Effectiveness of Nutrition and WASH/malaria educational community-based interventions in reducing anemia in children from Angola

AbstractWe found no published data in Angola regarding the effect of combining nutrition-specific and nutrition-sensitive approaches in the reduction of anemia in preschool children. Thus, we implemented a cluster-randomized controlled trial to determine the effectiveness of two educational-plus-therapeutic interventions, in Nutrition and WASH/Malaria, in reducing anemia. We compared them to (1) a test-and-treat intervention and (2) with each other. A block randomization was performed to allocate 6 isolated hamlets to 3 study arms. A difference-in-difference technique, using Fit Generalized estimating models, was used to determine differences between the children successfully followed in all groups, between 2015 and 2016. We found no significant differences in anemia´s and hemoglobin variability between educational and the control group. However, the WASH/Malaria group had 22.8% higher prevalence of anemia when compared with the Nutrition group, having also higher prevalence of P. falciparum. Thus, our results suggest that adding a 12-month educational Nutrition or a WASH/Malaria component to a test-and-treat approach may have a limited effect in controlling anemia. Possibly, the intensity and duration of the educational interventions were not sufficient to observe the amount of behavior change needed to stop transmission and improve the general child feeding practices.

Download Full-text

Efficacy of Nutrition and WASH/Malaria Educational Community-Based Interventions in Reducing Anemia in Preschool Children from Bengo, Angola: Study Protocol of a Randomized Controlled Trial

International Journal of Environmental Research and Public Health ◽

10.3390/ijerph16030466 ◽

2019 ◽

Vol 16 (3) ◽

pp. 466

Author(s):

Cláudia Fançony ◽

Ânia Soares ◽

João Lavinha ◽

Henrique Barros ◽

Miguel Brito

Keyword(s):

Randomized Controlled Trial ◽

Controlled Trial ◽

Mortality Rates ◽

Therapeutic Interventions ◽

Educational Community ◽

Community Based Interventions ◽

Community Based ◽

Urogenital Schistosomiasis ◽

Randomized Controlled ◽

Cluster Randomized

Angola reports one of the highest infant mortality rates in the world, and anemia represents one of its important causes. Recent studies, in under-five children from the Bengo province of Angola, described high prevalence’s, suggesting malaria, undernutrition and urogenital schistosomiasis as important contributors for the occurrence and spatial variations of anemia. Educational community-based interventions, either in Nutrition and Water, Sanitation, Hygiene and Malaria are recommended to correct anemia. Herein, we designed a cluster-randomized controlled trial to study the efficacy of two educational-plus-therapeutic interventions in the reduction of anemia: one in nutrition and the other in WASH/Malaria. Socioeconomic, nutritional, anthropometric, parasitological and biochemical data will be collected from all willing-to-participate children, aging under four and resident in the Health Research Center of Angola study area. Considering the multifactorial causes of this condition, determining the efficacy of both interventions might help documenting weaknesses and opportunities for planning integrated strategies to reduce anemia.

Download Full-text

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

Download Full-text

Evaluation of a collaborative protocolized approach by community pharmacies and general medical practitioners for an Australian minor ailments scheme: study protocol for a cluster-randomized controlled trial (Preprint)

10.2196/preprints.13973 ◽

2019 ◽

Author(s):

Sarah Dineen-Griffin ◽

Victoria Garcia Cardenas ◽

Kylie Williams ◽

Shalom Isaac Benrimoj

Keyword(s):

Randomized Controlled Trial ◽

Usual Care ◽

Controlled Trial ◽

Self Care ◽

Cluster Randomized Controlled Trial ◽

Control Group ◽

Community Pharmacies ◽

Randomized Controlled ◽

Minor Ailments ◽

Cluster Randomized

BACKGROUND Internationally, governments have been investing in supporting pharmacists to take on an expanded role to support self-care for health system efficiency. There is consistent evidence that minor ailment schemes (MAS) promote efficiencies within the healthcare system. The cost savings and health outcomes demonstrated in the UK and Canada opens up new opportunities for pharmacists to effect sustainable changes through MAS delivery in Australia. OBJECTIVE This trial is evaluating the clinical, economic and humanistic impact of an Australian minor ailments service (AMAS), compared with usual pharmacy care in a cluster-randomized controlled trial in Western Sydney, Australia. METHODS The cluster-randomized controlled trial design has an intervention and a control group, comparing individuals receiving a structured intervention with those receiving usual care for specific common ailments. Participants will be community pharmacies, general practices and patients located in Western Sydney Primary Health Network region. 30 community pharmacies will be randomly assigned to either intervention or control group. Each will recruit 24 patients seeking, aged 18 years or older, presenting to the pharmacy in person with a symptom-based or product-based request for one of the following ailments (reflux, cough, common cold, headache (tension or migraine), primary dysmenorrhoea and low back pain). Intervention pharmacists will deliver protocolized care to patients using clinical treatment pathways with agreed referral points and collaborative systems boosting clinician-pharmacist communication. Patients recruited in control pharmacies will receive usual care. The co-primary outcomes are rates of appropriate use of nonprescription medicines and rates of appropriate medical referral. Secondary outcomes include self-reported symptom resolution, time to resolution of symptoms, health services resource utilization and EQ VAS. Differences in the primary outcomes between groups will be analyzed at the individual patient level accounting for correlation within clusters with generalized estimating equations. The economic impact of the model will be evaluated by cost analysis compared with usual care. RESULTS The study began in July 2018. At the time of submission, 30 community pharmacies have been recruited. Pharmacists from the 15 intervention pharmacies have been trained. 27 general practices have consented. Pharmacy patient recruitment began in August 2018 and is ongoing and monthly targets are being met. Recruitment will be completed March 31st, 2019. CONCLUSIONS This study may demonstrate the utilization and efficacy of a protocolized intervention to manage minor ailments in the community, and will assess the clinical, economic and humanistic impact of this intervention in Australian pharmacy practice. Pharmacists supporting patient self-care and self-medication may contribute greater efficiency of healthcare resources and integration of self-care in the health system. The proposed model and developed educational content may form the basis of a MAS national service, with protocolized care for common ailments using a robust framework for management and referral. CLINICALTRIAL Registered with Australian New Zealand Clinical Trials Registry (ANZCTR) and allocated the ACTRN: ACTRN12618000286246. Registered on 23 February 2018.

Download Full-text

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.

Download Full-text

Primary dementia care based on the individual needs of the patient: study protocol of the cluster randomized controlled trial, DemStepCare

BMC Geriatrics ◽

10.1186/s12877-021-02114-z ◽

2021 ◽

Vol 21 (1) ◽

Author(s):

Isabella Bablok ◽

◽

Harald Binder ◽

Dominikus Stelzer ◽

Klaus Kaier ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Controlled Trial ◽

Dementia Care ◽

Cluster Randomized Controlled Trial ◽

Control Group ◽

Care Model ◽

Randomized Controlled ◽

Individual Needs ◽

Cluster Randomized ◽

The Individual

Abstract Background Most people with dementia (PwD) are cared for at home, with general practitioners (GPs) playing a key part in the treatment. However, primary dementia care suffers from a number of shortcomings: Often, diagnoses are made too late and therapies by GPs do not follow the guidelines. In cases of acute crises, PwD are too often admitted to hospital with adverse effects on the further course of the disease. The aim of this study is to implement and evaluate a new GP-based, complex dementia care model, DemStepCare. DemStepCare aims to ensure demand-oriented, stepped care for PwD and their caregivers. Methods/design In a cluster randomized controlled trial, the care of PwD receiving a complex intervention, where the GP is supported by a multi-professional team, is compared to (slightly expanded) usual care. GPs are clustered by GP practice, with 120 GP practices participating in total. GP practices are randomized to an intervention or a control group. 800 PwD are to be included per group. Recruitment takes place in Rhineland-Palatinate, Germany. In addition, a second control group with at least 800 PwD will be formed using aggregated routine data from German health insurance companies. The intervention comprises the training of GPs, case management including repeated risk assessment of the patients’ care situation, the demand-oriented service of an outpatient clinic, an electronic case record, external medication analyses and a link to regional support services. The primary aims of the intervention are to positively influence the quality of life for PwD, to reduce the caregivers’ burden, and to reduce the days spent in hospital. Secondary endpoints address medication adequacy and GPs’ attitudes and sensitivity towards dementia, among others. Discussion The GP-based dementia care model DemStepCare is intended to combine a number of promising interventions to provide a complex, stepped intervention that follows the individual needs of PwD and their caregivers. Its effectiveness and feasibility will be assessed in a formative and a summative evaluation. Trial registration German Register of Clinical Trials (Deutsches Register Klinischer Studien, DRKS), DRKS00023560. Registered 13 November 2020 - Retrospectively registered. HTML&TRIAL_ID=DRKS00023560.

Download Full-text

The effect of online multimedia psychoeducational interventions on the resilience and perceived stress of hospitalized patients with COVID-19: a pilot cluster randomized parallel-controlled trial

BMC Psychiatry ◽

10.1186/s12888-021-03085-6 ◽

2021 ◽

Vol 21 (1) ◽

Author(s):

Maryam Shaygan ◽

Zahra Yazdani ◽

Adib Valibeygi

Keyword(s):

Perceived Stress ◽

Mental Health Professionals ◽

Stress Reduction ◽

Controlled Trial ◽

Control Group ◽

Psychological Techniques ◽

Psychological Pressure ◽

Cluster Randomized ◽

High Level ◽

Psychoeducational Interventions

Abstract Background There is evidence suggesting that quarantine might have undesirable psychological impacts on the patients. Therefore, it is important to seek for ways to increase the resilience and alleviate the psychological pressure of the patients who are quarantined due to infection with COVID-19. The present study was conducted to assess an online multimedia psychoeducational intervention regarding the feasibility, adherence, patient satisfaction and effectiveness on resilience and perceived stress of patients hospitalized with confirmed COVID-19. Method This was a pilot cluster randomized parallel-controlled trial with hospital wards as the units of randomization. Participants in this fully online trial were 50 consecutive patients who were hospitalized in 2 hospitals in Shiraz, after being diagnosed with COVID-19. Before the beginning of the intervention, four inpatient wards inside two of the hospitals were randomly assigned to either intervention or control conditions. All eligible participants in the wards allocated to the intervention condition received online multimedia psychoeducational interventions during the 2 weeks, whilst the patients in the wards allocated to the control condition were offered the opportunity to receive telephone-based psychological counseling if needed. Psychoeducational interventions mainly included cognitive–behavioural techniques, stress management techniques, mindfulness-based stress reduction and positive psychotherapy. The patients were assessed regarding resilience and perceived stress at baseline and after two weeks. Results Of 27 patients starting multimedia psychoeducational interventions, 26 (96.29%) completed post-assessments. A high level of adherence (80.76%) and satisfaction (Mean = 29.42; SD = 4.18) with the online multimedia psychoeducational interventions was found. Compared with the control group, the patients who used online multimedia psychoeducational interventions reported greater resilience (Meanintervention = 81.74; Meancontrol = 72.86; adjusted t (46) = 2.10; p = 0.04; CI: 0.39 to 17.38; dppc2 = 0.83) and fewer perceived stress (Meanintervention = 22.15; Meancontrol = 29.45; adjusted t (46) = 2.66; p = 0.01; CI: − 12.81 to − 1.78; dppc2 = − 0.77) after 2 weeks. Discussion The findings of the present study provided a successful first attempt at implementing feasible online multimedia psychoeducational interventions to promote resilience and mitigate stress among the patients who were hospitalized due to infection with COVID-19. The present results could help mental health professionals to determine which psychological techniques should be emphasized to promote patients’ resilience in the context of COVID-19 disease. Trial registration Iranian Registry of Clinical Trials, IRCT20201001048893N1. Retrospectively registered, 29 Jan 2021.

Download Full-text

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

BMC Nursing ◽

10.1186/s12912-021-00616-0 ◽

2021 ◽

Vol 20 (1) ◽

Author(s):

Olga L. Cortés ◽

Mauricio Herrera-Galindo ◽

Juan Carlos Villar ◽

Yudi A. Rojas ◽

María del Pilar Paipa ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Critical Care ◽

Pressure Ulcers ◽

Controlled Trial ◽

Cluster Randomized Controlled Trial ◽

Control Group ◽

Randomized Controlled ◽

Link Type ◽

Cluster Randomized ◽

The Impact

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

Download Full-text

Narrative enhancement and cognitive therapy (NECT) to improve social functioning in people with serious mental illness: study protocol for a stepped-wedge cluster randomized controlled trial

Trials ◽

10.1186/s13063-021-05067-1 ◽

2021 ◽

Vol 22 (1) ◽

Author(s):

J. Dubreucq ◽

M. Faraldo ◽

M. Abbes ◽

B. Ycart ◽

H. Richard-Lepouriel ◽

...

Keyword(s):

Mental Illness ◽

Randomized Controlled Trial ◽

Cognitive Therapy ◽

Social Functioning ◽

Serious Mental Illness ◽

Controlled Trial ◽

Control Group ◽

Stepped Wedge ◽

Randomized Controlled ◽

Cluster Randomized

Abstract Background Self-stigma is highly prevalent in serious mental illness (SMI) and is associated with poorer clinical and functional outcomes. Narrative enhancement and cognitive therapy (NECT) is a group-based intervention combining psychoeducation, cognitive restructuring and story-telling exercises to reduce self-stigma and its impact on recovery-related outcomes. Despite evidence of its effectiveness on self-stigma in schizophrenia-related disorders, it is unclear whether NECT can impact social functioning. Methods This is a 12-centre stepped-wedge cluster randomized controlled trial of NECT effectiveness on social functioning in SMI, compared to treatment as usual. One hundred and twenty participants diagnosed with schizophrenia, bipolar disorder or borderline personality disorder will be recruited across the 12 sites. The 12 centres participating to the study will be randomized into two groups: one group (group 1) receiving the intervention at the beginning of the study (T0) and one group (group 2) being a control group for the first 6 months and receiving the intervention after (T1). Outcomes will be compared in both groups at T0 and T1, and 6-month and 12-month outcomes for groups 1 and 2 will be measured without a control group at T2 (to evaluate the stability of the effects over time). Evaluations will be conducted by assessors blind to treatment allocation. The primary outcome is personal and social performance compared across randomization groups. Secondary outcomes include self-stigma, self-esteem, wellbeing, quality of life, illness severity, depressive symptoms and personal recovery. Discussion NECT is a promising intervention for reducing self-stigma and improving recovery-related outcomes in SMI. If shown to be effective in this trial, it is likely that NECT will be implemented in psychiatric rehabilitation services with subsequent implications for routine clinical practice. Trial registration ClinicalTrials.gov NCT03972735. Trial registration date 31 May 2019.

Download Full-text

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.

Download Full-text

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.

Download Full-text