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

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

10.2196/12950 ◽  
2020 ◽  
Vol 9 (2) ◽  
pp. e12950
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 P<.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. Trial Registration 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 Identifier (IRRID) PRR1-10.2196/12950

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.

scholarly journals 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

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.

Meridian Cuffing Exercises Improved Functional Fitness and Cardiopulmonary Functioning of Community Older Adults

2018 ◽  
Vol 29 (1) ◽  
pp. 37-47 ◽  
Author(s):  
Hsiao-Ting Tung ◽  
Chi-Chieh Lai ◽  
Kuei-Min Chen ◽  
Han-Ya Tsai
Keyword(s):  
Older Adults ◽  
Community Care ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Functional Fitness ◽  
Randomized Controlled ◽  
Cluster Randomized ◽  
Study Intervention ◽  
Single Blind

This study was aimed to test the effects of a meridian cuffing exercise, the Healthy Beat Acupunch (HBA) regimen, on the functional fitness and cardiopulmonary functioning of community older adults. A single-blind, cluster randomized controlled trial was conducted. We randomly allocated eight community care centers to the intervention or control group and recruited 228 participants who completed the study (intervention: four centers, n = 111; control: four centers, n = 117). The intervention group underwent a 40-min session of HBA regimen 3 times per week for 6 months. Functional fitness and cardiopulmonary functioning were assessed at baseline, 3 months, and 6 months of the intervention. The intervention group demonstrated significantly greater improvements in functional fitness and cardiopulmonary functioning than the control group between baseline and either 3 months or 6 months. We suggest that activities designed to promote health among community older adults include acupunch exercises.

scholarly journals Universal Screening and Decolonization for Control of MRSA in Nursing Homes: A Cluster Randomized Controlled Study

2015 ◽  
Vol 36 (4) ◽  
pp. 401-408 ◽  
Author(s):  
Cristina Bellini ◽  
Christiane Petignat ◽  
Eric Masserey ◽  
Christophe Büla ◽  
Bernard Burnand ◽  
...  
Keyword(s):  
Universal Screening ◽  
Controlled Trial ◽  
Intervention Group ◽  
Controlled Study ◽  
Control Group ◽  
Standard Precautions ◽  
Carriage Rate ◽  
Randomized Controlled ◽  
Cluster Randomized ◽  
The Impact

OBJECTIVEThe risk of carrying methicillin-resistant Staphylococcus aureus (MRSA) is higher among nursing home (NH) residents than in the general population. However, control strategies are not clearly defined in this setting. In this study, we compared the impact of standard precautions either alone (control) or combined with screening of residents and decolonization of carriers (intervention) to control MRSA in NHs.DESIGNCluster randomized controlled trialSETTINGNHs of the state of Vaud, SwitzerlandPARTICIPANTSOf 157 total NHs in Vaud, 104 (67%) participated in the study.INTERVENTIONStandard precautions were enforced in all participating NHs, and residents underwent MRSA screening at baseline and 12 months thereafter. All carriers identified in intervention NHs, either at study entry or among newly admitted residents, underwent topical decolonization combined with environmental disinfection, except in cases of MRSA infection, MRSA bacteriuria, or deep skin ulcers.RESULTSNHs were randomly allocated to a control group (51 NHs, 2,412 residents) or an intervention group (53 NHs, 2,338 residents). Characteristics of NHs and residents were similar in both groups. The mean screening rates were 86% (range, 27%–100%) in control NHs and 87% (20%–100%) in intervention NHs. Prevalence of MRSA carriage averaged 8.9% in both control NHs (range, 0%–43%) and intervention NHs (range, 0%–38%) at baseline, and this rate significantly declined to 6.6% in control NHs and to 5.8% in intervention NHs after 12 months. However, the decline did not differ between groups (P=.66).CONCLUSIONUniversal screening followed by decolonization of carriers did not significantly reduce the prevalence of the MRSA carriage rate at 1 year compared with standard precautions.Infect Control Hosp Epidemiol 2015;00(0): 1–8

scholarly journals Effectiveness of a Non-pharmacological Intervention to Control Diabetes Mellitus in a Primary Care Setting in Kerala: A Cluster-Randomized Controlled Trial

2021 ◽  
Vol 9 ◽  
Author(s):  
Arya Rahul ◽  
Sujatha Chintha ◽  
Thekkumkara Surendran Anish ◽  
Kannamkottapilly Chandrasekharan Prajitha ◽  
Pillaveetil Sathyadas Indu
Keyword(s):  
Diabetes Mellitus ◽  
Primary Care ◽  
Randomized Controlled Trial ◽  
Glycemic Control ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Randomized Controlled ◽  
Baseline Values ◽  
Cluster Randomized

Background: Despite being the first Indian state with a dedicated Non-Communicable Disease (NCD) program, glycemic control among a large proportion of patients is low in Kerala. This study tries to find evidence for a standardized non-pharmacological strategy delivered through Junior Public Health Nurses (JPHNs) in achieving and maintaining glycemic control among diabetic patients registered with NCD clinics of primary health care settings.Design: A cluster randomized controlled trial was conducted among adult patients with Diabetes Mellitus attending NCD clinics of primary care settings of South Kerala, India. JPHNs of the intervention group received additional module-based training while standard management continued in the control group. Sequence generation was done by random permuted blocks method and a cluster of 12 patients was selected from each of the 11 settings by computer-generated random numbers. Patients were followed up for 6 months with monthly monitoring of Fasting Blood Sugar (FBS), Post-Prandial Blood Sugar (PPBS), blood pressure, Body Mass Index (BMI), and health-related behaviors. Knowledge and skills/practice of JPHNs were also evaluated. Analysis of Covariance was done to study the final outcome adjusting for the baseline values and a model for glycemic control was predicted using multilevel modeling.Results: We analyzed 72 participants in the intervention group and 60 participants in the control group according to the intention-to-treat principle. The intervention was associated with a significant reduction in FBS (p &lt; 0.001) and PPBS (p &lt; 0.001) adjusting for the baseline values. The achievement of glycemic control was 1.5 (95% CI: 1.05–2.3) times better with intervention and they showed a better trend of maintenance of glycemic control (FBS, p = 0.003 and PPBS, p = 0.039). Adjusting for clustering and the baseline values, the intervention showed a significant effect on FBS (B = −3.1, SE = 0.57; p &lt; 0.001) and PPBS (B = −0.81, SE = 0.3; p &lt; 0.001) with time. Drug adherence score (p &lt; 0.001), hours of physical activity (p &lt; 0.001), BMI (p = 0.002), fruit intake (p = 0.004), and green leafy vegetable intake (p = 0.01) were the major predictors of FBS control. The practice/skills score of the JPHNs significantly improved with intervention (p &lt; 0.001) adjusting for baseline values.Conclusion: A well-designed health worker intervention package incorporated into the existing health system can translate into attitude change and skill development in the health workers which can reflect in the improvement of glycemic control among the patients.Trial registration: [URL: http://www.ctri.nic.in], identifier [CTRI/2017/11/010622].

scholarly journals An App-Based Intervention for Caregivers to Prevent Unintentional Injury Among Preschoolers: Cluster Randomized Controlled Trial

10.2196/13519 ◽  
2019 ◽  
Vol 7 (8) ◽  
pp. e13519 ◽  
Author(s):  
Peishan Ning ◽  
Peixia Cheng ◽  
David C Schwebel ◽  
Yang Yang ◽  
Renhe Yu ◽  
...  
Keyword(s):  
Injury Prevention ◽  
Controlled Trial ◽  
Intervention Group ◽  
Unintentional Injury ◽  
Control Group ◽  
Injury Incidence ◽  
Child Injury ◽  
Randomized Controlled ◽  
Cluster Randomized

Background App-based interventions have the potential to reduce child injury in countries with limited prevention resources, but their effectiveness has not been rigorously examined. Objective This study aimed to assess the effectiveness of an app-based intervention for caregivers of preschoolers to prevent unintentional injury among Chinese preschoolers. Methods A 6-month cluster randomized controlled trial was conducted from December 2017 to June 2018. Recruitment was conducted through preschools, which were randomly allocated to either the control group (ie, app-based parenting education excluding unintentional injury prevention) or the intervention group (ie, app-based parenting education including unintentional injury prevention). A total of 2920 caregivers of preschoolers aged 3-6 years from 20 preschools in Changsha, China, were recruited offline through the schools. The primary outcome was unintentional injury incidences among preschoolers in the past 3 months; this measure was assessed through an online caregiver-report at the baseline visit and at 3-month and 6-month follow-up visits. Secondary outcome measures included caregivers’ self-reported attitudes and behaviors concerning child supervision during the last week. Generalized estimating equations (GEEs) were used to assess the effectiveness of the app-based intervention on responses at 3 and 6 months after adjusting for sociodemographic variables, baseline level of the outcome variable, and engagement with interventions in the assigned group. All analyses were intention-to-treat. A per-protocol sensitivity analysis was also conducted. Results In total, 1980 of the 2920 caregivers completed the study. The mean age of participants was 32.0 years (SD 5.5) and 68.99% (1366/1980) of them were female. During the 6-month follow-up visit, unintentional injury incidence did not change significantly in either group: incidence in the intervention group went from 8.76% (94/1073) to 8.11% (87/1073), P=.59; incidence in the control group went from 9.4% (85/907) to 7.5% (69/907), P=.15. The changes did not differ between the groups (odds ratio [OR] 1.14, 95% CI 0.80-1.62). Changes in the average score in attitude concerning unintentional injury prevention were also similar between the groups (B .05, 95% CI -0.03 to 0.13). Changes in unintentional injury prevention behaviors were greater in the intervention group than in the control group after the intervention (B .87, 95% CI 0.33-1.42). Analyses of individual injury prevention behaviors showed that the intervention reduced three risky behaviors: unsafe feeding of children (OR 0.73, 95% CI 0.60-0.89); incorrectly placing children in cars (OR 0.73, 95% CI 0.57-0.93); and allowing children to ride bicycles, electric bicycles, or motorcycles unsupervised (OR 0.80, 95% CI 0.64-0.99). The intervention also improved scores on three safety-focused behaviors: testing water temperature before giving children a bath (OR 1.26, 95% CI 1.05-1.52); properly storing sharp objects (OR 1.24, 95% CI 1.01-1.52); and safely storing medicines, detergents, and pesticides (OR 1.24, 95% CI 1.02-1.51). Conclusions The app-based intervention did not reduce unintentional injury incidence among preschoolers but significantly improved caregivers’ safety behaviors. This app-based intervention approach to improve caregiver behaviors surrounding child injury risk offers promise to be modified and ultimately disseminated broadly. Trial Registration Chinese Clinical Trial Registry ChiCTR-IOR-17010438; http://www.chictr.org.cn/showproj.aspx?proj=17376 (Archived by WebCite at http://www.webcitation.org/75jt17X84) International Registered Report Identifier (IRRID) RR2-10.1186/s12889-018-5790-1

scholarly journals Effect of an information leaflet on breast cancer screening participation: A cluster randomized controlled trial

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Jose Maria Montero-Moraga ◽  
Margarita Posso ◽  
Marta Román ◽  
Andrea Burón ◽  
Maria Sala ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Randomized Controlled Trial ◽  
Cancer Screening ◽  
Breast Cancer Screening ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Information Leaflet ◽  
Randomized Controlled ◽  
Cluster Randomized

Abstract Objective To evaluate the impact of an information leaflet about the risk-benefit balance of breast cancer screening on women’s participation. Methods This cluster randomized controlled trial was conducted within a population-based breast cancer screening program and included women from the catchment areas of two hospitals in Barcelona, Spain. We evaluated women aged 50–69 years invited to screening between September 2019 and January 2020. The intervention group received an information leaflet on the benefits and harms of mammography screening. The control group received the usual invitation letter. The clusters consisted of the processing days of the invitation letter, assigned to the intervention with a simple random allocation scheme. We compared the participation rate at the individual level between groups, stratified by hospital and by per-protocol and intention-to-treat analyses. Results We included 11,119 women (137 clusters): 5416 in the intervention group (66 clusters) and 5703 in the control group (71 clusters). A total of 36% (1964/5393) of the women in the intervention group and 37% (2135/5694) of those in the control group attended screening, respectively. Overall, we found no differences in participation among groups (difference in participation − 1.1%; 95%CI; − 2.9 to 0.7%). In a hospital attending a population with a low socioeconomic status, attendance was lower in the intervention group (− 1.4, 95%CI: − 5.7% to − 0.03%). Conclusions Overall participation in our program was unaffected by a new information leaflet on the risk-benefit balance of breast cancer screening. However, participation was lower in certain populations with lower socioeconomic status Trial registration Trial registration number ISRCTN13848929.

scholarly journals Five-year follow-up of a cluster-randomized controlled trial of a client-centred activities of daily living intervention for people with stroke

2018 ◽  
Vol 33 (2) ◽  
pp. 262-276 ◽  
Author(s):  
Annicka Hedman ◽  
Gunilla Eriksson ◽  
Lena von Koch ◽  
Susanne Guidetti
Keyword(s):  
Controlled Trial ◽  
Intervention Group ◽  
Significant Others ◽  
Control Group ◽  
Randomized Controlled ◽  
Stroke Impact Scale ◽  
Impact Scale ◽  
Cluster Randomized ◽  
Changes Over Time

Objective: To compare five-year outcomes and changes over time of a client-centred activities of daily living (ADL) intervention versus usual ADL interventions for people with stroke and their significant others. Design: Five-year follow-up of a cluster-randomized controlled trial where a client-centred ADL intervention ( n = 129) or usual ADL interventions ( n = 151) were delivered to people with stroke. Setting: Multicentre study including 16 inpatient or home-based rehabilitation units. Participants: People with stroke and significant others. Intervention: The client-centred ADL intervention aimed at enabling agency in daily activities and participation in everyday life and at reducing caregiver burden. Main measures: For people with stroke, perceived participation (Stroke Impact Scale), independence in ADL, life satisfaction, and use of formal/informal care were measured. For significant others, caregiver burden, life satisfaction, and mood (Hospital Anxiety and Depression Scale) were assessed. Results: Five years post-intervention, data were collected from 145 people with stroke (intervention group: n = 71/control group: n = 74) and 75 significant others (intervention group: n = 36/control group: n = 39). For those with stroke, the Participation domain of the Stroke Impact Scale showed no group differences at year five (68.9 vs 75.4, P = 0.062) or in changes over time. At year five, the control group had better outcomes regarding Other help/supervision. Significant others in the control group were more likely to show signs of depression at year five (odds ratio = 22.3; P < 0.001). Conclusion: The client-centred ADL intervention appears to render similar long-term effects as usual ADL interventions for people with stroke, but for significant others signs of depression might be reduced.

scholarly journals The effects of bright light treatment on affective symptoms in people with dementia: a 24-week cluster randomized controlled trial

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Eirin Kolberg ◽  
Gunnhild Johnsen Hjetland ◽  
Eirunn Thun ◽  
Ståle Pallesen ◽  
Inger Hilde Nordhus ◽  
...  
Keyword(s):  
Nursing Home ◽  
Controlled Trial ◽  
Intervention Group ◽  
Bright Light ◽  
Light Treatment ◽  
Control Group ◽  
Randomized Controlled ◽  
People With Dementia ◽  
Affective Symptoms ◽  
Cluster Randomized

Abstract Background The majority of people with dementia have behavioral and psychological symptoms of dementia (BPSD), including depression, anxiety and agitation. These may be elicited or aggravated by disrupted circadian rhythms. Bright light treatment (BLT) is a promising non-pharmacological approach to the management of BPSD, but previous research has yielded mixed results. Methods Eight nursing home dementia units (1 unit = 1 cluster) with 78 patients were invited to participate in a cluster randomized controlled trial from September 2017 to April 2018 investigating the effects of BLT on sleep and circadian rhythms (primary outcome) and BPSD (secondary outcome). Ceiling mounted LED-panels were installed in the intervention group (four units), providing light at 1000 lx and 6000 K (vertically at 1.2 m) between 10 a.m. and 3 p.m., with lower values in the mornings and evenings. Standard indoor light was used in the control group (four units). BPSD were assessed with The Cornell Scale for Depression in Dementia (CSDD) and the Neuropsychiatric Inventory Nursing Home Version (NPI-NH). Data collection took place at baseline and after 8, 16 and 24 weeks. Multilevel regression models with and without false discovery rate correction were used for the analysis, with baseline values and dementia stage entered as covariates. Results Sixty-nine patients were included in the study at baseline. Compared to the control group, the intervention group had a larger reduction on the composite scores of both the CSDD (95% CI = − 6.0 – − 0.3) and the NPI-NH (95% CI = − 2.2 – − 0.1), as well as on the NPI-NH Affect sub-syndrome, and the CSDD Mood related signs sub-scale at follow-up after 16 weeks. With FDR correction, the group difference was significant on the CSDD Mood related signs sub-scale (95% CI = − 2.7 – − 0.8) and the NPI-NH Affect sub-syndrome (95% CI = − 1.6 – − 0.2). No differences were found between conditions at weeks 8 or 24. Conclusion Compared to the control condition, affective symptoms were reduced after 16 weeks in the group receiving BLT, suggesting BLT may be beneficial for nursing home patients with dementia. Trial registration ClinicalTrials.gov Identifier: NCT03357328. Retrospectively registered on November 29, 2017.

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