mHealth Development and Evaluation Framework

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Chapter 3. Conceptualising the intervention mHealth Development and Evaluation Framework

As discussed in Chapter 2, mHealth is a new approach for intervention delivery, in particular for the CVD population. For a novel intervention to succeed, care must be taken to design interventions that the target audience is comfortable using. Technology-based health interventions are more effective when designed with consultation from consumers (i.e. patients), stakeholders, and developers (73).
Various frameworks have been used to develop mHealth interventions. The mHealth Development and Evaluation Framework (74) has been used in the development and evaluation of a number of mHealth-delivered behaviour change studies (75, 76). This framework was chosen over others for a number of reasons. First, it has an emphasis on end-user engagement at each step of the process (see Figure 2). Listening to the opinions and perspectives of the target audience allows researchers to develop interventions that are appropriate, acceptable and appealing to the eventual recipients.
Second, the framework supports the use of theory and evidence to guide the development of intervention content, which has demonstrated to improve the likelihood of effectiveness (58, 77). Third, the framework recommends the application of robust methodology (e.g. RCTs) to evaluate the effectiveness of an intervention. While other frameworks, such as the Multiphase Optimisation Strategy (MOST) or the Sequential Multiple Assignment Randomised Trial (SMART) (78) involve rigorous and sound research methods, the level of involvement by experts, key stakeholders, and the target audience is not a focus of their processes (78), and were therefore not chosen to underpin the work in this thesis.
The following sections and chapters describe how each step of the framework was used in the thesis. The first stage of the framework is conceptualisation, which includes the formation of an expert advisory group that decides on theoretical frameworks, reviews current evidence, and plans the development process (74). The second step of the process is formative research to investigate initial perceptions of mHealth programmes. If the concept is agreeable to the target audience, including participants and key stakeholders, content is developed and then pre-tested by end-users. Participant feedback is incorporated and content is further refined prior to conducting a trial to evaluate effectiveness. Finally feedback on the evaluated intervention informs further iteration and implementation in a real-world setting.

Conceptualisation

The overall vision of the intervention was conceived by the Candidate and her supervisory team. After the framework underpinning the intervention development and evaluation was chosen, the next step in the conceptualisation stage was to establish a content advisory group to gain advice on elements of the intervention. The group consisted of experts in the fields of behaviour change, health psychology, CHD, CR, and mHealth (see list of experts in Appendix 4). The content advisory group decided on the format for the content development process, including formative research and pre-testing studies. It was decided to call the intervention Text4Heart, which it will be now referred to for clarity.
The conceptualisation stage also involved summarising best-practice guidelines for CR and theoretical frameworks to guide the intervention content. The following sections describe in detail the evidence and theoretical underpinning of the intervention. As found in chapter 2, adequate description of intervention components is often missing from published studies (34, 79, 80), yet this detail is crucial in order to replicate and to advance the understanding of what mechanisms lead to successful behaviour change (58).

Evidence-based CR guidelines

The candidate attended local CR programmes run by three metropolitan hospitals (Auckland city, Northshore, and Middlemore) to summarise what was currently offered as standard care. The candidate then discussed the intervention concept with key stakeholders, including CR nurses, nurse practitioners, and cardiologists to determine what features of CR could be delivered by mHealth. Reports were compiled from the stakeholder meetings and CR sessions attended, which were presented to the content advisory group to ensure intervention content developed matched usual care and CR guidelines.
CR in the Auckland area consists of one hour-long education session per week for 6 weeks, with the option to join a supervised exercise programme (2 sessions per week for 8 weeks). The education component concentrates on six key health topics:
Understanding risks for heart disease
The importance of taking prescribed medications
Healthy eating
Starting and maintaining regular exercise
Smoking cessation
Psychological health following a cardiac event
To support these topics, a literature search was conducted to summarise best-practice guidelines for CR. Relevant literature was summarised and compiled into Table 7, to inform the intervention content. Data sources summarised for this table include the New Zealand Guidelines Group [7], the New Zealand Heart Foundation (81), the American College of Sports Medicine (82), Pollock’s Textbook of Cardiovascular Disease and Rehabilitation (83), and other journal articles (2, 8, 84).
The key guidelines summarised here formed the basis for the educational intervention content. To encourage behaviour change and adherence to recommended guidelines, the intervention was framed used psychological theory.

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Theoretical framework

Using a theoretical framework clarifies why interventions may or may not have been effective, and allows the research to be compared to previous work and more easily replicated (58, 77). The Text4Heart intervention was informed by Social Cognitive Theory (SCT), the Common Sense Model (CSM), and relevant Behaviour Change Techniques (BCT) associated with these theories (see Figure 3). BCTs proven to be effective in CR or behaviour change mHealth interventions were emphasised.

Social cognitive theory

SCT is a widely used framework that underpins many behavioural interventions, as constructs consistently predict physical activity and healthy eating behaviour change (85). The theory suggests that behaviour change and maintenance is determined by personal and environmental factors and the reciprocal interaction between them (85, 86) (see Figure 4)
Figure 4. Social cognitive theory conceptual model Behaviour can be modified through an individual’s ability to control their behaviour, known as self-efficacy, along with changes to the environment (86). Changing personal factors can be easier than changing the environment, and is the reason personal factors are often targeted in behaviour change interventions. For instance it may be easier to learn how to schedule exercise into one’s day than it is to create a neighbourhood suited to active transport (e.g. walking or cycling). One such factor and a key determinant of health behaviour change is perceived self-efficacy, or the extent to which people believe they can exercise control over situation specific behaviours (87). Higher levels of perceived self-efficacy is associated with increased resilience to relapse and an ability to cope with external environmental obstacles, such as a lack of time (88).
The Text4Heart intervention was designed to increase self-efficacy by targeting the four sources of influence: mastery experience, vicarious learning, social persuasion, and somatic and emotional states (87). Mastery experience involves building successful experiences, as success leads to higher self-efficacy. Successful experiences can be created by self-regulating one’s behaviour through setting realistic goals and monitoring progress. Self-regulation abilities depend on the capability to reflect on the consequences resulting from past experiences of engaging in the behaviour (known as outcome expectation) and using this to predict future outcomes (89). Vicarious learning refers to the process of viewing the behaviours of role models and the outcomes of that behaviour. By observing others’ (role models) behaviours and their favourable consequences, people are more likely to remember and repeat the behaviours endorsed by a model. Social persuasion contributes to self-efficacy by receiving verbal encouragement that one has the skills to succeed. Somatic and emotional states are the final source of influence. These involve interpretation of physiological and psychological responses; positive mood enhances self-efficacy, while stress and a negative mood diminish it.
SCT is a useful theory to underpin CHD disease management interventions as changing or managing lifestyle habits to improve health requires self-efficacy. With higher levels of self-efficacy individuals can self-regulate their behaviour by setting goals, creating incentives, and enlisting social support from others to maintain their motivation (88). Self-efficacy has shown to decline among CR non-attenders (90) and higher levels of the construct have been linked to better clinical outcomes such as lower blood pressure and reduced hospitalizations (91). People with CHD have particular challenges to leading a healthy lifestyle, thus enhancing efficacious beliefs may help people overcome some of these challenges. For example confidence to exercise can be low after a heart event, particularly if the event was brought on during exercise. Understanding and correctly interpreting normal physiological responses to exercise (somatic states), such as an increased heart rate and some shortness of breath, may enhance people’s efficacy to undertake exercise. Mastery experience is also crucial, as patients are encouraged to slowly begin to exercise after hospital discharge, and gradually build up their training intensity (see CR guidelines above). It is for these reasons that SCT was chosen to frame the intervention.
While targeting self-efficacy can help change lifestyle behaviours, people with CHD may need additional support to cope cognitively and emotionally with their heart event. Studies have shown that patients diagnosed with CHD can experience many negative emotions, including anxiety and depression, which can negatively impact their recovery process (92). One way to improve coping is to modify illness perceptions and emotional representations of the disease. Under the umbrella of personal factors influencing behaviour in SCT, illness perceptions can be targeted using the Common Sense Model (CSM).

The common sense model: illness perception and emotion regulation

Illness perceptions play an important role in disease self-management, as the patients’ understanding of their illness and how to treat it is key to long-term coping (93). Following a diagnosis of CHD, people are suddenly aware that their health and body has changed. They may have to learn new skills and make lifestyle changes to improve their health or prevent further decline. There are five domains of illness perceptions for initiating, maintaining, and evaluating outcomes of self-management behaviours (86, 94).
Identity of the illness: symptoms and label attached to the disease
Timeline: acute or chronic condition, or age of onset
Cause of the illness (internal and external)
Personal control over the illness
Consequences of the illness: physical, economic, and social losses
Patients who understand their heart condition, see that it has severe consequences, feel they can control it, and view unhealthy behaviours as a cause, may have greater motivation to initiate and sustain behaviour change. Interventions can modify illness perceptions by matching problem or emotional focused strategies with the situational context. For example, self-efficacy for self-management can be enhanced when interventions link causes of the disease with behaviours for disease control (86). In a CHD context, links need to be established between the identity (cardiac event: myocardial infarction or angina), the cause of the event (unhealthy behaviours such as smoking or physical inactivity), the potential to control the illness (lifestyle change and medication), and the consequences/timeline (prevent a recurring cardiac event in the future). Behaviours can also then be linked with clinical outcomes, for instance taking prescribed medication and eating a heart healthy diet (control) can lower blood cholesterol (consequence). In addition, behaviours can be linked with emotions, for example exercise can reduce stress by making you feel relaxed (control) which can lower blood pressure (consequence). Changing illness perceptions can lead to greater self-efficacy and behaviour change and other positive outcomes, such as greater CR attendance and a quick return to work and normal activities (18, 95).
A framework that helps target illness perceptions and regulation of emotions is the common sense model (CSM) (94). How a patient understands and feels about their heart event guides their coping responses, which can influence how they recover (95). CSM posits that two motivational systems are activated when an individual is diagnosed with a health threat, such as CHD (96, 97). One system involves cognitive or problem-solving processes for regulating the health threat, and the other involves emotional processes to control distress. The cognitive system activates illness perceptions, which guide the strategies chosen to control the illness. Outcomes of the coping strategies are then appraised for success, which then guides further illness perceptions and strategies (feedback loop).The emotional system activates different types of emotions, such as anxiety, fear, or worry, which guides strategies chosen to control distress. Appraisal of the success of these strategies is then evaluated and fed back (see Figure 5).

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Table of Contents
Abstract 
Acknowledgements 
Co-authorship forms 
Funding and support
Publications, conference presentations, and awards 
List of figures 
List of tables 
Abbreviations
Part 1. Setting the scene: introduction and literature review 
Chapter 1. Thesis introduction.
1.1 Cardiovascular disease: prevalence and economic consequences
1.2 Secondary prevention: the importance and uptake of cardiac rehabilitation
1.3 The use of technology in disease management
1.4 Aims and objectives of the thesis
Chapter 2. The effectiveness of mobile-health behaviour change interventions for cardiovascular disease self-management: a systematic review
2.1 Abstract
2.2 Introduction
2.3 Methods
2.4 Results
2.5 Discussion
2.6 Conclusions
2.7 Acknowledgements
2.8 Declaration of conflict of interest
Part 2. Development of an mHealth delivered comprehensive cardiac rehabilitation intervention
Chapter 3. Conceptualising the intervention
3.1 mHealth Development and Evaluation Framework
3.2 Conceptualisation
Chapter 4. Formative and pre-testing research
4.1 Formative research
4.2 Pre-testing step in the framework
4.3 Formative research study 1. Acceptability of an mHealth exercise-based cardiac rehabilitation intervention
4.4 Formative research Study 2 and pre-testing Study 3. Mobile phone usage survey and pilot testing of an mHealth healthy eating pilot programme
4.5 Pre-testing study 4. Measuring physical activity in a CR population by smartphone-based questionnaire
4.6 How the formative and pre-testing study findings informed the intervention
4.7 Text4Heart: the refined intervention
4.8 Development section conclusions
Part 3. Evaluation of an mHealth comprehensive cardiac rehabilitation intervention
Chapter 5. Protocol and results
5.1 Improving coronary heart disease self-management using mobile technologies (Text4Heart): a randomised controlled trial protocol
5.2 Texting for healthy lifestyle: results from the Text4Heart randomised controlled trial .
5.3 Acceptability of the Text4Heart intervention
Chapter 6. Discussion
6.1 Summary of the thesis findings
6.2 Implications for practice and future research
6.3 Strengths and limitations of the thesis
6.4 Limitations
6.4. 4A lack of generalisability
6.5 Summary of future research
6.6 Conclusions
7. Table of appendices
8. References
GET THE COMPLETE PROJECT
The development and evaluation of an mHealth-delivered comprehensive cardiac rehabilitation programme

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