Apathy in Nursing Home Residents with Dementia: Results From A Cluster-Randomized Controlled Trial

2015 ◽  
Vol 30 (2) ◽  
pp. 251-257 ◽  
Author(s):  
Y. Treusch ◽  
T. Majic ◽  
J. Page ◽  
H. Gutzmann ◽  
A. Heinz ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Intervention Group ◽  
Nursing Home Residents ◽  
Cluster Randomized Trial ◽  
Control Group ◽  
Intervention Period ◽  
Significant Group ◽  
Dementia Patients ◽  
Cluster Randomized ◽  
One Year

AbstractPurpose:Here we evaluate an interdisciplinary occupational and sport therapy intervention for dementia patients suffering from apathy.Subjects and methods:A prospective, controlled, rater-blinded, clinical trial with two follow-ups was conducted as part of a larger cluster-randomized trial in 18 nursing homes in Berlin. n = 117 dementia patients with apathy, defined as a score of 40 or more on the apathy evaluation scale (AES) or presence of apathy on the Neuropsychiatric Inventory (NPI), were randomly assigned to intervention or control group. The intervention included 10 months of brief activities, provided once a week. The primary outcome measure was the total score on the AES scale measured directly after the intervention period and again after 12 months.Results:We found significant group differences with respect to apathy during the 10 month intervention period (F2,82 = 7.79, P < 0.01), which reflected an increase in apathy in the control group, but not in the intervention group. Within one year after the intervention was ceased, the treatment group worsened and no longer differed significantly from the control group (P = 0.55).Conclusions:Our intervention was effective for the therapy of apathy in dementia, when applied, but not one year after cessation of therapy.

Effect of a Community-led Total Sanitation Intervention on the Incidence and Prevalence of Diarrhea in Children in Rural Ethiopia: A Cluster-randomized Controlled Trial

2021 ◽  
Author(s):  
Seungman Cha ◽  
Sunghoon Jung ◽  
Dawit Belew Bizuneh ◽  
Tadesse Abera ◽  
Young-Ah Doh ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Intervention Group ◽  
Prevalence Ratio ◽  
Cluster Randomized Trial ◽  
Control Group ◽  
Period Prevalence ◽  
Rural Villages ◽  
Diary Methods ◽  
Diarrhea Incidence ◽  
Cluster Randomized

We conducted a cluster-randomized trial in 48 rural villages of Ethiopia to assess the effect of community-led total sanitation (CLTS) on the diarrhea incidence of children. Twenty-four villages were randomly assigned to the intervention group and the other 24 were assigned to the control group. A CLTS intervention was implemented from January 2016 through January 2017. Baseline data collection was conducted during October and November 2015. At baseline, 906 children were recruited and followed-up until January 2017. These 906 children were randomly selected among all children in the 48 villages. To determine the 7-day period prevalence of diarrhea, four household-based surveys were conducted by independent data collectors at 3, 5, 9, and 10 months after the CLTS was initiated. To determine the incidence and longitudinal prevalence, the presence of daily diarrhea presence was recorded for 140 days using diary methods. The loss to follow-up rates were 95% for period prevalence and 93% for incidence and longitudinal prevalence. The incidence ratio and longitudinal prevalence ratio were 0.66 (95% confidence interval [CI], 0.45–0.97; P = 0.03) and 0.70 (95% CI, 0.52–0.95; P = 0.02) after adjusting for clustering and stratification. The relative risk of period prevalence was 0.66 (95% CI, 0.45–0.98; P = 0.04) at 3 months after initiation. Improved toilet coverage increased from 0.0% at baseline to 35.0% at 10 months in the intervention villages, whereas it increased from 0.7% to 2.8% in the control villages. Adherence to the intervention was comparable with that of previous studies; therefore, we suggest that the findings of this study are replicable.

Impact of a store-and-forward teledermatology intervention versus usual care on delay before beginning treatment: A pragmatic cluster-randomized trial in ambulatory care

2016 ◽  
Vol 23 (8) ◽  
pp. 725-732 ◽  
Author(s):  
Edouard Piette ◽  
Michel Nougairède ◽  
Valerie Vuong ◽  
Beatrice Crickx ◽  
Viet-Thi Tran
Keyword(s):  
Controlled Trial ◽  
Intervention Group ◽  
Cluster Randomized Trial ◽  
Skin Lesions ◽  
Control Group ◽  
Referral Letter ◽  
Open Label ◽  
Clinical Images ◽  
Store And Forward ◽  
Cluster Randomized

Introduction In France, 66% of patients forego getting specialized care by dermatologists because of difficulty obtaining appointments. Store-and-forward teledermatology could improve how promptly treatment begins by reducing the delay in obtaining a specialist’s opinion. In this study, we compared the delay before care between general practitioners (GPs) using a store-and-forward teledermatology intervention and GPs addressing their patients with a standard referral letter. Methods We performed an open-label, pragmatic cluster-randomized controlled trial with two parallel arms. GP clinics in Paris (France) were randomly assigned to use either teledermatology referral (use of electronics to send clinical images taken using a mobile phone) or conventional referral (using standard letters) to care for patients for whom a dermatologist’s advice was needed for the diagnosis or treatment of skin lesions. Dermatologists integrated responses to teledermatology requests in their usual schedule. Patients were followed up for three months. Primary outcome was the delay, in days, between the GP’s consultation and a reply by the specialist allowing treatment to begin. Analyses were adjusted for clustering of GPs and identities of dermatologists. Results Between February and June 2014, 103 patients were included in the study (53 patients of 20 GPs in the intervention group). The median delay between the initial GP’s consultation and the reply allowing for treatment to begin was four days in the intervention group and 40 days in the control group (adjusted hazard ratio = 2.55; p < 0.011). Discussion We showed that a simple store-and-forward teledermatology intervention significantly reduced the delay before beginning care (ClinicalTrials.gov identifier: NCT02122432).

scholarly journals Collaborative care for depression in UK primary care: a randomized controlled trial

2007 ◽  
Vol 38 (2) ◽  
pp. 279-287 ◽  
Author(s):  
D. A. Richards ◽  
K. Lovell ◽  
S. Gilbody ◽  
L. Gask ◽  
D. Torgerson ◽  
...  
Keyword(s):  
Primary Care ◽  
Collaborative Care ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Intervention Group ◽  
Cluster Randomized Trial ◽  
Phase Iii ◽  
Control Group ◽  
Randomized Control ◽  
Cluster Randomized

BackgroundCollaborative care is an effective intervention for depression which includes both organizational and patient-level intervention components. The effect in the UK is unknown, as is whether cluster- or patient-randomization would be the most appropriate design for a Phase III clinical trial.MethodWe undertook a Phase II patient-level randomized controlled trial in primary care, nested within a cluster-randomized trial. Depressed participants were randomized to ‘collaborative care’ – case manager-coordinated medication support and brief psychological treatment, enhanced specialist and GP communication – or a usual care control. The primary outcome was symptoms of depression (PHQ-9).ResultsWe recruited 114 participants, 41 to the intervention group, 38 to the patient randomized control group and 35 to the cluster-randomized control group. For the intervention compared to the cluster control the PHQ-9 effect size was 0.63 (95% CI 0.18–1.07). There was evidence of substantial contamination between intervention and patient-randomized control participants with less difference between the intervention group and patient-randomized control group (−2.99, 95% CI −7.56 to 1.58, p=0.186) than between the intervention and cluster-randomized control group (−4.64, 95% CI −7.93 to −1.35, p=0.008). The intra-class correlation coefficient for our primary outcome was 0.06 (95% CI 0.00–0.32).ConclusionsCollaborative care is a potentially powerful organizational intervention for improving depression treatment in UK primary care, the effect of which is probably partly mediated through the organizational aspects of the intervention. A large Phase III cluster-randomized trial is required to provide the most methodologically accurate test of these initial encouraging findings.

scholarly journals Effects of drinking water, sanitation, handwashing, and nutritional interventions on immune status in young children: a cluster-randomized controlled trial in rural Bangladesh

2021 ◽  
Author(s):  
Audrie Lin ◽  
Andrew N. Mertens ◽  
Sophia Tan ◽  
Md. Ziaur Rahman ◽  
Lisa Hester ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Intervention Group ◽  
Child Growth ◽  
Control Group ◽  
Rural Bangladesh ◽  
Immune System Development ◽  
Tnf Α ◽  
Ifn Γ ◽  
Cluster Randomized ◽  
One Year

While studies have speculated that immune function may play a role in how water, sanitation, hygiene, and nutritional (N+WSH) interventions may individually impact child growth and development, the combined effects of these interventions on immune system development are unknown. Here, we report on a trial in rural Bangladesh, where we cluster-randomized pregnant women into control and N+WSH arms. Among the birth cohort, we quantified plasma IL-1β, IL-6, TNF-α, IL-2, IL-12p70, IFN-γ, IL-4, IL-5, IL-13, IL-17A, IL-21, IL-10, and GM-CSF at ages 14 and 28 months. Cytokine ratios were included as prespecified outcomes to examine the net inflammatory environment. We assessed 704 children. After one year, TNF-α/IL-10, IL-12/IL-10, and IL-17A/IL-10 ratios were lower in the intervention group compared to the control group (mean difference: -0.12 to -0.19, p<0.05), indicating the intervention promoted IL-10 driven immunoregulation. Similar reductions in ratios of pro-inflammatory cytokines to IL-10 were sustained in the intervention group after two years. After one year, IL-12/IL-4, IL-12/IL-5, IFN-γ/IL-5, and IL-12/IL-13 ratios were lower in the intervention group (-0.18 to -0.27, p<0.05), suggesting a shift towards a Th2 cytokine response. These findings suggest that the N+WSH intervention enhanced the immunoprotective and immunoregulatory responses, and suppressed/counteracted the inflammatory/immunopathological response, of the immune triad.

Effectiveness of an Educational Intervention in Reducing New International Postgraduates’ Acculturative Stress in Malaysian Public Universities: Protocol for a Cluster Randomized Controlled Trial (Preprint)

2018 ◽  
Author(s):  
Musheer Abdulwahid Al-Jaberi ◽  
Muhamad Hanafiah Juni ◽  
Hayati Kadir Shahar ◽  
Siti Irma Fadhilah Ismail ◽  
Murad Abdu Saeed ◽  
...  
Keyword(s):  
International Students ◽  
Acculturative Stress ◽  
Educational Program ◽  
Public Universities ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Policy Makers ◽  
Randomized Controlled ◽  
Cluster Randomized

BACKGROUND Universities around the world, including Malaysia, have attracted many international students from different countries. Research has reported that acculturative stress resulting from international students’ attempts to adjust to the cultures of host countries is one of the most challenging issues that affects their lives in general and academic lives in particular. OBJECTIVE This study aims to examine the effectiveness of an educational intervention on acculturative stress among new postgraduate international students joining Malaysian public universities. METHODS A cluster randomized controlled trial design with Malaysian public universities as the unit of randomization will be used in this study. Public universities will be randomized in a 1:1 ratio to be either in the intervention (educational program) or control group (waiting list). Participants in the intervention group will receive 7 sessions in 9 hours delivered by an expert in psychology and the researcher. The control group will receive the intervention once the 3-month follow-up evaluation is completed. RESULTS The data will be analyzed using the generalized estimation equation with a confidence interval value of 95%; significant differences between and within groups are determined as <i>P</i>&lt;.05. The results of the study underlie the effectiveness of educational program in decreasing acculturative stress of new international students and enabling them to cope with a new environment. The results of this study will contribute to previous knowledge of acculturative stress, acculturation, and adjustment of international students. Furthermore, such results are expected to play a role in raising university policy makers’ awareness of their postgraduate international students’ acculturative stress issues and how they can help them avoid such stress and perform well in their academic life. CONCLUSIONS We expect that the intervention group will score significantly lower than the wait-list group on the immediate and 3-month postintervention evaluation of acculturative stress and achieve a higher level of adjustment. Results will have implications for international students, policy makers at universities, the Malaysian Ministry of Higher Education, and future research. CLINICALTRIAL Clinical Trials Registry India CTRI/2018/01/011223; http://ctri.nic.in/Clinicaltrials/showallp.php?mid1= 21978&amp;amp;EncHid=&amp;amp;userName=Muhamad%20Hanafiah%20Juni INTERNATIONAL REGISTERED REPORT PRR1-10.2196/12950

Effects of Teaching Resourcefulness in Patients with Coronary Heart Disease

2021 ◽  
pp. 019394592110207
Author(s):  
Min Wen ◽  
Yaqin Liang ◽  
Qianqian Shen ◽  
Juping Yu ◽  
Pingping He ◽  
...  
Keyword(s):  
Coronary Heart Disease ◽  
Heart Disease ◽  
Health Education ◽  
Controlled Trial ◽  
Coping Styles ◽  
Intervention Group ◽  
Control Group ◽  
Convenience Sample ◽  
Cluster Randomized ◽  
And Coping

This cluster randomized controlled trial aimed to investigate the effects of an intervention to teach resourcefulness on depression and coping style of patients with coronary heart disease (CHD). A convenience sample of 72 patients in community settings took part. Participants in the intervention group (n = 36) received an 8-week intervention based on the concept of resourcefulness, plus routine health education. Participants in the control group (n = 36) received routine health education only. After the intervention, participants in the intervention group had significantly higher scores on resourcefulness and coping styles, and lower scores on depression than those in the control group (both ps < .001). The findings suggest that a well-developed intervention to teach resourcefulness could help patients with CHD to be more resourceful, improve their level of depression, and choose more effective strategies to cope with stress.

scholarly journals A Cluster Randomized Controlled Trial Feasibility Study of a WhatsApp-Delivered Intervention to Promote Healthy Eating Habits in Male Firefighters

2021 ◽  
Vol 18 (12) ◽  
pp. 6633
Author(s):  
Winnie Wing Man Ng ◽  
Anthony Siu Wo Wong ◽  
Kin Cheung
Keyword(s):  
Randomized Controlled Trial ◽  
Healthy Eating ◽  
Eating Habits ◽  
Controlled Trial ◽  
Intervention Group ◽  
Cluster Randomized Controlled Trial ◽  
Control Group ◽  
Randomized Controlled ◽  
Healthy Eating Habits ◽  
Cluster Randomized

This cluster randomized controlled trial (CRCT)-designed study aimed to explore the feasibility of a promotion pamphlet and/or WhatsApp as a suitable mode of delivery to promote healthy eating habits with fruit and vegetables (F&V) among firefighters. Convenience and snowball sampling methods were used. Forty-five firefighters from 23 fire stations were recruited and they all received the printed pamphlet, while the intervention group participants (n = 20) received additional teaching material through WhatsApp every two weeks for eight weeks. Feasibility outcomes included retention, practicality, and implementation. The participants reported high levels of satisfaction with the intervention. There were significant improvements in the mean numbers of days consuming F&V (p = 0.002; p = 0.031) in the intervention group, and for fruit consumption (p = 0.033) in the control group between the baseline (T0) and 3 months after completion of intervention (T1). High levels of participants’ satisfaction with the intervention revealed that a full-scale CRCT of the WhatsApp-delivered intervention promoting healthy eating could be feasible, especially as a means of increasing the numbers of days they consumed F&V and the numbers of servings of these consumed per day.

Evaluation of a social media campaign to increase COVID-19 testing in migrant groups: A cluster randomized trial (Preprint)

2021 ◽  
Author(s):  
Ingeborg Hess Elgersma ◽  
Atle Fretheim ◽  
Thor Indseth ◽  
Anita Thorolvsen Munch ◽  
Live Bøe Johannessen ◽  
...  
Keyword(s):  
Social Media ◽  
Intervention Group ◽  
Cluster Randomized Trial ◽  
Control Group ◽  
Media Campaign ◽  
Predicted Probability ◽  
Simple Language ◽  
Media Intervention ◽  
Cluster Randomized ◽  
Migrant Groups

BACKGROUND A low test positivity rate is key to keeping the COVID-19 pandemic under control. Several migrant groups in Norway have seen higher rates of confirmed COVID-19 and related hospitalizations, while test positivity has remained high in the same groups. Social media sponsored ads have been an important part of the government’s strategy to reach these groups. OBJECTIVE In this study we aimed to investigate whether such a targeted Facebook campaign increased the rate of testing in certain migrant groups. METHODS We randomly assigned 386 Norwegian municipalities and city districts, to intervention or control groups. Individuals born in Syria, Pakistan, Eritrea, Turkey, Russia and Iraq residing in intervention areas were targeted with a social media campaign aiming at increasing the COVID-19 test rate. The campaign message was in simple language and conveyed in the users’ main language or in English. RESULTS During the follow-up period of two weeks, the predicted probability of conducting a COVID-19 test was 4.82 % (CI: 4.47 % - 5.18 %) in the control group, and 5.58 % (CI: 5.20 % - 5.99 %) in the intervention group (P=.004). CONCLUSIONS Our targeted social media intervention led to a modest, but potentially important, increase in test rates among migrants in Norway. CLINICALTRIAL ClinicalTrials.gov Identifier NCT04866589.

Evaluating the effects of a mindfulness mobile application on student pharmacists’ stress, burnout, and mindfulness

2021 ◽  
Author(s):  
Angela Chu ◽  
Tyler M Rose ◽  
Danielle A Gundrum ◽  
Tressa E McMorris ◽  
Eytan A Klausner ◽  
...  
Keyword(s):  
Mobile Application ◽  
Controlled Trial ◽  
Intervention Group ◽  
Secondary Outcome ◽  
Control Group ◽  
Intervention Period ◽  
Entire Study ◽  
Positive Effects ◽  
Waitlist Control Group

Abstract Disclaimer In an effort to expedite the publication of articles, AJHP is posting manuscripts online as soon as possible after acceptance. Accepted manuscripts have been peer-reviewed and copyedited, but are posted online before technical formatting and author proofing. These manuscripts are not the final version of record and will be replaced with the final article (formatted per AJHP style and proofed by the authors) at a later time. Purpose Pharmacists report high levels of burnout. Mindfulness approaches have been demonstrated to have positive results in the general population and in other healthcare professions. However, limited studies have been performed evaluating mindfulness approaches in student pharmacists. The aim of this study was to evaluate the effectiveness of daily use of a mindfulness mobile application in improving student pharmacists’ perceived stress, burnout, and mindfulness. Methods This study was a randomized, longitudinal, waitlist-controlled trial. The intervention group was asked to meditate using the mindfulness application Headspace daily for at least 6 weeks. The waitlist control group was asked to abstain from using the application for the entire study. Stress, burnout, and mindfulness were assessed using validated survey instruments at baseline, 6 weeks, and 10 weeks. A secondary outcome was to assess the persistence of application use after the intervention period. Results Fifty-six participants completed the study. The intervention group reported significantly lower scores on stress and burnout at 6 weeks compared to the control group. The intervention group also reported significantly higher scores on mindfulness. The differences in stress, burnout, and mindfulness persisted at follow-up. The mean percentage of students in the intervention group who used the application each day was 90% over the intervention period and 62% over the follow-up period. Conclusion A mindfulness mobile application significantly improved student pharmacists’ stress, burnout, and mindfulness with daily use. Most participants continued to use the application for 4 weeks after the end of the intervention. Positive effects on stress and mindfulness persisted even with decreased use.

The Effect of Theory-lead Intervention for Knee Osteoarthritis in Older Adults: A Cluster Randomized Trial

2020 ◽  
Author(s):  
Limin Wang ◽  
Hongbo Chen ◽  
Han Lu ◽  
Yunlin Wang ◽  
Congying Liu ◽  
...  
Keyword(s):  
Older Adults ◽  
Knee Osteoarthritis ◽  
Transtheoretical Model ◽  
Intervention Group ◽  
Exercise Program ◽  
Exercise Adherence ◽  
Cluster Randomized Trial ◽  
Knee Function ◽  
Control Group ◽  
Cluster Randomized

Abstract Background: Knee osteoarthritis (KOA) is a common joint disease in people over 60 years old. Exercise therapy is one of the most effective non-pharmacological treatments for KOA, but low exercise adherence needs to be improved. The present study aimed to evaluate the effect of the transtheoretical model-lead home exercise intervention (TTM-HEI) program on exercise adherence, KOA symptoms and knee function in older adults with KOA. Methods: A two-arm, superiority, assessor-blinded, cluster randomized trial was conducted. Community-dwelling older adults with KOA were recruited from 14 community centers in Beijing, China via print and social media advertisements from April to October 2018. The intervention was a two-stage and 24-week transtheoretical model-based exercise program, and the control group underwent a same length but non-theory-based exercise program. Exercise adherence was measured by an 11-point numerical self-rating scale at weeks 4, 12, 24, 36, and 48 after the program started. KOA symptoms (pain intensity and joint stiffness) and knee function (lower limb muscle strength and balance) were measured at baseline, week 24, and week 48. Latent growth model (GLM), repeated measures ANOVA and independent t-test were the main statistical tests.Results: A total of 189 older adults (intervention group: n = 103, control group: n = 86) were enrolled. Differences of any outcome measures at baseline were not significant between groups. The growth rate of exercise adherence in the intervention group increased 2.175 units compared with the control group (unstandardized coefficient of slope on group B2 = 2.175, p < 0.001), and the intervention program maintained participants’ exercise adherence with 5.56 (SD = 1.00) compared with 3.16 (SD = 1.31) in the control group at week 48. In addition, TTM-HEI program showed significant effects on relieving KOA symptoms and improving knee function.Conclusion: The TTM-HEI could improve the participants’ exercise adherence, knee osteoarthritis symptoms and knee function over time.

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