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The rehabilitation enhancing aging through connected health (REACH) study: study protocol for a quasi-experimental clinical trial.

ABSTRACT: BACKGROUND:Mobility limitations among older adults increase the risk for disability and healthcare utilization. Rehabilitative care is identified as the most efficacious treatment for maintaining physical function. However, there is insufficient evidence identifying a healthcare model that targets prevention of mobility decline among older adults. The objective of this study is to evaluate the preliminary effectiveness of a physical therapy program, augmented with mobile tele-health technology, on mobility function and healthcare utilization among older adults. METHODS:This is a quasi-experimental 12-month clinical trial conducted within a metropolitan-based healthcare system in the northeastern United States. It is in parallel with an existing longitudinal cohort study evaluating mobility decline among community-dwelling older adult primary care patients over one year. Seventy-five older adults (? 65-95 years) are being recruited using identical inclusion/exclusion criteria to the cohort study. Three aims will be evaluated: the effect of our program on 1) physical function, 2) healthcare utilization, and 3) healthcare costs. Changes in patient-reported function over 1 year in those receiving the intervention (aim 1) will be compared to propensity score matched controls (N = 150) from the cohort study. For aims 2 and 3, propensity scores, derived from logistic regression model that includes demographic and diagnostic information available through claims and enrollment information, will be used to match treatment and control patients in a ratio of 1:2 or 1:3 from a Medicare Claims Registry derived from the same geographic region. The intervention consists of a one-year physical therapy program that is divided between a combination of outpatient and home visits (6-10 total visits) and is augmented on a computerized tablet using of a commercially available application to deliver a progressive home-based exercise program emphasizing lower-extremity function and a walking program. DISCUSSION:Incorporating mobile health into current healthcare models of rehabilitative care has the potential to decrease hospital visits and provide a longer duration of care. If the hypotheses are supported and demonstrate improved mobility and reduced healthcare utilization, this innovative care model would be applicable for optimizing the maintenance of functional independence among community-dwelling older adults. TRIAL REGISTRATION:ClinicalTrial.gov Identifier: NCT02580409 (Date of registration October 14, 2015).

SUBMITTER: Ni M

PROVIDER: S-EPMC5607604 | biostudies-literature | 2017 Sep

REPOSITORIES: biostudies-literature

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The rehabilitation enhancing aging through connected health (REACH) study: study protocol for a quasi-experimental clinical trial.

Ni Meng M Brown Lorna G LG Lawler Danielle D Ellis Terry D TD Deangelis Tamara T Latham Nancy K NK Perloff Jennifer J Atlas Steve J SJ Percac-Lima Sanja S Bean Jonathan F JF

BMC geriatrics 20170920 1

<h4>Background</h4>Mobility limitations among older adults increase the risk for disability and healthcare utilization. Rehabilitative care is identified as the most efficacious treatment for maintaining physical function. However, there is insufficient evidence identifying a healthcare model that targets prevention of mobility decline among older adults. The objective of this study is to evaluate the preliminary effectiveness of a physical therapy program, augmented with mobile tele-health tech ...[more]

PMID: 28931377

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Project description:BackgroundBreast cancer is the leading cancer affecting women in Singapore. Its survivors commonly experience decline in physical function and quality of life post-mastectomy, due to their upper limb morbidity and wound issues. Rehabilitation can address the aforementioned issues. When rehabilitation is accessible and easy to adhere, it can optimize recovery. Home-based tele-rehabilitation guided by healthcare professionals and self-managed by patients can potentially optimize the patients' adherence to rehabilitation and recovery. With that in mind, a team of breast cancer specialists (oncologists, nurses, and therapists) in Singapore has developed one of the first tele-rehabilitation systems for local women undergoing a unilateral mastectomy. To our knowledge, no such systems have been evaluated or proven effective as a treatment option among local breast cancer patients with acute disabilities.MethodsThis is a pilot quasi-experimental trial that aims to evaluate the feasibility of tele-rehabilitation and tele-drain care compared to usual care. Up to 40 patients (20 per group) will be recruited for this trial. They will be assigned to an intervention group that receives rehabilitation via a tele-rehabilitation system or a control group that receives rehabilitation in person at their clinic. The primary outcome of this trial is rehabilitation participation (i.e., the time spent on rehabilitation). The secondary outcomes are upper extremity functioning, perceived health, and quality of life.DiscussionAs part of this pilot trial, patients who opt in for the tele-rehabilitation will be asked to share their experience with and thoughts on the tele-rehabilitation system. With the evidence obtained from the tele-rehabilitation patients of this trial, we will be able to improve the current system for our future trial. Further, our additional data on rehabilitation participation, physical function, and quality of life will help us design a sufficiently powered future main trial.Trial registrationThe trial was approved by the National Healthcare Group's Domain Specific Review Board (#2019/00283) and registered with www.ClinicalTrials.gov (# NCT04269967 ) in February 2020.

Project description:ObjectivesCongenital hemiplegia is the most common form of cerebral palsy (CP). Children with unilateral CP show signs of upper limb asymmetry by 8 months corrected age (ca) but are frequently not referred to therapy until after 12?months ca. This study compares the efficacy of infant-friendly modified constraint-induced movement therapy (Baby mCIMT) to infant friendly bimanual therapy (Baby BIM) on upper limb, cognitive and neuroplasticity outcomes in a multisite randomised comparison trial.Methods and analysis150 infants (75 in each group), aged between 3 and 6?months ca, with asymmetric brain injury and clinical signs of upper extremity asymmetry will be recruited. Children will be randomised centrally to receive equal doses of either Baby mCIMT or Baby BIM. Baby mCIMT comprises restraint of the unimpaired hand using a simple restraint (eg, glove, sock), combined with intensive parent implemented practice focusing on active use of the impaired hand in a play-based context. In contrast, Baby BIM promotes active play requiring both hands in a play-based context. Both interventions will be delivered by parents at home with monthly home visits and interim telecommunication support by study therapists. Assessments will be conducted at study entry; at 6, 12?months ca immediately postintervention (primary outcome) and 24?months ca (retention). The primary outcome will be the Mini-Assisting Hand Assessment. Secondary outcomes include the Bayley Scale for Infant and Toddler Development (cognitive and motor domains) and the Hand Assessment of Infants. A subset of children will undertake MRI scans at 24?months ca to evaluate brain lesion severity and brain (re)organisation after intervention.Ethics and disseminationFull ethical approvals for this study have been obtained from the relevant sites. The findings will be disseminated in peer-reviewed publications.Trial registration numberAustralian and New Zealand Clinical Trials Registry: ACTRN12615000180516, Pre results.

Project description:IntroductionGreat improvements in the health of newborns, children, and women in Pakistan are needed. A large body of literature has demonstrated that the majority of maternal, newborn, and child deaths are preventable with essential health strategies including immunization, nutrition interventions, and child health interventions. Despite the importance of these interventions for the health of women and children, access to services continues to be a barrier. Furthermore, demand for services also contributes to low coverage of essential health interventions. Given the emerging threat of COVID-19 coupled with already weak maternal and child health, delivering effective and feasible nutrition and immunization services to communities, and increasing demand and uptake of services is a pressing and important need.Methods and analysisThis quasi-experimental study aims to improve health service delivery and increase uptake. The study included four main intervention strategies including community mobilization, mobile health teams offering MNCH and immunization services, engagement of the private sector, and testing of a comprehensive health, nutrition, growth, and immunization app, Sehat Nishani, for a period of 12 months. The target group of the project were women of reproductive age (15-49 years) and children under-five. The project was implemented in three union councils (UCs) in Pakistan including Kharotabad-1(Quetta District, Balochistan), Bhana Mari (Peshawar District, Khyber Pakhtunkhwa) and Bakhmal Ahmedzai (Lakki Marwat district, Khyber Pakhtunkhwa). Propensity score matching based on size, location, health facilities, and key health indicators of UC was conducted to identify three matched UCs. A household baseline, midline, endline and close-out assessment will be conducted for evaluating coverage of interventions as well as the knowledge, attitude, and practices of the community in the MNCH and COVID-19 context. Descriptive and inferential statistics will be used to test hypotheses. As well, a detailed cost-effectiveness analysis will be conducted to generate costing data for these interventions to effectively inform policymakers and stakeholder on feasibility of the model. Trial registration: NCT05135637.

Project description:BackgroundUnhealthy lifestyles in early childhood are a major global health challenge. These lifestyles often persist from generation to generation and contribute to a vicious cycle of health-related and social problems. This design article presents a study evaluating the effects of two novel healthy school interventions. The main outcome measure will be changes in children's body mass index (BMI). In addition, lifestyle behaviours, academic achievement, child well-being, socio-economic differences, and societal costs will be examined.MethodsIn close collaboration with various stakeholders, a quasi-experimental study was developed, for which children of four intervention schools (n = 1200) in the southern part of the Netherlands are compared with children of four control schools (n = 1200) in the same region. The interventions started in November 2015. In two of the four intervention schools, a whole-school approach named 'The Healthy Primary School of the Future', is implemented with the aim of improving physical activity and dietary behaviour. For this intervention, pupils are offered an extended curriculum, including a healthy lunch, more physical exercises, and social and educational activities, next to the regular school curriculum. In the two other intervention schools, a physical-activity school approach called 'The Physical Activity School', is implemented, which is essentially similar to the other intervention, except that no lunch is provided. The interventions proceed during a period of 4 years. Apart from the effectiveness of both interventions, the process, the cost-effectiveness, and the expected legal implications are studied. Data collection is conducted within the school system. The baseline measurements started in September 2015 and yearly follow-up measurements are taking place until 2019.DiscussionA whole-school approach is a new concept in the Netherlands. Due to its innovative, multifaceted nature and sound scientific foundation, these integrated programmes have the potential to form a template for primary schools worldwide. The effects of this approach may extend further than the outcomes associated with well-being and academic achievement, potentially impacting legal and cultural aspects in our society.Trial registrationThe study protocol was registered in the database ClinicalTrials.gov on 14-06-2016 with the reference number NCT02800616 .

Project description:High prevalence of poor mental health is a major public health problem. Natural environments may contribute to mitigating stress and enhancing health. However, there is little evidence on whether community-level interventions intended to increase exposure to natural environments can improve mental health and related behaviours. In the first study of its kind, we evaluated whether the implementation of a programme designed to improve the quality of, and access to, local woodlands in deprived communities in Scotland, UK, was associated with lower perceived stress or other health-related outcomes, using a controlled, repeat cross-sectional design with a nested prospective cohort. Interventions included physical changes to the woodlands and community engagement activities within the woodlands, with data collected at baseline (2013) and post-intervention (2014 and 2015). The interventions were, unexpectedly, associated with increased perceived stress compared to control sites. However, we observed significantly greater increases in stress for those living >500 m from intervention sites. Visits to nearby nature (woods and other green space) increased overall, and moderate physical activity levels also increased. In the intervention communities, those who visited natural environments showed smaller increases in stress than those who did not; there was also some evidence of increased nature connectedness and social cohesion. The intervention costs were modest but there were no significant changes in quality of life on which to base cost-effectiveness. Findings suggest factors not captured in the study may have contributed to the perceived stress patterns found. Wider community engagement and longer post-intervention follow-up may be needed to achieve significant health benefits from woodland interventions such as those described here. The study points to the challenges in evidencing the effectiveness of green space and forestry interventions to enhance health in urban environments, but also to potential benefits from more integrated approaches across health and landscape planning and management practice.

Project description:INTRODUCTION:In sub-Saharan Africa, adolescent girls and young women (AGYW) face a range of sexual and reproductive health (SRH) challenges. Clinical, behavioural and structural interventions have each reduced these risks and improved health outcomes. However, combinations of these interventions have not been compared with each other or with no intervention at all. The 'Girl Power' study is designed to systematically make these comparisons. METHODS AND ANALYSIS:Four comparable health facilities in Malawi and South Africa (n=8) were selected and assigned to one of the following models of care: (1) Standard of care: AGYW can receive family planning, HIV testing and counselling (HTC), and sexually transmitted infection (STI) syndromic management in three separate locations with three separate queues with the general population. No youth-friendly spaces, clinical modifications or trainings are offered, (2) Youth-Friendly Health Services (YFHS): AGYW are meant to receive integrated family planning, HTC and STI services in dedicated youth spaces with youth-friendly modifications and providers trained in YFHS, (3) YFHS+behavioural intervention (BI): In addition to YFHS, AGYW can attend 12 monthly theory-driven, facilitator-led, interactive sessions on health, finance and relationships, (4) YFHS+BI+conditional cash transfer (CCT): in addition to YFHS and BI, AGYW receive up to 12 CCTs conditional on monthly BI session attendance.At each clinic, 250 AGYW 15-24 years old (n=2000 total) will be consented, enrolled and followed for 1 year. Each participant will complete a behavioural survey at enrolment, 6 months and 12 months . All clinical, behavioural and CCT services will be captured. Outcomes of interest include uptake of each package element and reduction in HIV risk behaviours. A qualitative substudy will be conducted. ETHICS/DISSEMINATION:This study has received ethical approval from the University of North Carolina Institutional Review Board, the University of Cape Town Human Research Ethics Committee and Malawi's National Health Sciences Research Committee. Study plans, processes and findings will be disseminated to stakeholders, in peer-reviewed journals and at conferences.

Project description:The primary aim of this paper is to describe the design of a project evaluating the effects of using a research-based strategy for managing housing adaptations (HAs). The evaluation targets clients' perspectives in terms of activity, participation, usability, fear of falling, fall incidence, use of mobility devices, and health-related quality of life, and determines the societal effects of HAs in terms of costs. Additional aims of the project are to explore and describe this strategy in relation to experiences and expectations (a) among clients and cohabitants and (b) occupational therapists in ordinary practice.This study is a quasi-experimental trial applying a multiphase design, combining quantitative and qualitative data. At the experimental sites, the occupational therapists (OTs) apply the intervention, i.e. a standardized research-based strategy for HA case management. At the control site, the occupational therapists are following their regular routine in relation to HA. Three municipalities in south Sweden will be included based on their population, their geographical dispersion, and their similar organizational structures for HA administration. Identical data on outcomes is being collected at all the sites at the same four time points: before the HA and then 3, 6, and 12 months after the HA. The data-collection methods are semi-structured qualitative interviews, observations, clinical assessments, and certificates related to each client's HA.The intervention in this study has been developed and tested through many years of research and in collaboration with practitioners. This process includes methodological development and testing research aimed at identifying the most important outcomes and research targeting current HA case-management procedures in Swedish municipalities. When the study is completed, the results will be used for further optimization of the practice strategy for HA, in close collaboration with the data-collecting OTs.No: NCT01960582.

Project description:IntroductionSweden has long been praised for a generous parental leave policy oriented towards facilitating a gender-equitable approach to work and parenting. Yet certain aspects of Swedish parental leave could also be responsible for the maintenance of (or even the increase in) health inequalities. Using a 'Health in All Policies' lens, this research project aims to assess the unintended health consequences of various components of Sweden's parental leave policy, including eligibility for and uptake of earnings based benefits.Methods and analysisWe will use individual-level data from multiple Swedish registers. Sociodemographic information, including parental leave use, will be retrieved from the total population register, Longitudinal Integration Database for Health Insurance and Labour Market Studies and Social Insurance Agency registers. Health information for parents and children will be retrieved from the patient, prescribed drug, cause of death, medical birth and children's health registers. We will evaluate parents' mental, mothers' reproductive and children's general health outcomes in relation to several policy reforms aiming to protect parental leave benefits in short birth spacing (the speed premium) and to promote father's uptake (the father's quota) and sharing of parental leave days (the double days reform). We will also examine effects of increases in basic parental leave benefit levels. Using quasi-experimental designs, we will compare health outcomes across these reforms and eligibility thresholds with interrupted time series, difference-in-difference and regression discontinuity approaches to reduce the risk of health selection and assess causality in the link between parental leave use and health.Ethics and disseminationThis project has been granted all necessary ethical permissions from the Stockholm Regional Ethical Review Board (Dnr 2019-04913) for accessing and analysing deidentified data. The final outputs will primarily be disseminated as scientific articles published in open-access, high-impact peer-reviewed international journals, as well as press releases and policy briefs.

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The rehabilitation enhancing aging through connected health (REACH) study: study protocol for a quasi-experimental clinical trial.

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The rehabilitation enhancing aging through connected health (REACH) study: study protocol for a quasi-experimental clinical trial.

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