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Study protocol: home-based telehealth stroke care: a randomized trial for veterans.

ABSTRACT: Stroke is one of the most disabling and costly impairments of adulthood in the United States. Stroke patients clearly benefit from intensive inpatient care, but due to the high cost, there is considerable interest in implementing interventions to reduce hospital lengths of stay. Early discharge rehabilitation programs require coordinated, well-organized home-based rehabilitation, yet lack of sufficient information about the home setting impedes successful rehabilitation. This trial examines a multifaceted telerehabilitation (TR) intervention that uses telehealth technology to simultaneously evaluate the home environment, assess the patient's mobility skills, initiate rehabilitative treatment, prescribe exercises tailored for stroke patients and provide periodic goal oriented reassessment, feedback and encouragement.We describe an ongoing Phase II, 2-arm, 3-site randomized controlled trial (RCT) that determines primarily the effect of TR on physical function and secondarily the effect on disability, falls-related self-efficacy, and patient satisfaction. Fifty participants with a diagnosis of ischemic or hemorrhagic stroke will be randomly assigned to one of two groups: (a) TR; or (b) Usual Care. The TR intervention uses a combination of three videotaped visits and five telephone calls, an in-home messaging device, and additional telephonic contact as needed over a 3-month study period, to provide a progressive rehabilitative intervention with a treatment goal of safe functional mobility of the individual within an accessible home environment. Dependent variables will be measured at baseline, 3-, and 6-months and analyzed with a linear mixed-effects model across all time points.For patients recovering from stroke, the use of TR to provide home assessments and follow-up training in prescribed equipment has the potential to effectively supplement existing home health services, assist transition to home and increase efficiency. This may be particularly relevant when patients live in remote locations, as is the case for many veterans.Clinical Trials.gov Identifier: NCT00384748.

SUBMITTER: Chumbler NR

PROVIDER: S-EPMC2904744 | biostudies-literature | 2010 Jun

REPOSITORIES: biostudies-literature

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Study protocol: home-based telehealth stroke care: a randomized trial for veterans.

Chumbler Neale R NR Rose Dorian K DK Griffiths Patricia P Quigley Patricia P McGee-Hernandez Nancy N Carlson Katherine A KA Vandenberg Phyllis P Morey Miriam C MC Sanford Jon J Hoenig Helen H

Trials 20100630

<h4>Background</h4>Stroke is one of the most disabling and costly impairments of adulthood in the United States. Stroke patients clearly benefit from intensive inpatient care, but due to the high cost, there is considerable interest in implementing interventions to reduce hospital lengths of stay. Early discharge rehabilitation programs require coordinated, well-organized home-based rehabilitation, yet lack of sufficient information about the home setting impedes successful rehabilitation. This ...[more]

PMID: 20591171

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Project description:BackgroundHypertension is the most important modifiable stroke risk factor, but blood pressure (BP) remains poorly controlled after stroke, especially among Black and Hispanic patients. We tested the feasibility of TASC (Telehealth After Stroke Care), a post-acute stroke care model integrating nurse-supported home BP telemonitoring, tailored infographics, and multidisciplinary team video visits.MethodsAcute stroke patients with hypertension were randomized at discharge to usual care or usual care with TASC. Usual care patients received video visits with primary care and stroke. TASC included a tablet and monitor to wirelessly transmit BP data to the electronic health record, with telenursing support, tailored infographics to explain BP readings, and pharmacist visits. Outcomes assessment was blinded. Feasibility outcomes included recruitment, randomization, adherence, and retention. Systolic BP from baseline to 3 months after discharge was evaluated using generalized linear modeling.ResultsFifty patients (64±14 years; 36% women' 44% Hispanic, 32% Black, 54% ≤high school education, 30% private insurance), and 75% of all eligible were enrolled over 6.3 months. Baseline systolic BP was similar in both (TASC n=25, 140±19 mm Hg; usual care n=25, 142±19 mm Hg). At 3 months, adherence to video visits (91% versus 75%, P=0.14) and retention (84% versus 64%, P=0.11) were higher with TASC. Home systolic BP declined by 16±19 mm Hg from baseline in TASC and increased by 3±24 mm Hg in usual care (P=0.01). Among Black patients, systolic BP control (<130 mm Hg) improved from 40% to 100% with TASC versus 14% to 29%, and among Hispanic patients, from 23% to 62% with TASC, versus 33% to 17% in usual care.ConclusionsEnhancing post-acute stroke care with home BP telemonitoring is feasible to improve hypertension in an underserved setting and should be tested in a definitive randomized clinical trial.RegistrationURL: https://www.Clinicaltrialsgov; Unique identifier: NCT04640519.

Project description:BACKGROUND:Individuals with spinal cord injuries (SCI) are prone to pressure ulcers (PUs) because of the loss of sensorimotor function involved as well as increased skin moisture. Treatment of PU after SCI is complicated, involving different specialties and with need for long-lasting follow-up. This study should identify risk factors for PU after SCI, and find an effective and less time-consuming treatment for the condition among different available methods for follow-up. METHOD/DESIGN:The first part of this research project aims to investigate the prevalence of PU among persons with SCI based on an epidemiological design. The study will identify possible risk factors for acquiring PU. A questionnaire focusing on previous and present PUs will be sent to persons who suffered SCIs between January 2004 and January 2014. In the second part we will compare two different treatment regimens of PU through a randomized controlled pilot trial (RCT) where we will compare outpatient SCI follow-up in a hospital versus outpatient follow-up from the patient's home, using telemedicine (teleSCI) interventions. We will compare the healing of the PU in the two groups (usual care versus teleSCI). The Tissue, Infection, Moisture Edge (TIME) registration form, the Photographic Wound Assessment Tool (PWAT) and the change in the ulcer size will be used to monitor the healing. Changes in health-related quality of life (HRQoL) and the need for assistance will be assessed using the Five Dimensions European Quality of Life scale (EQ-5D), the generic Medical Outcomes Study 12-item Short Form Health Survey (SF-12) modified version, the International Spinal Cord Injury Quality of Life Data set (ISCI-QoL Data set), and the Spinal Cord Independence Measure scale, version III (SCIM III). In addition to primary outcome measures, a cost-benefit evaluation and an assessment of patient satisfaction and participation will be performed, using customized questionnaires. DISCUSSION:The first part of the research project will reveal the epidemiology of PU after SCI, and explore the risk factors. This part enables further prevention of PU after SCI and this information will be used in the follow-up RCT. Videoconferencing in the outpatient follow-up of persons with SCI and PU will change clinical routines and facilitate interdisciplinary collaboration, communication and competence exchange among participants of the health care services. Our research protocol allows comparing methods for interaction between medical specialists at hospitals, local caregivers in the community, next of kin, and persons with SCI and PU. The RCT should identify advantages as well as challenges in the management of PU in different follow-up settings. This study aims to identify risk factors for PU after SCI, and find an effective and less time consuming treatment for the condition among different available methods for follow- up. TRIAL REGISTRATION:1. www.ClinicalTrials.gov , ID: NCT02800915 , last update 9 October 2017. 2. The National Regional Ethical Committee (REC) 2014/ 684/ REK-Nord. https://helseforskning.etikkom.no/prosjekterirek/prosjektregister/prosjekt?p_document_id=469163&p_parent_id=473640&_ikbLanguageCode=n 3. https://app.cristin.no/projects/show.jsf?id=545284 4. https://www.sunnaas.no/kliniske-studier/bruk-av-telemedisin-som-virkemiddel-til-samhandling-i-poliklinisk-oppfolging-av-pasienter-med-ryggmargsskade-og-trykksar.

Project description:BackgroundThis feasibility study is intended to assess the acceptability of home-based task-specific reach-to-grasp (RTG) training for people with stroke, and to gather data to inform recruitment, retention, and sample size for a definitive randomized controlled trial.Methods/designThis is to be a randomized controlled feasibility trial recruiting 50 individuals with upper-limb motor impairment after stroke. Participants will be recruited after discharge from hospital and up to 12 months post-stroke from hospital stroke services and community therapy-provider services. Participants will be assessed at baseline, and then electronically randomized and allocated to group by minimization, based on the time post-stroke and extent of upper-limb impairment. The intervention group will receive 14 training sessions, each 1 hour long, with a physiotherapist over 6 weeks and will be encouraged to practice independently for 1 hour/day to give a total of 56 hours of training time per participant. Participants allocated to the control group will receive arm therapy in accordance with usual care. Participants will be measured at 7 weeks post-randomization, and followed-up at 3 and 6 months post-randomization. Primary outcome measures for assessment of arm function are the Action Research Arm Test (ARAT) and Wolf Motor Function Test (WMFT). Secondary measures are the Motor Activity Log, Stroke Impact Scale, Carer Strain Index, and health and social care resource use. All assessments will be conducted by a trained assessor blinded to treatment allocation. Recruitment, adherence, withdrawals, adverse events (AEs), and completeness of data will be recorded and reported.DiscussionThis study will determine the acceptability of the intervention, the characteristics of the population recruited, recruitment and retention rates, descriptive statistics of outcomes, and incidence of AEs. It will provide the information needed for planning a definitive trial to test home-based RTG training.Trial registration isrctnISRCTN56716589.

Project description:BackgroundTrauma-focused psychotherapies for combat-related posttraumatic stress disorder (PTSD) in military veterans are efficacious, but there are many barriers to receiving treatment. The objective of this study was to determine if cognitive processing therapy (CPT) for PTSD among active duty military personnel and veterans would result in increased acceptability, fewer dropouts, and better outcomes when delivered In-Home or by Telehealth as compared to In-Office treatment.MethodsThe trial used an equipoise-stratified randomization design in which participants (N = 120) could decline none or any 1 arm of the study and were then randomized equally to 1 of the remaining arms. Therapists delivered CPT in 12 sessions lasting 60-min each. Self-reported PTSD symptoms on the PTSD Checklist for DSM-5 (PCL-5) served as the primary outcome.ResultsOver half of the participants (57%) declined 1 treatment arm. Telehealth was the most acceptable and least often refused delivery format (17%), followed by In-Office (29%), and In-Home (54%); these differences were significant (p = 0.0008). Significant reductions in PTSD symptoms occurred with all treatment formats (p < .0001). Improvement on the PCL-5 was about twice as large in the In-Home (d = 2.1) and Telehealth (d = 2.0) formats than In-Office (d = 1.3); those differences were statistically large and significant (d = 0.8, 0.7 and p = 0.009, 0.014, respectively). There were no significant differences between In-Home and Telehealth outcomes (p = 0.77, d = -.08). Dropout from treatment was numerically lowest when therapy was delivered In-Home (25%) compared to Telehealth (34%) and In-Office (43%), but these differences were not statistically significant.ConclusionsCPT delivered by telehealth is an efficient and effective treatment modality for PTSD, especially considering in-person restrictions resulting from COVID-19.Trial registrationClinicalTrials.gov ID NCT02290847 (Registered 13/08/2014; First Posted Date 14/11/2014).

Project description:BackgroundRacial and ethnic disparities persist in stroke occurrence, recurrence, morbidity and mortality. Uncontrolled hypertension (HTN) is the most important modifiable risk factor for stroke risk. Home health care organizations care for many patients with uncontrolled HTN and history of stroke; however, recurrent stroke prevention has not been a home care priority. We are conducting a randomized controlled trial (RCT) to compare the effectiveness, relative to usual home care (UHC), of two Community Transitions Interventions (CTIs). The CTIs aim to reduce recurrent stroke risk among post-stroke patients via home-based transitional care focused on better HTN management.Methods/designThis 3-arm trial will randomly assign 495 black and Hispanic post-stroke home care patients with uncontrolled systolic blood pressure (SBP) to one of three arms: UHC, UHC complemented by nurse practitioner-delivered transitional care (UHC + NP) or UHC complemented by an NP plus health coach (UHC + NP + HC). Both intervention arms emphasize: 1) linking patients to continuous, responsive preventive and primary care, 2) increasing patients'/caregivers' ability to manage a culturally and individually tailored BP reduction plan, and 3) facilitating the patient's reintegration into the community after home health care discharge. The primary hypothesis is that both NP-only and NP + HC transitional care will be more effective than UHC alone in achieving a SBP reduction. The primary outcome is change in SPB at 3 and 12 months. The study also will examine cost-effectiveness, quality of life and moderators (for example, race/ethnicity) and mediators (for example, changes in health behaviors) that may affect treatment outcomes. All outcome data are collected by staff blinded to group assignment.DiscussionThis study targets care gaps affecting a particularly vulnerable black/Hispanic population characterized by persistent stroke disparities. It focuses on care transitions, a juncture when patients are particularly susceptible to adverse events. The CTI is innovative in adapting for stroke patients an established transitional care model shown to be effective for HF patients, pairing the professional NP with a HC, implementing a culturally tailored intervention, and placing primary emphasis on longer-term risk factor reduction and community reintegration rather than shorter-term transitional care outcomes.Trial registrationClinicalTrials.gov NCT01918891 ; Registered 5 August 2013.

Project description:BACKGROUND:Coronary artery disease (CAD) is among the main causes of hospitalization and death worldwide, therefore, the implementation of programs to reduce its impact is necessary. Supervised cardiac rehabilitation has been shown to have positive effects on CAD control. However, there are barriers to patient participation in the traditional, face-to-face cardiac rehabilitation programs, mainly in low-resource environments. OBJECTIVE:This study aimed to verify patient compliance to a home-based cardiac rehabilitation program, which includes unsupervised health education and physical exercises, guided by telephone. Moreover, we compare this new method to the traditional supervised cardiac rehabilitation offered in most hospital centers. METHODS:We present here a two-arm, single-blinded, and randomized controlled design protocol, which compares the traditional cardiac rehabilitation (CenterRehab) with the home-based cardiac rehabilitation (Home-Based) in 72 patients affected by CAD. The primary outcome is the compliance to the cardiac rehabilitation sessions. The secondary outcomes (to evaluate effectiveness) include measurable variables such as functional capacity, CAD risk factors (blood pressure, waist circumference, glycemic, cholesterol levels, depressive symptoms, and the level of physical activity), the patient's quality of life, the disease knowledge, and the morbidity rate. Parameters such as the program cost and the usability will also be evaluated. The programs will last 12 weeks, with a total of 60 rehabilitation and 6 educational sessions. Patients of the CenterRehab program will participate in 24 supervised sessions and 36 home sessions, while the patients of the Home-Based program will participate in 2 supervised sessions and 58 home sessions, guided by telephone. After the 12-week period all participants will be recommended to continue practicing physical exercises at home or at a community center, and they will be invited for re-evaluation after 3 months. The outcomes will be evaluated at baseline, and after 3 and 6 months. RESULTS:Participants are currently being recruited for the trial. Data collection is anticipated to be completed by October 2019. CONCLUSIONS:This is the first study in Brazil comparing the traditional cardiac rehabilitation approach with a novel, home-based protocol that uses an accessible and low-cost technology. If positive results are obtained, the study will contribute to establish a new and viable model of cardiac rehabilitation. TRIAL REGISTRATION:ClinicalTrials.gov NCT03605992; https://clinicaltrials.gov/ct2/show/NCT03605992. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID):DERR1-10.2196/13901.

Project description:BackgroundStroke patients usually suffer primary cognitive impairment related to attention, memory, and executive functions. This impairment causes a negative impact on the quality of life of patients and their families, and may be long term. Cognitive rehabilitation has been shown to be an effective way to treat cognitive impairment and should be continued after hospital discharge. Computerized cognitive rehabilitation can be performed at home using exercise programs that advance with predetermined course content, interval, and pace. We hypothesize that computerized rehabilitation might be improved if a program could customize course content and pace in response to patient-specific progress. The present pilot study is a randomized controlled double-blind crossover clinical trial aiming to study if chronic stroke patients with cognitive impairment could benefit from cognitive training through a customized tele-rehabilitation platform ("Guttmann, NeuroPersonalTrainer"®, GNPT®).Methods/designIndividuals with chronic-stage stroke will be recruited. Participants will be randomized to receive experimental intervention (customized tele-rehabilitation platform, GNPT®) or sham intervention (ictus.online), both with the same frequency and duration (five sessions per week over 6 weeks). After a washout period of 3 months, crossover will occur and participants from the GNPT® condition will receive sham intervention, while participants originally from the sham intervention will receive GNPT®. Patients will be assessed before and after receiving each treatment regimen with an exhaustive neuropsychological battery. Primary outcomes will include rating measures that assess attention difficulties, memory failures, and executive dysfunction for daily activities, as well as performance-based measures of attention, memory, and executive functions.DiscussionCustomized cognitive training could lead to better cognitive function in patients with chronic-stage stroke and improve their quality of life.Trial registrationNCT03326349 . Registered 31 October 2017.

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Study protocol: home-based telehealth stroke care: a randomized trial for veterans.

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Study protocol: home-based telehealth stroke care: a randomized trial for veterans.

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