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

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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Effect of physician prescribed information on hospital readmission and death after discharge among patients with health failure: A randomized controlled trial

Health Informatics Journal ◽

10.1177/1460458221996409 ◽

2021 ◽

Vol 27 (1) ◽

pp. 146045822199640

Author(s):

Faranak Kazemi Majd ◽

Vahideh Zarea Gavgani ◽

Ali Golmohammadi ◽

Ali Jafari-Khounigh

Keyword(s):

Randomized Controlled Trial ◽

Hospital Readmission ◽

Medical Information ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Randomized Controlled ◽

Long Term Follow Up ◽

Oral Information

In order to understand if a physician prescribed medical information changes, the number of hospital readmission, and death among the heart failure patients. A 12-month randomized controlled trial was conducted (December 2013–2014). Totally, 120 patients were randomly allocated into two groups of intervention ( n = 60) and control ( n = 60). Accordingly, the control group was given the routine oral information by the nurse or physician, and the intervention group received the Information Prescription (IP) prescribed by the physician as well as the routine oral information. The data was collected via telephone interviews with the follow-up intervals of 6 and 12 months, and also for 1 year after the discharge. The patients with the median age of (IQR) 69.5 years old (19.8) death upon adjusting a Cox survival model, [RR = 0.67, 95%CI: 0.46–0.97]. Few patients died during 1 year in the intervention group compared to the controls (7 vs 15) [RR = 0.47, 95%CI: 0.20–1.06]. During a period of 6-month follow-up there was not statistically significant on death and readmission between two groups. Physician prescribed information was clinically and statistically effective on the reduction of death and hospital readmission rates among the HF patients in long term follow-up.

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

Trials ◽

10.1186/s13063-021-05333-2 ◽

2021 ◽

Vol 22 (1) ◽

Author(s):

Lena Violetta Krämer ◽

Nadine Eschrig ◽

Lena Keinhorst ◽

Luisa Schöchlin ◽

Lisa Stephan ◽

...

Keyword(s):

Physical Activity ◽

Randomized Controlled Trial ◽

Mixed Model ◽

Controlled Trial ◽

Control Group ◽

Web Based ◽

Intention To Treat ◽

Randomized Controlled ◽

Link Type

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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Effects of individualized follow-up with a smartphone-application after cardiac rehabilitation: protocol of a randomized controlled trial

BMC Sports Science Medicine and Rehabilitation ◽

10.1186/s13102-019-0148-2 ◽

2019 ◽

Vol 11 (1) ◽

Cited By ~ 2

Author(s):

Pernille Lunde ◽

Asta Bye ◽

Astrid Bergland ◽

Birgitta Blakstad Nilsson

Keyword(s):

Randomized Controlled Trial ◽

Cardiac Rehabilitation ◽

Controlled Trial ◽

Intervention Group ◽

Smartphone Application ◽

Control Group ◽

Power Calculation ◽

Large Sample Size ◽

Randomized Controlled

Abstract Background Cardiac rehabilitation (CR) programs are evidence-based and widely recommended. However, benefits from CR are likely lost among individuals who discontinue their regular exercise routines and healthy habits. One possible approach to enhance adherence to lifestyle advice after completion of CR, may be individualized follow-up enabled by a smartphone application (app). Methods A protocol of a single-blinded, pragmatic randomized controlled trial. The study will take place in the eastern part of Norway, and will include heart patients who have completed CR. Participants will be recruited from two CR centers. Based on power calculation, 113 participants will be included. The intervention group will receive individualized follow-up through an app on a weekly basis throughout a year. The app will be set up with the participant’s own goals, and the follow-up will be based on these individual goals. The control group will receive usual care, including general advice regarding physical activity, exercise and diet. The participants will be assessed at baseline (at completion of CR) and 12 months after baseline. Primary outcome of the study will be peak oxygen uptake. Secondary outcomes include exercise performance, quality of life, health status, health literacy, self-perceived goal achievement, exercise habits, body weight, blood pressure as well as lipids and triglycerides. Discussion To our knowledge, this will be the first study to examine the effects of individualized follow-up with an app for one year, in patients completing CR. Hence, it is reasonable to assume that the study may be groundbreaking. Due to the large sample size and the theoretically based intervention, the study has the potential to generate new knowledge that may improve the design of future technology-based follow-up interventions of patients that have completed rehabilitation. Trial registration ClinicalTrials.gov. NCT03174106. First registration, 19/05/2017.

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Long-term efficacy of indicated prevention of depression in non-professional caregivers: randomized controlled trial

Psychological Medicine ◽

10.1017/s0033291714002505 ◽

2014 ◽

Vol 45 (7) ◽

pp. 1401-1412 ◽

Cited By ~ 15

Author(s):

P. Otero ◽

F. Smit ◽

P. Cuijpers ◽

A. Torres ◽

V. Blanco ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Caregiver Burden ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Indicated Prevention ◽

Randomized Controlled ◽

Term Efficacy

BackgroundAlthough depression is a common problem among non-professional caregivers, only one trial has evaluated the efficacy of indicated prevention targeting this population and the long-term efficacy is unknown. The aim of this study was to evaluate the long-term efficacy of a brief intervention for the indicated prevention of depression in a sample of female caregivers.MethodA randomized controlled trial was conducted involving 173 participants (mean age 53.9 years) who were allocated to the intervention (n = 89) or the usual-care control group (n = 84). Blinded interviewers conducted assessments at 1, 3, 6 and 12 months of follow-up. The main outcome measure was the incidence of major depression and the secondary outcomes were compliance with treatment, depressive symptoms, emotional distress and caregiver burden.ResultsAt the 12-month follow-up, a lower incidence of depression as evaluated using the Structured Clinical Interview for Axis I Disorders of the DSM-IV was found in the intervention group compared with the control group (10.1%v.25.0%). The relative risk was 0.40 and statistically significant [χ2 = 6.68, degrees of freedom = 1,p = 0.010, 95% confidence interval (CI) 0.20–0.81], and the number needed to treat was 7 (95% CI 4–27). There was a significant delay in the onset of depression in the intervention group (p = 0.008). The good complier caregivers had a lower incidence of depression. The intervention effect on depressive symptoms, emotional distress and caregiver burden were maintained for 12 months.ConclusionsThis is the first study to demonstrate that a brief problem-solving intervention can prevent the onset of depression among non-professional caregivers over the longer term.

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Randomized Controlled Trial Evaluating Pictogram Augmentation of HIV Medication Information

Annals of Pharmacotherapy ◽

10.1345/aph.1q091 ◽

2011 ◽

Vol 45 (11) ◽

pp. 1378-1383 ◽

Cited By ~ 12

Author(s):

Kyle Wilby ◽

Carlo A Marra ◽

Jack H da Silva ◽

Maja Grubisic ◽

Stephanie Harvard ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Antiretroviral Therapy ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Fisher Exact Test ◽

Intended Meaning ◽

Randomized Controlled ◽

Medication Information

Background:: Antiretroviral therapy for the management of HIV typically requires the chronic use of 3 or more medications. As such, patients with HIV are required to manage complex dosing schedules and are at risk of multiple potential adverse effects. The use of pictograms on medication vials as a means of improving patients' understanding of medication information has been shown to positively influence understanding and adherence compared to those using text atone. Objective: To determine whether pictograms (Pharmaglyph) increase patient recall of targeted information associated with HIV medications and whether patients can interpret the intended meaning of pictograms that they had not seen previously. Methods: A randomized, controlled trial was conducted in HIV-positive patients aged 19 years or older who were receiving a new prescription for an antiretroviral medication from the ambulatory pharmacy at St. Paul's Hospital in Vancouver, British Columbia, Canada. Participants were randomized to receive either pictogram-enhanced medication information or standard counseling. At the first follow-up visit, each patient's recall of the medication information was evaluated, and differences between groups were compared. Results: Eighty-two subjects were randomized, 40 to the intervention group and 42 to the control arm. The mean (SD) number of HIV medications was nearly equal between the intervention and control groups: 3.0 (1.5) and 3.1 (1.4), respectively. After a mean of 34 days, 33 patients in the intervention arm and 39 in the control arm completed the study. The majority (88%) of the targeted pieces of information in the intervention group were correctly identified at follow-up, compared to only 2% in the control group (Fisher exact test; p < 0.0001). Conclusions: Pictograms improve the recall of targeted medication information among patients receiving antiretroviral therapy for HIV management; however, this appears to be dependent on the fact that these patients received a verbal explanation of each pictogram prior to use.

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Effectiveness of a smartphone-based, augmented reality exposure app to reduce fear of spiders in real-life: a randomized controlled trial

10.31219/osf.io/cjrgk ◽

2021 ◽

Author(s):

Anja Zimmer ◽

Nan Wang ◽

Merle Ibach ◽

Bernhard Fehlmann ◽

Nathalie Schicktanz ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Augmented Reality ◽

Controlled Trial ◽

Intervention Group ◽

Real Life ◽

Control Group ◽

Randomized Controlled ◽

Distress Scale

Although in vivo exposure therapy is highly effective in the treatment of specific phobias, only a minority of patients seeks therapy. Exposure to virtual objects has been shown to be better tolerated, equally efficacious, but the technology has not been made widely accessible yet. We developed an augmented reality (AR) application (app) to reduce fear of spiders and performed a randomized controlled trial comparing the effects of our app (six 30-min sessions at home over a two-week period) with no intervention. Primary outcome was subjective fear, measured by a Subjective Units of Distress Scale (SUDS) in a Behavioural Approach Test (BAT) in a real-life spider situation at six weeks follow-up. Between Oct 7, 2019, and Dec 6, 2019, 66 individuals were enrolled and randomized. The intervention led to significantly lower subjective fear in the BAT compared to the control group (intervention group, baseline: 7·12 [SD 2·03] follow-up: 5·03 [SD 2·19] vs. control group, baseline: 7·06 [SD 2·34], follow-up 6·24 [SD 2.21]; adjusted group difference -1·24, 95% CI -2·17 to -0·31; Cohen’s d=0·57, p=0·01). The repeated use of the AR app reduces subjective fear in a real-life spider situation, providing a low-threshold and low-cost treatment for fear of spiders.

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Influence of a Survival Swimming Training Programme on Water Safety Knowledge, Attitudes and Skills: A Randomized Controlled Trial among Young Adults in Sri Lanka

International Journal of Environmental Research and Public Health ◽

10.3390/ijerph182111428 ◽

2021 ◽

Vol 18 (21) ◽

pp. 11428

Author(s):

Jeewanthika Ekanayaka ◽

Chan Kim Geok ◽

Bernadette Matthews ◽

Samath D. Dharmaratne

Keyword(s):

Randomized Controlled Trial ◽

Young Adults ◽

Sri Lanka ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Water Safety ◽

Randomized Controlled ◽

Safety Knowledge

Drowning among young adults is high in Sri Lanka. Water safety education is a recommended strategy for drowning prevention but is often overlooked for young adults. This study aimed to evaluate the effectiveness of an adapted educational intervention, “Swim for Safety” on improving water safety knowledge, attitudes and survival swimming skills among undergraduates (19–28 years) in Sri Lanka. This study employed a parallel-group, two-arm randomized controlled trial design. The intervention group (n = 78) received a face-to-face, 12-lesson education programme, and the control group (n = 78) received a brochure and weekly mobile phone messages for six consecutive weeks. Baseline, post-intervention and three-month follow-up knowledge, attitudes and skills were evaluated. Knowledge and attitudes were assessed using a self-administered questionnaire and skills were evaluated following a skills assessment protocol. In total 116 participants, 60 intervention group and 56 control group, completed the study. At baseline there were no differences between groups in median scores of water safety knowledge, attitudes and survival swimming skills. The intervention group demonstrated statistically significant increases in median water safety knowledge, attitudes and survival swimming skill scores compared with the control group, following the intervention and maintained at three-month follow-up (p < 0.05). The adapted Swim for Safety programme significantly improved water safety knowledge, attitudes, and survival swimming skills among young adults in Sri Lanka. Therefore, it is recommended that the SfS programme be implemented widely to prevent drowning in young adults.

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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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The influence of expectation modification in knee arthroplasty on satisfaction of patients: a randomized controlled trial

The Bone & Joint Journal ◽

10.1302/0301-620x.103b4.bjj-2020-0629.r3 ◽

2021 ◽

Vol 103-B (4) ◽

pp. 619-626

Author(s):

Jaap J. Tolk ◽

Rob P. A. Janssen ◽

Tsjitske M. Haanstra ◽

M. C. van der Steen ◽

Sita M. A. Bierma-Zeinstra ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Controlled Trial ◽

Intervention Group ◽

Mean Difference ◽

Treatment Result ◽

Control Group ◽

Preoperative Education ◽

Randomized Controlled ◽

Preoperative Expectations

Aims Meeting preoperative expectations is known to be of major influence on postoperative satisfaction after total knee arthroplasty (TKA). Improved management of expectation, resulting in more realistic expectations can potentially lead to higher postoperative satisfaction. The objective of this study was to assess the effect of an additional preoperative education module, addressing realistic expectations for long-term functional recovery, on postoperative satisfaction and expectation fulfilment. Methods In total, 204 primary TKA patients with osteoarthritis were enrolled in this randomized controlled trial (RCT). Patients were allocated to either usual preoperative education (control group) or usual education plus an additional module on realistic expectations (intervention group). Primary outcome was being very satisfied (numerical rating scale for satisfaction ≥ 8) with the treatment result at 12 months' follow-up. Other outcomes were change in preoperative expectations and postoperative expectation fulfilment. Results A total of 187 patients (91.7%) were available for analysis at follow-up. In the intention-to-treat analysis, 58.5% (55/94) of patients were very satisfied with the treatment result in the control group, and 69.9% (65/93) of patients in the intervention group (adjusted odds ratio (AOR) 1.72, 95% confidence interval (CI) 0.90 to 3.29). A per-protocol analysis for patients who attended the education session (92.0%, n = 172) showed that 56.9% (49/86) of patients were very satisfied in the control group and 74.4% (61/86) in the intervention group (AOR 2.44, 95% CI 1.21 to 4.91). After preoperative education, the expectation scores in the intervention group were significantly lower (mean difference -6.9 (95% CI -10.2 to -3.6)) and did not alter in the control group (mean difference 0.5 (95% CI -2.9 to 3.9)). Overall, fulfilment of expectations at 12 months was significantly higher in the intervention group (mean difference 11.4% (95% CI 2.3 to 20.5)). Conclusion Improved preoperative patient education can modify patient expectations, resulting in higher postoperative fulfilment of expectation and higher satisfaction in the group that attended the preoperative education. This is the first RCT to confirm the potential of improved expectation management on satisfaction after TKA. Cite this article: Bone Joint J 2021;103-B(4):619–626.

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Does Internet-based cognitive behavioral therapy (iCBT) prevent major depressive episode for workers? A 12-month follow-up of a randomized controlled trial

Psychological Medicine ◽

10.1017/s0033291714003006 ◽

2015 ◽

Vol 45 (9) ◽

pp. 1907-1917 ◽

Cited By ~ 26

Author(s):

K. Imamura ◽

N. Kawakami ◽

T. A. Furukawa ◽

Y. Matsuyama ◽

A. Shimazu ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Cognitive Behavioral Therapy ◽

Behavioral Therapy ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Major Depressive ◽

Randomized Controlled ◽

Dsm Iv

BackgroundIn this study we investigated whether an Internet-based computerized cognitive behavioral therapy (iCBT) program can decrease the risk of DSM-IV-TR major depressive episodes (MDE) during a 12-month follow-up of a randomized controlled trial of Japanese workers.MethodParticipants were recruited from one company and three departments of another company. Those participants who did not experience MDE in the past month were randomly allocated to intervention or control groups (n = 381 for each). A 6-week, six-lesson iCBT program was provided to the intervention group. While the control group only received the usual preventive mental health service for the first 6 months, the control group was given a chance to undertake the iCBT program after a 6-month follow-up. The primary outcome was a new onset of DSM-IV-TR MDE during the 12-month follow-up, as assessed by means of the web version of the WHO Composite International Diagnostic Interview (CIDI), version 3.0 depression section.ResultsThe intervention group had a significantly lower incidence of MDE at the 12-month follow-up than the control group (Log-rank χ2 = 7.04, p < 0.01). The hazard ratio for the intervention group was 0.22 (95% confidence interval 0.06–0.75), when estimated by the Cox proportional hazard model.ConclusionsThe present study demonstrates that an iCBT program is effective in preventing MDE in the working population. However, it should be noted that MDE was measured by self-report, while the CIDI can measure the episodes more strictly following DSM-IV criteria.

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