scholarly journals Usage and Weekly Attrition in a Smartphone-Based Health Behavior Intervention for Adolescents: Pilot Randomized Controlled Trial

10.2196/21432 ◽  
2021 ◽  
Vol 5 (2) ◽  
pp. e21432
Author(s):  
Erlendur Egilsson ◽  
Ragnar Bjarnason ◽  
Urdur Njardvik
Keyword(s):  
Mental Health ◽  
Health Behavior ◽  
Outcome Measures ◽  
Self Efficacy ◽  
Secondary Outcome ◽  
Specific Information ◽  
Attrition Rates ◽  
Mhealth Intervention ◽  
Randomized Controlled ◽  
Time Specific

Background The majority of adolescents own smartphones, although only 8% of them use health apps. Attrition rates from adolescent mobile health (mHealth) interventions for treating mental health problems such as anxiety and depression are an issue with a high degree of variation. Attrition in mHealth interventions targeting adolescent populations is frequently presented in a two-point fashion, from initiation of the intervention to the end of treatment, lacking more time-specific information on usage and times of attrition. Self-efficacy could provide an avenue to lower attrition rates, although a better understanding of the relationship between mental health factors and time-specific attrition rates is needed. Objective The aims of this study were to obtain time-specific attrition rates among adolescents in an mHealth intervention, and to describe the intervention’s usage and feasibility in relation to adolescent self-efficacy levels, and emotional and physical health. Methods A single-center randomized controlled public school pilot trial was undertaken with 41 adolescents. Outcome measures were assessed at baseline and after 6 weeks, while in-app activity and attrition rates were continually assessed throughout the intervention period. The primary outcome was attrition based on time and type of in-app health behavior usage, and feasibility of the mHealth app. Secondary outcome measures were self-efficacy levels, depressive and anxiety symptoms, as well as standardized BMI and sleep. Analyses of group mean variances with adjusted α levels through Bonferroni corrections were used to assess main outcome effects. Results The attrition from initiation of the intervention to 6-week follow up was 35%. Attrition started in the third week of the intervention and was related to daily time of app usage (Rt=0.43, P<.001). The number of average weekly in-app health exercises completed decreased significantly from the first week of the intervention (mean 55.25, SD 10.96) to the next week (mean 13.63, SD 2.94). However, usage increased by 22% between week 2 and the last week of the intervention (mean 16.69, SD 8.37). Usability measures revealed satisfactory scores (mean 78.09, SD 9.82) without gender differences (P=.85). Self-reported daily physical activity increased by 19.61% in the intervention group but dropped by 26.21% among controls. Self-efficacy levels increased by 8.23% in the invention arm compared to a 3.03% decrease in the control group. Conclusions This pilot study demonstrated the feasibility and usability of an mHealth intervention among adolescent participants. Indications were toward beneficial effects on physical and mental health that warrant further research. Focus on time-specific attrition measures alongside daily times of usage and ways to increase participants’ self-efficacy levels appear to be a promising avenue for research on mHealth interventions for adolescent populations with the aim to ultimately lower attrition rates.

scholarly journals Usage and weekly attrition from a smartphone based health behaviour intervention for adolescents: Pilot study (Preprint)

2020 ◽  
Author(s):  
Erlendur Egilsson ◽  
Ragnar Bjarnason ◽  
Urdur Njardvik
Keyword(s):  
Mental Health ◽  
Pilot Study ◽  
Outcome Measures ◽  
Health Behaviour ◽  
Self Efficacy ◽  
Secondary Outcome ◽  
Specific Information ◽  
Attrition Rates ◽  
Mhealth Intervention ◽  
Time Specific

BACKGROUND Majority of adolescents own smartphones though only 8% of them use health apps. Attrition rates from adolescent mHealth interventions treating mental health problems, such as anxiety and depression, are an issue with high degree of variation and attrition rates. Attrition in mHealth interventions targeting adolescent populations is frequently presented in two-point fashion, from initiation of intervention to end of treatment, lacking more time-specific information on usage and times of attrition. Self-efficacy could provide avenue to lower attrition rates though a better understanding of the relationship between mental health factors and time specific attrition rates is needed. OBJECTIVE The study aimed at obtaining time-specific attrition rates among adolescents in an mHealth intervention and describe the intervention’s usage and feasibility in relation to adolescent self-efficacy levels, emotional- and physical health. METHODS A single-centre, randomized controlled elementary school pilot trial was undertaken with 41 adolescents. Outcome measures were assessed at baseline and after 6-weeks while in-app activity and attrition rates were continually assessed throughout intervention period. Primary outcome was attrition based on time and type of in-app health behaviour usage and feasibility of mHealth app. Secondary outcome measures were self-efficacy levels, depressive- and anxiety symptoms as well as BMI-SDS and sleep. Analyses of group mean variances with adjusted alpha levels through Bonferroni corrections were used to assess main outcome effects. RESULTS Attrition from initiation of intervention to 6-weeks follow-up was 35%. Attrition started in 3rd week of intervention and was related to daily time of app usage (Rt = 0.43, p <.05.). Average weekly in-app health exercises decreased significantly from 1st week of intervention (M = 55.25, SD = 10.96) to the next (M = 13.63, SD = 2.94). However, usage increased by 22% between week 2 and last week of intervention (M = 16.69, SD = 8.37). Usability measures revealed satisfactory scores or 78.09 (SD = 9.82) without gender differences (P=.85). Self-reported daily physical activity increased by 19.61% in intervention group while dropping by 26.21% among controls. Self-efficacy levels were increased by 8.23% in invention arm compared to 3.03% decrease in control group. CONCLUSIONS This pilot study demonstrated the feasibility and usability of a mHealth intervention among adolescent participants. Indications were towards beneficial effects on physical and mental health that warrant further research. Focus on time-specific attrition measures alongside daily times of usage and ways to increase participants’ self-efficacy levels appear to be a promising avenue for research on mHealth interventions for adolescent populations with the aim to ultimately lower attrition rates. CLINICALTRIAL

scholarly journals COMmunity PARticipation through Education (COMPARE): effectiveness of supported education for students with mental health problems, a mixed methods study – study protocol for a randomized controlled trial

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Jacomijn Hofstra ◽  
Jorien van der Velde ◽  
Petra Jannette Havinga ◽  
Lies Korevaar
Keyword(s):  
Mental Health ◽  
Randomized Controlled Trial ◽  
Mixed Methods ◽  
Mental Health Problems ◽  
Controlled Trial ◽  
Health Problems ◽  
Secondary Outcome ◽  
Study Success ◽  
Randomized Controlled ◽  
Supported Education

Abstract Background The onset of mental health problems generally occurs between the ages of 16 and 23 – the years in which young people follow post-secondary education, which is a major channel in our society to prepare for a career and enhance life goals. Several studies have shown that students with mental health problems have a higher chance of early school leaving. Supported Education services have been developed to support students with mental health problems to remain at school. The current project aims to study the effect of an individually tailored Supported Education intervention on remaining at school, study success, and satisfaction of students with mental health problems studying at an institute for intermediate vocational education and a university of applied sciences in the Netherlands. Methods/design The design combines quantitative research (Randomized Controlled Trial; RCT) with qualitative research (monitoring, interviews, focus groups). One hundred students with mental health problems recruited from the two educational institutes will be randomly allocated to either the intervention or control condition. The students in the intervention condition receive the Supported Education intervention given by a Supported Education specialist, the students in the active control condition receive support as usual plus advice from a trained staff member on potential supportive resources regarding studying with mental health problems. The primary outcome ‘remaining at school’, and the secondary outcome ‘study success’ will be determined using data from the school’s administration. The secondary outcome ‘student satisfaction’ and other variables that will be studied in a more exploratory way, such as self-efficacy and study skills, will be determined through online questionnaires at baseline, at 6 and at 12 months follow-up. Focus groups and interviews with the students and Supported Education specialists will be carried out to complement the trial. Discussion This RCT is the first to assess the effect of Supported Education on remaining at school, next to study success and student satisfaction among students with mental health problems. The use of a mixed-methods design will result in a thorough evaluation of the effect of the intervention. Issues regarding the influx and possible attrition of students in the follow-up are discussed. Trial registration The study was registered with Trialregister.nl, no. NL8349, date registered: February 4th 2020. Register name: Community participation through education. Effectiveness of Supported Education for youth with mental health problems, a mixed methods study – Study protocol for a Randomized Controlled Trial. Protocol Version: 3, date: May 28th, 2021.

scholarly journals PREWARMING FOR PREVENTION OF PERIOPERATIVE HYPOTHERMIA IN PATIENTS WITH COMBINED EPIDURAL AND GENERAL ANESTHESIA: A RANDOMIZED CONTROLLED TRIAL

2021 ◽  
Author(s):  
Dang Tinh Pham ◽  
Thi Ngoc Le ◽  
Ton Ngoc Vu Phan ◽  
Parshal Bhandari ◽  
Sairah Zia ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
General Anesthesia ◽  
Outcome Measures ◽  
Medical Center ◽  
Controlled Trial ◽  
Secondary Outcome ◽  
Perioperative Hypothermia ◽  
Randomized Controlled ◽  
Physical Status Classification ◽  
American Society

OBJECTIVE The aim of this study was to access the influence of active warming after epidural anesthesia (EDA) and before general anesthesia in prevention of perioperative hypothermia. METHOD This randomized controlled trial was conducted in the department of anesthesiology in university medical center of Ho Chi Minh city, Vietnam from December 2019 until April 2020. This trial included 60 adult patients who were scheduled for major abdominal surgery with a duration of at least 120 minutes and under combined general anesthesia and EDA. Patients were excluded if age was below 18 years, American Society Anesthesiologists’ physical status classification of IV or higher, or refusal of EDA. Written informed consent was obtained for all patients. Patients were divided randomly into two groups. The first group received 10 minutes of active air-forced warming after EDA before the induction of general anesthesia. The second group was covered with a blanket 10 minutes after EDA and before general anesthesia. Core temperatures were recorded throughout the study. The primary outcome measures were the incidence of perioperative hypothermia and the degree of hypothermia. The secondary outcome measures were rate and time for body temperature to return to normal and incidence of postoperative body shivering. RESULTS Without active warming (n = 21), 70% of patients became hypothermic (<36°C) postoperatively. Active air-forced warming for 10 minutes after EDA and before induction of general anesthesia decreased the incidence of postoperative hypothermia to 26.7% (n = 8). CONCLUSION Active air-forced warming for 10 minutes after EDA and before induction of general anesthesia is efficient in reducing the incidence of perioperative hypothermia.

Westeinde Sciatica Trial: randomized controlled study of bed rest and physiotherapy for acute sciatica

2002 ◽  
Vol 96 (1) ◽  
pp. 45-49 ◽  
Author(s):  
Derk J. Hofstee ◽  
Johanna M. M. Gijtenbeek ◽  
Peter H. Hoogland ◽  
Hans C. van Houwelingen ◽  
Alfred Kloet ◽  
...  
Keyword(s):  
Surgical Treatment ◽  
Outcome Measures ◽  
Bed Rest ◽  
Control Treatment ◽  
Secondary Outcome ◽  
Content Type ◽  
Randomized Controlled ◽  
And Control ◽  
Acute Sciatica ◽  
Fine Print

Object. The authors conducted a study to compare the efficacies of three nonsurgical treatment strategies in patients with sciatica. Their hypothesis was that bed rest, physiotherapy, and continuation of activities of daily living (ADLs) (control treatment) are each of equivalent efficacy. Methods. This randomized controlled trial was designed for comparison of bed rest, physiotherapy, and continuation of ADLs. The setting was an outpatient clinic. General practitioners were asked to refer patients for treatment as soon as possible. The authors enrolled 250 patients (< 60 years of age) with sciatica of less than 1-month's duration and who had not yet been treated with bed rest or physiotherapy. Primary outcome measures were radicular pain (based on a visual analog pain scale [VAPS]) and hampered ADLs (Quebec Disability Scale [QDS]). Secondary outcome measures were the rates of treatment-related failure and surgical treatment. Measures were assessed at baseline and during follow up at 1, 2, and 6 months. Mean differences in VAPS and QDS scores between bed rest and control treatment were 2.5 (95% confidence interval [CI] −6.4 to 11.4) and −4.8 (95% CI −10.6 to 0.9) at 1 month and 0.9 (95% CI −8.7 to 10.4) and −2.7 (95% CI −9.9 to 4.4) at 2 months, respectively. The respective differences between physiotherapy and control treatment were 0.8 (95% CI −8.2 to 9.8) and −0.5 (95% CI −6.3 to 5.3) at 1 month and −0.3 (95% CI −9.4 to 10) and 0.0 (95% CI −7.2 to 7.3) at 2 months. The respective odds ratios for treatment failure and surgical treatment of bed rest compared with control treatment were 1.6 (95% CI 0.8–3.5) and 1.5 (95% CI 0.7–3.6) at 6 months. When physiotherapy was compared with control treatment, these ratios were 1.5 (95% CI 0.7–3.2) and 1.2 (95% CI 0.5–2.9) at 6 months, respectively. Conclusions. Bed rest and physiotherapy are not more effective in acute sciatica than continuation of ADLs.

scholarly journals Physical Activity With Tailored mHealth Support for Individuals With Intellectual Disabilities: Protocol for a Randomized Controlled Trial (Preprint)

2020 ◽  
Author(s):  
Henriette Michalsen ◽  
Silje Camilla Wangberg ◽  
Gunnar Hartvigsen ◽  
Letizia Jaccheri ◽  
Miroslav Muzny ◽  
...  
Keyword(s):  
Physical Activity ◽  
Social Support ◽  
Intellectual Disabilities ◽  
Self Efficacy ◽  
Standard Care ◽  
Goal Attainment ◽  
Care Staff ◽  
Secondary Outcome ◽  
Randomized Controlled ◽  
Individuals With Intellectual Disabilities

BACKGROUND Individuals with intellectual disabilities (IDs) have lower levels of physical activity (PA) and greater barriers for participation in fitness activities compared with members of the general population. As increased PA has positive effects on cardiovascular and psychosocial health, it is exceedingly important to identify effective interventions for use in everyday settings. Mobile health (mHealth) methods such as motion sensor games (exergames) and smartphone reminders for PA have been explored and found to be promising in individuals with IDs. OBJECTIVE The purpose of this study is to examine the effectiveness of an individually tailored PA program with motivational mHealth support on daily levels of PA in youth and adults with IDs. METHODS The trial uses a randomized controlled design comprising 30 intervention participants and 30 control group participants, aged 16 to 60 years, with sedentary lifestyles or low PA levels. While the controls will receive standard care, the intervention aims to increase the level of PA, measured as steps per day, as the primary outcome. Secondary outcome variables are body mass index, blood pressure, physical performance, social support for PA, self-efficacy in a PA setting, behavior problems, and goal attainment. The intervention involves the delivery of tailored mHealth support, using smartphones or tablets to create structure with focus on the communicative abilities of individual participants. Rewards and feedback are provided in order to motivate individuals to increase participation in PA. Participants in the intervention group, their close relatives, and care staff will be invited to participate in a preintervention goal-setting meeting, where goal attainment scaling will be used to select the participants’ PA goals for the intervention period. All participants will be assessed at baseline, at 3 months, and at 6 months. RESULTS Enrollment was planned to start in April 2020 but will be delayed due to the pandemic situation. The main contribution of this paper is a detailed plan to run our study, which will produce new knowledge about tailored mHealth to support PA in individuals with intellectual disabilities. CONCLUSIONS We expect the new intervention to perform better than standard care in terms of improved PA, improved self-efficacy, and social support for activities. Technology offers new opportunities to promote healthy behaviors. The results of the study will determine the effectiveness and sustainability of a tailored mHealth support intervention to increase PA in youth and adults with IDs. CLINICALTRIAL ClinicalTrials.gov NCT04079439; https://clinicaltrials.gov/ct2/show/NCT04079439 INTERNATIONAL REGISTERED REPORT PRR1-10.2196/19213

scholarly journals The Efficacy and Safety of Acupuncture for Prophylaxis of Vestibular Migraine: A Study Protocol for a Randomized Controlled Trial

2021 ◽  
Vol 12 ◽  
Author(s):  
Tianye Hu ◽  
Hantong Hu ◽  
Feng Chen ◽  
Bin Jiang ◽  
Fengfei Shen ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Clinical Trial ◽  
Outcome Measures ◽  
Vestibular Migraine ◽  
Secondary Outcome ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Efficacy And Safety ◽  
Randomized Controlled

Introduction: With a high incidence rate and low diagnosis rate, vestibular migraine (VM) can seriously affect the quality of life of patients, but it remains difficult to manage by current treatment options. Acupuncture may be a potential treatment option for VM prophylaxis, but the currently available evidence is still uncertain. Therefore, this trial aims to evaluate the efficacy and safety of acupuncture for VM prophylaxis.Methods: This is a 28-week parallel, randomized, controlled clinical trial including 4 weeks of baseline, 8 weeks of treatment, and 16 weeks of follow-up. A total of 72 participants will be randomly assigned to two groups. The participants will receive acupuncture in the experimental group, while the participants in the control group will be treated with venlafaxine. The primary outcome measures are change in vertigo/migraine days and vertigo/migraine attacks, vertigo severity, and migraine intensity per 4 weeks from baseline. The secondary outcome measures are change in doses of rescue medication, anxiety level, depression level, and quality of life per 4 weeks from baseline. Adverse events will be recorded for safety evaluation.Discussion: This study will investigate the efficacy and safety of acupuncture for VM prophylaxis. The results will contribute to determining whether acupuncture can serve as an optional treatment strategy for treating VM.Clinical Trial Registration:www.ClinicalTrials.gov, identifier: NCT0464088.

scholarly journals Evaluating the CARE4Carer Blended Care Intervention for Partners of Patients With Acquired Brain Injury: Protocol for a Randomized Controlled Trial (Preprint)

2017 ◽  
Author(s):  
Vincent CM Cox ◽  
Vera PM Schepers ◽  
Marjolijn Ketelaar ◽  
Caroline M van Heugten ◽  
Johanna MA Visser-Meily
Keyword(s):  
Randomized Controlled Trial ◽  
Brain Injury ◽  
Outcome Measures ◽  
Controlled Trial ◽  
Acquired Brain Injury ◽  
Secondary Outcome ◽  
Face To Face ◽  
Randomized Controlled ◽  
Care Intervention ◽  
Blended Care

BACKGROUND Support programs for partners of patients with acquired brain injury are necessary since these partners experience several unfavorable consequences of caregiving, such as a high burden, emotional distress, and poor quality of life. Evidence-based support strategies that can be included in these support programs are psychoeducation, skill building, problem solving, and improving feelings of mastery. A promising approach would seem to be to combine web-based support with face-to-face consultations, creating a blended care intervention. OBJECTIVE This paper outlines the protocol of a randomized controlled trial to evaluate the CARE4Carer blended care intervention for partners of patients with acquired brain injury. METHODS A multicenter two-arm randomized controlled trial will be conducted. A total of 120 partners of patients with acquired brain injury will be recruited from five rehabilitation centers in the Netherlands. The blended care intervention consists of a nine-session web-based support program and two face-to-face consultations with a social worker. Themes that will be addressed are: giving partners insight into their own situation, including possible pitfalls and strengths, learning how to cope with the situation, getting a grip on thoughts and feelings, finding a better balance in the care for the patient with acquired brain injury, thinking about other possible care options, taking care of oneself, and communication. The intervention lasts 20 weeks and the control group will receive usual care. The outcome measures will be assessed at baseline and at 24- and 40-week follow-up. The primary outcome is caregiver mastery. Secondary outcome measures are strain, burden, family functioning, emotional functioning, coping, quality of life, participation, and social network. RESULTS The effect of the intervention on the primary and secondary outcome measures will be determined. Additional a process evaluation will be conducted. CONCLUSIONS The findings of this study will be used to improve the care for partners of patients with acquired brain injury. Barriers and facilitators that emerge from the process evaluation will be used in the nationwide implementation of the intervention. CLINICALTRIAL Dutch Trial Register NTR6197; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=6197 (Archived by WebCite at http://www.webcitation.org/6xHBAxx0y)

scholarly journals Effects of an attachment-based parent intervention on mothers of children with autism spectrum disorder: preliminary findings from a non-randomized controlled trial

2021 ◽  
Vol 15 (1) ◽  
Author(s):  
Nobuyo Kubo ◽  
Megumi Kitagawa ◽  
Sayaka Iwamoto ◽  
Toshifumi Kishimoto
Keyword(s):  
Mental Health ◽  
Randomized Controlled Trial ◽  
Self Efficacy ◽  
Controlled Trial ◽  
Intervention Group ◽  
Children With Autism ◽  
Autism Spectrum ◽  
Control Group ◽  
Randomized Controlled ◽  
Children With Asd

Abstract Background Caregivers of children with autism spectrum disorders (ASD) often experience difficulties in responding appropriately to the needs of those children, who typically express attachment in distinct and nonconventional ways. This highlights the need for an attachment-based approach targeted at caregivers of children with ASD. Circle of Security Parenting (COSP), an attachment-based parenting program, is designed to increase caregivers’ sensitivity to children’s attachment needs. The aim of this study was to provide verification of the effectiveness of COSP in mothers of children with ASD. Methods This study was a non-randomized controlled trial. Sixty mothers of children with ASD aged 4–12 were recruited. Twenty mothers received the COSP intervention, while 40 did not. The characteristics of children in the control group were matched with those of the intervention group. To evaluate the outcomes of the intervention, changes in parental self-efficacy and mental health were assessed using the Tool to Measure Parenting Self-Efficacy (TOPSE) and the General Health Questionnaire-30 (GHQ-30). The children’s improvement in emotional and behavioral problems was assessed from the mothers’ perspective using the Child Behavior Checklist (CBCL). Both groups completed the assessments in parallel. Evaluations were compared between baseline (T1) and 6-month follow-up (T2). Results Scores for self-efficacy and mental health of mothers and behavior of children were significantly improved from T1 to T2 in the intervention group, but not in the control group. Participants’ mental health was markedly worsened in the control group. Conclusion This study demonstrated that the COSP program for mothers of children with ASD improved their parental self-efficacy and mental health, and reduced their subjective sense of difficulties related to their children’s behaviors. Our findings support the effectiveness of the attachment-based program for mothers of children with ASD, providing the groundwork for further studies of the attachment-based intervention for children with ASD and their families. Future studies with larger samples and randomization are also needed for direct evaluation of the improvement of children's attachment security, and for exploration of the synergistic relationship between various family support strategies and COSP. Trial Registration This trial was registered with the University Hospital Medical Information Network Clinical Trial Registry (No. UMIN000039574)

scholarly journals Screening for burn-out in Australian medical students undertaking a rural clinical placement

BMJ Open ◽  
2019 ◽  
Vol 9 (7) ◽  
pp. e029029 ◽  
Author(s):  
Vivian Isaac ◽  
Craig S McLachlan ◽  
Lucie Walters ◽  
Jennene Greenhill
Keyword(s):  
Medical Student ◽  
Medical Students ◽  
Social Isolation ◽  
Outcome Measures ◽  
Self Efficacy ◽  
Rural Practice ◽  
Clinical Placement ◽  
Secondary Outcome ◽  
Factors Associated ◽  
Burn Out

ObjectiveTo investigate Australian medical student burn-out during rural clinical placement. Second, to examine the association between perceived burn-out and rural career intent at the time of finishing their rural placement.Design, settings and participantsThe 2016 Federation of Rural Australian Medical Educators evaluation survey is a cross-sectional study of medical students from 17 Australian universities. Specifically, those medical students who completed a full academic year or more at a Rural Clinical School (RCS). Responses from 638 medical students from regional Australia were analysed in the study of all eligible 756 medical students (response rate 84.3%).Primary and secondary outcome measuresThe primary objective was to determine self-reported burn-out (emotional exhaustion) in rural placements for medical students. Secondary outcome measures were designed to explore interactions with rural practice self-efficacy and rural intentions. Logistic regression models explored factors associated with burn-out.Results26.5% of students reported experiencing burn-out during a rural placement. Factors associated with burn-out were female gender, rural origin, low preference for RCS, stress in the year prior to a rural clinical placement, perceived social isolation during rural placement and lower rural practice self-efficacy. Burn-out was not associated with rural career intentions. Social isolation and low rural self-efficacy were independently associated with burn-out during rural placement and together explained 10% of variance in burn-out (Model Nagelkerke R2=0.23).ConclusionBurn-out during rural placement may be a consequence of stress prior to a medical school placement. Social isolation and rural self-efficacy are amendable factors to mitigate medical student burn-out during rural placements.

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