick leave days, higher workability, and less pain (p < 0.0001) at follow-up compared to baseline. At follow-up, the coordinating case management group showed fewer disability days (GPQ), lower disability scores (GPQ), and lower pain intensities (GPQ) than the supported self-management group (p < 0.05), but no superiority regarding MSD specific sick leave days, workability, nor self-efficacy. Module A showed more comprehensive differences. The accompanying process evaluation shows barriers and facilitators for the implementation of the program, especially in a RCT setting.

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