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

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.

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

European Psychiatry ◽

10.1016/j.eurpsy.2014.02.004 ◽

2015 ◽

Vol 30 (2) ◽

pp. 251-257 ◽

Cited By ~ 17

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.

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

Journal of Telemedicine and Telecare ◽

10.1177/1357633x16663328 ◽

2016 ◽

Vol 23 (8) ◽

pp. 725-732 ◽

Cited By ~ 12

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).

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

Psychological Medicine ◽

10.1017/s0033291707001365 ◽

2007 ◽

Vol 38 (2) ◽

pp. 279-287 ◽

Cited By ~ 83

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.

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

10.2196/preprints.12950 ◽

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><.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;EncHid=&amp;userName=Muhamad%20Hanafiah%20Juni INTERNATIONAL REGISTERED REPORT PRR1-10.2196/12950

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Effects of Teaching Resourcefulness in Patients with Coronary Heart Disease

Western Journal of Nursing Research ◽

10.1177/01939459211020757 ◽

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.

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

International Journal of Environmental Research and Public Health ◽

10.3390/ijerph18126633 ◽

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.

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

10.2196/preprints.34544 ◽

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.

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

10.21203/rs.2.22689/v1 ◽

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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Effectiveness of an Educational Video in Maternity Wards to Prevent Self-Reported Shaking and Smothering during the First Week of Age: A Cluster Randomized Controlled Trial

Prevention Science ◽

10.1007/s11121-020-01145-z ◽

2020 ◽

Vol 21 (8) ◽

pp. 1028-1036

Author(s):

Takeo Fujiwara ◽

Aya Isumi ◽

Makiko Sampei ◽

Yusuke Miyazaki ◽

Fujiko Yamada ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Educational Video ◽

Health Checkup ◽

Infant Crying ◽

Randomized Controlled ◽

Cluster Randomized ◽

And Control

Abstract This study aimed to investigate whether watching an educational video on infant crying and the dangers of shaking and smothering within 1 week after delivery at maternity wards reduces self-reported shaking and smothering, at a 1-month health checkup. A cluster randomized controlled trial, stratified by area and hospital function, was employed in 45 obstetrics hospitals/clinics in Osaka Prefecture, Japan. In the intervention group, mothers watched an educational video on infant crying and the dangers of shaking and smothering an infant, within 1 week of age, during hospitalization at maternity wards, without blinding on group allocation. Control group received usual care. A total of 4722 (N = 2350 and 2372 for intervention and control group, respectively) mothers who delivered their babies (still birth and gestational age < 22 weeks were excluded) between October 1, 2014, and January 31 were recruited. Outcomes were self-reported shaking and smothering behaviors, knowledge on infant crying and shaking, and behaviors to cope with infant crying, assessed via a questionnaire at a 1-month health checkup. In all, 2718 (N = 1078 and 1640) responded to the questionnaire (response rate: 58.3%), and analytic sample size was 2655 (N = 1058 and 1597 for intervention and control group, respectively). Multilevel analysis was used to adjust for correlation within the cluster. Prevalence of shaking was significantly lower in the intervention group (0.19%) than in the control group (1.69%). Intention-to-treat analysis showed an 89% reduction in the reported prevalence of self-reported shaking (OR: 0.11, 95% CI: 0.02–0.53) due to watching the educational video. However, self-reported smothering behavior showed no significant reduction (OR: 0.66, 95% CI: 0.27–1.60). No side effects were reported. Watching an educational video on infant crying and the dangers of shaking and smothering within 1 week after delivery at maternity wards reduced self-reported shaking at 1 month of age. UMIN Clinical Trial Registry UMIN000015558.

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Cluster Randomized Controlled Trial of Disability Education Module During Clinical Clerkship

Clinical Pediatrics ◽

10.1177/0009922819850475 ◽

2019 ◽

Vol 58 (13) ◽

pp. 1387-1393

Author(s):

Jonathan D. Santoro ◽

Emily E. Whitgob ◽

Lynne C. Huffman

Keyword(s):

Group Intervention ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Family Control ◽

Time Interaction ◽

Functional Aspects ◽

Management Participation ◽

Cluster Randomized ◽

Disability Education

The effect of a randomized disability education program on medical student knowledge and attitudes concerning disability was performed. Intervention group received bedside teaching of physical examination/interview skills and case-based discussion. Twenty-three participants completed the study (control group n = 11; intervention group n = 12). Pre-clerkship, 39% of all participants reported no personal experience and 43% reported no professional experience with people with disabilities. Post-clerkship knowledge was higher for both groups; the test of group-by-time interaction was not significant. Qualitative analysis of post-clerkship attitude responses demonstrated that intervention group gave more detailed answers. Intervention group used terms representing functional aspects of disability twice as frequently as control group. Intervention group responses described long-term experience of a disability within community and family; control group responses focused on acute medical management. Participation in disability education resulted in changed attitude toward disability and better understanding of aspects of disability.

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