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

ABSTRACT: This 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.

SUBMITTER: Clays E

PROVIDER: S-EPMC7970991 | biostudies-literature | 2021 Mar

REPOSITORIES: biostudies-literature

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

Clays Els E Puddu Paolo Emilio PE Luštrek Mitja M Pioggia Giovanni G Derboven Jan J Vrana Marilena M De Sutter Johan J Le Donne Rita R Baert Anneleen A Bohanec Marko M Ciancarelli Maria Costanza MC Dawodu Amos Adeyemo AA De Pauw Michel M De Smedt Delphine D Marino Flavia F Pardaens Sofie S Schiariti Michele Salvatore MS Valič Jakob J Vanderheyden Marc M Vodopija Aljoša A Tartarisco Gennaro G

Scientific reports 20210311 1

This 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 ...[more]

PMID: 33707523

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Project description:BackgroundCongestive 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.ObjectiveThe 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.MethodsA 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.ResultsFairly 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 (P=.02), whereas depression and anxiety rates were significantly reduced (P<.001), as were perceived sexual problems (P=.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.ConclusionsThe 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.Trial registrationClinicalTrials.gov NCT03497871; https://clinicaltrials.gov/ct2/history/NCT03497871.International registered report identifier (irrid)RR2-10.1186/s12872-018-0921-2.

Project description:BackgroundVoice user interfaces are becoming more prevalent in health care and are commonly being used for patient engagement. There is a growing interest in identifying the potential this form of interface has on patient engagement with digital therapeutics (DTx) in chronic disease management. Making DTx accessible through an alternative interaction model also has the potential to better meet the needs of some patients, such as older adults and those with physical and cognitive impairments, based on existing research.ObjectiveThis study aimed to evaluate how participants with heart failure interacted with a voice app version of a DTx, Medly, through a proof-of-concept implementation study design. The objective was to understand whether the voice app would enable the participants to successfully interact with the DTx, with a focus on acceptability and feasibility.MethodsA mixed methods concurrent triangulation design was used to better understand the acceptability and feasibility of the use of the Medly voice app with the study participants (N=20) over a 4-week period. Quantitative data included engagement levels, accuracy rates, and questionnaires, which were analyzed using descriptive statistics. Qualitative data included semistructured interviews and were analyzed using a qualitative descriptive approach.ResultsThe overall average engagement level was 73% (SD 9.5%), with a 14% decline between results of weeks 1 and 4. The biggest difference was between the average engagement levels of the oldest and youngest demographics, 84% and 43%, respectively, but these results were not significant-Kruskal-Wallis test, H(2)=3.8 (P=.14). The Medly voice app had an overall accuracy rate of 97.8% and was successful in sending data to the clinic. From an acceptability perspective, the voice app was ranked in the 80th percentile, and overall, the users felt that the voice app was not a lot of work (average of 2.1 on a 7-point Likert scale). However, the overall average score for whether users would use it in the future declined by 13%. Thematic analysis revealed the following: the theme feasibility of clinical integration had 2 subthemes, namely users adapted to the voice app's conversational style and device unreliability, and the theme voice app acceptability had 3 subthemes, namely the device integrated well within household and users' lives, users blamed themselves when problems arose with the voice app, and voice app was missing specific, desirable user features.ConclusionsIn conclusion, participants were largely successful in using the Medly voice app despite some of the barriers faced, proving that an app such as this could be feasible to be deployed in the clinic. Our data begin to piece together the patient profile this technology may be most suitable for, namely those who are older, have flexible schedules, are confident in using technology, and are experiencing other medical conditions.

Project description:BackgroundWith an explosive growth in mobile health, an estimated 500 million patients are potentially using mHealth apps for supporting health and self-care of chronic diseases. Therefore, this review focused on mHealth apps for use among patients with heart failure.ObjectiveThe aim of this integrative review was to identify and assess the functionalities of mHealth apps that provided usability and efficacy data and apps that are commercially available without supporting data, all of which are to support heart failure self-care management and thus impact heart failure outcomes.MethodsA search of published, peer-reviewed literature was conducted for studies of technology-based interventions that used mHealth apps specific for heart failure. The initial database search yielded 8597 citations. After filters for English language and heart failure, the final 487 abstracts was reviewed. After removing duplicates, a total of 18 articles that tested usability and efficacy of mobile apps for heart failure self-management were included for review. Google Play and Apple App Store were searched with specified criteria to identify mHealth apps for heart failure. A total of 26 commercially available apps specific for heart failure were identified and rated using the validated Mobile Application Rating Scale.ResultsThe review included studies with low-quality design and sample sizes ranging from 7 to 165 with a total sample size of 847 participants from all 18 studies. Nine studies assessed usability of the newly developed mobile health system. Six of the studies included are randomized controlled trials, and 4 studies are pilot randomized controlled trials with sample sizes of fewer than 40. There were inconsistencies in the self-care components tested, increasing bias. Thus, risk of bias was assessed using the Cochrane Collaboration's tool for risk of selection, performance, detection, attrition, and reporting biases. Most studies included in this review are underpowered and had high risk of bias across all categories. Three studies failed to provide enough information to allow for a complete assessment of bias, and thus had unknown or unclear risk of bias. This review on the commercially available apps demonstrated many incomplete apps, many apps with bugs, and several apps with low quality.ConclusionsThe heterogeneity of study design, sample size, intervention components, and outcomes measured precluded the performance of a systematic review or meta-analysis, thus introducing bias of this review. Although the heart failure-related outcomes reported in this review vary, they demonstrated trends toward making an impact and offer a potentially cost-effective solution with 24/7 access to symptom monitoring as a point of care solution, promoting patient engagement in their own home care.

Project description:ObjectiveThis study explored consumers' perspectives on self-monitoring, a common feature in behavioral interventions that helps inform consumers' progress and answer their questions, to learn what outcome metrics matter to consumers and whether self-selection of these metrics leads to greater engagement (i.e., compliance, satisfaction) in self-monitoring than monitoring only default options.MethodsIn a proof-of-concept randomized trial, 48 adult participants were randomly assigned to "clinician-determined monitoring" or "clinician + self-determined monitoring" conditions. Before starting monitoring, all participants shared outcomes that would matter to them in a mobile intervention for binge eating and weight management. Then, for 3 weeks, participants in the "clinician-determined" condition monitored their weight and binge-eating episodes, and participants in the "clinician + self-determined" condition monitored these and another metric of their choosing. After, satisfaction and compliance were assessed.ResultsParticipants identified 116 metrics, grouped into 12 themes, that mattered to them. During monitoring, participants in the "clinician + self-determined" condition monitored 41 metrics. Surprisingly, participants in the "clinician-determined" condition also monitored metrics besides weight and binge eating. This resulted in a failure of our experimental manipulation, which represents a significant limitation of this research. No significant differences emerged in satisfaction or compliance between conditions.DiscussionAlthough our proof-of-concept trial yielded null quantitative results, findings also suggested binge eating and weight management interventions may benefit from including an individually customizable monitoring option in addition to default metrics, warranting testing in future research.Public significanceExamining consumers' self-monitoring preferences for a mobile intervention for binge eating and weight management revealed a variety of metrics that matter to consumers, although binge eating and weight were still most valued. Findings from our proof-of-concept trial suggest design implications of encouraging an individually customizable monitoring option, in addition to default metrics, which needs to be tested in future research over a longer period and during actual mobile intervention delivery.

Project description:BackgroundMobile medical applications (Apps) offer innovative solutions for patients' self-monitoring and new patient management opportunities. Prior to routine clinical application feasibility and acceptance of disease surveillance using an App that includes electronic (e) patient-reported outcome measures (PROMs) warrant evaluation. Therefore, we performed a proof-of-concept study in which rheumatoid arthritis (RA) patients used an App (RheumaLive) to document their disease.MethodsAccurate PROM reporting via an App in comparison to paper-based versions was investigated to exclude media bias. Sixty participants recruited from 268 consecutive RA outpatients completed paper-based and electronic PROMs (Hannover Functional Questionnaire/derived HAQ; modified RA disease activity index) using the App at baseline and follow-up visits. Between visits, patients used their App on their own smartphone according to their preferences. The equivalence of PROM data and user experiences from patients and physicians were evaluated.ResultsPatients' (78.3% female) mean (SD) age was 50.1 (13.1) years, disease duration 10.5 (9.1) years, and paper-based HAQ 0.78 (0.59). Mean confidence in Apps scored 3.5 (1.1, Likert scale 1 to 6). ePROMs' scores obtained by patients' data entry in the App were equivalent to paper-based ones and preferred by the patients. After 3 months, the App retention rate was 71.7%. Patients' overall satisfaction with the App was 2.2 (0.9, Likert scale 1 to 6). Patients and physicians valued the App, i.e., for patient-physician interaction: 87% reported that it was easier for them to document the course of the disease using the App than "only" answering questions about their current health during routine outpatient visits. Further App use was recommended in 77.3% of the patients, and according to physicians, in seven patients, the App use contributed to an increased adherence to therapy.ConclusionOur study provides an essential basis for the broader implementation of medical Apps in routine care. We demonstrated the feasibility and acceptance of disease surveillance using a smartphone App in RA. App use was convincing as a reliable option to perform continuous, remote monitoring of disease activity and treatment efficacy.Trial registrationClinicalTrials.gov, NCT02565225 . Registered on September 16, 2015 (retrospectively registered).

Project description:BackgroundHeart failure (HF) is associated with frequent exacerbations and shortened lifespan. Informal caregivers such as significant others often support self-management in patients with HF. However, existing programs that aim to enhance self-management seldom engage informal caregivers or provide tools that can help alleviate caregiver burden or improve collaboration between patients and their informal caregivers.ObjectiveTo develop and pilot test a program targeting the needs of self-management support among HF patients as well as their significant others.MethodsWe developed the Dyadic Health Behavior Change model and conducted semi-structured interviews to determine barriers to self-management from various perspectives. Participants' feedback was used to develop a family-centered self-management program called "SUCCEED: Self-management Using Couples' Coping EnhancEment in Diseases." The goals of this program are to improve HF self-management, quality of life, communication within couples, relationship quality, and stress and caregiver burden. We conducted a pilot study with 17 Veterans with HF and their significant others to determine acceptability of the program. We piloted psychosocial surveys at baseline and after participants' program completion to evaluate change in depressive symptoms, caregiver burden, self-management of HF, communication, quality of relationship, relationship mutuality, and quality of life.ResultsOf the 17 couples, 14 completed at least 1 SUCCEED session. Results showed high acceptability for each of SUCCEED's sessions. At baseline, patients reported poor quality of life, clinically significant depressive symptoms, and inadequate self-management of HF. After participating in SUCCEED, patients showed improvements in self-management of HF, communication, and relationship quality, while caregivers reported improvements in depressive symptoms and caregiver burden. Quality of life of both patients and significant others declined over time.ConclusionIn this small pilot study, we showed positive trends with involving significant others in self-management. SUCCEED has the potential of addressing the growing public health problem of HF among patients who receive care from their significant other.

Dataset Information

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

Publications

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

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