scholarly journals Proof-of-concept trial results of the HeartMan mobile personal health system for self-management in congestive heart failure

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Els Clays ◽  
Paolo Emilio Puddu ◽  
Mitja Luštrek ◽  
Giovanni Pioggia ◽  
Jan Derboven ◽  
...  

AbstractThis study tested the effectiveness of HeartMan—a mobile personal health system offering decisional support for management of congestive heart failure (CHF)—on health-related quality of life (HRQoL), self-management, exercise capacity, illness perception, mental and sexual health. A randomized controlled proof-of-concept trial (1:2 ratio of control:intervention) was set up with ambulatory CHF patients in stable condition in Belgium and Italy. Data were collected by means of a 6-min walking test and a number of standardized questionnaire instruments. A total of 56 (34 intervention and 22 control group) participants completed the study (77% male; mean age 63 years, sd 10.5). All depression and anxiety dimensions decreased in the intervention group (p < 0.001), while the need for sexual counselling decreased in the control group (p < 0.05). Although the group differences were not significant, self-care increased (p < 0.05), and sexual problems decreased (p < 0.05) in the intervention group only. No significant intervention effects were observed for HRQoL, self-care confidence, illness perception and exercise capacity. Overall, results of this proof-of-concept trial suggest that the HeartMan personal health system significantly improved mental and sexual health and self-care behaviour in CHF patients. These observations were in contrast to the lack of intervention effects on HRQoL, illness perception and exercise capacity.

2020 ◽  
Author(s):  
Michael P. Dorsch ◽  
Karen B. Farris ◽  
Brigid E. Rowell ◽  
Scott L. Hummel ◽  
Todd M. Koelling

BACKGROUND Successful management of heart failure (HF) involves guideline based medical therapy as well as self-care behavior. As a result, the management of HF is moving toward a proactive real-time technological model of assisting patients with monitoring and self-management. OBJECTIVE Evaluate the effectiveness of a mobile application intervention that enhances self-monitoring on health-related quality of life, self-management, and reduces HF readmissions. METHODS A single-center randomized controlled trial was performed. Patients greater than 45 years of age and admitted for acute decompensated HF or recently discharged in the past 4 weeks were included. The intervention group used a mobile application (App). The intervention prompted daily self-monitoring and promoted self-management. The control group (No App) received usual care. The primary outcome was the change in Minnesota Living with Heart Failure Questionnaire (MLHFQ) from baseline to 6 and 12 weeks. Secondary outcomes were the Self-Care Heart Failure Index (SCHFI) questionnaire and recurrent HF admissions. RESULTS Eighty-three patients were enrolled and completed all baseline assessments. Baseline characteristics were similar between groups with the exception of HF etiology. The App group had a reduced MLHFQ at 6 weeks (37.5 ± 3.5 vs. 48.2 ± 3.7, P=0.039) but not at 12 weeks (44.2 ± 4 vs. 45.9 ± 4, P=0.778) compared to No App. There was no effect of the App on the SCHFI at 6 or 12 weeks. The time to first HF admission was not statistically different between the App versus No App groups (HR 0.89, 95% CI 0.39-2.02, P=0.781) over 12 weeks. CONCLUSIONS The mobile application intervention improved MLHFQ at 6 weeks, but did not sustain its effects at 12 weeks. No effect was seen on HF self-care. Further research is needed to enhance engagement in the application for a longer period of time and to determine if the application can reduce HF admissions in a larger study. CLINICALTRIAL NCT03149510


Author(s):  
Martha Shively ◽  
Nancy Gardetto ◽  
Mary Kodiath ◽  
Ann Kelly ◽  
Tom Smith

Background Disease management and chronic care models have evidenced success with heart failure (HF) patients but have not fully explored patients' engagement/activation in self- care. Objective Determine efficacy of a patient activation intervention (Heart PACT Program) compared to usual care on activation and self-care management in HF. Methods This study was a 4-year, randomized, 2-group, repeated-measures design (baseline, 3 months, and 6 months). Following consent, 84 patients were stratified by activation level and randomly assigned to usual care (n = 41), or usual care plus the activation intervention (n = 43). The primary outcome variables were patient activation using the Patient Activation Measure (PAM) (Hibbard et al., 2005), and self-care using the Self-Care for Heart Failure Index (SCHFI) (Riegel et al., 2004) and the Medical Outcomes Study (MOS) Specific Adherence Scale. The intervention consisted of individual meetings and phone call follow-up over 6 months based on the patient's level of activation: stage 1 or 2 (low activation), stage 3 (medium), or stage 4 (high) as assessed by the patient's self-report PAM score and brief interview. The leaders collaborated with patients to improve activation and self-management of HF: adhering to medications; monitoring weight, blood pressure, and symptoms; and implementing health behavior goals. Findings Participants were primarily male (99%), Caucasian (77%), and classified as NYHA III (52%). The mean age was 66 years (SD 11). The majority (71%) of participants reported 3 or more comorbid conditions. The intervention group compared to the usual care group showed a significant increase in activation/PAM scores from baseline to 6 months (significant group by time interaction linear contrast, F=16.90, p=.02). Although the baseline MOS mean was lower in the intervention group, results revealed a significant group by time effect (F=9.16, p = .001) with the intervention group improving more over time. There were no significant group by time interactions for the SCHFI. Conclusion Patient activation can be improved through targeted intervention. The patient activation model has the potential to change approaches to tailored patient education for self-management in heart failure.


2021 ◽  
Vol 104 (2) ◽  
pp. 264-270

Background: Asthma is a disease that causes a lot of suffering. It becomes a hurdle in everyday life. Asthma self-care program through mobile Line application (SALA) might be a good choice to help resolving this problem. Objective: To evaluate effectiveness of SALA program among asthma patients. Materials and Methods: The present study was a randomized controlled trial. The study sample consisted of 62 participants aged between 20 to 60 years with mild to moderate asthma. The study sample were randomly assigned to intervention plus usual care (intervention group, n=31) or usual care (control group, n=31) by computer generated. SALA program was sent to participants once a week for two months through their mobile phone, drug reminder appointment date for four months. The study period was six months. Clinical record form and Questionnaire were adapted to collect the demographic data and lung function via spirometer as FEV₁, FVC, FEV₁/FVC, PEFR, ACS, knowledge, attitude, and self-management. Mini Asthma Quality of Life (QOL) questionnaire was used to collect the data. Intention to treat (ITT), Repeated ANOVA, and General Linear model were statistical technique used to analyze the data. Results: Data from 60 asthma patients were available for analyses. The baseline characteristics of both groups were not significantly different. There were statistically significant mean differences in between the groups at three and six months. The mean difference in the following variables were FEV₁ 13.83 (5.01 to 22.65) FVC, 13.36 (2.62 to 24.09) FEV₁/FVC, 11.65 (4.8 to 18.49), PEFR 9.85 (0.03 to 19.67), ACS 2.45 (0.62 to 4.27), knowledge 2.64 (0.81 to 4.46), and self-management 4.26 (2.00 to 6.52). Conclusion: SALA improved knowledge, self-management, asthma status, and lung function among asthma patients. Keywords: Asthma, Self-care program, Mobile line application


2019 ◽  
Vol 2019 ◽  
pp. 1-7 ◽  
Author(s):  
Fan Zheng ◽  
Suixin Liu ◽  
Yuan Liu ◽  
Lihua Deng

Objective. This study is aimed at assessing the effectiveness of a simple outpatient diabetes self-management education programme. Methods. In the study, 60 patients with type 2 diabetes mellitus were randomly allocated into the control group (n=30) and intervention group (n=30). Regular and 2-session health education programmes were provided. The summary of diabetes self-care activity measure, problem areas in the diabetes scale, fasting blood glucose, postprandial 2 h blood glucose, and HbA1c were measured before and after the intervention to assess the effects of this 2-session diabetes education programme. Results. The total mean score of the summary of diabetes self-care activities measure was 17.60±6.63 points. The problem areas in the diabetes scale revealed that the total mean score was 29.82±15.22 points; 27% of the patients had diabetes-related distress, while 9% suffered from severe emotional distress. Compared with the control group, scores of the summary of diabetes self-care activities measure and problem areas in the diabetes scale, fasting blood glucose, postprandial 2 h blood glucose, and HbA1c were significantly improved in the intervention group after the intervention (P<0.01). Conclusion. This study showed that the 2-session diabetes education programme could effectively improve the level of self-reported self-management, psychological distress, and glycemic control in patients with type 2 diabetes mellitus.


2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
D.S Sahlin ◽  
S Gerward

Abstract Background A common heart failure (HF) aetiology is hypertension (HTN), second only to ischemic heart disease and with a prevalence in the HF community of between 62% and 84%, depending on sex and ejection-fraction. Undertreated HTN leads to worse prognosis and resistant HTN is defined as blood pressure (BP) exceeding 140/90 mmHg, in spite of pharmacological treatment. Since one constituent of self-care behaviour is treatment adherence, we wished to study whether patients exposed to a digital intervention shown to improve self-care behaviour, would also display improved BP control. Methods SMART-HF was a randomized controlled trial, recruiting patients from seven centres in Region Skåne in southern Sweden, where patients in the intervention group (IG) were equipped with a digital home-based tool, designed to enhance self-care behaviour for HF-patients and the control group (CG) were subject to standard care. BP data was registered at baseline and after eight months of intervention and self-care behaviour was measured using the European Heart Failure Self-care Behaviour Scale (EHFScB). We used a Chi-square test to analyse whether there was an inter-group difference of prevalence of resistant HTN or a mean arterial pressure (MAP) outside the recommended range of 60 mmHg &lt; MAP &lt;100 mmHg. Results Out of the 118 patients included in the original analysis, 92 (78%) had complete BP measurements. At baseline there was no difference in self-care behaviour between the groups, with CG: 25 [17.5; 32] and IG: 24.5 [18; 30], p=0.61, and 28% of the CG patients and 24% of the IG population displayed resistant HTN, p=0.73. After eight months of intervention the IG had 21% (or 4.5 points) better self-care behaviour compared to the CG, p=0.014, and the fraction of patients with resistant HTN was 30% for the CG and 11% for the IG, p=0.027. There was also a significant effect on the fraction of patients having a MAP &gt;100 mmHg, with 22% in the CG versus 16% in the IG having MAP &gt;100 mmHg at baseline (p=0.39) and 19% in the CG versus 0% in the IG at follow-up (p=0.002). Conclusions There was a significant improvement in self-care behaviour and also a significant reduction in the number of patients with resistant hypertension and elevated mean arterial pressure after eight months of intervention. Funding Acknowledgement Type of funding source: None


2018 ◽  
Vol 6 (1) ◽  
pp. 133
Author(s):  
Novita Nurkamilah ◽  
Rondhianto Rondhianto ◽  
Nur Widayati

Diabetes Mellitus (DM) is a chronic disease that requires a continous self-care. A low level ofknowledge about self-care can worsen health condition and cause diabetes distress. The continuingstress can cause hyperglycemia that lead to complications of DM. DSME/S is a structured healtheducation that facilitates DM patients in implementing and maintaining their behavior for sustainableself-care. This research aimed to analyze the effect of DSME/S on diabetes distress in patients withtype 2 DM. This research was quasi experimental with non randomized control group pretestposttest design. Thirty respondents in this study were divided into 15 respondents as theintervention group and 15 respondents as the control group by consequtive sampling technique.DSME/S was conducted in 6 sessions: 4 sessions in the hospital and 2 sessions at respondent'shouse. The data were analyzed by using dependent t test and independent t test with significancelevel of 0.05. The result of dependent t test revealed a significant difference of diabetes distressbetween pretest and posttest both in the intervention group (p=0.001) and in the control group(p=0.046). Furthermore, independent t test showed a significant difference between interventiongroup and control group (p=0.001). The decrease of diabetes distress was higher in the interventiongroup than control group. This result indicates that there was a significant effect of DSME/S ondiabetes distress in patients with type 2 DM. Nurses are expected to apply DSME/S as a dischargeplanning to reduce diabetes distress in patients with type 2 DM.Keywords: diabetes distress, DSME/S, Diabetes Mellitus


2021 ◽  
Vol 11 (2) ◽  
pp. 177-186
Author(s):  
Made Rini Damayanti ◽  
Gusti Ayu Ary Antari ◽  
Ni Luh Putu Nopriani

Background: Diabetes mellitus is a chronic disease that may pose serious complications if poorly managed. The application of mobile technology (m-health) ranging from simple to more complex programs in diabetes management has the potential to foster patients’ active involvement in their care. However, the evidence of m-health effectiveness on the self-management of type-2 diabetes patients in low- and middle-income countries is still mixed.Purpose: To evaluate the effect of a ten-week short message system (SMS)-based intervention (Tweek SMSDM) on self-management of type-2 diabetes patients.Methods: A quasi-experimental study was performed in two groups. The intervention group (n=30) received additional daily automated messages to enhance their diabetic self-care practice, while the control group (n=30) continued to follow the standard program only. Pre- and post-intervention data were measured in both groups using the Indonesian version of the Summary of Diabetes Self-Care Activities (SDSCA) questionnaire. T-test, Mann-Whitney, Wilcoxon Signed-Ranks, McNemar and Fisher exact tests were carried out to analyze the data.Results: After ten weeks, the intervention group showed significant mean changes in the domains of general diet (0.42±1.08; p=0.034), specific diet (1.75±1.42; p=0.0001), exercise (1.02±1.85; p=0.005), blood-glucose testing (0.53±1.67; p=0.009), and foot care (4.75±2.51; p=0.001) before and after the intervention, while the control group did not. This study also found significant differences in the mean scores for each domain of the SDSCA between the intervention and the control groups (p<0.05).Conclusion: The Tweek SMSDM program can improve the self-management of type-2 diabetes patients and positively affect each domain in the SDSCA. The findings of this study recommend that nurses integrate the program into patient treatment regimes in primary healthcare centers; therefore, patients and their significant others can play more proactive roles in their diabetic care.


2020 ◽  
Author(s):  
Mitja Luštrek ◽  
Marko Bohanec ◽  
Carlos Cavero Barca ◽  
Maria Costanza Ciancarelli ◽  
Els Clays ◽  
...  

BACKGROUND Congestive heart failure (CHF) is a disease that requires complex management involving multiple medications, exercise, and lifestyle changes. It mainly affects older patients with depression and anxiety, who commonly find management difficult. Existing mobile apps supporting the self-management of CHF have limited features and are inadequately validated. OBJECTIVE The HeartMan project aims to develop a personal health system that would comprehensively address CHF self-management by using sensing devices and artificial intelligence methods. This paper presents the design of the system and reports on the accuracy of its patient-monitoring methods, overall effectiveness, and patient perceptions. METHODS A mobile app was developed as the core of the HeartMan system, and the app was connected to a custom wristband and cloud services. The system features machine learning methods for patient monitoring: continuous blood pressure (BP) estimation, physical activity monitoring, and psychological profile recognition. These methods feed a decision support system that provides recommendations on physical health and psychological support. The system was designed using a human-centered methodology involving the patients throughout development. It was evaluated in a proof-of-concept trial with 56 patients. RESULTS Fairly high accuracy of the patient-monitoring methods was observed. The mean absolute error of BP estimation was 9.0 mm Hg for systolic BP and 7.0 mm Hg for diastolic BP. The accuracy of psychological profile detection was 88.6%. The F-measure for physical activity recognition was 71%. The proof-of-concept clinical trial in 56 patients showed that the HeartMan system significantly improved self-care behavior (<i>P</i>=.02), whereas depression and anxiety rates were significantly reduced (<i>P</i>&lt;.001), as were perceived sexual problems (<i>P</i>=.01). According to the Unified Theory of Acceptance and Use of Technology questionnaire, a positive attitude toward HeartMan was seen among end users, resulting in increased awareness, self-monitoring, and empowerment. CONCLUSIONS The HeartMan project combined a range of advanced technologies with human-centered design to develop a complex system that was shown to help patients with CHF. More psychological than physical benefits were observed. CLINICALTRIAL ClinicalTrials.gov NCT03497871; https://clinicaltrials.gov/ct2/history/NCT03497871. INTERNATIONAL REGISTERED REPORT RR2-10.1186/s12872-018-0921-2


2020 ◽  
pp. 1357633X1989926 ◽  
Author(s):  
Lucía M Yanicelli ◽  
Carla B Goy ◽  
Viviana del C González ◽  
Gerardo N Palacios ◽  
Ernesto C Martínez ◽  
...  

Introduction The low quality of life in heart failure patients is related to low self-care and treatment adherence. Consequently, innovative strategies are needed to improve them. The objective of this work is to determine the effectiveness of the use of a home telemonitoring system to improve the self-care and treatment adherence of heart failure patients. Methods A randomized clinical trial that compares the efficacy of a home telemonitoring system –intervention group versus usual care control group – among heart failure outpatients over a 90-day monitoring period was carried out. The home telemonitoring system consists of an application that collects measurements of different parameters on a daily basis and provides health education to patients. The home telemonitoring system processes data gathered and generates an alert if a risky situation arises. The outcomes observed were significant changes in patients’ self-care (European Heart Failure Self-care Behaviour Scale), treatment adherence (Morisky Modified Scale) and re-hospitalizations over the follow-up period. Results 104 heart failure patients were screened; 40 met the inclusion criteria; only 30 completed the study. After the follow-up, intragroup analysis of the control group indicated a decrease in treatment adherence ( p = 0.02). The mean European Heart Failure Self-care Behaviour Scale overall score indicated an improved self-care in the intervention group patients ( p = 0.03) and a worsened self-care in the control group ( p = 0.04) with a p value of 0.004 in the intergroup analysis. Thanks to the home telemonitoring system alerts, two re-hospitalizations were avoided. Discussion This study demonstrated that the proposed home telemonitoring system improves patient self-care when compared to usual care and has the potential to avoid re-hospitalizations, even considering patients with low literacy levels. Trial Registration: Home Telemonitoring System for Patients with Heart Failure. clinicaltrials.gov Identifier: NCT04071093


2020 ◽  
Vol 9 (3) ◽  
Author(s):  
Hedie Mesbahi ◽  
Fatihe Kermansaravi ◽  
Fatemeh Kiyani

Background: Teach-back training is one of the interactive teaching methods that assess the learner's understanding by asking questions and provide a proper educational context for behavior change. Involving patients with heart failure in treatment is a top priority. Objectives: Accordingly, the present study aimed to explore the effect of teach-back training on self-care and readmission of patients with heart failure. Methods: The present quasi-experimental study was conducted on 80 patients with heart failure in the Coronary Care Unit (CCU) and Post Coronary Care Unit (PCCU) of teaching hospitals affiliated to Zahedan University of Medical Sciences in southeastern Iran in 2019. The patients were selected via the convenience sampling method and randomly placed into two intervention and control groups. In the intervention group, self-care training was performed individually using the teach-back method in four sessions, each lasting 30 to 60 minutes. In contrast, the participants in the control group conventionally received self-care training. The instruments used to collect the data were the demographic information form and the European Heart Failure Self Care Behavior (EHFSCB). The EHFSCB was completed by the participants in the two groups in two stages before and three months after the intervention. The number of readmissions and the number of visits to the doctor at the end of the third month after discharge were recorded for all patients by directly asking the patients. The collected data were analyzed using SPSS-22 software, the independent samples t-test, paired-samples t-test, and chi-square test at a significant level of P < 0.05. Results: After three months, the mean scores of total self-care behaviors during the intervention were significantly different between the two groups (P < 0.001). Besides, the average number of readmissions due to heart disease three months after the intervention showed the positive effect of the intervention in reducing readmissions in patients in the intervention group (P = 0.002). Conclusions: This study showed that teach-back training could affect self-care behaviors positively and reduce the number of readmissions of patients with heart failure. Therefore, it is recommended that nurses use this training method to teach self-care behaviors to heart patients.


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