Dataset Information

Assessing the effectiveness and implementation of a chronic disease self-management programme in faith-based organisations in Barbados: protocol for a cluster randomised parallel trial.

ABSTRACT:

Introduction

In the COVID-19 environment of reduced patient interaction with the healthcare system, evidenced-based self-care of chronic disease is vital. We will evaluate the effect of an online chronic disease self-management programme (CDSMP) plus medication adherence tools on systolic blood pressure (SBP) (primary aim) and, seek to understand the barriers and facilitators to implementation of this modified CDSMP in faith-based organisations (FBOs) (secondary aim).

Methods

We will conduct an unblinded cluster randomised trial in FBOs throughout Barbados. Eligibility: Persons ages 35-70 years; a previous diagnosis of hypertension or currently on antihypertensive therapy and the occurrence of two or more blood pressure readings above 130 mm Hg (systolic) or 80 mm Hg (diastolic) on the day of recruitment. Persons not known to have hypertension but who have two or more blood pressure readings at or above 130 mm Hg (systolic) or 80 mm Hg (diastolic) on two recruitment days at least 1 week apart will also be eligible. The unit of randomisation is a church cluster which consists of 7-9 churches. We will perform block randomisation to assign 24 clusters to intervention or control. The intervention has three components: modified CDSMP workshops, distribution of medication pill boxes and use of social media (WhatsApp V.2.0) to encourage medication adherence. Controls will receive one didactic lecture only. We will determine the mean changes in SBP levels for the intervention group versus controls and compare differences in outcomes 6 months' post intervention using mixed effects regression models.

Ethics and dissemination

This project has received ethical approval from the Institutional Review Board of the University of the West Indies in Barbados. Dissemination will use peer-reviewed publications, policy briefs to government and guidelines to leaders of FBOs. We aim to increase the proportion of patients with controlled hypertension and inform implementation of self-management programmes in small populations.

Trail registration number

NCT04437966.

SUBMITTER: Sobers NP

PROVIDER: S-EPMC8491298 | biostudies-literature |

REPOSITORIES: biostudies-literature

ACCESS DATA

Similar Datasets

Project description:ObjectivesThe primary objective of this cluster randomised controlled trial was to compare the effectiveness of the three experimental continence promotion interventions against a control intervention on urinary symptom improvement in older women with untreated incontinence recruited from community organisations. A second objective was to determine whether changes in incontinence-related knowledge and new uptake of risk-modifying behaviours explain these improvements.Setting71 community organisations across the UK.Participants259 women aged 60 years and older with untreated incontinence entered the trial; 88% completed the 3-month follow-up.InterventionsThe three active interventions consisted of a single 60 min group workshop on (1) continence education (20 clusters, 64 women); (2) evidence-based self-management (17 clusters, 70 women); or (3) combined continence education and self-management (17 clusters, 61 women). The control intervention was a single 60 min educational group workshop on memory loss, polypharmacy and osteoporosis (17 clusters, 64 women).Primary and secondary outcome measuresThe primary outcome was self-reported improvement in incontinence 3 months postintervention at the level of the individual. The secondary outcome was change in the International Consultation on Incontinence Questionnaire (ICIQ) from baseline to 3-month follow-up. Changes in incontinence-related knowledge and behaviours were also assessed.ResultsThe highest rate of urinary symptom improvement occurred in the combined intervention group (66% vs 11% of the control group, prevalence difference 55%, 95% CI 43% to 67%, intracluster correlation 0). 30% versus 6% of participants reported significant improvement respectively (prevalence difference 23%, 95% CI 10% to 36%, intracluster correlation 0). The number-needed-to-treat was 2 to achieve any improvement in incontinence symptoms, and 5 to attain significant improvement. Compared to controls, participants in the combined intervention reported an adjusted mean 2.05 point (95% CI 0.87 to 3.24) greater improvement on the ICIQ from baseline to 3-month follow-up. Changes in knowledge and self-reported risk-reduction behaviours paralleled rates of improvement in all intervention arms.ConclusionsContinence education combined with evidence-based self-management improves symptoms of incontinence among untreated older women. Community organisations represent an untapped vector for delivering effective continence promotion interventions.Trial registrationClinicalTrials.gov ID number NCT01239836.

Project description:Bullying refers to verbal, physical or psychological aggression repeated over time that is intended to cause harm or distress to the victims who are unable to defend themselves. It is a key public health priority owing to its widespread prevalence in schools and harmful short- and long-term effects on victims' well-being. There is a need to strengthen the evidence base by testing innovative approaches to preventing bullying. KiVa is a school-based bullying prevention programme with universal and indicated elements and an emphasis on changing bystander behaviour. It achieved promising results in a large trial in Finland, and now requires testing in other countries. This paper describes the protocol for a cluster randomised controlled trial (RCT) of KiVa in Wales.The study uses a two-arm waitlist control pragmatic definitive parallel group cluster RCT design with an embedded process evaluation and calculation of unit cost. Participating schools will be randomised a using a 1:1 ratio to KiVa plus usual provision (intervention group) or usual provision only (control group). The trial has one primary outcome, child self-reported victimisation from bullying, dichotomised as 'victimised' (bullied at least twice a month in the last couple of months) versus 'not victimised'. Secondary outcomes are: bullying perpetration; aspects of child social and emotional well-being (including emotional problems, conduct, peer relations, prosocial behaviour); and school attendance. Follow-up is at 12 months post-baseline. Implementation fidelity is measured through teacher-completed lesson records and independent school-wide observation. A micro-costing analysis will determine the costs of implementing KiVa, including recurrent and non-recurrent unit costs. Factors related to the scalability of the programme will be examined in interviews with head teachers and focus groups with key stakeholders in the implementation of school-based bullying interventions.The results from this trial will provide evidence on whether the KiVa programme is transportable from Finland to Wales in terms of effectiveness and implementation. It will provide information about the costs of delivery and generate insights into factors related to the scalability of the programme.Current Controlled Trials ISRCTN23999021 Date 10-6-13.

Project description:OBJECTIVE:To determine the effectiveness of a theoretically based and individually tailored, text message based, diabetes self management support intervention (SMS4BG) in adults with poorly controlled diabetes. DESIGN:Nine month, two arm, parallel randomised controlled trial. SETTING:Primary and secondary healthcare services in New Zealand. PARTICIPANTS:366 participants aged 16 years and over with poorly controlled type 1 or type 2 diabetes (HbA1c ?65 mmol/mol or 8%) randomised between June 2015 and November 2016 (n=183 intervention, n=183 control). INTERVENTIONS:The intervention group received a tailored package of text messages for up to nine months in addition to usual care. Text messages provided information, support, motivation, and reminders related to diabetes self management and lifestyle behaviours. The control group received usual care. Messages were delivered by a specifically designed automated content management system. MAIN OUTCOME MEASURES:Primary outcome measure was change in glycaemic control (HbA1c) from baseline to nine months. Secondary outcomes included change in HbA1c at three and six months, and self efficacy, diabetes self care behaviours, diabetes distress, perceptions and beliefs about diabetes, health related quality of life, perceived support for diabetes management, and intervention engagement and satisfaction at nine months. Regression models adjusted for baseline outcome, health district category, diabetes type, and ethnicity. RESULTS:The reduction in HbA1c at nine months was significantly greater in the intervention group (mean -8.85 mmol/mol (standard deviation 14.84)) than in the control group (-3.96 mmol/mol (17.02); adjusted mean difference -4.23 (95% confidence interval -7.30 to -1.15), P=0.007). Of 21 secondary outcomes, only four showed statistically significant improvements in favour of the intervention group at nine months. Significant improvements were seen for foot care behaviour (adjusted mean difference 0.85 (95% confidence interval 0.40 to 1.29), P<0.001), overall diabetes support (0.26 (0.03 to 0.50), P=0.03), health status on the EQ-5D visual analogue scale (4.38 (0.44 to 8.33), P=0.03), and perceptions of illness identity (-0.54 (-1.04 to -0.03), P=0.04). High levels of satisfaction with SMS4BG were found, with 161 (95%) of 169 participants reporting it to be useful, and 164 (97%) willing to recommend the programme to other people with diabetes. CONCLUSION:A tailored, text message based, self management support programme resulted in modest improvements in glycaemic control in adults with poorly controlled diabetes. Although the clinical significance of these results is unclear, the findings support further investigation into the use of SMS4BG and other text message based support for this patient population. TRIAL REGISTRATION:Australian New Zealand Clinical Trials Registry ACTRN12614001232628.

Project description:INTRODUCTION:Faith-based organizations can contribute to improving population health, but few dissemination and implementation studies exist. This paper reports countywide adoption, reach, and effectiveness from the Faith, Activity, and Nutrition dissemination and implementation study. DESIGN:This was a group-randomized trial. Data were collected in 2016. Statistical analyses were conducted in 2017. SETTING/PARTICIPANTS:Churches in a rural, medically underserved county in South Carolina were invited to enroll, and attendees of enrolled churches were invited to complete questionnaires (n=1,308 participated). INTERVENTION:Churches (n=59) were randomized to an intervention or control (delayed intervention) condition. Church committees attended training focused on creating opportunities, setting guidelines/policies, sharing messages, and engaging pastors for physical activity (PA) and healthy eating (HE). Churches also received 12 months of telephone-based technical assistance. Community health advisors provided the training and technical assistance. MAIN OUTCOMES MEASURES:The Reach, Efficacy/Effectiveness, Adoption, Implementation, Maintenance (RE-AIM) framework guided measurement of adoption and reach. To assess effectiveness, church attendees completed post-test only questionnaires of perceptions of church environment, PA and fruit and vegetable (FV) self-efficacy, FV intake, and PA. Regression models controlled for church clustering and predominant race of congregation, as well as member age, gender, education, and self-reported cancer diagnosis. RESULTS:Church adoption was 42% (55/132). Estimated reach was 3,527, representing 42% of regular church attendees and 15% of county residents. Intervention church attendees reported greater church-level PA opportunities, PA and HE messages, and PA and HE pastor support (p<0.0001), but not FV opportunities (p=0.07). PA self-efficacy (p=0.07) and FV self-efficacy (p=0.21) were not significantly higher in attendees of intervention versus control churches. The proportion of inactive attendees was lower in intervention versus control churches (p=0.02). The proportion meeting FV (p=0.27) and PA guidelines (p=0.32) did not differ by group. CONCLUSIONS:This innovative dissemination and implementation study had high adoption and reach with favorable environmental impacts, positioning it for broader dissemination. TRIAL REGISTRATION:This study is registered at www.clinicaltrials.gov NCT02868866.

Project description:The protection and promotion of breastfeeding is considered a priority in Europe where only 22% of infants less than 6 months old are exclusively breastfed. In Spain this percentage reaches 24.8% but in our city it falls to 18.26%. Various studies emphasise that the improvement of these results should be based upon the training of health professionals. Following the recommendations of a breastfeeding guide can modify the practice of health professionals and improve results with respect to exclusively or predominatly breastfed children at 6 months of age.This study involves a community based cluster randomized trial in primary healthcare centres in Leganés (Madrid, Spain). The project aims to determine whether the use of an implementation strategy (including training session, information distribution, opinion leader) of a breastfeeding guideline in primary care is more effective than usual diffusion. The number of patients required will be 240 (120 in each arm). It will be included all the mothers of infants born during the study period (6 months) who come to the health centre on the first visit of the child care programme and who give their consent to participate. The main outcome variable is the exclusive o predominant breastfeeding at 6 moths of age..Main effectiveness will be analyzed by comparing the percentage of infants with exclusive or predominant breastfeeding at 6 months between the intervention group and the control group. All statistical tests will be performed with intention to treat. Logistic regression with random effects will be used to adjust for prognostic factors. Confounding factors or factors that might alter the effect recorded will be taken into account in this analysis.Strategies need to be found which facilitate the giving of effective advice on breastfeeding by professionals and which provide support to women during the breastfeeding period. By applying the guide's recommendations, clinical variability can be reduced and the care received by patients can be improved.The trial was registered with ClinicalTrials.gov, number NCT01474096.

Project description:BackgroundMelioidosis, an often-fatal infectious disease caused by the environmental Gram-negative bacillus Burkholderia pseudomallei, is endemic in tropical countries. Diabetes mellitus and environmental exposure are important risk factors for melioidosis acquisition. We aim to evaluate the effectiveness of a multifaceted prevention programme for melioidosis in diabetics in northeast Thailand.Methodology/principal findingsFrom April 2014 to December 2018, we conducted a stepped-wedge cluster-randomized controlled behaviour change trial in 116 primary care units (PCUs) in Ubon Ratchathani province, northeast Thailand. The intervention was a behavioural support group session to help diabetic patients adopt recommended behaviours, including wearing rubber boots and drinking boiled water. We randomly allocated the PCUs to receive the intervention starting in March 2016, 2017 and 2018. All diabetic patients were contacted by phone yearly, and the final follow-up was December 2018. Two primary outcomes were hospital admissions involving infectious diseases and culture-confirmed melioidosis. Of 9,056 diabetics enrolled, 6,544 (72%) received a behavioural support group session. During 38,457 person-years of follow-up, we observed 2,195 (24%) patients having 3,335 hospital admissions involved infectious diseases, 80 (0.8%) melioidosis, and 485 (5%) deaths. In the intention-to-treat analysis, implementation of the intervention was not associated with primary outcomes. In the per-protocol analysis, patients who received a behavioural support group session had lower incidence rates of hospital admissions involving infectious diseases (incidence rate ratio [IRR] 0.89; 95%CI 0.80-0.99, p = 0.03) and of all-cause mortality (IRR 0.54; 95%CI 0.43-0.68, p<0.001). However, the incidence rate of culture-confirmed melioidosis was not significantly lower (IRR 0.96, 95%CI 0.46-1.99, p = 0.66).Conclusions/significanceClear benefits of this multifaceted prevention programme for melioidosis were not observed. More compelling invitations for the intervention, modification of or addition to the behaviour change techniques used, and more frequent intervention may be needed.Trial registrationThis trial is registered with ClinicalTrials.gov, number NCT02089152.

Project description:Implementation research is concerned with bridging the gap between evidence and practice through the study of methods to promote the uptake of research into routine practice. Good quality evidence has been summarised into guideline recommendations to show that peri-operative fasting times could be considerably shorter than patients currently experience. The objective of this trial was to evaluate the effectiveness of three strategies for the implementation of recommendations about peri-operative fasting.A pragmatic cluster randomised trial underpinned by the PARIHS framework was conducted during 2006 to 2009 with a national sample of UK hospitals using time series with mixed methods process evaluation and cost analysis. Hospitals were randomised to one of three interventions: standard dissemination (SD) of a guideline package, SD plus a web-based resource championed by an opinion leader, and SD plus plan-do-study-act (PDSA). The primary outcome was duration of fluid fast prior to induction of anaesthesia. Secondary outcomes included duration of food fast, patients' experiences, and stakeholders' experiences of implementation, including influences. ANOVA was used to test differences over time and interventions.Nineteen acute NHS hospitals participated. Across timepoints, 3,505 duration of fasting observations were recorded. No significant effect of the interventions was observed for either fluid or food fasting times. The effect size was 0.33 for the web-based intervention compared to SD alone for the change in fluid fasting and was 0.12 for PDSA compared to SD alone. The process evaluation showed different types of impact, including changes to practices, policies, and attitudes. A rich picture of the implementation challenges emerged, including inter-professional tensions and a lack of clarity for decision-making authority and responsibility.This was a large, complex study and one of the first national randomised controlled trials conducted within acute care in implementation research. The evidence base for fasting practice was accepted by those participating in this study and the messages from it simple; however, implementation and practical challenges influenced the interventions' impact. A set of conditions for implementation emerges from the findings of this study, which are presented as theoretically transferable propositions that have international relevance.ISRCTN18046709--Peri-operative Implementation Study Evaluation (POISE).