Effectiveness of a psychological online training to promote physical activity among students: protocol of a randomized-controlled trial

Abstract Background Many students in Germany do not meet recommended amounts of physical activity. In order to promote physical activity in students, web-based interventions are increasingly implemented. Yet, data on effectiveness of web-based interventions in university students is low. Our study aims at investigating a web-based intervention for students. The intervention is based on the Health Action Process Approach (HAPA), which discriminates between processes of intention formation (motivational processes) and processes of intention implementation (volitional processes). Primary outcome is change in physical activity; secondary outcomes are motivational and volitional variables as proposed by the HAPA as well as quality of life and depressive symptoms. Methods A two-armed randomized controlled trial (RCT) of parallel design is conducted. Participants are recruited via the internet platform StudiCare (www.studicare.com). After the baseline assessment (t1), participants are randomized to either intervention group (immediate access to web-based intervention) or control group (access only after follow-up assessment). Four weeks later, post-assessment (t2) is performed in both groups followed by a follow-up assessment (t3) 3 months later. Assessments take place online. Main outcome analyses will follow an intention-to-treat principle by including all randomized participants into the analyses. Outcomes will be analysed using a linear mixed model, assuming data are missing at random. The mixed model will include group, time, and the interaction of group and time as fixed effects and participant and university as random effect. Discussion This study is a high-quality RCT with three assessment points and intention-to-treat analysis meeting the state-of-the-art of effectiveness studies. Recruitment covers almost 20 universities in three countries, leading to high external validity. The results of this study will be of great relevance for student health campaigns, as they reflect the effectiveness of self-help interventions for young adults with regard to behaviour change as well as motivational and volitional determinants. From a lifespan perspective, it is important to help students find their way into regular physical activity. Trial registration The German clinical trials register (DRKS) DRKS00016889. Registered on 28 February 2019

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Guided web-based treatment program for reducing cannabis use: a randomized controlled trial

Addiction Science & Clinical Practice ◽

10.1186/s13722-020-00185-8 ◽

2020 ◽

Vol 15 (1) ◽

Cited By ~ 1

Author(s):

Kristina Sinadinovic ◽

Magnus Johansson ◽

Ann-Sofie Johansson ◽

Thomas Lundqvist ◽

Philip Lindner ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Treatment Program ◽

Controlled Trial ◽

Cannabis Use ◽

Control Group ◽

Web Based ◽

Randomized Controlled ◽

Intervention Adherence ◽

Group Effects

Abstract Background The aim of this study was to investigate the effects of a web-based treatment program with therapist guidance for adults and adolescents with regular cannabis use from the general population. Methods A double blinded randomized controlled trial with a parallel group design was conducted (intervention group n = 151, wait-list control group n = 152). Follow-up 12 weeks from treatment commencement of a 13-module intervention. The primary outcome was frequency of cannabis use. Time by group interaction effects were modeled using generalized estimated equations and the instrumental variable approach was used to estimate the effect of intervention adherence. Results At follow-up, the intention to treat (ITT) analyses did not show any significant time by group effects. A significant association between intervention adherence and scores on the cannabis abuse screening test (CAST) was found. Secondary analysis excluding participants who had received other professional help revealed time by group effects for secondary outcomes gram cannabis consumed past week, number of dependency criteria and CAST score. Due to methodological limitations, these latter results should be interpreted with caution. Conclusions In this study we did not find a web-based treatment program with therapist guidance to be more effective than a waiting-list in reducing frequency of cannabis use. Trial registration The trial was pre-registered at ClinicalTrials.gov (NCT02408640) April 3, 2015

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Impact of a Knowledge Translation Intervention on Physical Activity and Mobility in Older Adults (the Move4Age Study): Randomized Controlled Trial (Preprint)

10.2196/preprints.15125 ◽

2019 ◽

Author(s):

Sarah Neil-Sztramko ◽

Jenna Smith-Turchyn ◽

Julie Richardson ◽

Maureen Dobbins

Keyword(s):

Physical Activity ◽

Older Adults ◽

Randomized Controlled Trial ◽

Knowledge Translation ◽

Controlled Trial ◽

Rapid Assessment ◽

Control Group ◽

Self Rated Health ◽

Randomized Controlled

BACKGROUND The McMaster Optimal Aging Portal (the Portal) was launched in 2014 as a knowledge translation (KT) tool to increase access to evidence-based health information. OBJECTIVE The purpose of this study was to understand if and how dissemination of mobility information through the Portal impacts physical activity (PA) in older adults. METHODS In this randomized controlled trial, participants (n=510) were assigned to a 12-week mobility-focused KT intervention or self-serve control group. The intervention included weekly email alerts and a study-specific social media hashtag linking to mobility-focused Portal materials. The control group was able to access the Portal on their own but did not receive targeted KT strategies. Participants completed questionnaires (including the Rapid Assessment of Physical Activity to quantify PA) at baseline, end of the study, and 3-month follow-up. RESULTS Participants were predominantly female (430/510, 84.3%), mean age 64.7 years, with no baseline differences between groups. Over half (277/510, 54.3%) of the participants were classified as “active” at baseline. There was no significant between-group difference in the PA category. Overall, both groups increased their PA with improvements maintained at 3-month follow-up (<i>P</i><.001). In planned subgroup analyses, the KT intervention had a significant effect for those with poor or fair baseline self-rated health (<i>P</i>=.03). CONCLUSIONS No differences were found between those who received the targeted intervention and a control group with self-serve access to the Portal, except in subgroups with low self-rated health. Both groups did report increases in PA that were sustained beyond participation in a research study. Findings suggest that different KT strategies may be needed for different types of users, with more intense interventions being most impactful for certain groups (ie, those with lower self-rated health). CLINICALTRIAL ClinicalTrials.gov NCT02947230; https://clinicaltrials.gov/ct2/show/NCT02947230

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Impact of a Knowledge Translation Intervention on Physical Activity and Mobility in Older Adults (the Move4Age Study): Randomized Controlled Trial

Journal of Medical Internet Research ◽

10.2196/15125 ◽

2020 ◽

Vol 22 (2) ◽

pp. e15125

Author(s):

Sarah Neil-Sztramko ◽

Jenna Smith-Turchyn ◽

Julie Richardson ◽

Maureen Dobbins

Keyword(s):

Physical Activity ◽

Older Adults ◽

Randomized Controlled Trial ◽

Knowledge Translation ◽

Controlled Trial ◽

Rapid Assessment ◽

Control Group ◽

Self Rated Health ◽

Randomized Controlled

Background The McMaster Optimal Aging Portal (the Portal) was launched in 2014 as a knowledge translation (KT) tool to increase access to evidence-based health information. Objective The purpose of this study was to understand if and how dissemination of mobility information through the Portal impacts physical activity (PA) in older adults. Methods In this randomized controlled trial, participants (n=510) were assigned to a 12-week mobility-focused KT intervention or self-serve control group. The intervention included weekly email alerts and a study-specific social media hashtag linking to mobility-focused Portal materials. The control group was able to access the Portal on their own but did not receive targeted KT strategies. Participants completed questionnaires (including the Rapid Assessment of Physical Activity to quantify PA) at baseline, end of the study, and 3-month follow-up. Results Participants were predominantly female (430/510, 84.3%), mean age 64.7 years, with no baseline differences between groups. Over half (277/510, 54.3%) of the participants were classified as “active” at baseline. There was no significant between-group difference in the PA category. Overall, both groups increased their PA with improvements maintained at 3-month follow-up (P<.001). In planned subgroup analyses, the KT intervention had a significant effect for those with poor or fair baseline self-rated health (P=.03). Conclusions No differences were found between those who received the targeted intervention and a control group with self-serve access to the Portal, except in subgroups with low self-rated health. Both groups did report increases in PA that were sustained beyond participation in a research study. Findings suggest that different KT strategies may be needed for different types of users, with more intense interventions being most impactful for certain groups (ie, those with lower self-rated health). Trial Registration ClinicalTrials.gov NCT02947230; https://clinicaltrials.gov/ct2/show/NCT02947230

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A web-based personally controlled health management system increases sexually transmitted infection screening rates in young people: a randomized controlled trial

Journal of the American Medical Informatics Association ◽

10.1093/jamia/ocu052 ◽

2015 ◽

Vol 22 (4) ◽

pp. 805-814 ◽

Cited By ~ 11

Author(s):

Nathan J Mortimer ◽

Joel Rhee ◽

Rebecca Guy ◽

Andrew Hayen ◽

Annie Y S Lau

Keyword(s):

Randomized Controlled Trial ◽

Health Management ◽

Controlled Trial ◽

Control Group ◽

Sexually Active ◽

Web Based ◽

Sexually Transmitted ◽

Randomized Controlled ◽

Sti Testing

Abstract Objective To determine if a web-based personally controlled health management system (PCHMS) could increase the uptake of sexually transmitted infections (STI) screening among a young university population. Methods A non-blinded parallel-group randomized controlled trial was conducted. Participants aged 18–29 years were recruited from a university environment between April and August 2013, and randomized 1:1 to either the intervention group (immediate online PCHMS access) or control group (no PCHMS access). The study outcome was self-reported STI testing, measured by an online follow-up survey in October 2013. Results Of the 369 participants allocated to the PCHMS, 150 completed the follow-up survey, and of the 378 in the control group, 225 completed the follow-up survey. The proportion of the PCHMS group who underwent an STI test during the study period was 15.3% (23/150) compared with 7.6% (17/225) in the control group (P = .017). The difference in STI testing rates within the subgroup of sexually active participants (20.4% (23/113) of the PCHMS group compared with 9.6% (15/157) of the control group) was significantly higher (P = .027) than among non-sexually active participants. Discussion Access to the PCHMS was associated with a significant increase in participants undergoing STI testing. This is also the first study to demonstrate efficacy of a PCHMS targeting a health concern where susceptibility is generally perceived as low and the majority of infections are asymptomatic. Conclusion PCHMS interventions may provide an effective means of increasing the demand for STI testing which, combined with increased opportunistic testing by clinicians, could reduce the high and sustained rates of STIs in young people.

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Effect of accelerometer-based feedback on physical activity in hospitalized patients with ischemic stroke: a randomized controlled trial

Clinical Rehabilitation ◽

10.1177/0269215518755841 ◽

2018 ◽

Vol 32 (8) ◽

pp. 1047-1056 ◽

Cited By ~ 11

Author(s):

Masashi Kanai ◽

Kazuhiro P Izawa ◽

Miki Kobayashi ◽

Akira Onishi ◽

Hiroki Kubo ◽

...

Keyword(s):

Physical Activity ◽

Randomized Controlled Trial ◽

Ischemic Stroke ◽

Controlled Trial ◽

Intervention Group ◽

Hospitalized Patients ◽

Control Group ◽

Baseline Measurement ◽

Randomized Controlled

Objective: To evaluate the effect of accelerometer-based feedback on physical activity in hospitalized patients with ischemic stroke. Design: Randomized controlled trial. Setting: Acute care hospital. Subjects: A total of 55 patients with ischemic stroke who could walk without assistance were randomly assigned to the intervention group ( n = 27) or the control group ( n = 28). Interventions: At the baseline measurement, patients did not receive accelerometer-based feedback. At follow-up, a physical therapist provided instruction on accelerometer-based feedback, discussed physical activity targets and encouraged the patients to walk more until discharge. Main measures: The average daily number of steps taken was used as the index of daily hospitalized physical activity. Results: The study sample consisted of 48 patients, of whom 23 patients comprised the intervention group and 25 patients comprised the control group. Although there were no significant differences in physical activity values between the two groups at the baseline measurement, the values in the intervention group at follow-up were significantly higher than those in the control group (5180.5 ± 2314.9 vs. 3113.6 ± 1150.9 steps/day, P = 0.0003). The effect size of physical activity values (Cohen’s d = 1.15) at follow-up was large between the two groups. Conclusion: Exercise training combined with accelerometer-based feedback effectively increased physical activity in hospitalized patients with ischemic stroke.

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A Randomized Controlled Trial Evaluating a Pain Assessment and Management Program for Respite Workers Supporting Children With Disabilities Part One: Pain-Related Knowledge and Perceptions

American Journal on Intellectual and Developmental Disabilities ◽

10.1352/1944-7558-126.4.271 ◽

2021 ◽

Vol 126 (4) ◽

pp. 271-288 ◽

Cited By ~ 1

Author(s):

Lara M. Genik ◽

Elisabeth L. Aerts ◽

Paula C. Barata ◽

Chantel C. Barney ◽

Stephen P. Lewis ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Pain Assessment ◽

Controlled Trial ◽

Management Program ◽

Control Group ◽

Intention To Treat ◽

Randomized Controlled ◽

Parallel Group ◽

Pain Knowledge

Abstract This parallel group randomized controlled trial tested effectiveness of the Let's Talk About Pain training on respite workers' (RW) pain-related knowledge and feasibility-confidence-skill ratings using between-group and within-group analyses. Fourteen children's respite organizations were randomized to pain or control training. Participants (nintervention = 66; ncontrol = 92) underwent a 3–3.5 hour training and completed measures at pre-, post-, and 4–6 week follow-up. Intention-to-treat (nintervention = 65; ncontrol = 92) and per-protocol (nintervention = 26–38; ncontrol = 40–57) analyses were conducted. Pain training participants demonstrated significantly higher pain knowledge and feasibility-confidence-skill ratings post-follow-up versus control group and significant increases in knowledge from pre-post. Significant gains were maintained from post-follow-up. Results represent a promising step towards enhancing pain-related care for children with IDD.

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Treating panic on the go: Results of a randomized controlled trial evaluating a hybrid online training for panic disorder and agoraphobia (Preprint)

10.2196/preprints.20829 ◽

2020 ◽

Author(s):

Lara Ebenfeld ◽

Dirk Lehr ◽

David Daniel Ebert ◽

Stefan Kleine Stegemann ◽

Heleen Riper ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Panic Disorder ◽

Controlled Trial ◽

Intervention Group ◽

Online Training ◽

Control Group ◽

Web Based ◽

Intention To Treat ◽

Randomized Controlled ◽

Panic Symptoms

BACKGROUND Previous studies provide evidence for the effectiveness of web-based interventions for panic disorder with and without agoraphobia (PD). Smartphone-based technologies hold significant potential for further enhancing accessibility and efficacy of such interventions. OBJECTIVE The aim of the present randomized controlled trial (RCT) was to evaluate the efficacy of a guided hybrid online training based on cognitive behavior therapy for adults suffering from PD symptoms. METHODS Participants (N=92) with total scores in the Panic- and Agoraphobia Scale (PAS) ranging from 9 to 28 were recruited from the general population and allocated either to a hybrid intervention (GET.ON Panic) or to a wait-list control group (WLC). The primary outcome was the reduction of panic symptoms as self-assessed with a web-based version of the PAS. RESULTS ANCOVA-based intention-to-treat analyses revealed a significantly stronger decrease in panic symptoms (F=9.77, p<0.01; d=0.66; 95% CI 0.24-1.08) in the intervention group compared with the WLC group at post-treatment. Comparisons between groups at the follow-up measures at 3 and 6 months yielded even stronger effects (3M-FU: F=17.40, p<0.001; d=0.89; 95% CI 0.46-1.31; 6M-FU: F=14.63, p<0.001; d=0.81; 95% CI 0.38-1.24). CONCLUSIONS Hybrid online trainings may help reduce symptoms of PD and hence play an important part in improving health care for patients suffering from this debilitating disorder. CLINICALTRIAL German Clinical Trial Register DRKS00005223 INTERNATIONAL REGISTERED REPORT RR2-10.1186/1745-6215-15-427

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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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Investigating the Impact of Cognitive Training for Individuals With Bothersome Tinnitus: A Randomized Controlled Trial

Otolaryngology ◽

10.1177/0194599821994742 ◽

2021 ◽

pp. 019459982199474

Author(s):

Maggie Xing ◽

Dorina Kallogjeri ◽

Jay F. Piccirillo

Keyword(s):

Randomized Controlled Trial ◽

Cognitive Training ◽

Mixed Model ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Functional Index ◽

Open Label ◽

Randomized Controlled ◽

The Impact

Objective To evaluate the effectiveness of cognitive training in improving tinnitus bother and to identify predictors of patient response. Study Design Prospective open-label randomized controlled trial. Setting Online. Methods Participants were adults with subjective idiopathic nonpulsatile tinnitus causing significant tinnitus-related distress. The intervention group trained by using auditory-intensive exercises for 20 minutes per day, 5 days per week, for 8 weeks. The active control group trained on the same schedule with non–auditory intensive games. Surveys were completed at baseline, 8 weeks, and 12 weeks. Results A total of 64 participants completed the study. The median age was 63 years (range, 25-69) in the intervention group and 61 years (34-68) in the control group. Mixed model analysis revealed that within-subject change in Tinnitus Functional Index in the intervention group was not different than the control group, with marginal mean differences (95% CI): 0.24 (–11.20 to 10.7) and 2.17 (–8.50 to 12.83) at 8 weeks and 2.33 (–8.6 to 13.3) and 3.36 (–7.91 to 14.6) at 12 weeks, respectively. When the 2 study groups were compared, the control group had higher Tinnitus Functional Index scores than the intervention group by 10.5 points at baseline (95% CI, –0.92 to 29.89), 8.1 at 8 weeks (95% CI, –3.27 to 19.42), and 9.4 at 12 weeks (95% CI, –2.45 to 21.34). Conclusion Auditory-intensive cognitive training was not associated with changes in self-reported tinnitus bother. Given the potential for neuroplasticity to affect tinnitus, we believe that future studies on cognitive training for tinnitus remain relevant.

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Frequency of repositioning for preventing pressure ulcers in patients hospitalized in ICU: protocol of a cluster randomized controlled trial

BMC Nursing ◽

10.1186/s12912-021-00616-0 ◽

2021 ◽

Vol 20 (1) ◽

Author(s):

Olga L. Cortés ◽

Mauricio Herrera-Galindo ◽

Juan Carlos Villar ◽

Yudi A. Rojas ◽

María del Pilar Paipa ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Critical Care ◽

Pressure Ulcers ◽

Controlled Trial ◽

Cluster Randomized Controlled Trial ◽

Control Group ◽

Randomized Controlled ◽

Link Type ◽

Cluster Randomized ◽

The Impact

Abstract Background Despite being considered preventable, ulcers due to pressure affect between 30 and 50% of patients at high and very high risk and susceptibility, especially those hospitalized under critical care. Despite a lack of evidence over the efficacy in prevention against ulcers due to pressure, hourly repositioning in critical care as an intervention is used with more or less frequency to alleviate pressure on patients’ tissues. This brings up the objective of our study, which is to evaluate the efficacy in prevention of ulcers due to pressure acquired during hospitalization, specifically regarding two frequency levels of repositioning or manual posture switching in adults hospitalized in different intensive care units in different Colombian hospitals. Methods A nurse-applied cluster randomized controlled trial of parallel groups (two branches), in which 22 eligible ICUs (each consisting of 150 patients), will be randomized to a high-frequency level repositioning intervention or to a conventional care (control group). Patients will be followed until their exit from each cluster. The primary result of this study is originated by regarding pressure ulcers using clusters (number of first ulcers per patient, at the early stage of progression, first one acquired after admission for 1000 days). The secondary results include evaluating the risk index on the patients’ level (Hazard ratio, 95% IC) and a description of repositioning complications. Two interim analyses will be performed through the course of this study. A statistical difference between the groups < 0.05 in the main outcome, the progression of ulcers due to pressure (best or worst outcome in the experimental group), will determine whether the study should be put to a halt/determine the termination of the study. Conclusion This study is innovative in its use of clusters to advance knowledge of the impact of repositioning as a prevention strategy against the appearance of ulcers caused by pressure in critical care patients. The resulting recommendations of this study can be used for future clinical practice guidelines in prevention and safety for patients at risk. Trial registration PENFUP phase-2 was Registered in Clinicaltrials.gov (NCT04604665) in October 2020.

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