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In addition to medical intervention and counseling, patients with cardiovascular disease (CVD) need to manage their disease and its consequences by themselves in daily life.
The aim of this paper is to describe the development of “Vascular View,” a comprehensive, multi-component, tailored, Web-based, self-management support program for patients with CVD, and how this program will be tested in an early randomized controlled trial (RCT).
The Vascular View program was systematically developed in collaboration with an expert group of 6 patients, and separately with a group of 6 health professionals (medical, nursing, and allied health care professionals), according to the following steps of the intervention mapping (IM) framework: (1) conducting a needs assessment; (2) creating matrices of change objectives; (3) selecting theory-based intervention methods and practical applications; (4) organizing methods and applications into an intervention program; (5) planning the adaption, implementation, and sustainability of the program, and (6) generating an evaluation plan.
The needs assessment (Step 1) identified 9 general health problems and 8 determinants (knowledge, awareness, attitude, self-efficacy, subjective norm, intention, risk perception, and habits) of self-managing CVD. By defining performance and change objectives (Step 2), 6 topics were distinguished and incorporated into the courses included in Vascular View (Steps 3 and 4): (1) Coping With CVD and its Consequences; (2) Setting Boundaries in Daily Life; (3) Lifestyle (general and tobacco and harmful alcohol use); (4) Healthy Nutrition; (5) Being Physically Active in a Healthy Way; and (6) Interaction With Health Professionals. These courses were based on behavioral change techniques (BCTs) (eg, self-monitoring of behavior, modeling, re-evaluation of outcomes), which were incorporated in the courses through general written information: quotes from and videos of patients with CVD as role models and personalized feedback, diaries, and exercises. The adoption and implementation plan (Step 5) was set up in collaboration with the members of the two expert groups and consisted of a written and digital instruction manual, a flyer, bimonthly newsletters, and reminders by email and telephone to (re-)visit the program. The potential effectiveness of Vascular View will be evaluated (Step 6) in an early RCT to gain insight into relevant outcome variables and related effect sizes, and a process evaluation to identify intervention fidelity, potential working mechanisms, user statistics, and/or satisfaction.
A comprehensive, multi-component, tailored, Web-based, self-management support program and an early RCT were developed in order to empower patients to self-manage their CVD.
Nederlands Trial Register NTR5412; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=5412 (Archived by WebCite at http://www.webcitation.org/6jeUFVj40)
Cardio vascular disease (CVD) is the leading cause of death worldwide [
CVD is predominantly caused by genetic and environmental factors, among which unhealthy lifestyle habits are the most important. Risk factors of CVD caused by atherosclerosis are divided into behavioral risk factors (physical inactivity, an unhealthy diet rich in salt, fat, and calories, tobacco use, and the harmful use of alcohol), metabolic risk factors (hypertension, diabetes, raised blood lipids, and overweight/obesity), and other risk factors (eg, advancing age, gender, stress, and depression). Since all risk factors interact with each other and play a key role in decreasing the process of atherosclerosis, they must be considered in the treatment of CVD and secondary prevention [
Health and social care services support patients with chronic diseases by providing specialized staff, medicines, and equipment to control symptoms. In addition to medical treatment and counseling, patients need to manage CVD and its consequences in daily life by themselves [
Self-management programs have the potential to decrease the load on health and social services, to lower the high costs of chronic care, and to improve patient quality of life. Self-management in chronic care appears to be effective, especially when focusing on behavioral change, supporting self-efficacy, and implemented in wider initiatives (eg, information provision, online peer support, monitoring symptoms with technology, and psychological and behavior change interventions) [
To our knowledge, there are no comprehensive, multi-component, Web-based, self-management support programs that focus on behavior change and support self-efficacy in secondary care patients with CVD. Within such programs, the tailoring of the content to a patient’s profile is important in order to increase their level of understanding, information recall, and adherence to lifestyle interventions [
The aim of this paper is to describe (1) the development of the “Vascular View” (“Vaat in Zicht” in Dutch) program for patients with CVD, according to six steps of the intervention mapping (IM) framework [
IM is an iterative, 6-step process for developing theoretically-based behavior change interventions [
Throughout the entire development process for the Vascular View program, two expert groups (one of patients and one of professionals) explored and discussed, at each IM step, the specific issues (disease and treatment) that may influence self-management. The groups met up to three times to ensure that the program would be tailored to the perceived problems and needs that are important to patients with CVD and their health professionals. The patient expert group consisted of 1 female and 5 males with CVD (stroke and/or cardiac events and/or peripheral artery disease). The professional expert group included a medical specialist in general and vascular medicine, a neurology nurse, a cardiology nurse, a vascular surgery nurse, a psychologist, a dietician, and a physical therapist. Two researchers (SPH and BvG) participated in both expert groups and SPH chaired each meeting. Before the start of each expert group meeting, the members were asked to prepare by reading information and finishing assignments on the themes of the meeting. The meetings were supported by PowerPoint presentations and the researchers emphasized the importance of the opinions and contributions of each member. This resulted in valuable discussions and agreements at the end of each meeting, which were audio recorded. After the meetings, the recordings were transcribed verbatim by a student. Analysis of all meetings took place by thematically verifying researcher’s (SPH) notes with the typed results of the audio recordings, in summary.
The needs assessment focused on identifying perceived problems and (support) needs in the self-management of CVD using the Predisposing, Reinforcing, and Enabling Constructs in Educational/Environmental Diagnosis and Evaluation (PRECEDE) model [
The aim of creating matrices of performance and change objectives was to provide a translation from needs to content in Vascular View. Behavioral and environmental conditions selected were related to self-management of the problems identified in Step 1. These were subdivided into performance objectives and combined with the important and modifiable determinants of the behavioral and environmental conditions based on the Integrated Change Model 2.0 (I-Change model 2.0) [
The purpose of Step 3 was to select theory-based intervention methods and practical applications based on the former steps. The Coding Manual for Behavior Change Techniques from de Bruin and colleagues [
The aim of Step 4 was to develop and pretest the program components and materials of Vascular View. The program outcomes, the selected BCTs, and the practical applications from Steps 2 and 3 were starting points for the development and pretest of the program. All members of the two expert groups were asked what the ideal Vascular View program should look like, in line with the message (eg, tailoring, text, video, and exercise), the channel (Internet), and the information sources (eg, websites, patient forum). All patients from the expert group were also asked for the most valuable perceived advices that they received during their treatment and rehabilitation, how these advices looked like, and from whom these messages came. All health professionals were asked how they adapted their advice given to a patient and how they validated this adaptation. The research group prepared blueprints for the production of the different program materials and discussed this within the two expert groups in one meeting. Based on the outcomes of this meeting, the final content (ie, text, personal stories, diaries, and videos) was determined and developed by the research group and incorporated into the Vascular View program by Mind District Development BV (The Netherlands), the information and communication technology (ICT) partner. Finally, the program was pretested by the members of both expert groups individually and their feedback was gathered by open-ended questionnaires in which the members could describe their comments on each page. All patients and health professionals were asked to use the program for one week and give feedback about the importance and comprehensibility of the information, quotes, pictures, videos, diaries, and exercises, and their views of the layout of Vascular View and whether it was user-friendly. All of the feedback was collected, structured per training session and specific page, and incorporated into the final program. See also the results of Step 4.
The focus of Step 5 was to make an implementation plan for Vascular View during the planned evaluation study. The adoption and implementation of Vascular View started in the development process with the involvement of patients and professionals by taking their expertise into account. In addition to their role in the development of the program, the two expert groups played an important role in the determination of facilitators for, and barriers to, the adoption and implementation of this intervention. For example, all members were asked, via questionnaires, what facilitates dissemination and exposure (eg, logging in for the first time and subsequent logging in), in order to complete the different courses of Vascular View. The researchers also determined performance objectives for a patient’s first visit and re-visits to Vascular View and combined these with the relevant determinants into change objectives, and discussed these results in one meeting with the members of the two expert groups. The findings of dissemination and exposure were incorporated in the final Vascular View program. The performance and change objectives, and the corresponding determinants, were included in the adoption and implementation plan for Vascular View.
The objective of the final step of IM was to design an evaluation study for Vascular View by conducting an early RCT to gain insight into relevant outcome variables and related effect sizes, and to perform a process evaluation to identify intervention fidelity, potential working mechanisms, and user satisfaction [
In this phase, we selected relevant measurable outcome variables related to the objectives of the Vascular View program, the defined performance outcomes, and whether the specific tailoring to changes in self-management behavior conformed to the applied I-Change Model 2.0. The process evaluation also includes a check of intervention fidelity (adherence to the program as proposed), incorporating outcomes compliant with the performance objectives and determinants as expressed in the matrix of change objectives in IM Step 2, as well as interviews with participants (program users and non-users) of the study, audio recordings of nursing visits with participating patients, and focus group interview(s) with health professionals.
The involvement of the members of both expert groups for each IM step during the development of Vascular View is described in
Involvement of stakeholders in the development of Vascular View.
Step | Intervention mapping | Meetings, n | Patients, n (gender) | Health professionals, n | |
1 | Needs assessment | 3 | 6 (1 female, 5 males) | 7a | |
2 | Objectives | 1 | 5 (males) | 3b | |
3 | Theory | 1 | 6 (1 female, 5 males) | 6c | |
4 | Intervention program | 1 | 4 (males) | 5d | |
Pretest Vascular View | N/A | 6 (1 female, 5 males) | 7a | ||
5 | Implementation | 1 | 4 (males) | 5d | |
6 | Evaluation | 1 | 4 (1 female, 3 males) | 4e |
aNeurology nurse, cardiology nurse, vascular surgery nurse, psychologist, dietician, physical therapist, and medical specialist in general and vascular medicine
bNeurology nurse, vascular surgery nurse, and medical specialist in general and vascular medicine.
cNeurology nurse, cardiology nurse, vascular surgery nurse, psychologist, dietician, medical specialist in general and vascular medicine.
dNeurology nurse, cardiology nurse, vascular surgery nurse, dietician, medical specialist in general and vascular medicine.
eNeurology nurse, cardiology nurse, vascular surgery nurse, medical specialist in general and vascular medicine.
A literature search and three meetings with the two expert groups (
Contextualized Predisposing, Reinforcing, and Enabling Constructs in Educational/Environmental Diagnosis and Evaluation (PRECEDE) model as a logic model for the needs assessment of self-managing cardiovascular disease.
The second and third meetings provided the selected underlying behaviors and environmental conditions of these health problems and symptoms, which varied from having insufficient insight into CVD to having an unhealthy lifestyle, and being unsuccessful in setting boundaries, or inadequate interaction with health professionals (
We selected the three most important and modifiable determinants of self-managing CVD from the I-Change Model 2.0 [
In one meeting, the members of the two expert groups (
Applied Integrated Change Model (I-Change) 2.0 for increasing the self-management behavior for cardiovascular disease.
For each selected determinant of self-management behavior (eg, knowledge, risk perception, awareness, attitude, self-efficacy, subjective norm, intention, and habits), the BCTs were selected [
In translated these BCTs to practical applications, the parameters under which a given technique is most likely to be effective were taken into account. For example, self-reevaluation can use feedback and confrontation; however, raising awareness must be quickly followed by increase in problem-solving ability and self-efficacy.
In one meeting, the two expert groups (
The course “Coping with CVD” addresses the determinants knowledge, awareness, risk perception, attitude, self-efficacy, subjective norm, intention, and action plans. The patient learns about dealing with CVD and its impact on daily life (eg, medication adherence, sexuality, emotions, fatigue, and pain), relatives, social environment, and resuming activities.
In the course “Setting Boundaries,” patients learn to clearly communicate with their social environment (eg, relatives, colleagues) about perceived boundaries in daily life and in resuming activities with respect to their current ability. This course addresses the determinants knowledge, awareness, attitude, self-efficacy, and subjective norm.
The course “Lifestyle” addresses the determinants knowledge, awareness, attitude, self-efficacy, subjective norm, intention, habits, and skills, and consists of information about a healthy lifestyle (eg, risk information about tobacco and alcohol use in CVD, and their health), and information to support abstention from tobacco and alcohol use.
In the courses “Healthy Nutrition” and “Being Physically Active in a Healthy Way,” patients gain insight into what they eat and drink, how physically active they are, and how to change their habits to healthier ones, step by step. These courses address the determinants knowledge, awareness, attitude, self-efficacy, subjective norm, intention, habits, and skills.
The course “Interaction With Your Health Professional” teaches patients to effectively communicate with the health professional (eg, preparing a consultation, asking questions, sharing worries). This course addresses the determinants knowledge, awareness, attitude, self-efficacy, and subjective norm.
The sessions in the courses are personalized and are supported by written information, quotes, pictures, videos, diaries, and exercises. In the courses “Healthy Nutrition” and “Being Physically Active in a Healthy Way,” two case studies involving two imaginary patients (a man and a woman) support the information and exercises offered through the sessions and courses (
In all courses of Vascular View, tailoring was done using variables or factors related to behavior change (such as stage of change), or to relevance (such as culture or socioeconomic status) [
The feedback of the pretest by all patients and health professionals of both expert groups (
As a result of the first 4 Steps and one meeting with both expert groups (
The members of the two expert groups also emphasized the importance of being motivated to use Vascular View by their health professionals, whether or not this was supported by a brochure. They added that health professionals should also be interested in the progress of a patient’s self-management behavior, and be able to answer questions during the study in order to show their involvement.
The key persons in adoption and implementation are the medical specialists in Internal and Vascular Medicine, and the nurse specialists in Neurology, Cardiology, and Vascular Surgery, because of their crucial roles in the recruitment of patients. They also brought Vascular View to the attention of patients during regular consultations across the study period by asking about the program. Before the program started, the nurse specialists were instructed in how to support a patient’s use of Vascular View.
A mixed-methods study design will be conducted with an early RCT and a process evaluation to (1) evaluate the potential effectiveness and effect size of Vascular View; (2) identify the outcome measures most likely to capture potential patient benefit; and (3) evaluate continued participation or withdrawal from Vascular View. The early RCT and the process evaluation will be performed at four outpatient clinics in one university hospital in the Netherlands (Internal Medicine, Cardiology, Neurology, and Vascular Surgery).
We will recruit 400 to 600 potential participants diagnosed with CVD, to allow the participation of 200 patients. Inclusion criteria are that patients (1) manifest atherosclerotic vascular disease, including ischemic heart disease, cerebrovascular disease (eg, stroke or transient ischemic attack), and peripheral artery disease (eg, claudication intermittens), or a combination; (2) are aged 18 years or older; (3) can speak, read, and understand the Dutch language; and (4) have access to a computer, the Internet, and an email account. Exclusion criteria are patients with (1) comorbidities, which may hinder the use of Vascular View, as defined by the medical specialist; and (2) psychiatric disorders.
The medical specialists will inform patients about the content and aim of the study via an information letter. After signing the informed consent and completing the baseline questionnaire (T0), patients will be included and randomized to an intervention group (access to Vascular View for 1 year on top of usual care) and a control group (usual care). Randomization will take place at the individual level, will be stratified for diagnoses, and will be executed by a statistician who will use a computer program. Patient characteristics will be assessed at baseline via an online questionnaire (T0) and medical file research. Repeated measures will be conducted 6 months (T1) and 12 months (T2) after baseline. Semi-structured interviews will be performed with patients and focus group interview(s) will be conducted with health professionals at 12 months.
This study has been improved by the Medical Ethical Research Committee of Arnhem - Nijmegen, Nijmegen, the Netherlands (registration number: 2015/1908), and is registered in the Netherlands Trial Registry (registration number: NTR5412).
The quantitative data will be collected via an online questionnaire and medical file research. The online questionnaires consist of patient demographics and the following, described 11 measurements. Illness attribution will be assessed by one question in the Illness Perception Questionnaire (IPQ) [
To investigate the factors that influence user statistics, intervention fidelity, and user satisfaction in the Vascular View program, a process evaluation will be performed based on the framework of Saunders et al [
Quantitative and qualitative analyses will be performed. Patient outcome measures will be treated as dependent and continuous variables and will be analyzed on the basis of intention-to-treat. All variables will be presented in percentages or in means and standard deviations of the sum-scores. Repeated measures analyses will be performed to explore effect sizes and the responsiveness of outcome measures. Multilevel analyses will be applied to compensate for the clustered nature of the data using mixed linear modeling techniques. The qualitative data gathered in semi-structured interviews and the focus group interviews will be analyzed using content analyses.
The aims of this paper are (1) to describe the development of the tailored, Web-based, self-management support program Vascular View for patients with CVD according to the 6 steps of the IM framework; and (2) to describe how the program will be evaluated. The 6 steps of IM provide a well-balanced processual guide for tailoring to the preferences and support needs of patients with CVD, by combining evidence and the perceived experiences of patients and their health professionals. A unique feature of the program is that it is based on the perceived problems of patients with CVD and that the corresponding determinants were combined with theory-based intervention methods into practical applications. This resulted in a Web-based program which may influence the relevant determinants—knowledge, awareness, attitude, self-efficacy, subjective norm, risk perception motivation (intention), habits, and maintenance—of self-management in patients with CVD by applying different methods through the courses. The Vascular View program was tailored to patient preferences, the level of elaborateness of the information, the content, factors related to behavior change, and relevance. To our knowledge, such a comprehensive, tailored, Web-based, self-management program for secondary care patients with CVD has not been previously developed; other programs have mainly focused on one or two risk factors or risk factor determinants only [
A strength of the Vascular View program is the intensive cooperation of the two expert groups in every step of IM. The two expert groups ensured that the general information from the literature fitted the target group. Their knowledge, experiences, and visions led to the comprehensive, Web-based program developed.
Vascular View was developed for a heterogeneous population of patients with manifest CVD, including, among others, ischemic heart disease, cerebrovascular disease, and peripheral artery disease. This diversity in patients and diagnoses required a well-balanced approach from the Web-based program. To overcome this possible limitation, we tailored the content of the courses to patient diagnoses and interests by using short questionnaires before or during a course and “read more” options within the courses.
Despite the comprehensiveness of this Web-based program, Vascular View is limited in its influence over the different environmental factors of patients with CVDs. Different interpersonal (eg, partner, relatives, colleagues), organizational (eg, unavailability of accompanied exercise facilities by a health professional), community (eg, availability of work and income), and societal (eg, no smoking allowed in public buildings) factors were incorporated in Vascular View because the program aimed to increase self-management behavior and the way patients living in this (interpersonal, organization, community, and society) environment are able to cope, via the patients themselves. However, we do not know how these different environmental factors interact in order to change behavior [
This paper describes the systematic development of the comprehensive, tailored, Web-based self-management support program Vascular View for patients with CVD, according to the IM framework. Vascular View aims to increase self-management behavior in patients with CVD by influencing the risk factors of CVD and through an improvement in quality of life, via a unique combination of tailoring, personalizing, and behavior change, by influencing determinants (knowledge, awareness, attitude, self-efficacy, subjective norm, risk perception, intention, and habits) of self-management behavior. The proposed early RCT will indicate whether these aims can be achieved. Furthermore, this feasibility study will give insight into relevant outcome variables and related effect sizes and allow us to identify any flaws or technical difficulties. This information will be used to set up a larger RCT. A process evaluation will identify, amongst other things, patient experiences in using the program and at which level the Vascular View program is helpful in supporting self-managed CVD. This information will be used in the future development of the Vascular View program.
Matrix of performance and change objectives for patients with cardiovascular disease (according to the boxes in the applied Integrated Change Model 2.0).
Matrix of performance and change objectives for patients with cardiovascular disease (according to the boxes in the applied Integrated Change model 2.0).
Screenshot of Vascular View ("Awareness").
Screenshot of Vascular View ("Intention").
Screenshot of Vascular View ("Self-efficacy").
Development of Vascular View from determinants to practical applications.
An overview of the 6 courses of Vascular View.
behavior change techniques
body mass index
cardiovascular disease
Integrated Change Model 2.0
intervention mapping
Predisposing, Reinforcing, and Enabling Constructs in Educational/Environmental Diagnosis and Evaluation
randomized controlled trial
This study is funded by ZonMw, the Netherlands Organization for Health Research and Development (520001001).
None declared.