A participatory [23] and pragmatic approach including mixed methods [28] was used to design a digital tool that meets users’ needs. In a participatory co-design approach, end users are viewed as experts on their experiences, and they can be engaged at different levels, with some becoming partners in the research team [23,29]. To ensure patient involvement, a patient with stroke who was engaged in a support association and had a background in information technology projects became a patient partner and coauthor. Initially, this patient partner (AKA) provided valuable advice regarding recruitment, participant involvement, and how to introduce the prototype. He reviewed the tool content and was involved in workshops with members of the research team (EKK, GC, and KSS). He also reviewed the summaries of the preliminary themes.

Participants were included in 2 phases between December 2017 and October 2020. Staff identified eligible individuals in 3 settings: an outpatient unit, Stroke Forum (a center for support and advice after initial care), and a support association. Potential participants were briefly informed about the study, and those who agreed to participate were contacted by a researcher (EKK) via phone to provide detailed information. After purposive sampling with an attempt to achieve heterogeneity in terms of age, sex, communication, and mobility, participants were scheduled for an interview. They also were sent study information by email, including web links to a pilot version of the tool and to a web survey for the amendment phase. The inclusion criterion was having had a stroke. The exclusion criterion was severe communication or cognitive difficulties that made participation impossible, even in a small group discussion or together with next of kin. The sample size was guided by the concept of information power to enhance the richness of data according to the aim [30]. All participants gave their informed consent before data collection.

Members of the expert panel were contacted by the first author throughout the process during 2017-2020. Potential members were purposively recruited to represent different services, including members of the stroke association and health care professionals. Expert panel members received the link to the second pilot version and a separate MS Word document with the text included in the tool. Written feedback on text revisions was collected via email, unless verbal input was preferred. Members of relevant professions then were approached for specific feedback when appropriate. The expert panel (n=11, 3 males) had a median age of 55 years (range 42-70 years) and represented the following competencies: nurse (n=1), occupational therapist (n=3), physician (n=1), physiotherapist (n=1), neuropsychologist (n=1), speech therapist (n=2), service designer (n=1), and patient partner (n=1). Professionals had a median of 20 years (range 10-40 years) of stroke experience with the following education levels: doctoral degree (PhD; n=2), PhD student (n=3), and master’s degree (n=4).

The co-design process integrated the development of the tool and the data collection, including user experiences. The process was performed in 2 phases: the conceptualization phase and the amendment phase, including a variety of methods involving different stakeholders (Figure 1).

The starting point for the conceptual phase comprised previous research regarding follow-up and suggestions for a patient version of the Post-Stroke Checklist (PSC) [31]. It was specified in advance that a digital previsit tool should be developed based on the PSC. Existing research related to stroke and person-centered care informed this development to ensure an evidence-based tool. The initial prototyping workshops were conducted by a service designer and the first author (EKK). The PSC [31,32], which constituted the basis for mapping the “patient journey” [20], is an easy tool for identifying common health problems and facilitating further actions, such as referrals to health services or patient organizations. It comprises 11 questions within the following areas: secondary prevention, activities of daily living, mobility, spasticity, pain, incontinence, communication, mood, cognition, life after stroke, and relationship with family. One example of a question is, “Since your stroke or last assessment, are you finding it more difficult to communicate with others?” The PSC is available from the World Stroke Organization and free for anyone to use. To foster an understanding of the potential user group, “personas” [20] were developed to represent users of different sexes, ages, personalities, life situations, values, and interests.

The content of and amendments to the tool were discussed during formal workshops and in dialogs with the research team, including the patient partner (EKK, GC, KSS, and AKA). These workshops guided the design of new pilot versions, and decisions were taken in consensus. Decisions were based on the data collection, expert panel feedback, and relevant evidence, and addressed, for example, clarification of the language by the addition or removal of text and answer options. All relevant data were combined into a single document before being systematically discussed in the workshops.

During the conceptualization phase from December 2017 to March 2019, focus group discussions [33] were conducted within each location to explore user needs and the perceived relevance of an early prototype, known as pilot 1. Participants tested the pilot in their home environment before the focus group took place. In all groups, an interview guide [33] with open-ended questions was used (Multimedia Appendix 1), and the moderator gave a summary at the end, leaving open the possibility of correcting potential misunderstandings. Each focus group was conducted face-to-face, lasted approximately 60-90 minutes, and was audio recorded and transcribed verbatim. The focus group data and field notes informed further amendments and prototyping.

In the amendment phase from September to October 2020, pilot versions 2 and 3 were tested before data collection. Participants completed a web survey, followed by an individual interview, to explore perceived usefulness, ease of use, and acceptability, as inspired by the TAM [24]. The survey included previous web habits, demographic data, and satisfaction ratings, as follows: very satisfied, satisfied, dissatisfied, very dissatisfied, and don’t know. Along with the interview, self-reported characteristics were collected, including stroke type, time since stroke, and level of dependence in activities of daily living. The interviews were conducted by the first author (EKK) via phone, who followed an interview guide (Multimedia Appendix 1). During the interview, participants did “think aloud” [34] as they were using the tool. Support from next of kin was allowed during data collection.

Substantive cross-sectional data analysis was performed, in line with the Framework Method [35]. In accordance with this pragmatic approach, the analysis combined data from focus groups and individual interviews and involved 5 steps, performed mainly by the first author (EKK) in cooperation with the last author (GC). In the first step, all transcribed interviews were read to achieve familiarization and get an overview of the content. In the second step, an initial framework was constructed based on the different parts of the tool (ie, information and answering), which was then revised after the first interviews. In the third step, the transcribed data were indexed according to “codes” and sorted based on the initial framework. NVivo 11 software was used for data management. In the fourth step, the data extracts were reviewed together to ensure that similar content was sorted together and to determine whether the theme titles should be adapted. In the fifth step, data were summarized and displayed in a matrix in an MS Word file. Each subtheme was summarized based on the codes and raw data. The individual interviews, combined, were handled as one case and each focus group as separate cases. Data from each case was summarized separately before all cases were merged. The systematic data management using NVivo enabled easy access back to the initial subthemes and interview transcripts. Finally, the patient partner and coauthors read the summaries and were involved in refining the themes. Throughout the process, memos were written to summarize reflections, alternative interpretations, and potential amendments. Data collected from the web survey and self-reported characteristics were analyzed using descriptive statistics and are presented as numbers or medians and ranges. Analyses were performed using SPSS version 24 (IBM, Inc.).

The study was approved by the Swedish Ethical Review Authority (no. 556-17 and 2020-03324).

The participatory design process grounded in user experiences resulted in a digital previsit tool. The following description of participants, the process for development, and user experiences provide insights into the rationale for amendments that were made.

The study included a total of 22 individuals with stroke (9 women), with a median age of 59 (range 42-83) years, and a median of 51 (range 4-228) months since stroke onset. Together, the participants represented a wide range of individual characteristics (Table 1).

The development process included 3 pilot versions of the tool (Figure 1) and stepwise alterations (Multimedia Appendix 2) before version 1.0 was completed (for visual presentation, see Multimedia Appendix 3).

In the conceptualization phase, the initial prototypes (webpages) were developed in collaboration with the first author and a service designer. During this stage, the focus was on user’s needs rather than fitting into a specific platform. The first digital pilot, version 1, included the following components: a logotype and title Strokehälsa [Strokehealth], introductory information, questions about health problems to be answered with yes or no, explanatory text (linked to “read more”) placed in direct connection with each question, and summary of results. The questions were in accordance with the PSC when applicable. The name Strokehälsa was chosen based on the aim of promoting health and improved life after stroke. The layout was intended to be clean and to avoid overwhelming text while remaining open to the possible addition of more information in the future. The information was layered using “read more” texts, with the aim of adapting the information level to each individual. The explanatory (read more) texts were inspired by existing patient information, such as pamphlets and booklets, as a starting point for gathering opinions.

In the amendment phase, alterations were performed based on preliminary findings from the focus groups and the theoretical framework. The integration between the central components, validated questions, health information, and technical aspects was essential to improve usability. Thus, beyond revising the questions, adding real-life examples in the explanatory text enhanced usability. Important changes in pilot 2 were the inclusion of advisory texts, with brief information about support options and self-management, and a free textbox offering the opportunity to describe “other challenges.” In pilot 3, a general question about rehabilitation and a place for free-text comments were added. This pilot was incorporated into the national platform. However, the platform has some limitations regarding layout options, such as no hidden read more text option and predefined typography and colors. Figure 2 shows a screenshot of the patient view of the tool. The functionality of the platform includes sending the patient an email or SMS text message notification with an invitation to use the tool and to answer the questions before a care visit. Responsible health professionals can send version 1.0 of the tool to patients and view the summary of results (using a staff log-in at the secure platform 1177) before a care visit.

Results regarding user experiences were based on the satisfaction survey and qualitative interviews.

A participatory co-design was used to develop a digital previsit health care tool based on experiences of people with stroke, health professionals, and researchers. Integration of health information, validated questions, and digital functionality contributed to the development of a tool perceived as easy to use. The findings suggest that a condition-specific tool can confirm commonly perceived experiences and give targeted support and that the elements in the tool can be adapted to other health conditions.

This study included discussions about the optimal scope of information and questions in the tool. The theme Valuable accessible information describes needs that can potentially be met by eHealth services [13]. Besides condition-specific information, participants in this study particularly valued information encouraging them to be involved in their care. Accordingly, the information in the tool was created with the goals of preparing patients for active participation and enhancing their involvement in decision making [1]. Nonetheless, given the various levels of eHealth literacy [18] and the different expectations among participants, it was challenging to provide information at an optimal level for the group.

During the conceptualization phase, participants valued reliable information of various kinds, and the amount of information to be included was not yet determined. Of note, on the secure platform, the possibility of including and layering a larger amount of information was restricted, so that only brief information was included. Furthermore, the validated questions in the tool were perceived to cover the most important topics. These findings reinforce those of a previous study suggesting that the PSC directly or indirectly covers most problems [36]. The risk of health problems (eg, nutrition, sex life, and fatigue) not being covered has been previously discussed [31,37] and was mentioned in this study. A previously reported digital tool developed for long-term conditions included a more comprehensive list of nonvalidated items [17], but its usability in a clinical context remains to be tested.

It is important to reflect on whether adding more questions or measurements counteracts the perceived usability of a tool [24]. When an adapted version of the PSC was employed in combination with other measurements in a digital platform, it was used by only 11.8% of the patients, although they were offered training to use it [26]. However, usability aspects are not provided in detail. In our study, instead of increasing the number of questions, the principal decision was made to adjust the texts and encourage users to use the separate free-text option at the end, when appropriate. The hope was that the design of the tool and mode of information provision would accommodate a large group of people with long-term conditions, among whom eHealth literacy can be low [18]. Evaluation in clinical practice is important to explore whether the scope and level are optimal. Nevertheless, the level of information and questions in version 1.0 were considered a good starting point for empowering patients to be actively involved in their conversations with health care professionals.

Within the theme Utility and complexity of answering, aspects of reporting perceived needs and health problems were highlighted. Previous findings indicate that identifying unmet needs through self-report is complex for people [38]. Unmet needs are influenced by perceptions and experiences, such as value of independence or insights regarding available services. Participants in this study stated that their abilities were likely to shift over time and because of changing circumstances, which is consistent with previous research [38]. Moreover, people may not be capable of fully understanding and answering the questions in relation to their own situation [9,18].

In this study, a combined solution was used to facilitate answering for a broad range of patients. First, it was considered best to provide the answer options of yes/no/“choose not to answer” together with a free-text option at the end. People seem to take longer to consider the information in a question when a yes/no format is used compared with ticking a box in a list [39]. This format encourages people to think about the question in relation to their own situation, thereby preparing them for shared decision making [1]. Second, the explanatory texts underneath each question were revised as an additional solution. When using the questions at a care visit, the related dialog has been highlighted as important for ensuring that health problems are identified [31]. Similarly, participants described the explanatory texts as an asset when answering, although they did not consider the texts to replace the dialog at a visit. Third, answering was improved by clarifying that patients could explain their answers at the care visit. Overall, it is likely that the complexity of answering was decreased through the combined solutions, including the questions, answer alternatives, and the information in the tool.

Throughout the development process, multifaceted solutions were applied to accommodate limitations revealed in the interviews and to improve usability. The view of shared decision making as a holistic process, including visit preparation and the visit itself, is congruent with the service design approach [19]. Solutions to complex problems can be better solved holistically; for example, a digital tool used as part of a service [20], compared with just fragmented text presented out of its context.

In this study, the true value of the tool was perceived to depend on whether identified health problems would be addressed in the conversation at the care visit. Self-reported measures completed beforehand and received by the provider lead to patients more commonly discussing nonspecific long-term health problems, without prolonging the care visit [40]. However, using checklists [41] and previsit tools alone may not result in benefits for patients [42]. Several components are important for the delivery of effective care, such as infrastructure, people resources [43], and health care professionals’ skills and motivation to provide a person-centered conversation [1,41]. Moreover, successful implementation requires consideration of the meaning value for all users, and how the team can use the tool to change their routines and improve services [44]. However, participants in this study suggested that a tool that included information could empower people to act on their own more readily and seek support.

In our study, the users’ needs were in focus, in line with the service design procedure [20], and in contrast to being restricted by an existing digital system. In recent years, digital maturity in the population has increased [3], and digital health systems have changed dramatically. Therefore, attention has focused on developing a flexible and sustainable solution [28]. Only later in the development process were the core functions in the pilots transferred to a health platform that both patients and providers know and trust. The intention was for the tool to be easy to copy, modify, and connect to other platforms and contexts. Usability for the individual was considered high, as people could go through the tool quickly and found it appropriate in relation to their needs. This easy access means that the tool is more likely to be used [20,24]. Nevertheless, to accommodate patients with low eHealth literacy [10,18], a paper-based version in various languages will be developed. Together with guidelines suggesting digitally based information and support [7], the tool Strokehälsa could contribute to a move toward a more proactive health care team and patient preparedness [4]. Participants’ responses supported the value of the tool and its potential to capture their needs, but both need to be tested in a larger sample in a clinical setting.

A strength of this study is the comprehensive participatory approach, including mixed methods, enabling a deep understanding of user experiences. However, some limitations must be addressed. First, despite purposive sampling, selection bias cannot be excluded. Most participants were independent in activities of daily living and used the internet daily. Furthermore, because of COVID-19, people had to connect to the tool digitally on their own device and participate in a phone interview, which may have limited the recruitment of people less familiar with digital tools in the amendment phase. However, support from next of kin was allowed, and the early focus groups were conducted face to face. Of note, the remote data collection worked out better than expected and yielded rich data. Altogether, the use of several sources allowed triangulation of data and a broad range of participants from different settings. The detailed descriptions of participant data analysis strengthen the transferability of the findings to other contexts.

Second, in line with the qualitative approach, attempts were made to sustain rigor and reflexivity, and interpretations were influenced by prior knowledge, for example, about stroke, the PSC, and person-centered care. The members of the research team were part of the co-design process, emphasizing the collective creativity with all stakeholders [23]. Although involvement of the researcher is part of the method, it cannot be excluded that a researcher role could have affected participant statements. However, they were encouraged to speak freely and contribute to improvements in the tool. Suggestions from participants, the expert panel, and the research team were systematically registered along with reflections in memos [35]. If controversies arose during decisions, advice was sought from members of the expert panel. Third, from a co-design perspective, the level of partnership in the study can be discussed. The patient partner was not directly involved in the initial workshop built on previous research. Although interaction on equal terms is the goal, it may not be realistic or possible for the same individual to be involved in all stages, for example, because of cognitive impairment or fatigue [29]. Nevertheless, the patient partner was continuously involved in the co-design and research process. Additionally, feedback was obtained from people with long-term conditions, health professionals providing care, and researchers in different fields. The participatory approach through service design principles led to the creation of a tool based on user needs (updated versions of the tool can be found on a webpage [45]).

The development process with a participatory approach resulted in a previsit digital health care tool viewed as useful for people with stroke. In this process, the integration of health information, validated questions, and digital functionality was essential to overcoming the complexity of responding to the tool’s questions. Even when questions were perceived as easy to comprehend, the additional information supported answering and confirmed patients’ experiences. Moreover, the information encouraged people to develop their answers in dialog with the health care professional. However, larger studies that include evaluation in conjunction with a clinical visit are needed. The tool is freely shared to be adapted and improved in different contexts for ecological validity.