This study uses a mixed methods design augmenting quantitative analyses with qualitative assessments of patients and health care providers through an interrupted time series (ITS) study design, a robust quasi-experimental design that is often used to evaluate real-world feasibility and effectiveness of behavioral change interventions [31]. A mixed methods study was adopted to provide greater insight, deeper understanding, and more comprehensive analysis of the connections and contradictions between quantitative and qualitative data. The quantitative component provides a numeric description of participants’ attitudes and behaviors, while the qualitative component provides context and explores their subjective perceptions and experiences. The pilot study will be conducted over a period of 12 months.

We conducted a systematic review of women’s heart health policies to enhance understanding of current recommendations and gaps at the macrolevel [32]. This review was used to consolidate current research findings and policies to identify gaps in women’s heart health practice. The review screened 21,476 records and synthesized results from 124 English-language publications worldwide. Using a life course approach, we assessed the connection between clinical recommendations and policy and documented global recommendations and policies addressing prevention of CVD in women. Specifically for midlife and menopausal women, we found that an interdisciplinary approach adopting both lifestyle changes and pharmacological interventions should be introduced in perimenopausal (transitional period before menopause) women to minimize cardiovascular risk [32].

This pilot study is conducted in a Women’s Heart Health Clinic in a restructured public hospital in Singapore. A total of 100 English-speaking participants aged 45 to 65 years who attend the Women’s Heart Health Clinic will be invited to participate in this study. Participants will be approached either while waiting to see their health care provider in the clinic or after the clinic visit. Women who are pregnant, outside the menopausal transition age range of 45 to 65 years, or unable to provide informed consent will be excluded from the study.

For the semistructured survey and interview, purposive sampling (ie, the deliberate choice of a participant due to particular qualities they possess) will be used to recruit at least 5 women aged between 45 and 65 years who have attended the preventive heart health program and 10 health care providers aged 21 years and above who are involved in this program. There will be a specific focus on recruiting patients representative of a broad range of CVD risk factors and health literacy levels. The concept of information power will be used to guide final sample size for the qualitative interviews based on the following considerations: (1) whether the study aim is broad or narrow, (2) dense or sparse sample specificity, (3) application or nonapplication of an established theory; (4) quality of the dialogue, and (5) whether case or cross-case analysis, with cross-case requiring more participants. Information power indicates that the more information the sample holds relevant to the actual study, the lower the number of participants required [33].

Quantitative data regarding participants’ clinical status, symptoms, and self-administered surveys will be collected 6 months before the intervention, during the 6-month intervention period, and 6 months after the intervention to capture level and trend changes of one or more outcomes over time. Upon recruitment and preintervention assessment at the baseline visit, participants will undergo personalized health coaching. Compliance will be tracked through health logging and follow-up assessments. Participants will also undergo interviews and surveys to evaluate changes in physical activity, diet scores, and QOL.

Qualitative interviews will be conducted with these participants and health care providers using a one-to-one semistructured questionnaire carried out either in person, over the telephone, or via video call to obtain feedback and explanatory data about the program.

The proposed research will use various implementation science frameworks to answer questions regarding future scale-up and long-term sustainability of the intervention if it is determined to be effective. These conceptual frameworks will aid in evaluating how individual and contextual variables influence program implementation and acceptability.

We adopted the Proctor framework (Figure 1 [28]) to ensure the inclusion of essential implementation science outcomes and measurements with respect to users, stakeholders, and the context of the intervention, which were then measured using a mixed methods approach involving validated quantitative scales and in-depth interviews where applicable.

The in-depth questionnaires were constructed from both the Theoretical Domains Framework (TDF) [34] and capability, opportunity, motivation, and behavior (COM-B) models [35] to understand the underlying individual and contextual determinants that can positively impact programs implementation using behavior change strategies and how individuals adopt and maintain health behavior changes.

In addition, we used the RE-AIM framework [29] to guide the planning and evaluation of the program to identify the contextual barriers and facilitators associated with implementation success. This involves gaining insight from previous evidence and key stakeholders in health care at the macrolevels, mesolevels, and microlevels (illustrated in Multimedia Appendix 1) to understand how multiple interventions can be effectively packaged, integrated, and delivered within outpatient clinic settings.

Investigating at the microlevel would allow us to relate to the day-to-day practices and interactions between patients and health care providers. Investigating the mesolevel would allow us to understand local health service and community factors, such as attitudes and support from patients and health care providers involved in the women’s heart health program. Exploring the macrolevel would help identify the interrelated network among all core stakeholders within the health care system that are essential to the success of this program. Findings elucidated at the respective levels will then be used to iteratively improve the current pilot program strategies and address identified barriers where possible.

The women’s preventive heart health program is a multidisciplinary program that aims to prevent the onset of CVD by empowering women with the knowledge and skills to achieve optimal cardiovascular health even after they have exited the program.

The integrated behavioral determinant intervention logic model for CVD screening and prevention in midlife women was used to devise the program and is elaborated upon in Figure 2. The logic model of the problem was established following the PRECEDE model [36], which puts the diagnosis into action and measures the program's effectiveness. A logic model of change (program strategies) was then developed to describe what needs to change in behavior at the individual and environmental levels. Logic models have been used to design interventions for cardiac populations in previous studies [37,38].

For instance, women underestimating their CVD risks is an internal barrier, whereas underdiagnosis and undertreatment of CVD in women by physicians are external barriers [12,20,21]. Program strategies to tackle these barriers would include individualized risk assessment and sex-specific tailored care for women undergoing the menopause transition, and increased physician awareness.

The intervention comprises women having access to trained onsite personalized health coaching according to their CVD risk levels, health goals, and lifestyle. Health coaching sessions will be conducted by certified health coaches within the hospital sites on a one-to-one basis in the Women’s Heart Health Clinic. Collaborative consultations between the physician and health coach will include motivational interviewing to identify any barriers causing the knowledge and execution gap and target changes in both internal and external factors of behavioral determinants, ultimately helping participants attain health goals. Information provided to the participants by the physicians and health coaches is aligned with the national clinical practice, dietary, and physical activity guidelines and personalized where appropriate.

Follow-up visits with the physician and health coach will be aligned to the A-B-A reversal design of 6-month intervals (baseline [A]—participants’ healthy heart behaviors before health coaching (intervention) is introduced will be measured to establish a pretreatment level, intervention [B]—biweekly health coaching is introduced and participants’ healthy heart behaviors are measured to see if it changes from the baseline level, and return to baseline [A]—health coaching is removed and there is a return to baseline conditions, participants’ healthy heart behaviors are monitored to determine whether their behavior reverts to baseline, thus confirming that the intervention has caused the change), concluding with the postintervention time point. Clinical data collection and questionnaires will be administered during those visits. Relevant outcomes will be collected during the follow-up visits.

Women will be encouraged to track their health parameters using the existing hospital eHealth platform between the follow-up visits. Timely encouragements and reminders relevant to individuals’ targets set together with the health coach will also be sent via the eHealth platform.

Women will be stratified into low-, moderate-, or high-risk groups based on whether their individualized health goals are achieved, symptoms are relieved, and program participation is completed. Low-risk women will be discharged to their family physician with detailed handovers and health targets, while moderate- to high-risk women may continue in the program.

One-to-one semistructured interview sessions with participants and health care providers lasting approximately 30 to 45 minutes each will be conducted at the end of the study. The interviews will be conducted during the last visit or at a time and place convenient for the participant. The TIDieR (Template for Intervention Description and Replication) checklist [39], including the description of the behavior change intervention is presented in Checklist 1. A summary of the program is shown in Figure 3.

Questionnaire responses relating to lifestyle (Global Physical Activity Questionnaire [GPAQ] and Self-Efficacy for Managing Chronic Disease 6-Item Scale [SEMCD-6]) will be self-administered by participants at all 3 time points. Questionnaires pertaining to patients’ knowledge of CVD (CVD-knowledge, attitude, and practice [KAP29]), menopausal symptoms (Menopause Rating Scale), and QOL (Utian QOL Scale) will be self-administered at both baseline and final visits.

Physical activity behavior is assessed using the GPAQ [40], a tool that evaluates the moderate-to-vigorous physical activity time and sedentary time during a week. Physical activity has been associated with reduced CVD incidence and mortality [41]. The GPAQ has been used to evaluate physical activity behavior in menopausal women in previous studies [42].

Self-efficacy and patient engagement will be assessed using the SEMCD-6 questionnaire [43]. The SEMCD-6 has been applied to evaluate the effect of self-management programs in CVDs [44,45].

The KAP regarding CVD, CVD risk factors, and CVD symptoms will be evaluated using the CVD-KAP29 questionnaire [46].

Menopausal symptoms will be assessed using the Menopause Rating Scale [47], a validated tool that is widely used to assess symptom severity in midlife women [48]. It has been used in a previous study conducted among midlife Singaporean women [49].

The Utian QOL Scale [50] will be used to quantify the sense of well-being in midlife women. It is a validated tool that has been used in Asian populations [51,52].

Routine clinic business and operations data obtained from the clinic operations team and physical or cardiovascular lab results available during the study that are not collected as part of the research procedures will also be reviewed. Recordings of the relevant health parameters will also be collected from an online health monitoring platform. All data will be deidentified and kept confidential.

Semistructured interview guides have been developed for patients and health care providers (refer to Multimedia Appendices 3 and 4). The semistructured interviews were developed based on the constructs of the TDF [34] and COM-B models [35] and refined by the research team. The TDF can be used as a lens to explore adherence to heart-healthy habits and provides comprehensive insight into key influences on the targeted behavior which are affective, cognitive, social, and environmental in nature [53]. The TDF integrates 33 theories of behavior and behavior change into 14 domains which have been shown to be related to healthy heart behaviors [53]. The COM-B model [35] was applied alongside the TDF to provide a comprehensive, theory-driven evaluation of participants’ beliefs and motivations regarding adherence to healthy heart behavior. Previous studies adopting the COM-B model have been effective in understanding complex health behaviors [54]. For participants, we will investigate feasibility, fidelity, acceptability, uptake, sustainability, and patient-centeredness. For health care providers, we will investigate knowledge, skills, roles, beliefs, perceptions, barriers, and facilitators.

This study has been approved by the National Healthcare Group Domain Specific Review Board (2022/00350) on August 15, 2023. Any modification to the study protocol would require preapproval from the committee. Written informed consent will be obtained from all participants involved in the study. To ensure participant privacy, all data will be anonymized before analysis. Personal identifiers such as names and contact details will be removed from all transcripts and datasets. Each participant will be assigned a unique identifier, and only anonymized data will be used in the analysis. Audio and visual recordings will be securely stored and destroyed after transcription. Access to the data will be restricted to the research team, and all sensitive data will be stored on encrypted hospital servers to ensure confidentiality. Participants will be reimbursed SG $20 (US $15.60) for each study visit.

This study plans to design, develop, test, and evaluate a preventive heart health program for midlife women. We adopted various implementation science frameworks, such as Proctor framework [28] and RE-AIM [29], to provide “real-world” insights into how a sex-specific, tailored CVD program may benefit midlife women.

Previous studies indicate that although women can recognize common CVD risk factors, they often fail to apply this knowledge to themselves. As a result, even women with multiple risk factors may not view themselves as being at risk, and this low perceived personal susceptibility can reduce engagement in preventive behaviors [57]. Moreover, major lifestyle changes can be difficult to adopt or sustain, particularly when health messages are delivered through a top-down approach. However, research indicates that women are more likely to relate to heart health strategies when they are presented in ways that feel personally meaningful [58]. To address this, we developed a preventive heart health program that comprises a personalized health coaching intervention tailored according to participants’ CVD risk levels, health goals, and lifestyle.

Because of the nature and context of the preventive heart health program, the use of an ITS approach is the most appropriate to estimate effects of behavioral change strategy as randomization is not feasible. This approach can provide valuable insights into the effectiveness of the program by assessing the changes over time and is more sensitive to differences in intervention effects, as it involves self-comparison of the participants, which controls for confounding variables to the greatest extent possible. It can also be conducted with a small sample size, which is ideal for our pilot study. The application of a mixed methods approach also allows for a comprehensive and nuanced understanding of the barriers and potential feasibility issues associated with this program.

Despite the benefits of an ITS approach, the lack of randomization is a limitation that restricts the ability to draw definitive conclusions regarding the effects of the program. Another limitation of the study protocol is the reliance on self-administered questionnaires for subjective measurements, which may induce response bias and limit the depth of responses. The study team has mitigated this limitation by including semistructured interviews, which can bridge these gaps by allowing the team to probe deeper into responses, clarify ambiguities, and address complex topics. This approach will result in more detailed and nuanced data.

The intended result of this study is to evaluate the effectiveness and feasibility of a preventive heart health program among midlife women. By recognizing barriers and facilitators associated with the sustainability of a preventive heart health program in midlife women, identifying microlevel, mesolevel, and macrolevel factors associated with the provision of such a program, and enhancing understanding of health care provider and patient perceptions of preventive heart health care in women, this study will enable us to further refine the process and framework of sex-specific, tailored CVD prevention care, thereby enabling the upscaling of such services to other hospitals and improving future preventive care for midlife women.