Six-month Study Research Articles

Effectiveness of Long-Term Rehabilitation Treatment After Stroke

Objectives: Stroke is the leading cause of long-term disability. Therefore, we studied the effects of comprehensive long-term rehabilitation after stroke in improving the quality of life. Methods: Participants were compared in an experimental intervention model, with 120 control subjects, which received conventional short-stay inpatient hospitalization rehab, with 105 study subjects who received comprehensive rehabilitation program using the Guidelines for Adult Stroke Rehabilitation and Recovery from the American Heart Association/American Stroke Association starting in the hospital and extending for 6 months. The effects of rehabilitation were assessed Modified Rankin Scale (mRS), Functional Independence Measure (FIM), Barthel Index (BI) methods at admission, discharge, and 3 and 6 months after discharge. Results: There was no significant difference in the NIHSS, mRS, BI, and FIM scores between study and control patients at admission (p > 0.05). For the mRS, BI, and FIM scores, there was a significant interaction between treatment and time, indicating that the scores improved more rapidly for patients in the study group than the control group over the six-month study period (p < 0.001). A significant improvement in the scores with time was observed in the study and control groups at each time interval (p < 0.001). However, by 3 months after discharge the mRS, BI, and FIM scores of the study group were significantly better than the control group and the gap widened at 6 months, indicating further improvement. Conclusions: We found that providing prolonged by a multidisciplinary rehabilitation team results in higher functional independence and improvements in daily living activities.

Impact of Adherence Education and Monitoring on Community Pharmacy Performance Scores and Patient Satisfaction.

Adherence, specifically to noninsulin diabetes medications, statins, and renin-angiotensin system antagonists (i.e. angiotensin-converting-enzyme inhibitors (ACEi), angiotensin II receptor blockers (ARBs), and aliskiren), is a measure tracked by the Centers for Medicare and Medicaid Services (CMS) to give Medicare Part D plans a star rating; pharmacies are impacted by these star ratings. The pharmacy is given a performance score based on the measure. Some pharmacies use a performance information management platform (PIMP) that allows pharmacies to better understand performance information to impact patient care. (1) To evaluate if a monthly adherence monitoring and education service impacts the percentage of patientsadherent determined by pharmacy performance scores; (2) To determine patient satisfaction with the service in a large community pharmacy chain. A six-month prospective interventional pilot study including patients with a proportion of days covered (PDC) of less than 80% for oral diabetes or renin-angiotensin system antagonists (RASA) medications was conducted in two pharmacies of a large community pharmacy chain in Southwest Virginia. Using pharmacy internal data analytics and PIMP data, the percentage of patients who are adherent to oral diabetes or RASA medications was determined including the baseline PDC for each patient. At the start of the study, the standard of care in this large community chain pharmacy was to address adherence, follow-up in one month and every three months thereafter. In this study, pharmacists provided monthly telephonic adherence monitoring and education for a six-month period. Each session was scripted for medication adherence history, education and data collection. The pharmacist provided guidance and counseling based on how the patient answered the questions. Pharmacists gathered information about adherence patterns and behaviors using a 14 item Likert-scale and multiple choice-based questionnaire during the first session. After completion of the final adherence monitoring and education session, pharmacists gathered patient satisfaction information using an eight item Likert-scale questionnaire. At the end of the six-month period, using PIMP data, the percentage of patients adherent to oral diabetes or RASA medications was determined based on pharmacy performance scores. The data was analyzed using uni-variate and bi-variate statistics to determine if there was a difference in pharmacy performance scores from the pre-study analysis. The adherence patterns and behaviors, as well as patient satisfaction with the program was evaluated to determine factors influencing nonadherence. A total of 55 patients were identified in two pharmacies, ten of which were excluded or declined involvement, leaving 45 enrolled in the adherence monitoring and education service. Of the 45 enrolled patients, ten completed the adherence patterns and behaviors questionnaire. About half of the patients were men (50.95%) with an average age of 71.17 years and taking an average of 6.55 prescription medications. All patients had Medicare Part D insurance and majority had a yearly income of less than $40,000. The average baseline PDC was 68.92. In pharmacy 1, the average performance score for oral diabetes medications trended down and the average performance score for hypertension medications trended up over the study period. In pharmacy 2, the average performance score for oral diabetes medications trended up and the average performance score in hypertension medications trended up over the study period. The adherence patterns and behaviors questionnaire revealed the majority of patients rarely forgot to take medications or run out of medications. Additionally, cost of medications did not seem to impact adherence and majority of patients knew the names and indications of their medications. Only one patient completed the patient satisfaction survey. An adherence monitoring and education service had mixed results in improving patient adherence and pharmacy performance scores. Only one patient completed the satisfaction survey, thus no conclusions can be made regarding patient satisfaction of the program. More research needs to be done regarding telephonic adherence programs.

Water reuse and aquaculture: Pharmaceutical bioaccumulation by fish during tertiary treatment in a wastewater stabilization pond

With increasing demand for aquaculture products, water reuse is likely to increase for aquaculture operations around the world. Herein, wastewater stabilization ponds (WSP) represents low cost and sustainable treatment technologies to reduce nutrients and various contaminants of emerging concern from effluent. In the present study, we examined bioaccumulation of selected pharmaceuticals from several therapeutic classes by two important fish species in aquaculture with different feeding preferences (Cyprinus carpio and Sander lucioperca) and their common prey to test whether species specific accumulation occurs. Forty and nineteen from 66 selected pharmaceuticals and their metabolites were positively found in water and sediment samples, respectively from the representative WSP. After a six-month study, which corresponds to aquaculture operations, fourteen pharmaceuticals and their metabolites were detected (at a frequency of higher than 50% of samples) in at least one fish tissue collected from the WSP. We observed striking differences for species and organ specific BAFs among study compounds. Though muscle tissues consistently accumulated lower levels of the target analytes, several substances were elevated in brain, liver and kidney tissues (e.g., sertraline) of both species. Low residual concentrations of these target analytes in aquaculture products (fish fillets) suggest WSPs are promising to support the water-food nexus in aquaculture.

Effects of the Intervention "Reflective STRENGTH-Giving Dialogues" for Older Adults Living with Long-Term Pain: A Pilot Study.

Background Long-term musculoskeletal pain is a major, often undertreated, disabling health problem among an increasing number of older adults. Reflective STRENGTH-giving dialogues (STRENGTH) may be a tool to support older adults living with long-term pain. The main aim of this pilot study was to investigate the immediate and longitudinal effect of the intervention STRENGTH on levels of pain, wellbeing, occurrence of depression symptoms, and sense of coherence (SOC) among community-dwelling older adults suffering from musculoskeletal pain compared to a control group. Methods The study was semiexperimental with an intervention group and a control group. The effect of a single STRENGTH intervention was reported on the Numeric Rating Scale (NRS) regarding pain and wellbeing. To evaluate the longitudinal effect of STRENGTH, using the Brief Pain Inventory-Short Form (BPI-SF), the Geriatric Depression Scale-20 (GDS-20), SOC-13 at baseline (T1), and six months after the intervention/no intervention (T2), a total of 30 older adults, aged 72 to 97 years (Mdn 86 years), were included consecutively and fulfilled the intervention series (n = 18) or untreated controls (n = 12). Results The intervention with STRENGTH decreases pain (NRS 6 Mdn versus NRS 4 Mdn, p < 0.001) and increases wellbeing (NRS 7 Mdn versus NRS 8 Mdn, p < 0.001). After a six-month study period with STRENGTH, no longitudinal effect difference was found compared to baseline. Compared to the control group, there was an increasing trend between decreased pain level and increased SOC level for STRENGTH intervention. Conclusions This pilot study supports STRENGTH's effect as a pain-alleviating model that provides a decrease in pain levels and an increase of wellbeing in older adults with long-term pain. STRENGTH dialogues could be a useful intervention to provide individually holistic care in older adults living with long-term pain.

Hospital-based epilepsy care in Uganda: A prospective study of three major public referral hospitals

ObjectiveThis study sets out to describe the current demographics of people with epilepsy (PWE) attending hospital-based care in Uganda and the epilepsy treatment practices within three of the largest Ugandan public referral hospitals. MethodsIn a six-month prospective cohort study, 626 children and adults attending epilepsy clinics at Mulago National Referral Hospital, Butabika National Referral Mental Hospital and Mbarara Regional Referral Hospital were enrolled. Using a study questionnaire, data were collected at baseline and at 3 weeks, 3 months, and 6 months following enrollment. Specific data surrounding individual patient demographics, clinical characteristics and severity of epilepsy, and treatment of epilepsy with antiepileptic drugs (AEDs) were collected. ResultsFemale patients totaled to 50.8%, with a nearly equal gender distribution at each hospital. There was no statistical difference in gender or age between sites. The majority of PWE had completed primary school, with less than 15% of patients completing more than a secondary education. Seizure severity was high, with most patients having multiple seizures per week at the initial onset of epilepsy, and greater than 90% of patients reporting a loss of consciousness with seizures. The majority of patients (54.95%) also reported a developmental or learning delay. Most patients were on 1 AED (46.01%) or 2 AEDs (36.90%), with carbamazepine being the most frequently prescribed AED. There was a trend towards improved seizure severity over the follow-up period, as assessed by the corresponding Personal Impact of Epilepsy Scale (PIES) subscale. ConclusionsPeople with epilepsy attending hospital-based care in Uganda tend to have severe forms of epilepsy requiring management with AEDs. Current hospital-based practices show a positive trend for seizure burden and quality of life of PWE in Uganda. Further interventions to improve overall access to biomedical care are required to continue to advance the management of PWE across all communities.This article is part of the Special Issue “The Intersection of Culture, Resources, and Disease: Epilepsy Care in Uganda"

False belief understanding and narrative comprehension in the preschool years

Prior work shows that theory of mind (ToM), typically assessed with false belief understanding (FBU) tasks, predicts reading comprehension in school-aged children. This paper extends this research by examining the link in preschool-aged children in an exploratory study. We examined associations among FBU and several aspects of narrative abilities (story comprehension, picture sequencing, inferences generated in a narrative task, and goal-directed narratives) in a six-month longitudinal study. We found that FBU was related to all narrative abilities within Time 1 and with inferencing within Time 2. There were also cross-lagged associations between FBU and inferencing between Time 1 and 2. However, only goal-directed narratives were significantly related to FBU after controlling for child age and language. Interestingly, a factor analysis demonstrated that FBU and all narrative abilities but picture sequencing loaded onto a single factor. This study suggests that FBU and narrative abilities may overlap during the preschool years rather than representing distinct constructs. It also suggests that during the preschool years, narrative production rather than narrative comprehension may be more strongly linked to FBU as both the inference and goal-directed narrative tasks were derived from children’s oral narratives.

Home mechanical ventilation: quality of life patterns after six months of treatment

BackgroundIt has been shown that home mechanical ventilation improves quality of life, but it has not been widely studied which particular patient groups benefit the most from starting this type of therapy. The purpose of this prospective observational study was to evaluate quality of life change patterns 6 months after initiation of home mechanical ventilation in patients suffering from chronic respiratory failure using patient reported outcomes.MethodsWe enrolled 74 chronic respiratory failure patients starting invasive or noninvasive home mechanical ventilation through the Semmelweis University Home Mechanical Ventilation Program. Quality of life was evaluated at baseline and at 6 months after initiation of home mechanical ventilation using the Severe Respiratory Insufficiency Questionnaire.ResultsOverall quality of life showed 10.5% improvement 6 months after initiation of home mechanical ventilation (p < 0.001). The greatest improvement was observed in Respiratory complaint (20.4%, p = 0.015), Sleep and attendant symptoms (19.3%, p < 0.001), and Anxiety related subscales (14.4%, p < 0.001). Interface (invasive versus noninvasive ventilation) was not associated with improvement in quality of life (p = 0.660). Severely impaired patients showed the greatest improvement (CC = -0.328, p < 0.001). Initial diagnosis contributed to the observed change (p = 0.025), with chronic obstructive pulmonary disease and obesity hypoventilation syndrome patients showing the greatest improvement, while amyotrophic lateral sclerosis patients showed no improvement in quality of life. We found that patients who were started on long term ventilation in an acute setting, required oxygen supplementation and had low baseline quality of life, showed the most improvement during the six-month study period.ConclusionsOur study highlights the profound effect of home mechanical ventilation on quality of life in chronic respiratory failure patients that is indifferent of ventilation interface but is dependent on initial diagnosis and some baseline characteristics, like acute initiation, oxygen supplementation need and baseline quality of life.Trial registrationThis study was approved by and registered at the ethics committee of Semmelweis University (SE TUKEB 251/2017; 20th of December, 2017).

How Does Ideology Impact the Design of Algorithmic Governance?

Algorithmic management and algorithmic governance have emerged as prominent topics of concern over the past decade. The notions of algorithmic management and algorithmic governance are particularly salient in the age of platform ecosystems and flatter hierarchies enabled by IT’s affordances (Turco, 2016). Public attention algorithmic management often focuses on concerns of programmers and designers “encoding their biases and assumptions” into the design of social-technical systems. This research seeks to uncover how designers’ assumptions and ideologies impact the design of algorithmic governance systems. Prior research predicts that top-down “managerial” logics would be encoded into the design, resulting in feuding or “loose coupling” by end-users who refuse to be controlled (Berente & Yoo, 2012). However, in my empirical setting, I identify the emergence of a “bottom-up” governance design that was heavily influenced by multiple logics and points of view. While prior research has tended to black-box the impact of “ideological work” on the design and implementation of information systems, my data speaks strongly to this being a central element of the design process. Drawing on a six-month ethnographic study of a community of blockchain developers, I ask: what roles do ideology and worldview play in the design and implementation of algorithmic governance systems?

Silence and its mechanisms as the discursive production of the ‘normal’ in the early childhood classroom

In this paper, we aim to better understand and trouble the discursive (re)production of what is taken as the ‘normal’ in ‘inclusive’ early childhood classrooms. We do so by exploring the practices of the ‘including’ group, the so-called ‘normal, in relation to or in the presence of those who are variously labeled as ‘non-normal’. We highlight those mechanisms that are associated with silence and taboo, and through which the including group produces and maintains itself. We present data produced during a six-month ethnographic study in three early childhood classrooms in Australia. Using the notion of category boundary work in the analysis, we illuminate the practices of silence: ‘ignoring’, ‘moving away’, ‘turning away’ and ‘keeping silent’ through which children undertake the category work of the ‘normal’. The effect of this category work, we argue, is that disability or the diagnosed subject becomes ‘the elephant in the room’, strongly present but avowedly ignored. We draw out some considerations for practice in the concluding part of the paper.

Arizona Reopening Phase 3 and COVID-19: Returning to Normal

Arizona is about the same size as Italy, and the sixth largest in size of the United States 50 states. The state’s Reopening Phase 3 began on March 5, 2021. There were declines in the weekly COVID-19 cases from March through June. In July and August, the cases rose as the Delta variant spread throughout the United States. Arizona had passed one million case milestone. This six-month longitudinal study examined the changes in the numbers of vaccinations given, new COVID-19 cases, hospitalized cases, deaths, testing given, and the weekly positively percentages during Reopening Phase 3. The data source used was from the Arizona Department of Health Services COVID-19 dashboard database. Even with the case surges, the new normal was low number of severe cases, manageable hospitalization numbers, and very low number of deaths.

Non-Compartment and compartmental pharmacokinetics, efficacy, and safety of Kedrion FIX concentrate

BackgroundAn open-label phase II, multicenter clinical trial was conducted at 11 Haemophilia Centres in Italy, Romania, and Turkey, to evaluate the pharmacokinetics (PK), efficacy, and safety of high purity, plasma-derived, double virus inactivated and double nano-filtered factor IX (pd-FIX) concentrate (Kedrion FIX), EudraCT Number: 2005–006186-14. Material and Methods16 previously treated patients (PTPs) with severe or moderately severe haemophilia B were enrolled in the study. At enrolment, 14 underwent the first PK assessment (PK I), and the second PK (PK II) assessment was performed after six months of treatment (5 on-demand and nine prophylaxis) at the end of the study. PK parameters were evaluated by Non-Compartmental Analysis (NCA), One-Compartment model (OCM), and Two-Compartment Model (TCM). Efficacy of Kedrion FIX in all 16 patients was evaluated by the number of bleeding events, and clinical response following the infusions. Periodic FIX inhibitor assays and thrombogenicity tests were scheduled throughout the study to assess the safety of the drug. ResultsAs compared to the published data on PK of pdFIX, Kedrion FIX displayed a longer half-life (22.37–55.73 hrs), reduced clearance, and regular volume of distribution at PK I by both NCA and OCM. The comparison of outcomes of PK II with those of PK I by OCM, also showed significant changes, particularly in patients on prophylaxis, who showed some improved parameters of PK. Due to two outlier values at the end of the trial, the NCA parameters of PK I were not compared to those of PK II. Breakthrough bleeds were successfully treated with 1 or 2 infusions. No significant adverse events were observed during the study. DiscussionDuring the six-month clinical study period, the use of Kedrion FIX resulted in a safe and effective pd-FIX concentrate with excellent PK characteristics.

Liver elastometry and alcohol withdrawal: Median-term follow-up in a psychiatric unit.

The measurement of liver stiffness (LS) shows promise as a follow-up tool after alcohol withdrawal, but it has mainly been studied in the early phase or in patients with severe liver disease. A 6-month ancillary study of a specific psychiatric cohort of alcoholic patients without known liver disease followed after withdrawal was conducted (Clinical Trial NCT01491347). Clinical and biological data and LS values were collected every 2 months. A total of 129 patients were included in the study; 93 had an LS assessment within the first 7 days, and 37 had all four LS measurements. Only seven (7.5%) patients had an initial LS>12.1kPa, the threshold used to define severe fibrosis. Abstinence was not associated with changes in LS at the various median-term follow-up periods. However, LS of abstinent subjects decreased significantly relative to that of non-abstinent subjects between M0 and M2. CAP™ values were not associated with abstinence. The systematic median-term follow-up of withdrawn patients does not appear to be contributory. However, LS could help to detect relapse in the first 2 months after withdrawal for subjects treated in a psychiatric hospital for dependence. It thus could serve as a motivation tool. Prospective studies with various and higher baseline LS values are warranted for simultaneous longitudinal assessment, including for very short- and long-term LS after withdrawal.

Leading in an Amish Paradise: humanistic leadership in the Old Order Amish

PurposeThe authors examined the traditional leadership practiced by the Old Order Amish located in the Holmes and Wayne counties of America. Despite popular stereotypes, this community is remarkably innovative and resilient. Amish leadership aligns with the central tenets of humanistic leadership and provides a rich illustration of how such a leadership paradigm can foster a vibrant, inclusive and sustainable community. Unlike current leadership models that focus on instrumental values like wealth, profit and growth, Amish leadership is concerned with faith, community and living a simple life with purpose and dignity.Design/methodology/approachThe primary data required for this paper were collected by the lead author during a six-month ethnographic study on several Amish communities located in Ohio. The authors also consulted a large set of archival data, including think tank reports, census data, biographies, magazine features and academic publications, which helped in placing the primary data in perspective and reminding of the particularities of the contexts from which the primary data were collected. For the data analysis, the authors used a thematic analysis approach to allow the salient themes of Amish humanistic leadership emerge from the data.FindingsA total offour themes emerged from this study: (1) leadership as local identity and practice; (2) leaders without benefits, chosen by the lot; (3) leaders present matters, followers discuss and decide; (4) community welfare as the yardstick for evaluation. These themes highlighted some of the key aspects of humanistic leadership eclipsed in the mainstream theories of management and leadership. They showed how the Amish respond to the encroachment of technology, which holds critical clues for how humanistic leaders can place the needs of their people before the demands of their shareholders. By examining Amish leadership in detail, this study demonstrated the potential of humanistic leadership for creating a strong and sustainable community while also contributing to the empirical foundation of humanistic management.Originality/valueGiven the closed nature of the Amish, only few academic studies exist, which examined their leadership style. Furthermore, the traditional and conservative nature of the Amish community has prevented critics from investigating their leadership as a model for revitalizing other communities.

Exploring the role of goal setting in weight loss for adults recently diagnosed with pre-diabetes

BackgroundThe management of prediabetes in the community setting is a global priority. We evaluated the feasibility of a 6-month multilevel practice nurse-led prediabetes dietary intervention which involved goal setting. The aim of this paper is to explore the weight loss goals and strategies reported by participants to achieve their weight loss goals as recorded by practice nurses, and report on factors that influenced dietary behaviours.MethodsThis study used a convergent mixed-methods design. A six-month pragmatic non-randomised pilot study with a qualitative process evaluation was conducted in two neighbouring provincial cities in New Zealand. A structured dietary intervention delivered by practice nurses was implemented in four practices in 2014–2016. Content analysis of the text and descriptive statistics were used to analyse the data.ResultsOne hundred and fifty seven people with prediabetes were enrolled (85 intervention, 72 control). The intervention group lost a mean 1.3 kg more than the control group (p < .0.001). The majority of the intervention group indicated either a high level of readiness (n = 42, 53%) or some readiness (n = 31, 39%) to make food changes. The majority of weight loss goals aligned with clinical guidelines (between 5 and 10% of body weight). While just over half (n = 47, 55%) demonstrated weight loss at the end of the six month period, the majority of participants did not achieve their predetermined weight loss goal (n = 78, 83%). Gender, ethnicity and budget were not related to weight loss at six months. Readiness to change and reported challenges to making dietary changes were related to weight loss at six months. Negative factors or set-backs included sporadic adherence to diet due to other health problems, change in context or environment and coping with ill health, most notably stress and low mood.ConclusionsThe data relating to weight loss and dietary goals provided insight into the challenges that people faced in making dietary changes for weight loss across a six month period. Simplifying goal setting to those goals with the greatest potential clinical impact or the greatest significance to the person, in a socially supportive environment, may increase the success of goal achievement.Trial registrationANZCTR ACTRN1261500080656. Registered 3 August 2015 (Retrospectively registered). https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=366560&isReview=true

Measuring the impact of solid waste management workshop activities in elementary schools: a six-month case study in Da Nang city, Vietnam

Sustainable waste management is an urgent issue in developing countries. This study describes how lectures and group games influence knowledge in waste management of fourth-grade elementary students whose development stage is thought to be effective concerning positive attitude shifts. We employed a control-treatment design and two schools were selected for a comparison purpose in Da Nang city, Vietnam. The results showed significant differences in students’ knowledge before and after 6 months of the workshop activities. Lectures and group games worked differently to improve different areas of knowledge on waste management.

Efectos y seguridad del perfluorohexiloctano en la superficie ocular y el endotelio corneal

ObjectiveTo evaluate the effects and safety of topical drops of perfluorohexyloctane (F6H8) on the ocular surface and the corneal endothelium. MethodsForty-five patients (90 eyes) diagnosed with dry eye disease were recruited and prescribed treatment with F6H8 as part of a six-month prospective multicentre study. Variables in corneal staining were documented using the National Eye Institute/Industry Workshop scale. The conjunctival variables included using the Oxford scale, as well as corneal parameters, such as central corneal thickness, cell density, coefficient of variation, hexagonality, and mean cell area, at the start of the study, and at 3months and 6months. Compliance and satisfaction with the treatment were measured. ResultsF6H8 drops reduced mean corneal staining based on the NEI scale in compliant patients to a mean of −0.84 ± 1.95 at 3months (P=.001) and to −1.65 ± 2.42 at 6months (P<.001). Conjunctival staining at 6months showed a mean decrease of −0.13 (P=.319). The endothelial parameters did not show a significant difference, in contrast to the central corneal thickness that showed a statistically significant decrease (545.30 ± 32.25 at the start of the study to 538.40 ± 31.36 after 6months, P=.009). At the end of the study, 46% of patients reported feeling subjectively better, 40.5% felt the same, and 13.5% felt subjectively worse. ConclusionsTopical treatment with F6H8 for dried eye disease did not alter the measured variables of the corneal endothelium, but showed improvement in corneal staining and satisfaction.

A cluster randomized controlled trial to assess the efficacy of a telehealth-based train-the-trainer mealtime intervention delivered by respite care center volunteers to caregivers of persons with dementia to improve nutritional outcomes and quality of life

BackgroundPersons with dementia with mild to moderate cognitive impairment are at risk for developing impairments with activities of daily living such as the ability to feed oneself, that negatively influence health. Lack of caregiver skills related to mealtime planning for persons with dementia and the ability to cope with dysfunctional behaviors are well-documented factors that influence nutritional status outcomes, lead to weight loss, poor quality of life, and impact their ability to remain at home.MethodsA cluster randomized controlled trial with a parallel mixed methods evaluation processes will be conducted to examine the efficacy of a train-the-trainer program using non-paid volunteers in respite care centers to deliver a telehealth mealtime intervention guided by the theory-based C3P Model—Change the Person, Change the People, Change the Place (C3P). In this six-month study, dyads of caregivers and persons with mild to moderate dementia receiving respite care services will be randomized to receive either the telehealth intervention or enhanced usual care. Within the intervention group, dyads will be partnered with a C3P trained volunteer who will work with caregivers via videoconference to devise and implement mealtime plans. Under usual care, dyads will receive standardized educational materials modified from The Savvy Caregiver Program for Alzheimer’s disease. The primary outcomes include weight maintenance or gain of the person with dementia and quality of life of the caregiver. A multi-level evaluation process utilizing respite center administrators and directors, volunteers, and caregivers will explore intervention fidelity, acceptability and sustainability. Using both the CONSORT and SPIRIT checklists as guidance, the comprehensive study design is more fully described in this manuscript.DiscussionIn this trial, we will lay the groundwork to examine the efficacy and sustainability of a train-the-trainer telehealth program that could be widely disseminated by national Alzheimer’s organizations and readily adopted by community agencies to provide additional resources to assist families in managing mealtimes at home, while promoting the quality of life of both the caregiver and the person with dementia.Trial registrationThis study was registered with clinicaltrials.gov: NCT03622814 on August 9, 2018..

Influence of Socio-Cultural and Family Factors on Educational Difficulties for Primary School Pupils in Conakry

The purpose of this case study on educational difficulties (DS) was to highlight the different types of educational difficulties among repeaters and to identify the various factors, especially the socio-cultural and family factors involved. This is a six-month control case study conducted from January 1, to June 30, 2018, covering 100 cases of school difficulties and 100 control cases. We collected the data from class attendance books, school report books and a questionnaire of 22 people divided into two public: the 1st public explored the pupil / school parameter and the 2nd public explored the family. Included in this study were cases and control students with school report books and whose parents accepted the interview. School delay was the most encountered type of school difficulty (84%). The majority of children in difficulty did not attend kindergarten (52% versus 33% of the control group) and if they did kindergarten it was irregular (15% versus 5%). The majority of mothers in the case group was not educated (41%) or had the primary level (41%). 56% of the children in the case group did not live with the biological parents versus 33% in the control group. In the family of 84% of the children in the case group, it was the national or local language that was commonly spoken versus 8% of the control group. The national or local language and French were commonly spoken in the family of 14% of the case group against 25% of the control group (p = 0.0000). The School difficulties should no longer be considered as the schoolboy's only fault; its analysis must necessarily take into account the factors that are: the child, the school and the family in order to assess their mutual interaction. They can be considered as a real public health problem.

Prospective, Single-Center, Six-Month Study of Intravitreal Ranibizumab for Macular Edema with Nonproliferative Diabetic Retinopathy: Effects on Microaneurysm Turnover and Non-Perfused Retinal Area.

PurposeTo analyze the effects on microaneurysm (MA) and perifoveal perfusion in nonproliferative diabetic retinopathy (NPDR) patients with macular edema (ME) after early intensive treatment using intravitreal ranibizumab (IVR) injections.Patients and MethodsProspectively, 25 eyes of 25 type 2 diabetes mellitus patients with ME were included between August 2016 and February 2019. For 6 months, patients were administered 0.5-mg IVR injections monthly. Ocular evaluation, including best-corrected visual acuity (BCVA; using the Early Treatment Diabetic Retinopathy Study chart), central retinal thickness (CRT; using optical coherence tomography), fundus photography, and fluorescein angiography, was performed for all participants. Results obtained at baseline were compared to those observed after 6 months.ResultsMean BCVA increased significantly from 67.6±3.29 letters at baseline to 76.36±1.61 letters after 6 months (P=0.002) of IVR therapy. CRT decreased significantly from 479.12±16.66 µm at baseline to 369.12±13.02 µm at 6 months. Similarly, the total number of MAs decreased significantly from 5.68±3.41 to 1.60±1.73 (P<0.0001). MA turnover, calculated by adding the MA formation rate to the MA disappearance rate (both calculated as MA number/month) also decreased significantly from 6.88±3.83 to 1.92±1.75 after treatment (P<0.0001). Perifoveal non-perfused area decreased from 2.517±0.456 mm2 at baseline to 2.495±0.293 mm2 at 6 months, but the results were not statistically significant (P=0.954).ConclusionTreatment with early intensive IVR therapy in NPDR patients with ME not only improved BCVA and CRT but also decreased MA turnover. However, in the study period of 6 months, IVR therapy did not show significant improvement in perifoveal non-perfused area.

P1848SUSTAINABILITY OF ACTIVE LIFESTYLE INTERVENTION BENEFITS FOR KIDNEY TRANSPLANT RECIPIENTS AFTER STUDY COMPLETION: POST-HOC ANALYSIS OF THE CAVIAR RANDOMISED CONTROLLED TRIAL

Abstract Background and Aims. CAVIAR (Comparing glycaemic benefits of Active Versus passive lifestyle Intervention in kidney Allograft Recipients) was a single-centre, randomised, controlled trial that recruited stable kidney transplant recipients without diabetes between 3-24 months’ post-transplantation. Participants were randomly assigned to active (personalised renal dietetic-led sessions using evidence-based behaviour change techniques) versus passive lifestyle intervention (current standard of care) for a six-month intervention period. Our findings showed encouraging clinical improvements including reduction in weight (mean difference -2.47kg [-.401 to -0.92], p=0.002), fat mass (-1.537 [-2.947 to -0.127], p=0.033) and rates of post-transplantation diabetes (7.6% versus 15.6% respectively, p=0.123). However, evidence from the general population suggests lifestyle intervention behaviour change techniques must be sustained to achieve the greatest benefit. It is unclear whether the same is true for kidney transplant recipients. Therefore, the aim of this study was to conduct a post-hoc analysis of the CAVIAR study to explore 1-year study outcomes (6-months after completion of the study interventions) to explore how clinical outcomes have evolved. Methods. The methodology of the CAVIAR study has already been summarised above and main findings published (Kuningas et al. Transplantation 2019; early online). Assessment of 1-year study outcomes was prespecified in the CAVIAR trial protocol to understand post-intervention outcomes. Between August 2015 and December 2017, 130 individuals were recruited to the trial and final study visits were conducted in February 2018. Electronic patient records were analysed for all study participants and 1-year outcome data (up to August 2019) were extracted in relation to cardio-metabolic risk outcomes where available. The trial is registered on clinicaltrials.org (identifier: NCT02233491). Results. While CAVIAR participants randomised to active versus passive lifestyle intervention demonstrated beneficial weight change in the six-month study period with a negative mean difference, in the six-month period after study completion we observed the opposite effect with a positive mean difference (+1.23 kg [-0.05 to 2.51], p=0.060). Two participants from both active and passive intervention arms subsequently developed post-transplantation diabetes in the six-months after study closure, although difference in post-transplantation diabetes rates remained clinically significant at 1-year (10.6% versus 18.8% respectively, p=0.143). There was no significant correlation between study baseline Situational Motivation Score components (intrinsic motivation, intrinsic regulation, extrinsic regulation or amotivation) and weight change either during or after CAVIAR study completion Conclusion. Our post-hoc analysis of the CAVIAR study suggest active lifestyle intervention using renal dietitian-led behaviour change techniques must be a continuous rather than a one-off strategy to sustain long-term clinical benefits and is unrelated to baseline motivation. This has implications for service delivery and workforce planning for established kidney transplant programs across Europe.