Trachoma Prevalence and Associated Risk Factors in The Gambia and Tanzania: Baseline Results of a Cluster Randomised Controlled Trial

Abstract Background To improve communication of risk messages, they must be communicated in a way that is understandable and relevant to the patient. Communicating risk of cardio-vascular-disease is a complex and individualised task, since the risk itself is a combination of multiple personal risk factors. Raised blood pressure is but one of these risk factors. In Denmark, one third of hypertensive patients are adequately treated, with regards to national guidelines. One reason for this meagre status is low treatment adherence, and tools with documented effects for increasing patient adherence are limited. Our objective is to evaluate the effect of a personalised, interactive and dynamic risk-assessment and risk-communication tool: “Your Heart Forecast” on blood pressure control, primary non-compliance, health literacy and patient empowerment.Methods Cluster-randomised controlled trial in general practice. Effect measures are adherence, blood pressure, lipid levels and empowerment at inclusion and after 6 and 12 months. To identify other benefits or possible adverse effects of the intervention, qualitative interviews will be conducted with a subgroup of patients. Discussion The investigators will explore effects of Your Heart Forecast on patients’ health literacy, adherence, empowerment and blood pressure control. The DANish evaluation of Your heart forecast (DANY) project will be the first to rigorously evaluate effects of YHF in Denmark and to link adherence of hypertensive patients exposed to Your Heart Forecast with the national databases of prescriptions and health services provided.

Download Full-text

Uptake and effectiveness of a tailor-made online lifestyle programme targeting modifiable risk factors for dementia among middle-aged descendants of people with recently diagnosed dementia: study protocol of a cluster randomised controlled trial (Demin study)

BMJ Open ◽

10.1136/bmjopen-2020-039439 ◽

2020 ◽

Vol 10 (10) ◽

pp. e039439

Author(s):

Joyce Vrijsen ◽

Ameen Abu-Hanna ◽

Els LM Maeckelberghe ◽

Peter Paul De Deyn ◽

Andrea F de Winter ◽

...

Keyword(s):

Risk Factors ◽

Randomised Controlled Trial ◽

Controlled Trial ◽

Cluster Randomised Controlled Trial ◽

Lifestyle Advice ◽

Cluster Randomised ◽

Dementia Risk ◽

Memory Clinics ◽

Randomised Controlled ◽

Lifestyle Programme

IntroductionDescendants of patients with dementia have a higher risk to develop dementia. This study aims to investigate the uptake and effectiveness of an online tailor-made lifestyle programme for dementia risk reduction (DRR) among middle-aged descendants of people with recently diagnosed late-onset dementia.Methods and analysisDemin is a cluster randomised controlled trial, aiming to include 21 memory clinics of which 13 will be randomly allocated to the passive (poster and flyer in a waiting room) and 8 to the active recruitment strategy (additional personal invitation by members of the team of the memory clinic). We aim to recruit 378 participants (40–60 years) with a parent who is recently diagnosed with Alzheimer’s disease or vascular dementia at one of the participating memory clinics. All participants receive a dementia risk assessment (online questionnaire, physical examination and blood sample) and subsequently an online tailor-made lifestyle advice regarding protective (Mediterranean diet, low/moderate alcohol consumption and high cognitive activity) and risk factors (physical inactivity, smoking, loneliness, cardiovascular diseases (CVD), hypertension, high cholesterol, diabetes, obesity, renal dysfunction and depression) for dementia. The primary outcome is the difference in uptake between the two recruitment strategies. Secondary outcomes are change(s) in (1) the Lifestyle for Brain Health score, (2) individual health behaviours, (3) health beliefs and attitudes towards DRR and (4) compliance to the tailor-made lifestyle advice. Outcomes will be measured at 3, 6, 9 and 12 months after baseline. The effectiveness of this online tailor-made lifestyle programme will be evaluated by comparing Demin participants to a matched control group (lifelines cohort).Ethics and disseminationThis study has been approved by the Dutch Ministry of Health, Welfare and Sport according to the Population Screening Act. All participants have to give online informed consent using SMS-tan (transaction authentication number delivered via text message). Findings will be disseminated through peer-reviewed journals and (inter)national conferences.Trial registration numberNTR7434.

Download Full-text

A factorial cluster-randomised controlled trial combining home-environmental and early child development interventions to improve child health and development: rationale, trial design and baseline findings

10.1101/465856 ◽

2018 ◽

Cited By ~ 3

Author(s):

Stella M Hartinger ◽

Nestor Nuño ◽

Jan Hattendorf ◽

Hector Verastegui ◽

Mariela Ortiz ◽

...

Keyword(s):

Risk Factors ◽

Drinking Water ◽

Randomised Controlled Trial ◽

Child Development ◽

Controlled Trial ◽

Cluster Randomised Controlled Trial ◽

Early Child Development ◽

Early Child ◽

Cluster Randomised ◽

Randomised Controlled

ABSTRACTBackgroundExposure to unhealthy environments and poor cognitive development are the main risk factors that affect children’s health and wellbeing in low- and middle-income countries. Interventions that simultaneously address several risk factors at the household level have great potential to reduce these negative effects. We present the design and baseline findings of a cluster-randomised controlled trial to evaluate the impact of an integrated home-environmental intervention package and an early child development programme to improve diarrhoea, acute respiratory infections and childhood developmental outcomes in children under 36 months of age living in resource-limited rural Andean Peru.MethodsWe collected baseline data on children’s developmental performance, health status and demography as well as microbial contamination in drinking water. In a sub-sample of households, we measured indoor and personal 24-hour air concentration levels of carbon monoxide (CO) and fine particulate matter (PM2.5).ResultsWe recruited and randomised 317 children from 40 community-clusters to four study arms. At baseline, all arms had similar health and demographic characteristics, and the developmental status of children was comparable between arms. The analysis revealed that more than 25% of mothers completed primary education, a large proportion of children were stunted and diarrhoea prevalence was above 18%. Fifty-two percent of drinking water samples tested positive for thermo-tolerant coliforms and the occurrence of E.coli was evenly distributed between arms. The mean levels of kitchen PM2.5 and CO concentrations were 213 μg/m3 and 4.8 ppm, respectively.ConclusionsThe trial arms are balanced with respect to most baseline characteristics, such as household air and water pollution, and child development. These results ensure the possible estimation of the trial effectiveness. This trial will yield valuable information for assessing synergic, rational and cost-effective benefits of the combination of home-based interventions.Trial registrationretrospectively registered on 15th January 2018. SRCTN reference: 26548981

Download Full-text

Danish Evaluation of Your Heart Forecast (DANY): study protocol for a cluster randomised controlled trial on an interactive risk-communication tool aimed at improving adherence of patients with high blood pressure

Trials ◽

10.1186/s13063-019-3886-2 ◽

2020 ◽

Vol 21 (1) ◽

Author(s):

Anders Elkær Jensen ◽

Jens Søndergaard ◽

Niels Kristian Kjær ◽

Rod Jackson ◽

Jesper Bo Nielsen

Keyword(s):

Risk Factors ◽

Blood Pressure ◽

Randomised Controlled Trial ◽

Controlled Trial ◽

Cluster Randomised Controlled Trial ◽

Pressure Control ◽

Communication Tool ◽

Hypertensive Patients ◽

Cluster Randomised ◽

Randomised Controlled

Abstract Background To improve communication of risk messages, they must be communicated in a way that is understandable and relevant to the patient. Communicating risk of cardiovascular disease is a complex and individualised task, since the risk itself is a combination of multiple personal risk factors. Raised blood pressure is but one of these risk factors. In Denmark, only one-third of hypertensive patients are adequately treated, with regards to national clinical guidelines. One reason for this problem is low treatment adherence; tools with documented effects for increasing adherence of patients are limited. Our objective is to evaluate the effect of a personalised, interactive and dynamic risk-assessment and risk-communication tool: ‘Your Heart Forecast’ (YHF) on blood pressure control, primary non-compliance, health literacy and patient empowerment. Methods Cluster-randomised controlled trial in general practice. Effect measures are adherence, blood pressure, lipid levels and empowerment at inclusion and after 6 and 12 months. To identify other benefits or possible adverse effects of the intervention, qualitative interviews will be conducted with a subgroup of patients. Discussion The investigators will explore effects of Your Heart Forecast on patients’ health literacy, adherence, empowerment and blood pressure control. The DANish evaluation of Your heart forecast (DANY) project will be the first to rigorously evaluate effects of YHF in Denmark and to link adherence of hypertensive patients exposed to YHF with the national databases of prescriptions and health services provided. Trial registration Clinicaltrials.gov, NCT04058847. Registered on 16 August 2019.

Download Full-text