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Impact of pharmaceutical care on the quality of life of patients with Chagas disease and heart failure: randomized clinical trial.

ABSTRACT: Pharmaceutical care is the direct interaction between pharmacist and patient, in order to improve therapeutic compliance, promote adequate pharmacotherapeutic follow-up, and improve quality of life. Pharmaceutical care may be effective in reducing complications and in improving the quality of life of patients with chronic diseases, like Chagas heart disease, while bringing a positive impact on health system costs. The morbidity and mortality indexes for patients with Chagas heart disease are high, especially if this heart disease is complicated by heart failure. In this setting, we hypothesize that pharmaceutical care might be an important tool for the clinical management of these patients by improving their quality of life, as a better compliance to their treatment and the avoidance and prompt correction of drug-related problems will minimize their symptoms, improve their functional class, and decrease the number of hospital admissions. Therefore, the aim of this trial is to evaluate the contribution of pharmaceutical care to clinical treatment of patients with Chagas heart disease complicated by heart failure.A prospective, single-center randomized clinical trial will be conducted in patients with Chagas heart disease complicated by heart failure. A total of 88 patients will be randomly assigned into two parallel groups: an intervention group will receive standard care and pharmaceutical care, and a control group will receive only standard care. Both groups will be subjected to a follow-up period of 12 months. The primary outcome of this trial is the evaluation of quality of life, measured by the 36-item short-form and the Minnesota Living with Heart Failure Questionnaire. Secondary outcomes include drug-related problems, exercise tolerance as measured by the standard six-minute-walk test, and compliance.Patients with Chagas heart disease complicated by heart failure under pharmaceutical care are expected to improve their quality of life, present with a lower incidence of drug-related problems, improve their functional capacity, and improve in their compliance to treatment.ClinicalTrials.gov Identifier: NCT01566617.

SUBMITTER: Sperandio da Silva GM

PROVIDER: S-EPMC3543334 | biostudies-literature | 2012 Dec

REPOSITORIES: biostudies-literature

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Impact of pharmaceutical care on the quality of life of patients with Chagas disease and heart failure: randomized clinical trial.

Sperandio da Silva Gilberto M GM Chambela Mayara C MC Sousa Andrea S AS Sangenis Luiz Henrique C LH Xavier Sergio S SS Costa Andréa R AR Brasil Pedro Emmanuel A A PE Hasslocher-Moreno Alejandro M AM Saraiva Roberto M RM

Trials 20121227

<h4>Background</h4>Pharmaceutical care is the direct interaction between pharmacist and patient, in order to improve therapeutic compliance, promote adequate pharmacotherapeutic follow-up, and improve quality of life. Pharmaceutical care may be effective in reducing complications and in improving the quality of life of patients with chronic diseases, like Chagas heart disease, while bringing a positive impact on health system costs. The morbidity and mortality indexes for patients with Chagas he ...[more]

PMID: 23270509

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Project description:AimsPatients with heart failure (HF) have impaired quality of life (QoL). The randomized controlled trial PHARM-CHF investigated whether an interdisciplinary intervention consisting of regular contacts with the community pharmacy and weekly dosing aids improves medication adherence in patients with HF. It is unknown how an intervention involving frequent structured pharmacy visits affects QoL. Our aim was to explore adherence to the intervention and effects on QoL.Methods and resultsAmong 237 patients, n = 110 were randomized to pharmacy care and n = 127 to usual care. The pharmacy care group received a medication review followed by (bi-)weekly dose dispensing and counselling. The median follow-up was 2.0 years [inter-quartile range (IQR) 1.2-2.7]. Median interval between pharmacy visits was 8.4 days (IQR 8.0-10.3) and the visits lasted in median 14 min (IQR 10-15). Median adherence to the intervention was 96% (IQR 84-100). QoL at 365 days was predefined as a main secondary and at 730 days as another secondary endpoint in PHARM-CHF. QoL was measured by the Minnesota Living with Heart Failure Questionnaire; and for 111 patients (n = 47 in the pharmacy care group and n = 64 in the usual care group), data were available at baseline, and after 365 and 730 days (mean age 74 years; 41% female). Improvement in QoL was numerically higher in the pharmacy care group after 365 days and was significantly better after 730 days (difference in total scores -7.7 points [-14.5 to -1.0]; P = 0.026) compared to the usual care group. In all subgroups examined, this treatment effect was preserved. Improvements in the physical and emotional dimensions were numerically higher in the pharmacy care group after 365 days and were significantly better after 730 days: -4.0 points [-6.9 to -1.2]; P = 0.006, and -1.9 points [-3.7 to -0.1]; P = 0.039, respectively.ConclusionsA pharmacy-based interdisciplinary intervention was well received by the patients and suggests clinically important improvements in QoL.

Project description:ObjectivesPersons with concomitant heart failure (HF) and diabetes mellitus (DM) have complicated, often competing, self-care expectations and treatment regimens that may reduce quality of life (QOL). This randomized controlled trial tested an integrated self-care intervention on outcomes of HF and DM QOL, physical function, and physical activity (PA).Methods and resultsParticipants with HF and DM (n = 134; mean age 57.4 ± 11 years, 66% men, 69% minority) were randomized to usual care (control) or intervention. The control group received standard HF and DM educational brochures with follow-up telephone contact. The intervention group received education and counseling on combined HF and DM self-care (diet, medications, self-monitoring, symptoms, and PA) with follow-up home visit and telephone counseling. Measures included questionnaires for HF- and DM-specific and overall QOL, PA frequency, and physical function (6-min walk test [6MWT]) and were obtained at baseline and 3 and 6 months. Analysis included mixed models with a priori post hoc tests. Adjusting for age, body mass index, and comorbidity, the intervention group improved in HF total (P = .002) and physical (P < .001) QOL scores at 3 months with retention of improvements at 6 months, improved in emotional QOL scores compared with control at 3 months (P = .04), and improved in health status ratings (P = .04) at 6 months compared with baseline. The intervention group improved in 6MWT distance (924 ft to 952 ft; P = .03) whereas the control group declined (834 ft to 775 ft; F1,63 = 6.86; P = .01). The intervention group increased self-reported PA between baseline and 6 months (P = .01).ConclusionsAn integrated HF and DM self-care intervention improved perceived HF and general QOL but not DM QOL. Improved physical functioning and self-reported PA were also observed with the integrated self-care intervention. Further study of the HF and DM integrated self-care intervention on other outcomes, such as hospitalization and cost, is warranted.

Project description:Chronic heart failure, is increasing due to the aging population and improvements in heart disease detection and management. The prevalence is estimated at ~10% of the French general practice patient population over 59 years old. The primary objective of this study is to improve the quality of life for heart failure patients though a complex intervention involving patient and general practitioner (GP) education in primary care.A randomised, cluster controlled trial, stratified over 4 areas of the Auvergne region in France comparing intervention and control groups. The inclusion criteria are: patients older than 50 years with New York Heart Association (NYHA) stage I, II, or III heart failure, with reduced ejection fraction or with preserved ejection fraction. Heart failure should be confirmed by the patient's cardiologist according to the European Society of Cardiology guidelines criteria. The exclusion criteria include: severe cognitive disorders, living in an institution, participating in another clinical trial, having NYHA stage IV heart failure, or a lack of French language skills. The complex intervention consists of training at the GP practice with an interactive 2-day workshop to provide a patient's education programme. GPs are trained to perform case management, lifestyle counselling and motivational interviewing, to educate patients on the main topics including clinical alarm signs, physical activity, diet and cardiovascular risk factors. The patients' education sessions are scheduled at 1, 4, 7, 10, 13 and 19 months following the start of the trial. The primary outcome to be assessed is the impact on the quality of life as determined using two questionnaires: the Minnesota Living with Heart Failure Questionnaire and SF-36. To detect a difference in the mean quality of life at 19 months, we anticipate studying a minimum of 400 patients from 80 GPs.This trial will provide insight into the effectiveness of a complex intervention to educate patients with heart failure including a 2-day GP workshop and patients' education programme in the setting of a GP consultation to improve the quality of life in patients with chronic heart failure. This complex intervention tool could be used during initial and further medical training.ETIC is a cluster-randomised, controlled trial registered on ClinicalTrials.gov [ NCT01065142 , 2010, Feb 8] and the French drug agency [Agence Nationale de Sécurité du Médicament et des produits de santé; registration number: 2009-A01142-55, on March 5th, 2010].

Project description:Background:Syrian refugees residing in Jordan suffer from chronic illnesses, low quality of life (QoL) and anxiety. Pharmacists delivering the medication review service can have a role in improving this growing worldwide problem. Objectives:To assess the effect of the medication review service on QoL and anxiety scores for Syrian refugees living with chronic medical conditions. Methods:This randomized single-blinded intervention control study was conducted in Jordan. Syrian refugees were recruited and randomized into intervention and control groups. Two home visits were organized with each participant, at baseline and three months later. The medication review service was delivered to the participants and questionnaires regarding QoL and anxiety were completed by all participants. As a part of the medication review service, drug-related problems (DRPs) were identified by a clinical pharmacist for all patients, but recommendations to resolve these DRPs were delivered to intervention group refugees' physicians only (control group patients did not receive this part of the service till the end of the study); DRPs were corrected and pharmacist-delivered counseling and education were provided as well. At follow-up, DRPs assessment, QoL and anxiety scores were assessed for refugees in the intervention and control groups. Results:Syrian refugees (n=106) were recruited and randomized into intervention (n=53) and control (n=53) groups with no significant difference between both groups at baseline. The number of medications and diagnosed chronic diseases per participant was 5.8 (SD 2.1) and 2.97 (SD 1.16), respectively. At follow-up, a significant decrease in the number of DRPs for refugees in the intervention group was found (from 600 to 182, p<0.001), but not for the control group (number stayed at 541 DRPs, p=0.116). Although no significant difference between the groups was found with regards to QoL at follow-up (p=0.266), a significant difference was found in the anxiety scores between the groups (p<0.001). Conclusion:The medication review service delivered by clinical pharmacists can significantly improve refugees' DRPs and anxiety scores. As for QoL, significant improvements can be seen for all refugee patients, regardless of whether the DRPs identified were resolved or not.

Project description:BackgroundDespite therapies proven effective for heart failure with systolic dysfunction, the condition continues to cause substantial hospitalization, disability, and death, especially among African- American and other nonwhite populations.ObjectiveTo compare the effects of a nurse-led intervention focused on specific management problems versus usual care among ethnically diverse patients with systolic dysfunction in ambulatory care practices.DesignRandomized effectiveness trial conducted from September 2000 to September 2002.SettingThe 4 hospitals in Harlem, New York.Patients406 adults (45.8% were non-Hispanic black adults, 32.5% were Hispanic adults, 46.3% were women, and 36.7% were > or =65 years of age) who met eligibility criteria: systolic dysfunction, English- or Spanish-language speakers, community-dwelling patients, and ambulatory care practice patients.InterventionDuring a 12-month intervention, bilingual nurses counseled patients on diet, medication adherence, and self-management of symptoms through an initial visit and regularly scheduled follow-up telephone calls and facilitated evidence-based changes to medications in discussions with patients' clinicians.MeasurementsHospitalizations (in 406 of 406 patients during follow-up) and self-reported functioning (in 286 of 406 patients during follow-up) at 12 months.ResultsAt 12 months, nurse management patients had had fewer hospitalizations (143 hospitalizations vs. 180 hospitalizations; adjusted difference, -0.13 hospitalization/person-year [95% CI, -0.25 to -0.001 hospitalization/person-year]) than usual care patients. They also had better functioning: The Short Form-12 physical component score was 39.9 versus 36.3, respectively (difference, 3.6 [CI, 1.2 to 6.1]), and the Minnesota Living with Heart Failure Questionnaire score was 38.6 versus 47.3, respectively (difference, -8.8 [CI, -15.3 to -2.2]). Through 12 months, 22 deaths occurred in each group and percentages of patients who were hospitalized at least once were similar in each group (30.5% of nurse management patients vs. 36.5% of control patients; adjusted difference, -7.1 percentage points [CI, -16.9 to 2.6 percentage points]).LimitationsThree nurses at 4 hospitals delivered interventions in this modest-sized trial, and 75% of the participants were from 1 site. It is not clear which aspects of the complex intervention accounted for the results.ConclusionsNurse management can improve functioning and modestly lower hospitalizations in ethnically diverse ambulatory care patients who have heart failure with systolic dysfunction. Sustaining improved functioning may require continuing nurse contact.

Project description:BackgroundFunctional training may be an effective non-pharmacological therapy for heart failure (HF). This study aimed to compare the effects of functional training with strength training on peak VO2 and quality of life in individuals with HF.MethodsA randomized, parallel-design and examiner-blinded controlled clinical trial with concealed allocation, intention-to-treat and per-protocol analyses. Twenty-seven participants with chronic HF were randomly allocated to functional or strength training group, to perform a 12-week physical training, three times per week, totalizing 36 sessions. Primary outcomes were the difference on peak VO2 and quality of life assessed by cardiopulmonary exercise testing and Minnesota Living with Heart Failure Questionnaire, respectively. Secondary outcomes included functionality assessed by the Duke Activity Status Index and gait speed test, peripheral and inspiratory muscular strength, assessed by hand grip and manovacuometry testing, respectively, endothelial function by brachial artery flow-mediated dilation, and lean body mass by arm muscle circumference.ResultsParticipants were aged 60 ± 7 years, with left ventricular ejection fraction 29 ± 8.5%. The functional and strength training groups showed the following results, respectively: peak VO2 increased by 1.4 ± 3.2 (16.9 ± 2.9 to 18.6 ± 4.8 mL.kg-1.min-1; p time = 0.011) and 1.5 ± 2.5 mL.kg-1.min-1 (16.8 ± 4.0 to 18.6 ± 5.5 mL.kg-1.min-1; p time = 0.011), and quality of life score decreased by 14 ± 15 (25.8 ± 14.8 to 10.3 ± 7.8 points; p time = 0.001) and 12 ± 28 points (33.8 ± 23.8 to 19.0 ± 15.1 points; p time = 0.001), but no difference was observed between groups (peak VO2: p interaction = 0.921 and quality of life: p interaction = 0.921). The functional and strength training increased the activity status index by 6.5 ± 12 and 5.2 ± 13 points (p time = 0.001), respectively, and gait speed by 0.2 ± 0.3 m/s (p time = 0.002) in both groups.ConclusionsFunctional and strength training are equally effective in improving peak VO2, quality of life, and functionality in individuals with HF. These findings suggest that functional training may be a promising and innovative exercise-based strategy to treat HF.Trial registrationNCT03321682. Registered date: 26/10/2017.

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Impact of pharmaceutical care on the quality of life of patients with Chagas disease and heart failure: randomized clinical trial.

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Impact of pharmaceutical care on the quality of life of patients with Chagas disease and heart failure: randomized clinical trial.

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