Dataset Information

Rationale and design of a smartphone-enabled, home-based exercise program in patients with symptomatic peripheral arterial disease: The smart step randomized trial.

ABSTRACT:

Background

Supervised exercise therapy (SET) is recommended in patients with symptomatic peripheral arterial disease (PAD) as first-line therapy, although patient adoption remains low. Home-based exercise therapy (HBET) delivered through smartphones may expand access. The feasibility of such programs, especially in low-resource settings, remains unknown.

Methods

Smart Step is a pilot randomized trial of smartphone-enabled HBET vs walking advice in patients with symptomatic PAD in an inner-city hospital. Participants receive a smartphone app with daily exercise reminders and educational content. A trained coach performs weekly phone-based coaching sessions. All participants receive a Fitbit Charge HR 2 to measure physical activity. The primary outcome changes in 6-minute walking test (6MWT) distance at 12 weeks over baseline. Secondary outcomes are the degree of engagement with the smartphone app and changes in health behaviors and quality of life scores after 12 weeks and 1 year.

Results

A total of 15 patients are randomized as of December 15, 2019 with a mean (SD) age of 66.1 (5.8) years. The majority are female (60%) and black (87%). At baseline, the mean (SD) ABI and 6MWT were 0.86 (0.29) and 363.5 m, respectively. Enrollment is expected to continue until December 2020 to achieve a target size of 50 participants.

Conclusions

The potential significance of this trial will be to provide preliminary evidence of a home-based, "mobile-first" approach for delivering a structured exercise rehabilitation program. Smartphone-enabled HBET can be potentially more accessible than center-based programs, and if proven effective, may have a potential widespread public health benefit.

SUBMITTER: Harzand A

PROVIDER: S-EPMC7298994 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BackgroundPhysical exercise is a first-line treatment for peripheral arterial disease (PAD) and intermittent claudication (IC) reducing pain and increasing the distances walked. Home-based exercise therapy (HBET) has the advantage of reaching a higher number of patients and increasing adherence to physical exercise as it is performed in the patient's residential area and does not have the time, cost, and access restrictions of supervised exercise therapy (SET) implemented in a clinical setting. Even so, rates of adherence to physical exercise are relatively low, and therefore, m-health tools are promising in increasing motivation to behavior change and adherence to physical exercise. A built-in virtual assistant is a patient-focused tool available in a mobile interface, providing a variety of functions including health education, motivation, and implementation of behavior change techniques.MethodsThis is a single-center, prospective, three-arm, single-blind, randomized, controlled, superior clinical trial with stratified and blocked random allocation. Three hundred participants with PAD and IC will be recruited from an Angiology and Vascular Surgery Department, Centro Hospitalar Universitário Porto (CHUPorto), Porto, Portugal. All patients will receive the same medical care recommended by current guidelines. Participants in all three groups will receive a personalized prescription for an HBET program and a behavioral change and motivational intervention. Participants in experimental groups 1 and 2 will receive a smartphone with the WalkingPad app to monitor exercise sessions. Experimental group 2 WalkingPad app will have a built-in virtual assistant that will promote behavioral change and provide motivational support. Participants allocated to the active control group will not receive the m-health tool, but a practice diary to encourage monitoring. The program will last for 6 months with three evaluation moments (baseline, 3, and 6 months). The primary outcome will be the change in distances walked (maximal and pain-free) from baseline to 3 and 6 months. Secondary outcomes will be changes in quality of life, patients' perception of resistance, and walking speed.DiscussionThis study will allow measuring the effectiveness of an m-health tool in increasing motivation for behavior change and adherence to an HBET program in patients with PAD. The superiority of experimental group 2 in the primary and secondary outcomes will indicate that the virtual assistant is effective for motivating behavioral change and encouraging the practice and adherence to physical exercise. The use of m-health tools and virtual health assistants can potentially fill a gap in the access and quality of health services and information, reducing the burden on the health system and promoting self-management and self-care in chronic illness.Trial registrationClinicalTrials.gov NCT04749732 . Registered on 10 February 2021.

Project description:AimsInvestigate whether a Home-based Exercise Therapy (HBET) program for patients with Peripheral Arterial Disease (PAD) and Intermittent Claudication (IC) with a behavior change intervention, supported by a smartphone application, is effective in improving walking distances and performance, and quality of life (QoL) over 6 months.Methods and resultsThis was a single-center, prospective, two-arm, single-blinded randomized controlled trial including 73 patients with PAD and IC, and three assessment moments: baseline, 3, and 6 months. Participants were randomized to receive a walking exercise prescription, with the support (n = 38) or without the support (n = 35) of the WalkingPad app, between January 2021 and July 2022. Both groups received two face-to-face behavior change sessions and 12 structured and targeted reinforcement phone calls over 6 months. Primary outcomes were between-group differences in pain-free walking distance (PFWD), functional walking distance (FWD), maximal walking distance (MWD), and 6-min walk distance (6 MWD) at 3 and 6 months. Secondary outcomes were QoL and walking impairment. Seventy-three patients (mean age 64 ± 7.2 years, 88% men) participated in this study, 60 of whom completed the three assessment moments. The whole sample significantly improved all primary outcomes in the first 3 months; that is, the average PFWD (151.1 m), FWD (175.2 m), MWD (171.1 m), and 6 MWD (30.8 m) increased from T1 to T2. Only MWD exhibited a significant average increase (35.0 m). Secondary outcomes also increased from baseline to 3 and 6 months. There were no between-group differences, except for MWD, which showed a greater increase at 6 months in the group that used the app, excluding patients with weak walking ability and extreme anxiety symptoms at baseline.ConclusionThe intervention improved distances and walking skills as well as the physical, mental, and disease-related quality of life among adults with PAD and IC. The group that used the WalkingPad app improved their MWD in 6 months compared to the control group, except for patients with poor walking ability and extreme anxiety symptoms, which suggests the effectiveness of the WalkingPad app for patients with high walking ability and no severe anxiety symptoms. More research is needed to determine the durability of these findings and to explore what app functionality might promote the other outcomes.Clinical trial registrationhttps://clinicaltrials.gov (NCT04749732).

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Project description:BackgroundIn the home care industry, the assignment and tracking of care services are controlled by care centers that are centralized in nature and prone to inefficient information transmission. A lack of trust among the involved parties, information opaqueness, and large manual manipulation result in lower process efficiency.ObjectiveThis study aimed to explore and demonstrate the application of blockchain and smart contract technologies to innovate/renovate home care services for harvesting the desired blockchain benefits of process transparency, traceability, and interoperability.MethodsAn object-oriented analysis/design combined with a unified modeling language tool was used to construct the architecture of the proposed home care service system. System feasibility was evaluated via an implementation test, and a questionnaire survey was performed to collect opinions from home care service respondents knowledgeable about blockchain and smart contracts.ResultsAccording to the comparative analysis results, the proposed design outperformed the existing system in terms of traceability, system efficiency, and process automation. Moreover, for the questionnaire survey, the quantitative analysis results showed that the proposed blockchain-based system had significantly (P<.001) higher mean scores (when compared with the existing system) in terms of important factors, including timeliness, workflow efficiency, automatic notifications, insurance functionality, and auditable traceability. In summary, blockchain-based home care service participants will be able to enjoy improved efficiency, better transparency, and higher levels of process automation.ConclusionsBlockchain and smart contracts can provide valuable benefits to the home care service industry via distributed data management and process automation. The proposed system enhances user experiences by mitigating human intervention and improving service interoperability, transparency/traceability, and real-time response to home care service events. Efforts in exploring and integrating blockchain-based home care services with emerging technologies, such as the internet of things and artificial intelligence, are expected to provide further benefits and therefore are subject to future research.