Home-based Intervention Group Research Articles

Impact of ¡Míranos! on parent-reported home-based healthy energy balance-related behaviors in low-income Latino preschool children: a clustered randomized controlled trial

BackgroundWidespread establishment of home-based healthy energy balance-related behaviors (EBRBs), like diet, physical activity, sedentary behavior, screen time, and sleep, among low-income preschool-aged children could curb the childhood obesity epidemic. We examined the effect of an 8-month multicomponent intervention on changes in EBRBs among preschool children enrolled in 12 Head Start centers.MethodsThe Head Start (HS) centers were randomly assigned to one of three treatment arms: center-based intervention group (CBI), center-based plus home-based intervention group (CBI + HBI), or control. Before and following the intervention, parents of 3-year-olds enrolled in participating HS centers completed questionnaires about their child’s at-home EBRBs. Adult-facilitated physical activity (PA) was measured by an index based on questions assessing the child’s level of PA participation at home, with or facilitated by an adult. Fruit, vegetable, and added sugar intake were measured via a short food frequency questionnaire, and sleep time and screen time were measured using 7-day logs. A linear mixed effects model examined the intervention’s effect on post-intervention changes in PA, intake of fruit, vegetable, and added sugar, sleep time, and screen time from baseline to post-intervention.ResultsA total of 325 parents participated in the study (CBI n = 101; CBI + HBI n = 101; and control n = 123). Compared to control children, CBI and CBI + HBI parents reported decreases in children’s intake of added sugar from sugar-sweetened beverages. Both CBI and CBI + HBI parents also reported smaller increases in children’s average weekday screen time relative to controls. In addition, CBI + HBI parents reported CBI + HBI parents reported increases in children’s adult-facilitated PA, fruit and vegetable intake, and daily sleep time during weekdays (excluding weekends) and the total week from baseline to post-intervention, while children in the CBI increased sleep time over the total week compared to the children in the control group.ConclusionsParent engagement strengthened the improvement in parent-reported EBRBs at home in young children participating in an evidence-based obesity prevention program in a childcare setting. Future studies should investigate equity-related contextual factors that influence the impact of obesity prevention in health-disparity populations.Trial registrationClinicalTrials.gov, NCT03590834. Registered July 18, 2018, https://clinicaltrials.gov/ct2/show/NCT03590834

A home-based exercise program for children with congenital heart disease following interventional cardiac catheterization: study protocol for a randomized controlled trial

BackgroundCardiac catheterization has opened an innovative treatment field for cardiac disease; this treatment is becoming the most popular approach for pediatric congenital heart disease (CHD) and has led to a significant growth in the number of children with cardiac catheterization. Unfortunately, based on evidence, it has been demonstrated that the majority of children with CHD are at an increased risk of “non-cardiac” problems. Effective exercise therapy could improve their functional status significantly. As studies identifying the efficacy of exercise therapy are rare in this field, the aims of this study are to (1) identify the efficacy of a home-based exercise program to improve the motor function of children with CHD with cardiac catheterization, (2) reduce parental anxiety and parenting burden, and (3) improve the quality of life for parents whose children are diagnosed with CHD with cardiac catheterization through the program.Methods/designA total of 300 children who will perform a cardiac catheterization will be randomly assigned to two groups: a home-based intervention group and a control group. The home-based intervention group will carry out a home-based exercise program, and the control group will receive only home-based exercise education. Assessments will be undertaken before catheterization and at 1, 3, and 6 months after catheterization. Motor ability quotients will be assessed as the primary outcomes. The modified Ross score, cardiac function, speed of sound at the tibia, functional independence of the children, anxiety, quality of life, and caregiver burden of their parents or the main caregivers will be the secondary outcome measurements.DiscussionThe proposed prospective randomized controlled trial will evaluate the efficiency of a home-based exercise program for children with CHD with cardiac catheterization. We anticipate that the home-based exercise program may represent a valuable and efficient intervention for children with CHD and their families.Trial registrationhttp://www.chictr.org.cn/ on: ChiCTR-IOR-16007762. Registered on 13 January 2016.

Effects of pharmacist-led patient education on diabetes-related knowledge and medication adherence: A home-based study

Objective: Patient education is key to the management of acute and chronic conditions. However, the majority of such educational interventions have been reported from health-care settings. In contrast, this study aims to evaluate whether a home-based intervention can result in better understanding about type 2 diabetes mellitus and can increase adherence to prescribed medications. Method: A non-clinical randomised controlled trial was conducted whereby participants received a home-based educational intervention through a registered pharmacist. A total of 150 patients were randomly assigned to two groups (75 patients in each arm). Diabetes knowledge and medication adherence were measured by means of the 14-item Michigan Diabetes Knowledge Test and the 8-item Morisky Medication Adherence Scale, respectively. Results: No significant differences were observed in either group for demographic variables. There was, however, a significant increase in the participants’ levels of knowledge about type 2 diabetes mellitus and medication adherence in the home-based intervention group at the completion of the intervention ( p < .001). Significantly lower HbA1c levels were also observed among the home-based intervention group following the intervention ( p < .001). Conclusion: A pharmacist-led home-based intervention can significantly increase disease-related knowledge and medication adherence in patients with type 2 diabetes mellitus. Home-based interventional programmes offer a promising method of patient education and counselling.

Passive movement and active exercise for very young infants with congenital heart disease: a study protocol for a randomized controlled trial.

BackgroundDelayed motor development is reported in patients with congenital heart disease (CHD). Exercise is widely used to facilitate motor development and improve motor ability. Exercise for adolescents and adults with CHD has been extensively studied. However, the evidence of exercise for infants with CHD is sparse. This study aims to identify the effect of passive movement and active exercise on motor development within very young CHD infants with cardiac catheterization.Methods/DesignA prospective and randomized controlled trial will be conducted in very young CHD infants with cardiac catheterization. A total of 147 infants with CHD will be randomized by a 1:1:1 allocation ratio by computer to an exercise intervention group, a home-based intervention group and a control group. The exercise intervention group will receive passive movement and active exercise from experienced physiotherapists in pediatrics three times a week for 12 weeks. The home-based intervention group will receive passive movement and active exercise from their parents or caregivers at home three times a week for 12 weeks. The control group will receive follow up only. The follow-up duration is 20 months. The primary outcome measures are the motor quotient measured by the Peabody Developmental Motor Scales-II. The secondary outcome measures are the Ross score, ventricular function, bone quality, body length, weight, head circumference, upper arm circumference, and adverse events.DiscussionThis study has several important features, including the randomization process, the long follow-up duration, the control group, and the large sample size. The aim of this study is to determine whether 12-week passive movement and active exercise promotes motor development and produces other beneficial effects for very young CHD infants with cardiac catheterization. Therefore, this study will contribute new knowledge regarding the rehabilitation program in very young CHD infants with cardiac catheterization.Trial registrationCurrent Controlled Trials ChiCTR-IOR-15005909 (January 31, 2015).

Differential impact of a nurse-led, home-based intervention for optimal secondary cardiac prevention on recurrent hospitalization in men and women: the Young @ Heart multicentre, randomized trial

Background: We examined the impact of a two year secondary prevention program on recurrent hospitalization in cardiac patients with ready access to specialist care. Methods: The Young at Heart Study was a multicentre, randomized controlled trial comparing usual post-discharge care (UC) with a flexible, nurse-led, home-based intervention (HBI). The primary endpoint was rate of all-cause hospital stay during 31.5±7.5 months follow-up. Results: Overall, 602 (mean age 70±10 years, 72% men and 62% hospitalized for coronary artery disease of whom 39% underwent coronary revascularization) patients were randomized to UC (n=296) or HBI (n=306 - 96% received at least one home visit). Women were on average 5 years older (p<0.001) and had greater levels of co-morbidity (p=0.009) than men; these differences were consistent across the two study groups. At 2 years, more HBI versus UC (39 vs. 27%; OR 1.67; 95% CI 1.15 – 2.41; p=0.007) patients were assessed as stable and optimally managed. Overall, 42 patients (7.0%) died and 492 patients (82%) were hospitalized with 2338 all-cause admissions and 10,045 days of hospitalization. There were no group differences (HBI vs. UC) in the primary endpoint of all-cause hospital stay (0.78±2.01 vs. 0.68±1.96/month; p=0.546) or all-cause hospitalization (0.14±0.20 vs. 0.14±0.30/month; p=0.867). Overall, men in the HBI group (40/215 [19%]) were significantly less likely to experience a cardiovascular admission compared to UC (61/216 [28%]) with the reverse situation for women in the HBI group (30/91 [33%]) vs. UC (20/80 [25%]). Independent correlates of cardiovascular admission were living alone (HR 1.62, 95% CI 1.03-2.54; p=0.038) and increasing comorbidity (HR 1.09, 95% CI 1.02 – 1.16 per unit score; p=0.013) for men and women combined. For men only, assignment to the HBI group (HR 0.61, 95% CI 0.41-0.93 for HBI vs. UC; p=0.019) and advancing age was associated with reduced likelihood of a cardiovascular readmission (HR 0.97, 95% CI 0.94-1.00 per year; p=0.05) with 583 less days of (p=0.036) hospital stay. In women, advancing age (HR 1.06, 95% CI 1.01-1.10 per year; p=0.012) and study site (HR 0.57, 95% CI 0.40-0.82, site A vs. B; p=0.002) were the only significant correlates, with assignment to HBI associated with a non-significant 1.4-fold increased risk of such an event. Conclusions: Despite high levels of engagement and potential clinical improvements at 2 years, HBI did not reduce levels of recurrent hospital stay compared to usual care. However, improved cardiovascular outcomes in men, but not women, requires further investigation.

Impact of Home Versus Clinic-Based Management of Chronic Heart Failure: The WHICH? (Which Heart Failure Intervention Is Most Cost-Effective & Consumer Friendly in Reducing Hospital Care) Multicenter, Randomized Trial

The goal of this study was to make a head-to-head comparison of 2 common forms of multidisciplinary chronic heart failure (CHF) management. Although direct patient contact appears to be best in delivering CHF management overall, the precise form to optimize health outcomes is less clear. This prospective, multicenter randomized controlled trial with blinded endpoint adjudication comprised 280 hospitalized CHF patients (73% male, age 71 ± 14 years, and 73% with left ventricular ejection fraction ≤45%) randomized to home-based intervention (HBI) or specialized CHF clinic-based intervention (CBI). The primary endpoint was all-cause, unplanned hospitalization or death during 12- to 18-month follow-up. Secondary endpoints included type/duration of hospitalization and healthcare costs. The primary endpoint occurred in 102 of 143 (71%) HBI versus 104 of 137 (76%) CBI patients (adjusted hazard ratio [HR]: 0.97 [95% confidence interval (CI): 0.73 to 1.30], p = 0.861): 96 (67.1%) HBI versus 95 (69.3%) CBI patients had an unplanned hospitalization (p = 0.887), and 31 (21.7%) versus 38 (27.7%) died (p = 0.252). The median duration of each unplanned hospitalization was significantly less in the HBI group (4.0 [interquartile range (IQR): 2.0 to 7.0] days vs. 6.0 [IQR: 3.5 to 13] days; p = 0.004). Overall, 75% of all hospitalization was attributable to 64 (22.9%) patients, of whom 43 (67%) were CBI patients (adjusted odds ratio: 2.55 [95% CI: 1.37 to 4.73], p = 0.003). HBI was associated with significantly fewer days of all-cause hospitalization (-35%; p = 0.003) and from cardiovascular causes (-37%; p = 0.025) but not for CHF (-24%; p = 0.218). Consequently, healthcare costs ($AU3.93 vs. $AU5.53 million) were significantly less for the HBI group (median: $AU34 [IQR: 13 to 81] per day vs. $AU52 [17 to 140] per day; p = 0.030). HBI was not superior to CBI in reducing all-cause death or hospitalization. However, HBI was associated with significantly lower healthcare costs, attributable to fewer days of hospitalization. (Which Heart failure Intervention is most Cost-effective & consumer friendly in reducing Hospital care [WHICH?]; ACTRN12607000069459).

Extending the Horizon in Chronic Heart Failure

The long-term impact of chronic heart failure management programs over the typical life span of affected individuals is unknown. The effects of a nurse-led, multidisciplinary, home-based intervention (HBI) in a typically elderly cohort of patients with chronic heart failure initially randomized to either HBI (n=149) or usual postdischarge care (UC) (n=148) after a short-term hospitalization were studied for up to 10 years of follow-up (minimum 7.5 years of follow-up). Study end points were all-cause mortality, event-free survival (event was defined as death or unplanned hospitalization), recurrent hospital stay, and cost per life-year gained. Median survival in the HBI cohort was almost twice that of UC (40 versus 22 months; P<0.001), with fewer deaths overall (HBI, 77% versus 89%; adjusted relative risk, 0.74; 95% CI, 0.53 to 0.80; P<0.001). HBI was associated with prolonged event-free survival (median, 7 versus 4 months; P<0.01). HBI patients had more unplanned readmissions (560 versus 550) but took 7 years to overtake UC; the rates of readmission (2.04+/-3.23 versus 3.66+/-7.62 admissions; P<0.05) and related hospital stay (14.8+/-23.0 versus 28.4+/-53.4 days per patient per year; P<0.05) were significantly lower in the HBI group. HBI was associated with 120 more life-years per 100 patients treated compared with UC (405 versus 285 years) at a cost of 1729 dollars per additional life-year gained when we accounted for healthcare costs including the HBI. In altering the natural history of chronic heart failure relative to UC (via prolonged survival and reduced frequency of recurrent hospitalization), HBI is a remarkably cost- and time-effective strategy over the longer term.

Prolonged Effects of a Home-Based Intervention in Patients With Chronic Illness

Data on the long-term benefits of nonspecific disease management programs are limited. We performed a long-term follow-up of a previously published randomized trial. We compared all-cause mortality and recurrent hospitalization during median follow-up of 7.5 years in a heterogeneous cohort of patients with chronic illness initially exposed to a multidisciplinary, home-based intervention (HBI) (n = 260) or to usual postdischarge care (n = 268). During follow-up, HBI had no impact on all-cause mortality (relative risk, 1.04; 95% confidence interval, 0.80-1.35) or event-free survival from death or unplanned hospitalization (relative risk, 1.03; 95% confidence interval, 0.86-1.24). Initial analysis suggested that HBI had only a marginal impact in reducing unplanned hospitalization, with 677 readmissions vs 824 for the usual care group (mean +/- SD rate, 0.72 +/- 0.96 vs 0.84 +/- 1.20 readmissions/patient per year; P = .08). When accounting for increased hospital activity in HBI patients with chronic obstructive pulmonary disease during follow-up for 2 years, post hoc analyses showed that HBI reduced readmissions by 14% within 2 years in patients without this condition (mean +/- SD rate, 0.54 +/- 0.72 vs 0.63 +/- 0.88 readmission/patient per year; P = .04) and by 21% in all surviving patients within 3 to 8 years (mean +/- SD rate, 0.64 +/- 1.26 vs 0.81 +/- 1.61 readmissions/patient per year; P = .03). Overall, recurrent hospital costs were significantly lower (14%) in the HBI group (mean +/- SD, 823 dollars +/- 1642 dollars vs 960 dollars +/- 1376 dollars per patient per year; P = .045). This unique study suggests that a nonspecific HBI provides long-term cost benefits in a range of chronic illnesses, except for chronic obstructive pulmonary disease.