| Background: The increasingly population of patients with chronic heart failure(HF)brings up the need for new healthcare strategies that can access medical service more conveniently and effectively,especially in remote areas.With the development of electronic technology,tele-health is getting more and more attention,which may offer a glimmer of light for patients and doctors.Objective: The purpose of this study was to evaluate the feasibility and clinical value of the Hospital-Community-Family(HCF)-based Tele-health program.Methods: The first part of the present study was a single-arm prospective study,from February to May 2015,70 HF patients participated in the HCF-based Tele-health program for remote intervention at least 4 months.In the program,participants were educated on the use of smart health-tracking devices and mobile APP to collect and upload comprehensive data elements related to the risk of HF self-care management,such as symptom and sign changes,medication adherence,and etc.They were also instructed to send text messages,view notifications,and receive individualized guidance on the mobile APP.The general practitioners viewed index of each participant on mobile APP and provided primary care periodically,and cardiologists in regional central hospital offered remote guidance and management if necessary.Outcomes assessed included accomplishments of the program,usability and satisfaction,engagement with the intervention,and changes of heart failure-related health behaviors.In the second part of the study,a three-arm parallel controlled randomized trial will be conducted from February 2015 to February 2017.Patients who would not like to participate or have no chance to be told about the program were arranged into(1)Usual Care(UC)group;subjects who would like to participate are randomly assigned to latter two interventional groups,(2)Remote Health Service Platform(RHSP)group: a remote health service platform for data integration and some smart digital devices for health-tracking in addition to usual care;or(3)Tele-health group: an app in addition to RHSP group to access personal healthcare record,receive personalized lifestyle coaching contents and implement remote hierarchical management by general practitioners and cardiologists in regional central hospital.In total,362 patients managed in Subei People Hospital of Jiangsu Province HF out-patient clinics or in the twelve surrounding community hospitals will be included and followed for 12 months.The indicator we observed included cardiac function,self-care and quality of life.Results: In the first part of the present study,a total of 66 individuals,aged 40-79 years,completed the 4-month study.Throughout the study period,294 electronic medical records were formed on the remote monitoring service platform.And there were 89 times of remote consultation and 196 times of remote ward round in total.Participants manifested they were generally satisfied with the intervention for its ease of use and usefulness.Almost all the physicians(21/23,91.3%)believed the program was effective,and 20/23(87.0%)stated their professional knowledge can always be refreshed and enhanced through library on the platform and remote consultation.And86.4%(57/66)of study participants showed great adherence to care plan in the study period.The program showed positive effect on self-management for patients(diet,monitoring of weigh and blood pressure,medicine adherence,P<0.05).In the second part of the present study,a total of 340 individuals completed the 12.4±4.4-month study.Compared with baseline,LVEF,6MWD and NT-pro BNP were improved in the tele-health group(P=0.01,0.03,0.02,respectively).In RHSP group,LVEF,6MWD and NT-pro BNP were not significantly improved after follow-up(P=0.25,0.32 and 0.50,respectively).In UC group,LVEF had no significant change(P=0.60),6MWD was decreased(P =0.04)and NT-pro BNP increased(P =0.02).After 6 months of follow-up,an improvement in self-care were observed when HF patients received the RHSP or Tele-health compared to UC alone(18.6 vs.20.8,P<0.001;and 17.5 vs.20.8,P<0.001,respectively).These effects attenuated during the following months.Quality of life showed a similar trend;Patients’ medication adherence decreased month by month.There was no significant difference between the groups at 3 months(total P=0.24).By 6months,patients in the UC group had lower compliance than the RHSP group and the Tele-health group(73.6 vs 86.7,P<0.001;73.6 vs 90.1,P<0.001).By 12 months,the difference is even more pronounced(UC 65.3 vs RHSP 79.9,P=0.002;UC 65.3 vs Tele-health 85.7,P<0.001;RHSP 79.9 vs Tele-health 85.7,P=0.02).Conclusion: The HCF-based Tele-health program is feasible,and it provided researchers with evidence of remote hierarchical management for HF patients that can enhance participants and their families’ access and motivation to engage in self-management.Further prospective study with a larger sample size confirmed that both the RHSP website and Tele-health management program improved cardiac function,quality of life and compliance,and the latter is more effective. |