Extrait

Background and study aims Heart failure (HF) is a common disease that gets worse over time, is responsible for many hospital admissions and deaths, results in a poor quality of life for the patient and places an economic burden on the health care system. HF happens when the heart becomes unable to pump enough blood around the body at the right pressure. Symptoms include difficulty with breathing and leg swelling. When the part of the heart that pumps blood around the body (the left ventricle) becomes too weak to work properly, the heart failure is being caused by left ventricular systolic dysfunction (LVSD). When the left ventricle becomes stiff, making it difficult for the heart chamber to fill with blood, this is heart failure with preserved ejection fraction (HFPEF). HFPEF may account for up to two-thirds of cases in patients over 70. HF is the final common stage for several diseases more common in aging patients, like hypertension (high blood pressure), valvular heart disease (heart disease involving one or more valves of the heart) or coronary heart disease, but it can also be the result of physical changes due to age itself. HF is most common in older people and is the leading cause of hospitalization and the third cause of cardiovascular death in this age group. Although advanced pharmacological intervention (drug treatments) has improved the prognosis for people with HF, hospital readmission and mortality rates (number of deaths), particularly for hospitalized elderly patients, remain high. There is good evidence that patients with HF and at high risk of being admitted to hospital can benefit from disease management programs (DMP), resulting in fewer admissions to hospital, lower mortality rates, improvements in quality of life and lower medical costs. In these DMPs a case manager provides patients and their caregivers with enough information and support to develop and follow a plan to control HF. However, most studies investigating HF have not included elderly patients with cognitive impairment (for example, trying to remember or learn new things, concentrating or making decisions), despite the fact that this would affect how successful a DMP would be, especially with regard to HF knowledge, self-care, and treatment adherence (sticking with the treatment). This is important because cognitive impairment (CI) is common in elderly adults with HF (more than 25%) and is associated with poor health outcomes, so it is important to determine which interventions (treatments) are beneficial in individuals with both conditions. This study aimed to test the effectiveness of a DMP in elderly HF patients with CI after being discharged from hospital, involving both patients and caregivers, and its follow-up by a multidisciplinary team. Who can participate? Adults over 65, with CI, discharged from hospital after a stay of at least 48 hours for HF, that have a responsible caregiver. What does the study involve? The participants are randomly allocated to one of two groups. Both groups will receive medical treatment in accordance with current clinical practice. Those in group 1 (control group) receive the usual care given after being discharged from hospital. Those in group 2 (intervention group) are placed on the DMP after discharge from hospital. The DMP includes, for example, education on the management of HF for both caregivers and patients, monitoring treatments and how the patients is progressing and it also looks at how much of a burden the DMP is placing on the participants caregiver and social network. All participants on the DMP are closely followed-up at a geriatric day-hospital by a multidisciplinary team consisted of a geriatrician (case manager), a nurse and a social worker. The participants are monitored by telephone and also face-to-face visits at the clinic. What are the possible benefits and risks of participating? All participants, including controls, are given medical treatment. The principal goals of HF therapy will be to relieve symptoms, maintain or improve the ability of the participants to do everyday activities and quality of life, preserve their independence, and extend survival. There are no known risks to participants. Where is the study run from? Hospital of Caceres (Complejo Hospitalario de Cáceres) When is study starting and how long is it expected to run for? March 2016 to March 2019 Who is funding the study? Hospital of Caceres (Complejo Hospitalario de Cáceres) Who is the main contact? Dr José Luis González Guerrero [email protected]

Critère d'inclusion

• Heart failure; Disease management programs; Elderly patients; Cognitive Impairment

Liens

• isrctn
• ictrp