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

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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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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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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Exploring Efficacy of a Serious Game (Tobbstop) for Smoking Cessation During Pregnancy: Randomized Controlled Trial (Preprint)

10.2196/preprints.12835 ◽

2018 ◽

Author(s):

Francesc X Marin-Gomez ◽

Rocio Garcia-Moreno Marchán ◽

Anabel Mayos-Fernandez ◽

Gemma Flores-Mateo ◽

Esther Granado-Font ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Smoking Cessation ◽

Tobacco Use ◽

Controlled Trial ◽

Intervention Group ◽

Serious Game ◽

Control Group ◽

Randomized Controlled ◽

Pregnant Smokers

BACKGROUND Tobacco use during pregnancy entails a serious risk to the mother and harmful effects on the development of the child. Europe has the highest tobacco smoking prevalence (19.3%) compared with the 6.8% global mean. Between 20% to 30% of pregnant women used tobacco during pregnancy worldwide. These data emphasize the urgent need for community education and implementation of prevention strategies focused on the risks associated with tobacco use during pregnancy. OBJECTIVE The aim of this study was to investigate the efficacy of an intervention that incorporates a serious game (Tobbstop) to help pregnant smokers quit smoking. METHODS A two-arm randomized controlled trial enrolled 42 women who visited 2 primary care centers in Catalonia, Spain, between March 2015 and November 2016. All participants were pregnant smokers, above 18 years old, attending consultation with a midwife during the first trimester of pregnancy, and had expressed their desire to stop smoking. Participants were randomized to the intervention (n=21) or control group (n=21). The intervention group was instructed to install the game on their mobile phone or tablet and use it for 3 months. Until delivery, all the participants were assessed on their stage of smoking cessation during their follow-up midwife consultations. The primary outcome was continuous tobacco abstinence until delivery confirmed by the amount of carbon monoxide at each visit, measured with a carboxymeter. RESULTS Continuous abstinence until delivery outcome was 57% (12/21) in the intervention group versus 14% (3/21) in the control group (hazard ratio=4.31; 95% CI 1.87-9.97; P=.001). The mean of total days without smoking until delivery was higher in the intervention group (mean 139.75, SD 21.76) compared with the control group (mean 33.28, SD 13.27; P<.001). In addition, a Kapplan-Meier survival analysis showed that intervention group has a higher abstinence rate compared with the control group (log-rank test, χ21=13.91; P<.001). CONCLUSIONS Serious game use is associated with an increased likelihood to maintain abstinence during the intervention period if compared with those not using the game. Pregnancy is an ideal opportunity to intervene and control tobacco use among future mothers. On the other hand, serious games are an emerging technology, growing in importance, which are shown to be a good tool to help quitting smoking during pregnancy and also to maintain this abstinent behavior. However, because of the study design limitations, these outcomes should be interpreted with caution. More research, using larger samples and longer follow-up periods, is needed to replicate the findings of this study. CLINICALTRIAL ClinicalTrials.gov NCT01734421; https://clinicaltrials.gov/ct2/show/NCT01734421 (Archived by WebCite at http://www.webcitation.org/75ISc59pB)

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Enhancing adoptive parenting: A randomized controlled trial

Clinical Child Psychology and Psychiatry ◽

10.1177/1359104510365041 ◽

2010 ◽

Vol 15 (4) ◽

pp. 529-542 ◽

Cited By ~ 22

Author(s):

Alan Rushton ◽

Elizabeth Monck ◽

Morven Leese ◽

Paul McCrone ◽

Jessica Sharac

Keyword(s):

Randomized Controlled Trial ◽

Controlled Trial ◽

Intervention Group ◽

Adoptive Parents ◽

Control Group ◽

Parenting Interventions ◽

Post Intervention ◽

Randomized Controlled ◽

Significant Difference

The aim was to conduct a pragmatic randomized controlled trial (RCT) to evaluate two parenting programmes designed for adopters of children late placed from care. Adoptive parents, with children between 3 and 8 years who were screened to have serious behavioural problems early in the placement, participated in home-based, manualized, parenting programmes delivered by trained and supervised family social workers. The adopters who agreed to join the study were randomly allocated to one of two parenting interventions or to a “services as usual” group. Baseline, immediate post-intervention and six-month follow-ups were assessed using questionnaires and adopter interviews. No cases were lost to follow-up at any point and satisfaction was high with both parenting interventions. At the six-month follow-up, a significant difference ( p < 0.007) was found for “satisfaction with parenting” in favour of the intervention group (Effect Size d = 0.7). Negative parenting approaches were reduced in the intervention group. However, no significant differences in child problems were found between the intervention groups and control group, adjusting for baseline scores. Costs analysis showed that a relatively modest investment in post-adoption support would be well spent in improving adopters’ satisfaction with parenting in the intervention group compared to the routine service group.

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Efficacy of tailored recommendations to promote healthy lifestyles: a post hoc analysis of a randomized controlled trial

Translational Behavioral Medicine ◽

10.1093/tbm/ibab035 ◽

2021 ◽

Author(s):

María Barroso ◽

M Dolors Zomeño ◽

Jorge L Díaz ◽

Silvia Pérez ◽

Ruth Martí-Lluch ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Cardiovascular Diseases ◽

Mediterranean Diet ◽

Controlled Trial ◽

Intervention Group ◽

Individual Risk ◽

Control Group ◽

Healthy Lifestyles ◽

Randomized Controlled

Abstract Prevention is the key to stopping the ravages of cardiovascular diseases, the main cause of death worldwide. The objective was to analyze the efficacy of tailored recommendations to promote healthy lifestyles. Parallel-arm randomized controlled trial with 1 year follow-up. Individuals aged 35–74 years from Girona (Spain) randomly selected from a population with no cardiovascular diseases at baseline were included. Participants in the intervention group received a brochure with tailored healthy choices according to the individual risk profile and a trained nurse explained all recommendations in detail in a 30 min consultation. One year changes in smoking, Mediterranean diet adherence, physical activity, and weight were analyzed with McNemar, Student’s t, Wilcoxon, and Fisher exact tests according to an intention-to-treat strategy. Of 955 individuals (52.3% women; mean age 50 [±10] years) randomly allocated to the intervention or control group, one participant in each group presented a cardiovascular event and 768 (81%) were reexamined at 1 year follow-up. The prevalence of nonsmokers increased in both the intervention and control groups (78.1%–82.5%, p = <.001, and 76.7% to 78.8%, p = .015, respectively); however, significance persisted only in the intervention group when stratified by sex, age group, and educational level. Adherence to a Mediterranean diet increased in the intervention group (22.3%–26.5%, p = .048). In conclusion, a brief personalized intervention with science-based recommendations according to individual risk profiles appears to improve healthy lifestyles, particularly nonsmoking and adherence to a Mediterranean diet. This promising intervention system offers evidence-based recommendations to develop healthy lifestyles.

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