Effectiveness of the SUGAR intervention on hypoglycaemia in elderly patients with type 2 diabetes: A pragmatic randomised controlled trial.

BACKGROUND: A pharmacist-led, individualised, educational intervention (SUGAR) was formulated to prevent hypoglycaemia among elderly patients with type 2 diabetes mellitus (T2DM) in Jordan. OBJECTIVE(S): To evaluate the effectiveness of the SUGAR intervention added to usual care compared with usual care only in preventing hypoglycaemic attacks in elderly patients with T2DM in Jordan. METHODS: A single-centre, pragmatic, open-label, randomised controlled trial with embedded process evaluation was conducted at the outpatient clinics of a hospital in Jordan. Elderly patients (≥65 years) with T2DM and on sulfonylurea, insulin, or at least three anti-diabetic medications were recruited and parallelly randomised to the SUGAR intervention with usual care or the control (usual care) groups. The primary outcome was the rate of total hypoglycaemic attacks per patient after 3 months from randomisation. Secondary outcomes included rate of hypoglycaemia subtypes, the incidence of any and subtypes of hypoglycaemia, hypoglycaemia-free survival probability, and incidence of fasting hyperglycaemia necessitating therapy modification. Outcomes were measured through glucose meters and diaries, assessed at 3 months, and analysed by intention to treat. RESULTS: A total of 212 participants (mean age 68.98 years, 58.96% men) were randomly allocated (106 in each group), with 190 (89.62%) participants completing the study. The mean of total hypoglycaemic attacks was less in the intervention group compared with the control group (3.91 [SD 7.65] vs. 6.87 [SD 11.99]; p < 0.0001) at three months. The intervention significantly reduced the rate of hypoglycaemia subtypes; the odds to experience any, severe, and symptomatic hypoglycaemia; and increased hypoglycaemia-free survival probability compared with the control group at three months. Incidence of fasting hyperglycaemia necessitating therapy modification was similar between groups. CONCLUSIONS: The SUGAR intervention can prevent hypoglycaemia without increasing the risk of fasting hyperglycaemia warranting therapy adjustment in elderly Jordanians with T2DM.

Randomised controlled trial of pharmacist-led patient counselling in controlling hypoglycaemic attacks in older adults with type 2 diabetes mellitus (ROSE-ADAM): A study protocol of the SUGAR intervention.

INTRODUCTION: Hypoglycaemia is one of the most serious adverse effects of diabetes treatment. Older adults are at the highest risk to develop hypoglycaemia. Several studies have established the important positive role of educational interventions on achieving glycaemic control and other clinical outcomes, however, there is still a lack in studies that evaluate the impact of such type of interventions on hypoglycaemia risk in elderly patients with type 2 diabetes. The purpose of this research is to evaluate the effectiveness of pharmacist-led patient counselling on reducing hypoglycaemic attacks in older adults with type 2 diabetes mellitus. METHODS: and analysis: This study is an open-label, parallel controlled randomised trial, which will be conducted in the outpatient clinics at the largest referral hospital in the north of Jordan. Participants who are elderly (age ≥ 65 years), diagnosed with type 2 diabetes mellitus, and taking insulin, sulfonylurea, or any three anti-diabetic medications will be randomly assigned to intervention (SUGAR Handshake) and control (usual care) groups. The SUGAR Handshake participants will have an interactive, individualised, medications-focused counselling session reinforced with a pictogram and a phone call at week six of enrolment. The primary outcome measure is the frequency of total hypoglycaemic events within 12 weeks of follow up. Secondary outcomes include the frequency of asymptomatic, symptomatic, and severe hypoglycaemic events, hypoglycaemia incidence, and time to the first hypoglycaemic attack. We will also conduct a nested qualitative study for process evaluation. ETHICS AND DISSEMINATION: The Human Research Ethics Committee of the University of Lincoln and the Institutional Review Board of King Abdullah University Hospital approved this protocol. The findings of this study will be presented in international conferences and published in a peer-reviewed journal. TRIAL REGISTRATION NUMBER: The study protocol has been registered with ClinicalTrials.gov, NCT04081766.

Impact of malnutrition in the embolic-haemorrhagic trade-off of elderly patients with atrial fibrillation.

AIMS: Nutrition is an important determinant of health above the age of 80 years. Malnutrition in the elderly is often underdiagnosed. The aim of this study was to report the prevalence and prognostic value of malnutrition in patients ≥80 years old with atrial fibrillation (AF) with and without anticoagulant therapy. METHODS AND RESULTS: We assessed the nutritional status of 4724 octogenarian patients with diagnoses of AF in a single centre from Spain between 2014 and 2017 with the CONUT score. Malnutrition was confirmed in 2036 patients (43.1%). Anticoagulation prescription was more frequent in patients with good nutrition than in those malnourished (79.5% vs. 71.7%, P < 0.001). The impact of malnutrition on mortality was evaluated by Cox regression, whereas its association with ischaemic stroke and major bleeding was studied through competing risk analysis. After multivariate adjusting, malnutrition was associated with mortality [hazard ratio (HR) 1.36, 95% confidence interval (CI) 1.24-1.49], stroke [sub-distribution HR (sHR) 1.37, 95% CI 1.10-1.69], and major bleeding (sHR 1.29, 95% CI 1.02-1.64). In anticoagulated patients, the embolic-haemorrhagic trade-off event was virtually neutral for those who had normal nutritional status [average daily rates (ADRs) for stroke and bleeding: 4.70 and 4.69 per 100 000 patients/day, respectively; difference = +0.01 per 100 000 patients/day; P = 0.99] and negative for those with malnutrition (ADR for stroke and bleeding: 5.38 and 7.61 per 100 000 patients/day, respectively; difference = -2.23 per 100 000 patients/day; P = 0.07). CONCLUSION: Malnutrition is very common in octogenarian patients with AF, being a clinical predictor for poor prognosis. For anticoagulated patients, malnutrition was associated with a negative embolic-haemorrhagic balance.

Rationale and methods of the multicenter randomised trial of a heart failure management programme among geriatric patients (HF-Geriatrics).

BACKGROUND: Disease management programmes (DMPs) have been shown to reduce hospital readmissions and mortality in adults with heart failure (HF), but their effectiveness in elderly patients or in those with major comorbidity is unknown. The Multicenter Randomised Trial of a Heart Failure Management Programme among Geriatric Patients (HF-Geriatrics) assesses the effectiveness of a DMP in elderly patients with HF and major comorbidity. METHODS/DESIGN: Clinical trial in 700 patients aged ≥ 75 years admitted with a primary diagnosis of HF in the acute care unit of eight geriatric services in Spain. Each patient should meet at least one of the following comorbidty criteria: Charlson index ≥ 3, dependence in ≥ 2 activities of daily living, treatment with ≥ 5 drugs, active treatment for ≥ 3 diseases, recent emergency hospitalization, severe visual or hearing loss, cognitive impairment, Parkinson's disease, diabetes mellitus, chronic obstructive pulmonary disease (COPD), anaemia, or constitutional syndrome. Half of the patients will be randomly assigned to a 1-year DMP led by a case manager and the other half to usual care. The DMP consists of an educational programme for patients and caregivers on the management of HF, COPD (knowledge of the disease, smoking cessation, immunizations, use of inhaled medication, recognition of exacerbations), diabetes (knowledge of the disease, symptoms of hyperglycaemia and hypoglycaemia, self-adjustment of insulin, foot care) and depression (knowledge of the disease, diagnosis and treatment). It also includes close monitoring of the symptoms of decompensation and optimisation of treatment compliance. The main outcome variables are quality of life, hospital readmissions, and overall mortality during a 12-month follow-up. DISCUSSION: The physiological changes, lower life expectancy, comorbidity and low health literacy associated with aging may influence the effectiveness of DMPs in HF. The HF-Geriatrics study will provide direct evidence on the effect of a DMP in elderly patients with HF and high comorbidty, and will reduce the need to extrapolate the results of clinical trials in adults to elderly patients. TRIAL REGISTRATION: (ClinicalTrials.gov number, NCT01076465).

Social network as a predictor of hospital readmission and mortality among older patients with heart failure.

BACKGROUND: This study examines the relationship between social network and hospital readmission and mortality in older patients with heart failure. METHODS AND RESULTS: Prospective study conducted with 371 patients, age 65 and older, admitted for heart failure-related emergencies at 4 Spanish hospitals. Social network was measured at baseline with a 4-item questionnaire that ascertained whether subjects were married, lived with another person(s), saw or had telephone contact with family members daily or almost daily, and were at home alone for less than 2 hours per day. Social network was deemed "high" where all 4 items were present, "moderate" where 3 were present, and "low" where 2 or fewer were present. Analyses were performed using Cox models, and adjusted for the main confounders. A total of 55% of patients had high or moderate social networks. During a median follow-up of 6.5 months, 135 (36.4%) patients underwent a first emergency rehospitalization and 68 (18.3%) died. Compared with patients with high social network, hospital readmission was more frequent among those who had moderate (hazard ratio [HR] 1.87; 95% confidence interval [CI] 1.06-3.29; P < .05) and low social networks (HR 1.98; 95% CI 1.07-3.68; P < .05). This relationship showed a positive dose-response (p for linear trend 0.042). The magnitude of this association was comparable to that of other important predictors of readmission, such as previous hospitalization. No relationship was observed between social network and death. CONCLUSION: A very simple questionnaire measuring social network can identify patients with a higher short-term risk of hospital readmission.

Health-related quality of life as a predictor of hospital readmission and death among patients with heart failure.

BACKGROUND: We sought to examine the relationship between health-related quality of life (HRQL) and a first emergency rehospitalization and mortality in patients with heart failure (HF) having a wide variation in ventricular ejection fraction and functional status. METHODS: Prospective study conducted with 394 patients admitted for HF-related emergencies at 4 Spanish hospitals. Baseline HRQL was measured with a generic questionnaire, the Medical Outcomes Study 36-item Short Form Survey (SF-36), and with an HF-specific instrument, the Minnesota Living With Heart Failure (MLWHF) questionnaire. Cox proportional hazards models were used to calculate hazard ratios (HRs) for hospitalization and death on the basis of HRQL scores. RESULTS: During a median follow-up of approximately 6 months, 138 patients (35.0%) underwent a first emergency rehospitalization and 70 (17.8%) died. After adjustment for biomedical, psychosocial, and health care variables, the frequency of hospital readmission was higher in patients with worse scores on the SF-36 physical functioning (HR, 1.65; 95% confidence interval [CI], 1.11-2.44; P = .01), general health (HR, 1.73; 95% CI, 1.19-2.52; P = .003), and mental health (HR, 1.65; 95% CI, 1.10-2.47; P = .02) subscales. Results were similar for the mortality end point. For the MLWHF questionnaire, worse overall and worse physical and emotional summary scores were associated with higher mortality. CONCLUSIONS: Worse HRQL is associated with hospital readmission and death in patients with HF. The magnitude of this association, for both physical and mental HRQL components, is comparable to that for other well-known predictors of hospital readmission and death, such as personal history of diabetes, previous hospitalizations, and treatment with angiotensin-converting enzyme inhibitors.