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1,281
result(s) for
"cluster‐randomized trial"
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Getting Parents Involved: A Field Experiment in Deprived Schools
2014
This article provides evidence that schools can influence parents' involvement in education, and this has causal effects on pupils' behaviour. Furthermore, it shows how the impact of more involved parents on their children is amplified at the class level by peer group interaction. We build on a large-scale controlled experiment run in a French deprived educational district, where parents of middle-school children were invited to participate in a simple program of parent-school meetings on how to get better involved in their children's education. At the end of the school year, we find that treated families have increased their schooland home-based involvement activities. In turn, pupils of treatment classes have developed more positive behaviour and attitudes in school, notably in terms of truancy and disciplinary sanctions (with effects-size around 15% of a standard deviation). However, test scores did not improve under the intervention. Our results suggest that parents are an input for schooling policies and it is possible to influence important aspects of the schooling process at low cost.
Journal Article
Community-based lifestyle intervention for diabetes (Co-LID study) management in rural Nepal: study protocol for a clustered randomized controlled trial
by
Shakya, Prabin
,
Shrestha, Archana
,
Sugishita, Tomohiko
in
Biomedicine
,
Care and treatment
,
Clinical trials
2023
Background
Type 2 diabetes mellitus (T2DM) has increased globally; with a disproportionate burden in South and Southeast Asian countries, including Nepal. There is an urgent need for clinically and cost-effective culturally adapted T2DM management programs. In this study, we aim to assess the effectiveness of community based culturally appropriate lifestyle intervention in improving the management and care of people with T2DM.
Methods
We will conduct a cluster randomized control trial to evaluate the effectiveness of community based culturally appropriate lifestyle intervention in improving T2DM outcomes. The trial will be conducted in 30 randomly selected healthcare facilities from two purposively selected districts (Kavrepalanchowk and Nuwakot districts) of Bagmati province, Nepal. The selected healthcare facilities are being randomized into 15 interventions (
n
= 15) and usual care (
n
= 15) groups. Those in the intervention will receive group-based 12 an hour-long fortnightly session delivered over 6 months period. The intervention package includes 12 planned modules related to diabetes care, ongoing support, supervision and monitoring, follow-up from the trained community health workers, and educational materials on diabetes self-management. The participants in the usual care groups will receive pictorial brochure on diabetes management and they will continue receiving the usual care available from the local health facilities. The primary outcome is HbA1c level, and the secondary outcomes include quality of life, health care utilization, and practice of self-care behaviour, depression, oral health quality of life, and economic assessment of the intervention. Two points measurements will be collected by the trained research assistants at baseline and at the end of the intervention.
Discussion
This study will provide tested approaches for culturally adapting T2DM interventions in the Nepalese context. The findings will also have practice and policy implications for T2DM prevention and management in Nepal.
Trial registration
Australia and New Zealand Clinical Trial Registry (ACTRN12621000531819). Registered on May 6, 2021.
Journal Article
Community-based lifestyle intervention for diabetes (Co-LID study) management in rural Nepal: study protocol for a clustered randomized controlled trial
by
Hanako Iwashita
,
Rajendra Koju
,
Uday Yadav
in
Cluster randomized controlled trial
,
Community-based
,
Diabetes Mellitus, Type 2
2023
Journal Article
Increasing energy- and greenhouse gas-saving behaviors among adolescents: a school-based cluster-randomized controlled trial
2014
Individual behavior change can serve as a key strategy for reducing energy use to mitigate greenhouse gas (GHG) emissions and improve energy security. A theory-based, school-based intervention to promote energy- and GHG-saving behaviors was developed by applying strategies and approaches from prior successful work in health behavior change. The focus was on changing behaviors rather than increasing knowledge, awareness, and attitudes, making extensive use of experimentally validated behavioral theory and principles. The intervention was evaluated in a cluster-randomized controlled trial. Public high school students (
N
= 165) in a required course were randomized by teacher to receive a 5-week, five-lesson behavior change curriculum promoting changes to reduce home electricity-, transportation-, and food-related energy use and GHG emissions or their usual coursework. Students reported their energy- and GHG-saving behaviors at baseline and 6 weeks later (1 week after the completion of the curriculum for the treatment group students). Effects were tested with hierarchical linear models to account for potential clustering within classrooms. Students randomized to receive the curriculum statistically significantly increased their total energy- and GHG-saving behaviors compared to controls [adjusted difference = 0.43 on a scale from 0 to 6 behavioral categories, 95 % confidence interval (CI) = 0.07 to 0.80,
p
= 0.02; number needed to treat (NNT) = 4.1]. The largest effects occurred in hang drying clothing (adjusted difference = 0.098, 95 % CI 0.028 to 0.165, NNT = 4.1) and shutting off appliances and other energy-using devices when not in use (adjusted difference = 0.095; 95 % CI 0.055 to 0.135; NNT 3.5). These results indicate that a theory-driven, school-based classroom intervention can increase energy- and GHG-saving behaviors among adolescents.
Journal Article
Systematic pain assessment in nursing homes: a cluster-randomized trial using mixed-methods approach
by
Sköldunger, Anders
,
Sjölund, Britt-Marie
,
Fläckman, Birgitta
in
Activities of Daily Living
,
Aged
,
Aged, 80 and over
2017
Background
Chronic pain affects nursing home residents’ daily life. Pain assessment is central to adequate pain management. The overall aim was to investigate effects of a pain management intervention on nursing homes residents and to describe staffs’ experiences of the intervention.
Methods
A cluster-randomized trial and a mixed-methods approach. Randomized nursing home assignment to intervention or comparison group. The intervention group after theoretical and practical training sessions, performed systematic pain assessments using predominately observational scales with external and internal facilitators supporting the implementation. No measures were taken in the comparison group; pain management continued as before, but after the study corresponding training was provided. Resident data were collected baseline and at two follow-ups using validated scales and record reviews. Nurse group interviews were carried out twice. Primary outcome measures were wellbeing and proxy-measured pain. Secondary outcome measures were ADL-dependency and pain documentation.
Results
Using both non-parametric statistics on residential level and generalized estimating equation (GEE) models to take clustering effects into account, the results revealed non-significant interaction effects for the primary outcome measures, while for ADL-dependency using Katz-ADL there was a significant interaction effect. Comparison group (
n
= 66 residents) Katz-ADL values showed increased dependency over time, while the intervention group demonstrated no significant change over time (
n
= 98). In the intervention group, 13/44 residents showed decreased pain scores over the period, 14/44 had no pain score changes ≥ 30% in either direction measured with Doloplus-2. Furthermore, 17/44 residents showed increased pain scores ≥ 30% over time, indicating pain/risk for pain; 8 identified at the first assessment and 9 were new, i.e. developed pain over time. No significant changes in the use of drugs was found in any of the groups. Nursing pain related documentation was sparse. In general, nurses from the outset were positive regarding pain assessments. Persisting positive attitudes seemed strengthened by continued assessment experiences and perceptions of improved pain management.
Conclusion
The implementation of a systematic work approach to pain issues in nursing homes indicates that an increased awareness, collaboration across and shared understanding among the team members of the pain assessment results can improve pain management and lead to decreased physical deterioration or the maintenance of physical and functional abilities among NH residents. However, pain (proxy-measured) and wellbeing level did not reveal any interaction effects between the groups over time.
Trial registration
The study was registered in
ISRCTN71142240
in September 2012, retrospectively registered.
Journal Article
Community‐based differentiated service delivery models incorporating multi‐month dispensing of antiretroviral treatment for newly stable people living with HIV receiving single annual clinical visits: a pooled analysis of two cluster‐randomized trials in southern Africa
by
Ngorima‐Mabhena, Nicoletta
,
Lombard, Carl
,
Chasela, Charles
in
Acquired immune deficiency syndrome
,
Adult
,
Africa, Southern
2021
Introduction Differentiated service delivery (DSD) models for HIV treatment decrease health facility visit frequency and limit healthcare facility‐based exposure to severe acute respiratory syndrome coronavirus 2. However, two important evidence gaps include understanding DSD effectiveness amongst clients commencing DSD within 12 months of antiretroviral treatment (ART) initiation and amongst clients receiving only single annual clinical consultations. To investigate these, we pooled data from two cluster‐randomized trials investigating community‐based DSD in Zimbabwe and Lesotho. Methods Individual‐level participant data of newly stable adults enrolled between 6 and 12 months after ART initiation were pooled. Both trials (conducted between August 2017 and July 2019) had three arms: Standard‐of‐care three‐monthly ART provision at healthcare facilities (SoC, control); ART provided three‐monthly in community ART groups (CAGs) (3MC) and ART provided six‐monthly in either CAGs or at community‐distribution points (6MC). Clinical visits were three‐monthly in SoC and annually in intervention arms. The primary outcome was retention in care and secondary outcomes were viral suppression (VS) and number of unscheduled facility visits 12 months after enrolment. Individual‐level regression analyses were conducted by intention‐to‐treat specifying for clustering and adjusted for country. Results and Discussion A total of 599 participants were included; 212 (35.4%), 128 (21.4%) and 259 (43.2%) in SoC, 3MC and 6MC, respectively. Few participants aged <25 years were included (n = 32). After 12 months, 198 (93.4%), 123 (96.1%) and 248 (95.8%) were retained in SoC, 3MC and 6MC, respectively. Retention in 3MC was superior versus SoC, adjusted risk difference (aRD) = 4.6% (95% CI: 0.7%−8.5%). Retention in 6MC was non‐inferior versus SoC, aRD = 1.7% (95% CI: −2.5%−5.9%) (prespecified non‐inferiority aRD margin −3.25%). VS was similar between arms, 99.3, 98.6 and 98.1% in SoC, 3MC and 6MC, respectively. Adjusted risk ratio's for VS were 0.98 (95% CI: 0.92−1.03) for 3MC versus SoC, and 0.98 (CI: 0.95−1.00) for 6MC versus SoC. Unscheduled clinic visits were not increased in intervention arms: incidence rate ratio = 0.53 (CI: 0.16−1.80) for 3MC versus SoC; and 0.82 (CI: 0.25−2.79) for 6MC versus SoC. Conclusions Community‐based DSD incorporating three‐ and six‐monthly ART refills and single annual clinical visits were at least non‐inferior to standard facility‐based care amongst newly stable ART clients aged ≥25 years. ClinicalTrials.gov: NCT03238846 & NCT03438370
Journal Article
Fixed‐dose combination therapy‐based protocol compared with free pill combination protocol: Results of a cluster randomized trial
by
Ojji, Dike B.
,
Eze, Helen
,
Kandula, Namratha R.
in
Adult
,
Antihypertensive Agents - adverse effects
,
Blood Pressure
2023
Fixed‐dose combination (FDC) therapy is recommended for hypertension management in Nigeria based on randomized trials at the individual level. This cluster‐randomized trial evaluates effectiveness and safety of a treatment protocol that used two‐drug FDC therapy as the second and third steps for hypertension control compared with a protocol that used free pill combinations. From January 2021 to June 2021, 60 primary healthcare centers in the Federal Capital Territory of Nigeria were randomized to a protocol using FDC therapy as second and third steps compared with a protocol that used the same medications in free pill combination therapy for these steps. Eligible patients were adults (≥18 years) with hypertension. The primary outcome was the odds of a patient being controlled at their last visit between baseline to 6‐month follow‐up in the FDC group compared to the free pill group. 4427 patients (mean [SD] age: 49.0 [12.4] years, 70.5% female) were registered with mean (SD) baseline systolic/diastolic blood pressure 155 (20.6)/96 (13.1) mm Hg. Baseline characteristics of groups were similar. After 6‐months, hypertension control rate improved in the two treatment protocols, but there were no differences between the groups after adjustment (FDC = 53.9% versus free pill combination = 47.9%, cluster‐adjusted p = .29). Adverse events were similarly low (<1%) in both groups. Both protocols improved hypertension control rates at 6‐months in comparison to baseline, though no differences were observed between groups. Further work is needed to determine if upfront FDC therapy is more effective and efficient to improve hypertension control rates.
Journal Article
An educational intervention to prevent overweight in pre-school years: a cluster randomised trial with a focus on disadvantaged families
by
Hodgkinson, Alison
,
Qualter, Pamela
,
Hurley, Margaret A.
in
Biostatistics
,
Child, Preschool
,
Childhood
2019
Background
Early prevention is a promising strategy for reducing obesity in childhood, and Early Years settings are ideal venues for interventions. This work evaluated an educational intervention with the primary aim of preventing overweight and obesity in pre-school children.
Methods
A pragmatic, cluster randomised trial with a parallel, matched-pair design was undertaken. Interventions were targeted at both the cluster (Early Years’ Centres, matched by geographical area) and individual participant level (families: mother and 2-year old child). At the cluster level, a staff training intervention used the educational resource
Be Active, Eat Healthy.
Policies and provision for healthy eating and physical activity were evaluated at baseline and 12-months. The intervention at participant level was the
Healthy Heroes Activity Pack
: delivered over 6 months by Centre staff to promote healthy eating and physical activity in a fun, interactive way. Child and parent height and weight were measured at four time-points over 2 years. The trial primary outcome was the change in BMI z-score of the child between ages 2 and 4 years. Secondary outcomes consisted of parent-reported measures administered at baseline and two-year follow-up.
Results
Five pairs of Early Years’ Centres were recruited. Four pairs were analysed as one Centre withdrew (47 intervention families; 34 control families). At the cluster level, improvement in Centre policies and practices was similar for both groups (
p
= 0.830). At the participant level, the intervention group reduced their mean BMI z-score between age 2 and 4 years (
p
= 0.002; change difference 0.49; 95% CI 0.17 to 0.80) whereas the control group showed increasing BMI z-score throughout. Changes in parent-reported outcomes and parent BMI (
p
= 0.582) were similar in both groups.
Conclusions
The
Healthy Heroes
educational resource deterred excess weight gain in pre-school children from poor socioeconomic areas. With training, Early Years’ staff can implement the
Healthy Heroes
programme.
Trial registration
ISRCTN22620137
Registered 21st December 2016.
Journal Article
Effect of a Spiritual Care Program on Treatment Adherence and Sleep Quality in Hemodialysis Patients: A Cluster‐Randomized Clinical Trial
by
Parizad, Naser
,
Alinejad, Vahid
,
Khorami Markani, Abdullah
in
Anxiety
,
Chronic illnesses
,
Clinical trials
2025
Background and Aims Declining sleep quality is common among hemodialysis patients, adversely affecting their quality of life and treatment adherence. Improving sleep is a nursing priority, and targeted interventions might be beneficial. This study aimed to evaluate the effect of a spiritual care program on treatment adherence and sleep quality in hemodialysis patients. Methods This study was a parallel, two‐group, cluster‐randomized clinical trial with a pretest–posttest design. In 2023, 80 hemodialysis patients from two teaching hospitals in Urmia, Iran, were enrolled via convenience sampling and cluster‐randomized by hospital unit to intervention (n = 39) or control (n = 37 completers) groups. The intervention involved four 1 h spiritual care sessions twice weekly post‐dialysis. Outcomes were measured using the End‐Stage Renal Disease Adherence Questionnaire (ESRD‐AQ) and Pittsburgh Sleep Quality Index (PSQI) at baseline and 1 month post‐intervention. Data were analyzed in SPSS v26.0. Normality was checked with Kolmogorov−Smirnov, between‐group differences with independent t‐tests, and within‐group changes with paired t‐tests. Results The mean age of the 76 participants was 52.09 years (range: 20–84 years); 65 participants (85.5%) were male, and 11 (14.5%) were female. Baseline scores showed no significant between‐group differences (adherence: p = 0.848; sleep quality: p = 0.891). Post‐intervention, the intervention group had significantly higher adherence (mean difference: 219.60 [95% CI: 159.51–279.69]; p < 0.001; Cohen's d = 1.92) and better sleep quality (mean difference: −2.67 [95% CI: −1.46 to −3.88]; p = 0.006; Cohen's d = 0.68) compared to the control group. Within the intervention group, adherence improved (p < 0.001; Cohen's d = 2.15) and sleep quality enhanced (p < 0.001; Cohen's d = 0.79); no changes were observed in the control group (p > 0.05). Conclusion A spiritual care program improves treatment adherence and sleep quality in hemodialysis patients. Hospital administrators should integrate spiritual interventions like meditation and counseling, considering barriers such as staffing. Future studies should include diverse populations and longer follow‐ups. Reporting Tool The CONSORT 2010 checklist was used. Summary What does this paper contribute to the wider global community? The Spiritual Care Program can improve treatment adherence and enhance sleep quality in hemodialysis patients. This study's results emphasize the importance of spiritual care for patients receiving hemodialysis. This report urges health authorities to take spiritual care seriously for hemodialysis patients. As the number of hemodialysis patients increases in Iran and worldwide, these findings could significantly help reduce complications and mortality rates.
Journal Article
Changes in risk behaviour following a network peer education intervention for HIV prevention among male Tajik migrants who inject drugs in Moscow: a cluster‐randomized controlled trial
by
Mackesy‐Amiti, Mary Ellen
,
Luc, Casey M.
,
Jonbekov, Jonbek
in
Acquired immune deficiency syndrome
,
Adult
,
AIDS
2024
Introduction The “Migrants’ Approached Self‐Learning Intervention in HIV/AIDS for Tajiks” (MASLIHAT) recruits and trains Tajik labour migrants who inject drugs as peer educators (PEs) in delivering HIV prevention information and encouragement to adopt risk‐reduction norms and practices within their diaspora social networks while reducing their own HIV risk. Methods The MASLIHAT intervention was tested in Moscow in a cluster‐randomized controlled trial with 12 recruitment sites assigned to either the MASLIHAT intervention or an equal‐time peer‐educator training focused on other health conditions (TANSIHAT). From October 2021 to April 2022, 140 male Tajik migrants who inject drugs were recruited as PEs to attend the 5‐session MASLIHAT training or the TANSIHAT non‐HIV comparison condition. Each participant in both groups recruited two network members (NMs) who inject drugs with the intent to share with them the information and positive strategies for change they had learned (n = 280). All PEs and NMs (n = 420) participated in baseline and follow‐up interviews at 3‐month intervals for 1 year. All received HIV counselling and testing. Modified mixed effects Poisson regressions tested for group differences in injection practices, sexual risk behaviours and heavy alcohol use over time. Results At baseline, across both groups, 75% of participants reported receptive syringe sharing (RSS), 42% reported condomless sex and 20% reported binge drinking at least once a month. In contrast to TANSIHAT where HIV risk behaviours remained the same, significant intervention effects that were sustained over the 12 months were observed for receptive syringe and ancillary equipment sharing among both MASLIHAT PEs and NMs (p < 0.0001). Significant declines in the prevalence of sexual risk behaviours were also associated with the MASLIHAT intervention (p < 0.01), but not the comparison condition. Binge alcohol use was not affected in either condition; the MASLIHAT intervention had a transitory effect on drinking frequency that dissipated after 9 months. Conclusions The MASLIHAT peer‐education intervention proved highly effective in reducing HIV‐related injection risk behaviour, and moderately effective in reducing sexual risk behaviour among both PEs and NMs. Network‐based peer education is an important tool for HIV prevention among people who inject drugs, especially in environments that are not amenable to community‐based harm reduction.
Journal Article