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Heart failure (HF) is a progressive, debilitating, and complex disease, and due to an increasing incidence and prevalence, it represents a global health and economic problem. Hence, there is an urgent need to evaluate alternative care modalities to current practice to safeguard a high level of care for this growing population.
Our goal was to examine the feasibility of engaging patients to use patient-centered and personalized tools coupled with a Web-based, shared care and interactive platform in order to empower and enable them to live a better life with their disease.
We used a mixed methods, single-center, pre-post design. Patients with HF and reduced left ventricular ejection fraction (n=26) were recruited from the outpatient HF clinic at Odense University Hospital (Svendborg Hospital), Denmark, between October 2015 and March 2016. Patients were asked to monitor their health status via the platform using the standardized, disease-specific measure, the Kansas City Cardiomyopathy Questionnaire (KCCQ), and to register their weight. A subset of patients and nursing staff were interviewed after 3-month follow-up about their experiences with the platform.
Overall, patients experienced improvement in patient-reported health status but deterioration in self-care behavior between baseline and 3-month follow-up. The mean score reflecting patient expectations toward use prior to start of the study was lower (16 [SD 5]) than their actual experiences with use of the platform (21 [SD 5]) after 3-month follow-up. Of all patients, 19 completed both a baseline and follow-up KCCQ. A total of 9 experienced deterioration in their health status (range from 3-34 points), while 10 experienced an improvement (range from 1-23 points). The qualitative data indicated that the majority of patients found the registration and monitoring on the platform useful. Both nursing staff and patients indicated that such monitoring could be a useful tool to engage and empower patients, in particular when patients are just diagnosed with HF.
The use of patient tracking and monitoring of health status in HF using a standardized and validated measure seems feasible and may lead to insights that will help educate, empower, and engage patients more in their own disease management, although it is not suitable for all patients. Nursing staff found the patient-centered tool beneficial as a communication tool with patients but were more reticent with respect to using it as a replacement for the personal contact in the outpatient clinic.
Heart failure (HF) is the end stage of most heart diseases and a progressive, debilitating, and complex clinical syndrome characterized by dyspnea, edema, pulmonary congestion, decompensation, fatigue, impairments to daily functioning and quality of life [
To date, HF care and disease management modalities that have been more clinically driven and relied on a mixture of telemonitoring, clinician monitoring and rating of symptoms based on more biometric measures and clinician-initiated contact have shown mixed results [
Thus, patient-rated health status could be used with advantage as one of the patient-centered tools in clinical practice to monitor patients’ health status, which may allow the timely detection of clinical deterioration in their HF condition and enable treatment recommendations to be tailored to individual patient needs and preferences [
Hence, we designed the ACQUIRE-HF study (a personalized and interactive Web-based health care innovation to advance the quality of life and care of patients with heart failure) to examine the feasibility of engaging patients to use patient-centered and personalized tools coupled with a Web-based, shared care, and interactive platform in order to empower and enable them to live a better life with their disease. The feasibility study is a precursor to a large randomized controlled trial that will open up for more features on the platform and include a psychological intervention for the subset of patients who score high on anxiety and depression. The results presented in this paper include both quantitative and qualitative data on experiences with the platform and the intervention both from the perspective of patients and nursing staff.
We used a mixed methods, single-center, pre-post design. Patients with HF (n=26) were recruited from the outpatient HF clinic at Odense University Hospital (Svendborg Hospital), Denmark, in the period between October 2015 and March 2016 as a convenience sample. Patients were asked to complete purpose-designed, standardized, and validated questionnaires at baseline and at 3-month follow-up. Nursing staff (n=6) from the outpatient HF clinic was involved in the study.
The qualitative study consisted of (1) observations during the workshop and training course of the nursing staff in use of the platform, which was provided by CGI Denmark, (2) observations during the workshop and training of 5 of the 26 patients on how to use the platform, which was provided by nursing staff, (3) semistructured telephone or face-to-face interviews with 10 patients after they had used the platform for 3 months (patients were interviewed toward the end of January 2016), and (4) focus group interviews with 3 of the 6 nurses, which were conducted at a time when the majority of the 26 patients had been included in the study.
The Health Innovation Centre of Southern Denmark was responsible for all observations and interviews. Nurses provided continuous feedback, and a midway evaluation was conducted with nursing staff, CGI Denmark, and the research team from the University of Southern Denmark.
We submitted the study protocol to the Regional Committees on Health Research Ethics for Southern Denmark. According to Danish law on ethics related to health research (Law 593 of June 14, 2011), ethical committee approval is not required for this kind of study. The study was performed according to the Helsinki Declaration. Permission was also sought and granted from the Danish Data Protection Agency under the umbrella agreement of the University of Southern Denmark (2015-57-0008).
We used CGI’s modular and cloud-based CommunityCare360 (CC360) platform in the study, with patients and nursing staff having access to the platform and its tools via a Web interface on a tablet, smartphone, or computer. CC360 makes it possible for patients, health care professionals, and other stakeholders to access, monitor, and update personal health data. It allows for (1) integration of information from various sources including health technology (eg, weight scale) that patients may use, electronic health record (EHR), labs, imaging, and prescribing; (2) relatives to gain access to patient data provided that patients give their permission; (3) patients to write messages to the HF team; (4) patients and caregivers and health care professionals to engage in video dialogs; and (5) setting targets for patients’ medication, which may serve as a reminder to patients and health care professionals if targets are not met. Manuals are available to support use for patients, clinicians, and other health care professionals. The platform has a health care classification toolkit (SNOMED,
We used only 2 features on the platform for the feasibility study: patient registration of their weight and completion of a health status measure, allowing for patients to monitor their weight and health status over time. We started out with only these 2 features as HF patients tend to be somewhat older and not necessarily used to using technology [
CommunityCare360 interface as seen by patients.
Information on baseline demographic and clinical characteristics was either captured from purpose-designed questions in the questionnaire or from the patient medical records. Data on patient compliance with reporting their weight and health status on the CC360 was available from the platform. Patients were asked to complete the following measures pretest (ie, at baseline) and posttest (ie, at 3-month follow-up).
We developed a 11-item purpose-designed questionnaire to tap into patient expectations and experiences with the platform, with choice of items inspired by the standardized and validated Expectations Towards ICD Therapy (EXPECT-ICD) questionnaire [
The Kansas City Cardiomyopathy Questionnaire (KCCQ) is a disease-specific, validated, patient self-report international standard used to quantify patient experiences with HF [
The European Heart Failure Self-Care Behavior (EHFScB) scale is a 9-item standardized and validated questionnaire that assesses patient opinions on their ability to manage their HF (eg, “I take my medication as prescribed”), with items answered on a 5-point Likert scale from 1 (completely agree) to 5 (completely disagree) with a score range of 9 to 45, with 9 representing best possible self-care behavior [
Nurses from the outpatient HF clinic approached patients for study participation and provided them with written and oral information about the study. After signing an informed consent form, patients were asked to complete the baseline questionnaire. Patients were also asked if they would be willing to be interviewed about their experiences with use of the platform after 3 months. Nurses from the hospital set up patients on the platform, and patients received a log-in and password to gain access. Nurses also trained all patients how to use the platform and patients received a user manual for CC360 to take home to facilitate use. Patients could contact the outpatient clinic if they encountered any problems with use of the platform (eg, problems with logging in, questions related to the use of the platform) with the nurses being the first point of contact for technical support. CGI Denmark provided back-up support to the nursing staff. Patients were also informed that use of the platform was not a substitute for usual care and that they should contact the clinic if they felt unwell and experienced deterioration in their condition or contact emergency services outside office hours.
As part of the intervention, patients were asked to do the following:
Weigh themselves every day in the morning on their own scale and enter the weight into the platform. The rationale was that both the patient and the nursing staff in the outpatient clinic could monitor the patient’s weight and that patients might gain more insight into their weight fluctuations.
Complete the KCCQ every 2 weeks during the 3-month study period as an indication of their health status. Scores were plotted in a graph that was visible both to patients and the nursing staff. Patients were instructed how to interpret their score and could also see the evolution in their health status over time.
The nursing staff had the following responsibilities:
Call patients 1 week after study inclusion to ensure that patients could log in to and use the platform and were able to comply with the tasks (ie, entering and monitoring their weight and health status) as indicated above.
Check every time patients had completed the health status measure (KCCQ). A reduction in patient score by 20% or more as compared to their baseline value instigated a red alert, a reduction between 10% and 20% an amber alert, and a reduction of 10% or less a green alert. These alerts appeared in the nursing staff’s module on CC360, which required them to contact the patient to discuss if the patient needed to be seen in the clinic.
If patients would forget to enter their weight or to complete the KCCQ, a red light would appear on the nursing staff’s module on CC360. They would then be required to contact the patient to remind the patient to complete the measures.
Results related to the quantitative data are reported as frequencies with percentages or as means and standard deviation. Pearson correlation coefficients were calculated to examine the relationship between continuous measures. Data were analyzed using RStudio version 0.99 (RStudio Inc) and SPSS Statistics for Macintosh version 22.0 (IBM Corp). The qualitative data were analyzed using thematic analysis, with the aim of grouping data and finding patterns that give insight into the user experiences with the platform [
Baseline characteristics of the patient sample are presented in
The 7 patients who did not complete the posttest questionnaire had a lower baseline mean score on expectations toward the platform (15 [SD 4] vs 16 [SD 6]), a better self-care behavior score (13 [SD 3] vs 18 [SD 5]), and a lower health status score (61 [SD 21] vs 69 [SD 21]) as compared to the 19 patients who completed both the pre- and posttest questionnaires.
Baseline characteristics of the patient cohort (n=26).
Total | ||
Age (years), mean (SD) | 67 (11) | |
Men, n (%) | 21 (81) | |
Married/have a partner, n (%) | 20 (77) | |
Lower educational level (<14 years), n (%) | 15 (58) | |
Employed, n (%) | 7 (27) | |
I-II | 24 (92) | |
III-IV | 2 (8) | |
Stroke | 4 (15) | |
Diabetes | 2 (12) | |
Aneurism | 1 (4) | |
Liver disease | 0 (0) | |
Kidney disease | 0 (0) | |
Claudicatio intermittens | 0 (0) | |
COPDb | 3 (12) | |
Ulcer | 1 (4) | |
Cancer during last 5 years | 1 (4) | |
Other | 5 (19) |
aNYHA: New York Heart Association functional class (III-IV: most severe heart failure).
bCOPD: chronic obstructive pulmonary disease.
Pre- and posttest scores on the questionnaires.
Baseline |
3-month follow-up |
|||
Valid cases (n) | Mean (SD) | Valid cases (n) | Mean (SD) | |
Expectations: use of the platforma | 25 | 16 (5) | — | — |
Experiences: use of the platforma | — | — | 18 | 21 (5) |
Health status: KCCQb | 26 | 62 (21) | 19 | 68 (15) |
Self-care behavior: EHFScBc | 26 | 17 (5) | 19 | 18 (6) |
aThe same items were used to tap into patient expectations toward use of the platform pretest and their experiences posttest with the only difference in the wording being the use of the present versus past tense (see the Methods section). Score range was 0 to 44 (44 = highest level of expectations and best possible experience).
bKansas City Cardiomyopathy Questionnaire (KCCQ) score range 0 to 100 (100 = best possible health status).
cEuropean Heart Failure Self-Care Behavior (HFScB) score range 9 to 45 (9 = best possible self-care behavior).
Patient scores with respect to expectations toward and experiences with the platform are displayed in
Pre-, posttest, and change health status Kansas City Cardiomyopathy Questionnaire scores and weight entries on the platform for individual patients during 3-month follow-up.
Patient ID | KCCQa score |
KCCQ score |
KCCQ change score | KCCQ platform entries (count)b | Weight platform entries (count)c |
1 | 85 | — | — | 0 | 1 |
2 | 72 | 63 | –9 | 4 | 84 |
3 | 76 | — | — | 0 | 0 |
4 | 87 | 92 | 5 | 6 | 65 |
5 | 46 | 51 | 5 | 6 | 84 |
6 | 31 | — | — | 2 | 14 |
7 | 69 | — | — | 5 | 77 |
8 | 37 | 57 | 20 | 6 | 84 |
9 | 43 | — | — | 1 | 1 |
10 | 98 | 64 | –34 | 5 | 82 |
11 | 51 | 74 | 23 | 5 | 85 |
12 | 81 | 75 | –6 | 6 | 78 |
13 | 48 | 50 | 2 | 6 | 75 |
14 | 45 | 60 | 15 | 6 | 76 |
15 | 72 | 62 | –10 | 6 | 64 |
16 | 93 | 90 | –3 | 5 | 85 |
17 | 76 | — | — | 4 | 51 |
18 | 46 | — | — | 6 | 85 |
19 | 74 | 52 | –22 | 6 | 84 |
20 | 96 | 92 | –4 | 2 | 21 |
21 | 100 | 88 | –12 | 1 | 1 |
22 | 65 | 57 | –8 | 6 | 83 |
23 | 52 | 55 | 3 | 6 | 78 |
24 | 58 | 66 | 8 | 4 | 86 |
25 | 84 | 85 | 1 | 5 | 84 |
26 | 50 | 58 | 8 | 6 | 79 |
aKCCQ: Kansas City Cardiomyopathy Questionnaire.
bPossible KCCQ entries during 3-month follow-up period = 6.
cPossible weight entries 3-month follow-up period = 90.
Pre-, posttest, and change health status scores and number of weight entries for individual patients are presented in
Based on interview data and observations, patient and nursing staff evaluations of the platform are summarized below according to specific topics.
Given the demographics of patients with HF, one of the obvious questions to ask is whether an information technology (IT) solution as presented in ACQUIRE-HF is feasible. HF patients are typically older and do not necessarily have a lot of experience with such solutions or the confidence or the energy to engage in digitization. Our experiences show that patients who are unfamiliar with iPads and touch screens were significantly challenged already when having to log on to the platform. These challenges included scrolling down too quickly, not knowing how hard to touch the screen, etc. The observer noticed in some cases an increasing sense of insecurity and decreasing motivation, in particular in patients who borrowed an iPad for the project (they were not used to using it). For patients using their computer, it was much easier for them to understand and use the platform irrespective of their IT experience and user level.
Technological problems and nursing staff uncertainty when introducing and teaching patients about the platform—particularly in the beginning of the study—increased patient insecurity and discouragement with respect to participating. Thus, it is important that training of nursing staff in use of the platform occurs close to study start so they still have benefits from the training. However, experience is also built up over time. Hence, more intensive use of the system will likely create more confidence when problems do occur about how to resolve them.
Patients with very limited IT experience need a more thorough introduction to the use of computer/tablet, and they have a need for troubleshooting particularly in the early stage as these patients might be more prone to dropping out.
I could not figure it out—I kept trying but I couldn’t—but it is difficult. Nobody had the time to come and help me. They are all too busy—my children and grandchildren, they go to work and school. Then the nurse told me I could hand it in [the tablet]. ...I never really got into it. I didn’t really feel like familiarizing myself with it—but they also did not spend a lot of time showing me. Perhaps had it been my grandchildren I would have been more motivated to try it.
Patients also indicated that more information is warranted on use of the platform and not just on the technical aspects. There are several concepts that they would have liked explained in more detail: “What is a reference value?” “What does health status refer to?” “What do the numbers mean?” “What can you use the diary for—how does that help me?”
I spent a lot of time reading the manual. I don’t think that everybody can understand it. It should probably be more detailed and informative both with respect to text and pictures.
Patient experiences with computers and technology vary considerably. Hence, there is a need to customize the platform such that patients who have less experience start with a very simple set-up, while more experienced and curious users might be able to use and have benefit from more features on the platform.
We also have patients who would like to receive it digitally.
Patients agree that it is important that the platform can send reminders to patients when they need to complete the health status measure and report their weight or if they have forgotten to do so. However, they prefer that the user is able to decide whether the reminder system should be switched on or off.
The majority of interviewed patients found the questions strange and criticized that they had to answer the same questions every time.
The questionnaires are too general. Who has come up with these questions? Is it at all people who know about patients with heart disease?
Despite this criticism, other patients found the questionnaires valuable because they made them reflect and think things through. Nursing staff feels that completion of the questionnaires 2 times a month is too frequent and that once a month might increase motivation.
The principles behind the questionnaires are fine—as a matter of fact I think it is nice.
Patients voice a preference for being able to have a complete overview and see the evolution in their weight and health status scores over time.
I would like to see the entire month. I use the graph, as I have experienced a drastic weight loss in the middle of the period.
Patients have different views of the platform and its potential usefulness. Generally, as the interview progresses patients attribute more and more value to the rationale behind the platform as they voice their experiences during the last 3 months. However, there are patients at both ends of the acceptance and value continuum. Overall, patients find the rationale and the idea behind the platform good, but the questions as formulated in the questionnaires are considered a major drawback. A few patients—3 out of 10 interviewed—do not find the platform useful nor do they believe that it could be useful to them in the future.
Of the 10 patients interviewed, 7 patients either experience or believe that in the future the platform will help them better understand themselves, their body, and their disease and increase empowerment. They find both the insight but also the responsibility valuable.
I have been staying at home for many years. It was nice to have the platform to be able to monitor my own health. You gain knowledge about your disease and get a feeling that you are more involved in the process.
It is a nice tool that makes it possible to see how hard it has been. It is food for thought. It is nice to gain this insight. I become aware of things when I answer the questions—I can follow my own developments.
I have become aware of what I gain from weighing myself daily with respect to fluid retention. It is nice to know that you can follow your own disease in such a simple way. But you can become worried! But it gives a sense of security that you know what is going on—this way you can quickly relate your condition to your weight.
Patients feel that the platform is valuable as a communication tool and that the questions support their dialog with the nursing staff. In addition, it makes them remember important aspects related to their condition and health.
We can talk better now. Because you can refer to the questions—and it makes it a more equal dialog with the nursing staff.
The nursing staff feels that the platform is primarily valuable to patients, as the staff members already have dialogs with patients and their own way of monitoring patients’ weight and methods of screening. When asked about the potential of the platform in the future for themselves and patients, they feel that they learn something new about the patients and gain new (and more honest) insight into patients’ conditions. They experience that use of the KCCQ tells something new about patients’ health status and also that it provides them with different information than what patients tell them when they are seen in the outpatient clinic.
It is about how they deal with and accept their disease. We can have an opinion about how they feel, but here the questionnaire data can show a different and more true picture.
Generally, the nursing staff felt that the platform facilitates a more equal dialog between patients and staff but that it cannot replace the personal contact in the outpatient clinic.
It is paramount that the expectations of patients and nursing staff are aligned and that patients are aware that they need to take an active role and act on their own scores when clinically relevant changes occur. The majority of patients express that they thought there would have been more dialog and follow-up based on their scores. They feel that they did not know what was going on at the other end (the nurses’ role).
I thought that there would have been more dialog between me and the hospital, such as videoconferencing, et cetera. I wrote a remark on the platform in the comment field, but nobody saw it. So it felt like somewhat of a dead end.
Nurses are concerned that patients might have inexpedient expectations that nurses act as contact person.
It is important to be prudent and not to cultivate the idea that we have to be part of their network.
Both patients and nursing staff feel that the platform could be of considerable value to newly diagnosed HF patients as a tool to develop good routines from the beginning and to gain knowledge of oneself, one’s disease, and the evolution of the disease.
It would be good when you are first diagnosed to learn about your disease.
It would give us important information about their level of functioning if the platform was used as part of the introduction to the outpatient clinic. Instead of us having to ask them, they could complete the questionnaire via the platform. Then patients would also have time to think about how they actually feel before they respond. Then we would have something to go on—then we know what the problem is without having to spend time on asking these questions... But it should probably not be digital—an IT platform is a bit overwhelming for most of our patients in the beginning.
As such, nursing staff emphasizes that the platform should be viewed as a tool to support dialog, not as a replacement for contact with the outpatient clinic, and also a tool that patients can take with them and use once they are no longer seen in the clinic.
Based on the interview data and observations, recommendations for use of a platform and patient-centered tools in studies like ACQUIRE-HF are provided in
Use of the platform and monitoring of symptoms:
Should be customized to the individual patient’s user level and preferences if feasible
Should facilitate that patients can use the technology that they are familiar with
Is not a one-size fits all solution
Is not a replacement for clinical practice
Could be a useful tool for newly diagnosed patients
Is a useful communication tool
Gives patients a more equal relationship with nursing staff
Provide nursing staff with new, additional and more honest information about patients
Might induce anxiety in some patients
Practical and logistic issues:
Alignment of patient and nursing staff expectations is paramount
Patients prefer to see total overview and evolution in scores
Reexamination of questionnaire use for health status monitoring
Train nursing staff in use of the platform close to recruitment and allow a few test cases to increase familiarization
The ACQUIRE-HF study was designed to examine the feasibility of using a Web-based platform combined with patient-centered tools to empower and engage patients as more coactive partners in their own disease management. Despite concerns that such a solution might not be feasible to use in the HF population due to their higher age and risk of being inexperienced and challenged with respect to the use of a technology-based intervention, our results based on both quantitative and qualitative data show that such a solution is feasible but also that it is not a one-size fits all solution, with some patients (albeit a minority) never logging on to the platform or only using the platform a few times. Patients were not explicitly singled out for interviews if they did not enter their weight or use the platform. When patients were recruited for the study they were asked whether they would be willing to be contacted later for an interview. However, as indicated in one of the quotes included in the paper, insufficient coaching and familiarity with the platform could be one reason why this subset of patients did not engage with the platform. This was also supported in a recent study on extra device monitoring in patients with HF [
In this study, both patients and nursing staff recommended that patient health status tracking and monitoring could be used as a communication tool between the parties in clinical practice. This finding is similar to that of a recent study using participatory design methods, asking patients about their needs, values, and preferences with respect to the use of eHealth tools in the management of their disease [
When implementing a solution, as evaluated in ACQUIRE-HF, in clinical practice, it is important to emphasize that patient tracking and monitoring may induce anxiety in some patients, in particular if they see a significant reduction in their health status. This was mentioned by one of the patients in the post-hoc interviews. On the other hand, several of the patients who were interviewed also mentioned that tracking of their own health status was insightful, constituted a learning opportunity, and for some was an indication of how far they had come in managing their disease. The importance of patients gaining increased awareness about their disease and disease status through eHealth solutions is also supported by others [
For the purpose of the study, we designed a questionnaire to tap into patient expectations toward the platform prior to use and perceived experiences post use. Based on our results, patient expectations toward use of the platform prior to actual use were at a lower level than their actual experiences with the platform at the end of 3 months, suggesting that patients generally experienced gains that they might not have anticipated. In future studies, it will be important to focus on patient expectations toward the eHealth intervention or tools that will be evaluated, as such expectations may not only influence patient engagement and user experience but also patient-reported outcomes [
The results of this study should be interpreted with the following limitations in mind. We recruited patients from only one center, and the majority of patients were men. Hence, the results may not necessarily be generalizable to the general HF population and in particular to women. Due to the small sample size, we were not able to perform sophisticated statistical analyses and thus are only able to report simple descriptive statistics. Although the focus of the feasibility study was to evaluate the experiences of patients with HF when tracking and monitoring their own health status and the potential value to nursing staff, we are not able to delineate whether use of the platform had a direct impact on patient HF symptoms, as there could be many alternative reasons as to why patients improved or deteriorated in their health status as measured by the KCCQ.
The use of patient tracking and monitoring of health status in HF using a standardized and validated measure seems feasible and may lead to insights that will help educate, empower, and engage patients more in their own disease management. Nursing staff found the patient-centered tool beneficial as a communication tool with patients, indicating that the dialog might become more equal and that it might represent a more honest picture of patient cardiovascular health and disease status. However, they were more reticent with respect to using it as a replacement for the personal contact in the outpatient clinic. Further studies are warranted to examine how technology and a more elaborate intervention than provided in our study may facilitate the dialog between health care professionals and patients and improve patient outcomes.
Advance the Quality of Life and Care of Patients With Heart Failure
CommunityCare360
European Heart Failure Self-Care Behavior scale
electronic health record
Expectations Towards ICD Therapy
heart failure
International Classification of Diseases, 10th Edition
ICD-10 procedure codes
information technology
Kansas City Cardiomyopathy Questionnaire
Nomenclature for Properties and Units
New York Heart Association
We would like to thank the staff at CGI Denmark for their excellent and timely support and Apple Denmark for lending us iPads for the duration of the project period. We would also like to thank the nursing staff at Svendborg Hospital for their involvement. This study was supported with a seeding grant from Patient@home, University of Southern Denmark (www.en.patientathome.dk) and grants from the Lundbeck Foundation (grant #R198-2015-175) and TrygFonden (grant #109704).
None declared.