Dataset Information

Randomised trial of telephone intervention in chronic heart failure: DIAL trial.

ABSTRACT:

Objective

To determine whether a centralised telephone intervention reduces the incidence of death or admission for worsening heart failure in outpatients with chronic heart failure.

Design

Multicentre randomised controlled trial.

Setting

51 centres in Argentina (public and private hospitals and ambulatory settings).

Participants

1518 outpatients with stable chronic heart failure and optimal drug treatment randomised, stratified by attending cardiologist, to telephone intervention or usual care.

Intervention

Education, counselling, and monitoring by nurses through frequent telephone follow-up in addition to usual care, delivered from a single centre.

Main outcome measure

All cause mortality or admission to hospital for worsening heart failure.

Results

Complete follow-up was available in 99.5% of patients. The 758 patients in the usual care group were more likely to be admitted for worsening heart failure or to die (235 events, 31%) than the 760 patients who received the telephone intervention (200 events, 26.3%) (relative risk reduction = 20%, 95% confidence interval 3 to 34, P = 0.026). This benefit was mostly due to a significant reduction in admissions for heart failure (relative risk reduction = 29%, P = 0.005). Mortality was similar in both groups. At the end of the study the intervention group had a better quality of life than the usual care group (mean total score on Minnesota living with heart failure questionnaire 30.6 v 35, P = 0.001).

Conclusions

This simple, centralised heart failure programme was effective in reducing the primary end point through a significant reduction in admissions to hospital for heart failure.

SUBMITTER: GESICA Investigators

PROVIDER: S-EPMC1188105 | biostudies-literature | 2005 Aug

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Randomised trial of telephone intervention in chronic heart failure: DIAL trial.

BMJ (Clinical research ed.) 20050801 7514

<h4>Objective</h4>To determine whether a centralised telephone intervention reduces the incidence of death or admission for worsening heart failure in outpatients with chronic heart failure.<h4>Design</h4>Multicentre randomised controlled trial.<h4>Setting</h4>51 centres in Argentina (public and private hospitals and ambulatory settings).<h4>Participants</h4>1518 outpatients with stable chronic heart failure and optimal drug treatment randomised, stratified by attending cardiologist, to telephon ...[more]

PMID: 16061499

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Project description:BACKGROUND:Presently, 6.5 million Americans are living with heart failure (HF). These patients are expected to follow a complex self-management regimen at home. Several demographic and psychosocial factors limit patients with HF in following the prescribed self-management recommendations at home. Poor self-care is associated with increased hospital re-admissions. Under the Affordable Care Act, there are financial implications related to hospital re-admissions for hospitals and programs such as the Program of All-Inclusive Care for the Elderly (PACE) in Pinellas County, Florida. Previous studies and systematic reviews demonstrated improvement in self-management and quality of life (QoL) in patients with HF with structured telephone support (STS) and short message service text messaging (SMS). OBJECTIVE:This study aimed to evaluate the effects of STS and SMS on self-care, knowledge, medication adherence, and QoL of patients with HF. METHODS:A prospective quality improvement project using a pre-post design was implemented. Data were collected at baseline, 30 days, and 3 months from 51 patients with HF who were enrolled in PACE in Pinellas County, Florida. All participants received STS and SMS for 30 days. The feasibility and sustained benefit of using STS and SMS was assessed at a 3-month follow-up. RESULTS:A paired t test was used to compare the mean difference in HF outcomes at the baseline and 30-day follow-up, which demonstrated improved HF self-care maintenance (t49=0.66; P=.01), HF knowledge (t49=0.71; P=.01), medication adherence (t49=0.92; P=.01), and physical and mental health measured using Short-Form-12 (SF-12; t49=0.81; P=.01). The results also demonstrated the sustained benefit with improved HF self-care maintenance, self-care management, self-care confidence, knowledge, medication adherence, and physical and mental health (SF-12) at 3 months with P<.05 for all outcomes. Living status and social support had a strong correlation with HF outcomes. Younger participants (aged less than 65 years) performed extremely well compared with older adults. CONCLUSIONS:STS and SMS were feasible to use among PACE participants with sustained benefits at 3 months. Implementing STS and SMS may serve as viable options to improve HF outcomes. Improving outcomes with HF affects hospital systems and the agencies that monitor and provide care for outpatients and those in independent or assisted-living facilities. Investigating viable options and support for implementation will improve outcomes.

Project description:BackgroundDepression is common among chronic heart failure (CHF) patients, and it is associated with significant re-hospitalization and mortality as well as lower quality of life. While psychotherapy is efficacious treatment for depression, the effect for depression among CHF is uncertain. And barriers preclude widely utility of psychotherapy among the elderly. Telephone-delivered psycho-behavioural intervention specifically focuses on depression among the elderly with CHF, and could be a promising alternative to conventional treatment. The present study was designed to prospectively investigate the effect of a telephone-delivered psycho-behavioural intervention on depression in the elderly with chronic heart failure (CHF).Method/designIn this prospective, multicentre, parallel, randomized, and controlled trial, 236 participants with depression associated with CHF (New York Heart Association classes II and III) will be enrolled. The study will consist of a 12-week intensive intervention and a 24-week maintenance intervention. Eligible participants will be randomized to either the intervention arm or the control arm. During the intensive phase, participants will receive either a guided telephone psycho-behavioural intervention or regular telephone contacts from the counsellors weekly. During the maintenance phase, participants will receive either psychological behavioural support or regular telephone contacts monthly from counsellors. Depressive symptoms, cardiac outcome and quality of life will be assessed at baseline and weeks 1, 2, 4, 8, 12, 24 and 36. Participants will undergo echocardiography and the plasma concentrations of N-terminal pro-brain natriuretic peptide (NT-proBNP) tested at baseline, weeks 12 and 36. The primary outcome is the response rate of depression, from baseline to week 12. The second outcomes include the change in cardiac function, quality of life and severity of depressive symptoms during the trial.DiscussionTo our knowledge, this study is the first prospective randomized trial to test the effective of the telephone-delivered psycho-behavioural intervention on depression in the elderly with CHF. The findings are expected to provide a new and evidence-based approach for depression among the elderly with CHF.Trial registrationThe trial was registered at www.clinicaltrials.gov (identification number: NCT03233451 ) on 28 July 2017 and updated on 18 August 2017.

Project description:PurposeTo evaluate the effects of person-centred support via telephone in two chronically ill patient groups, chronic obstructive pulmonary disease (COPD) and/or chronic heart failure (CHF).Method221 patients ≥ 50 years with COPD and/or CHF were randomized to usual care vs. usual care plus a person-centred telephone-support intervention and followed for six months. Patients in the intervention group were telephoned by a registered nurse initially to co-create a person-centred health plan with the patient and subsequently to discuss and evaluate the plan. The primary outcome measure was a composite score comprising General Self-Efficacy (GSE), re-hospitalization and death. Patients were classified as deteriorated if GSE had decreased by ≥ 5 points, or if they had been re-admitted to hospital for unscheduled reasons related to COPD and/or CHF or if they had died.ResultsAt six-month follow-up no difference in the composite score was found between the two study groups (57.6%, n = 68 vs. 46.6%, n = 48; OR = 1.6, 95% CI: 0.9-2.7; P = 0.102) in the intention-to-treat analysis (n = 221); however, significantly more patients in the control group showed a clinically important decrease in GSE (≥ 5 units) (22.9%, n = 27 vs. 9.7%, n = 10; OR = 2.8, 95% CI: 1.3-6.0; P = 0.011). There were 49 clinical events (14 deaths, 35 re-admissions) in the control group and 41 in the intervention group (9 deaths, 32 re-admissions). Per-protocol analysis (n = 202) of the composite score showed that more patients deteriorated in the control group than in the intervention group (57.6%, n = 68 vs. 42.9%, n = 36; OR = 1.8, 95% CI 1.0-3.2; P = 0.039).ConclusionPerson-centred support via telephone mitigates worsening self-efficacy without increasing the risk of clinical events in chronically ill patients with CHF and/or COPD. This indicates that a patient-healthcare professional partnership may be established without the need for face-to-face consultations, even in vulnerable patient groups.Trial registrationISRCTN.com ISRCTN55562827.

Project description:BackgroundThe Education Thérapeutique des patients Insuffisants Cardiaques (ETIC; Therapeutic Education for Patients with Cardiac Failure) trial aimed to determine whether a pragmatic education intervention in general practice could improve the quality of life of patients with chronic heart failure (CHF) compared with routine care.ResultsThis cluster randomised controlled clinical trial included 241 patients with CHF attending 54 general practitioners (GPs) in France and involved 19 months of follow-up. The GPs in the Intervention Group were trained during a 2-day interactive workshop to provide a patient education programme. The mean age of the patients was 74 years (±10.5), 62 % were men and their mean left-ventricular ejection fraction was 49.3 % (± 14.3). At the end of the follow-up period, the mean Minnesota Living with Heart Failure Questionnaire scores in the Intervention and Control Groups were 33.4 (± 22.1) versus 27.2 (± 23.3; P = 0.74, intra-cluster coefficient [ICC] = 0.11). At the end of the follow-up period, the 36-Item Short Form Health Survey (mental health and physical health) scores in the Intervention and Control Groups were 58 (± 22.1) versus 58.7 (± 23.9; P = 0.58, ICC = 0.01) and 52.8 (± 23.8) versus 51.6 (± 25.5; P = 0.57, ICC = 0.01), respectively.ConclusionsPatient education delivered by GPs to elderly patients with stable heart failure in the ETIC programme did not achieve an improvement in their quality of life compared with routine care. Further research on improving the quality of life and clinical outcomes of elderly patients with CHF in primary care is necessary.Trial registrationThe Education Thérapeutique des patients Insuffisants Cardiaques (ETIC; Therapeutic Education for Patients with Cardiac Failure) trial is a cluster randomised controlled trial registered with ClinicalTrials.gov (Registration numberNCT01065142 ) and the French Drug Agency (Agence Nationale de Sécurité du Médicament et des Produits de Santé;Registration number2009-A01142-55).

Project description:BackgroundHeart failure is a prevalent health problem associated with costly hospital readmissions. Transitional care programs have been shown to reduce readmissions but are costly to implement. Evidence regarding the effectiveness of telemonitoring in managing the care of this chronic condition is mixed. The objective of this randomized controlled comparative effectiveness study is to evaluate the effectiveness of a care transition intervention that includes pre-discharge education about heart failure and post-discharge telephone nurse coaching combined with home telemonitoring of weight, blood pressure, heart rate, and symptoms in reducing all-cause 180-day hospital readmissions for older adults hospitalized with heart failure.Methods/designA multi-center, randomized controlled trial is being conducted at six academic health systems in California. A total of 1,500 patients aged 50 years and older will be enrolled during a hospitalization for treatment of heart failure. Patients in the intervention group will receive intensive patient education using the 'teach-back' method and receive instruction in using the telemonitoring equipment. Following hospital discharge, they will receive a series of nine scheduled health coaching telephone calls over 6 months from nurses located in a centralized call center. The nurses also will call patients and patients' physicians in response to alerts generated by the telemonitoring system, based on predetermined parameters. The primary outcome is readmission for any cause within 180 days. Secondary outcomes include 30-day readmission, mortality, hospital days, emergency department (ED) visits, hospital cost, and health-related quality of life.DiscussionBEAT-HF is one of the largest randomized controlled trials of telemonitoring in patients with heart failure, and the first explicitly to adapt the care transition approach and combine it with remote telemonitoring. The study population also includes patients with a wide range of demographic and socioeconomic characteristics. Once completed, the study will be a rich resource of information on how best to use remote technology in the care management of patients with chronic heart failure.Trial registrationClinicalTrials.gov # NCT01360203.

Project description:BackgroundChronic (systolic) heart failure (CHF) represents a clinical syndrome with high individual and societal burden of disease. Multifaceted interventions like case management are seen as promising ways of improving patient outcomes, but lack a robust evidence base, especially for primary care. The aim of the study was to explore the effectiveness of a new model of CHF case management conducted by doctors' assistants (DAs, equivalent to a nursing role) and supported by general practitioners (GPs).MethodsThis patient-randomised controlled trial (phase II) included 31 DAs and employing GPs from 29 small office-based practices in Germany. Patients with CHF received either case management (n = 99) consisting of telephone monitoring and home visits or usual care (n = 100) for 12 months. We obtained clinical data, health care utilisation data, and patient-reported data on generic and disease-specific quality of life (QoL, SF-36 and KCCQ), CHF self-care (EHFScBS) and on quality of care (PACIC-5A). To compare between groups at follow-up, we performed analyses of covariance and logistic regression models.ResultsBaseline measurement showed high guideline adherence to evidence-based pharmacotherapy and good patient self-care: Patients received angiotensin converting enzyme inhibitors (or angiotensin-2 receptor antagonists) in 93.8% and 95%, and betablockers in 72.2% and 84%, and received both in combination in 68% and 80% of cases respectively. EHFScBS scores (SD) were 25.4 (8.4) and 25.0 (7.1). KCCQ overall summary scores (SD) were 65.4 (22.6) and 64.7 (22.7). We found low hospital admission and mortality rates. EHFScBS scores (-3.6 [-5.7;-1.6]) and PACIC and 5A scores (both 0.5, [0.3;0.7/0.8]) improved in favour of CM but QoL scores showed no significant group differences (Physical/Mental SF-36 summary scores/KCCQ-os [95%CI]: -0.3 [-3.0;2.5]/-0.1 [-3.4;3.1]/1.7 [-3.0;6.4]).ConclusionsIn this sample, with little room for improvement regarding evidence-based pharmacotherapy and CHF self-care, case management showed no improved health outcomes or health care utilisation. However, case management significantly improved performance and key intermediate outcomes. Our study provides evidence for the feasibility of the case management model.Trial registration numberISRCTN30822978.

Dataset Information

Randomised trial of telephone intervention in chronic heart failure: DIAL trial.

Objective

Design

Setting

Participants

Intervention

Main outcome measure

Results

Conclusions

Publications

Randomised trial of telephone intervention in chronic heart failure: DIAL trial.

Similar Datasets

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