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Background Physical training has beneficial effects on exercise capacity, quality of life and mortality in patients after a cardiac event or intervention and is therefore a core component of cardiac rehabilitation. However, cardiac rehabilitation uptake is low and effects tend to decrease after the initial rehabilitation period. Home-based training has the potential to increase cardiac rehabilitation uptake, and was shown to be safe and effective in improving short-term exercise capacity. Long-term effects on physical fitness and activity, however, are disappointing. Therefore, we propose a novel strategy using telemonitoring guidance based on objective training data acquired during exercise at home. In this way, we aim to improve self-management skills like self-efficacy and action planning for independent exercise and, consequently, improve long-term effectiveness with respect to physical fitness and physical activity. In addition, we aim to compare costs of this strategy with centre-based cardiac rehabilitation. Methods/design This randomized controlled trial compares a 12-week telemonitoring guided home-based training program with a regular, 12-week centre-based training program of equal duration and training intensity in low to moderate risk patients entering cardiac rehabilitation after an acute coronary syndrome or cardiac intervention. The home-based group receives three supervised training sessions before they commence training with a heart rate monitor in their home environment. Participants are instructed to train at 70-85% of their maximal heart rate for 45–60 minutes, twice a week. Patients receive individual coaching by telephone once a week, based on measured heart rate data that are shared through the internet. Primary endpoints are physical fitness and physical activity, assessed at baseline, after 12 weeks and after one year. Physical fitness is expressed as peak oxygen uptake, assessed by symptom limited exercise testing with gas exchange analysis; physical activity is expressed as physical activity energy expenditure, assessed by tri-axial accelerometry and heart rate measurements. Secondary endpoints are training adherence, quality of life, patient satisfaction and cost-effectiveness. Discussion This study will increase insight in long-term effectiveness and costs of home-based cardiac rehabilitation with telemonitoring guidance. This strategy is in line with the trend to shift non-complex healthcare services towards patients’ home environments. Trial registration Dutch Trial Register: NTR3780. Clinicaltrials.gov register: NCT01732419

Heart failure (HF) patients suffer from frequent and repeated hospitalizations, causing a substantial economic burden on society. Hospitalizations can be reduced considerably by better compliance with self-care. Home telemonitoring has the potential to boost patients' compliance with self-care, although the results are still contradictory. A randomized controlled trial was conducted in order to study whether the multidisciplinary care of heart failure patients promoted with telemonitoring leads to decreased HF-related hospitalization. HF patients were eligible whose left ventricular ejection fraction was lower than 35%, NYHA functional class ≥2, and who needed regular follow-up. Patients in the telemonitoring group (n=47) measured their body weight, blood pressure, and pulse and answered symptom-related questions on a weekly basis, reporting their values to the heart failure nurse using a mobile phone app. The heart failure nurse followed the status of patients weekly and if necessary contacted the patient. The primary outcome was the number of HF-related hospital days. Control patients (n=47) received multidisciplinary treatment according to standard practices. Patients' clinical status, use of health care resources, adherence, and user experience from the patients' and the health care professionals' perspective were studied. Adherence, calculated as a proportion of weekly submitted self-measurements, was close to 90%. No difference was found in the number of HF-related hospital days (incidence rate ratio [IRR]=0.812, P=.351), which was the primary outcome. The intervention group used more health care resources: they paid an increased number of visits to the nurse (IRR=1.73, P<.001), spent more time at the nurse reception (mean difference of 48.7 minutes, P<.001), and there was a greater number of telephone contacts between the nurse and intervention patients (IRR=3.82, P<.001 for nurse-induced contacts and IRR=1.63, P=.049 for patient-induced contacts). There were no statistically significant differences in patients' clinical health status or in their self-care behavior. The technology received excellent feedback from the patient and professional side with a high adherence rate throughout the study. Home telemonitoring did not reduce the number of patients' HF-related hospital days and did not improve the patients' clinical condition. Patients in the telemonitoring group contacted the Cardiology Outpatient Clinic more frequently, and on this way increased the use of health care resources. Clinicaltrials.gov NCT01759368; http://clinicaltrials.gov/show/NCT01759368 (Archived by WebCite at http://www.webcitation.org/6UFxiCk8Z).

To test an intervention for hospice caregivers designed to help them better manage symptoms experienced by patients with cancer. A three-group comparative design with repeated measures. A large nonprofit hospice that primarily provides home care. 329 hospice homecare patients with cancer and their caregivers were randomized into three groups: a control group (n = 109) receiving standard care, a group (n = 109) receiving standard care plus friendly visits, and a group (n = 111) receiving standard care plus the COPE intervention. Caregivers received experimental training in the COPE intervention (creativity, optimism, planning, expert information) over nine days to assist with symptom management. Intensity of pain, dyspnea, and constipation, overall symptom distress, and quality of life (QOL). Data were collected on admission and days 16 and 30. Although symptom intensity for three target symptoms did not decrease, symptom distress was significantly improved (p = 0.009) in the COPE intervention group. QOL was not significantly different. Symptom distress, a measure that encompasses patient suffering along with intensity, was significantly decreased in the group in which caregivers were trained to better manage patient symptoms. The COPE intervention is effective and immediately translatable to the bedside for hospice homecare patients with advanced cancer.

Objectives. We evaluated whether a brief, universal, postnatal nurse home-visiting intervention can be implemented with high penetration and fidelity, prevent emergency health care services, and promote positive parenting by infant age 6 months. Methods. Durham Connects is a manualized 4- to 7-session program to assess family needs and connect parents with community resources to improve infant health and well-being. All 4777 resident births in Durham, North Carolina, between July 1, 2009, and December 31, 2010, were randomly assigned to intervention and control conditions. A random, representative subset of 549 families received blinded interviews for impact evaluation. Results. Of all families, 80% initiated participation; adherence was 84%. Hospital records indicated that Durham Connects infants had 59% fewer infant emergency medical care episodes than did control infants. Durham Connects mothers reported fewer infant emergency care episodes and more community connections, more positive parenting behaviors, participation in higher quality out-of-home child care, and lower rates of anxiety than control mothers. Blinded observers reported higher quality home environments for Durham Connects than for control families. Conclusions. A brief universal home-visiting program implemented with high penetration and fidelity can lower costly emergency medical care and improve family outcomes.

Background and Purpose: Establishing evidence of content validity and satisfaction is an integral part of intervention research. The purpose of this article is to describe content validity and satisfaction relative to the Telephone Assessment and Skill‐Building Kit (TASK), an 8‐week follow‐up program based on individualized assessment of stroke caregiver needs. Design and Methods: The TASK intervention enables caregivers to develop skills based on assessment of their own needs. During the development of the TASK program, 10 experts rated the validity of the TASK intervention components for accuracy, feasibility, acceptability, and problem relevance. After incorporating feedback from the experts, a randomized controlled clinical trial was instituted using a convenience sample of 40 stroke caregivers to determine satisfaction (usefulness, ease of use, and acceptability) with the TASK intervention (n=21) compared with an attention control group (n=19). Data collection occurred between March 2005 and June 2006. Data were analyzed using descriptive statistics, independent sample t tests, and content analysis. Findings: Expert ratings on a 1 to 5 scale, with 5 being strongly agree, provided evidence of content validity (accuracy 4.71, feasibility 4.46, acceptability 4.40, problem relevance 4.67). Caregivers in the TASK group scored significantly higher than the attention control group on all satisfaction measures (usefulness p=.02; ease of use p=.02; acceptability p=.05). Qualitative comments from caregivers provided further evidence of satisfaction. Conclusions: Evidence of content validity and user satisfaction for the TASK intervention relative to an attention control group was found. Clinical Relevance: The TASK program may be a viable telephone‐based program that can be implemented by nurses to support family caregivers during the first few months after stroke survivors are discharged home.

Background: The standard treatment of severe malnutrition in Malawi often utilises prolonged inpatient care, and after discharge results in high rates of relapse. Aims: To test the hypothesis that the recovery rate, defined as catch-up growth such that weight-for-height z score >0 (WHZ, based on initial height) for ready-to-use food (RTUF) is greater than two other home based dietary regimens in the treatment of malnutrition. Methods: HIV negative children >1 year old discharged from the nutrition unit in Blantyre, Malawi were systematically allocated to one of three dietary regimens: RTUF, RTUF supplement, or blended maize/soy flour. RTUF and maize/soy flour provided 730 kJ/kg/day, while the RTUF supplement provided a fixed amount of energy, 2100 kJ/day. Children were followed fortnightly. Children completed the study when they reached WHZ >0, relapsed, or died. Outcomes were compared using a time-event model. Results: A total of 282 children were enrolled. Children receiving RTUF were more likely to reach WHZ >0 than those receiving RTUF supplement or maize/soy flour (95% v 78%, RR 1.2, 95% CI 1.1 to 1.3). The average weight gain was 5.2 g/kg/day in the RTUF group compared to 3.1 g/kg/day for the maize/soy and RTUF supplement groups. Six months later, 96% of all children that reached WHZ >0 were not wasted. Conclusions: Home based therapy of malnutrition with RTUF was successful; further operational work is needed to implement this promising therapy.

Purpose: The purpose of this study was to determine if a nighttime home monitoring system, designed to track the movements of a care recipient with dementia, would relieve worry and improve sleep in caregivers of persons with dementia. Design and Methods: In this controlled clinical trial, 49 dementia caregivers were followed for up to 1 year. Sleep was measured for 7‐day intervals at nine points in time using actigraphy and a sleep diary. Findings: Although the experimental caregivers generally reported that the system was “of great help” in relieving worry about nighttime activity, no significant group differences were found using multilevel modeling analyses. With regard to total sleep time, time awake after sleep onset, and sleep quality, multilevel models did not demonstrate any changes in sleep between groups, either averaged over time or for the interaction of group and time. Conclusions: Since previous analysis of our qualitative data suggested improvements in caregiver worry and sleep, problems other than night awakenings may be perpetuating the sleep problem. Future studies should include testing of multimodal sleep interventions. Clinical Relevance: Caregivers have high amounts of unwanted wake time during the night and additional research is needed to identify effective interventions to improve their sleep.