The influence of stress and lifestyle in hereditary angioedema

Patients with hereditary angioedema (diagnosed by a Clinical Immunologist) which does not respond to antihistamine or corticosteroid treatment, will participate in a 12 week lifestyle change programme delivered over a 3-month period. The purpose of the programme is to help participants understand their individual lifestyle quality data, enhance their knowledge about living a healthy lifestyle and support them with making and sustaining targeted lifestyle changes. The intervention is based on lifestyle medicine approaches and established behavioural change methods, including for example William Miller’s and Stephen Rollnick’s motivational interviewing (Bundy, 2004) and designing choice architectures (Quigley, 2013). The intervention starts with a Firstbeat Lifestyle Assessment (a multi-day heart rate variability measurement) to provide participants with data-based insights into their lifestyle quality and how their current routines and activities influence stress, recovery, sleep, and health benefits from physical activity. Participants will then engage in group seminars, individual coaching sessions and be offered self-directed online learning resources and activities about living a healthy lifestyle and ways to successfully make lifestyle changes. The Firstbeat Lifestyle Assessment involves participants wearing a small and light (25grams) ECG device (the Firstbeat Bodyguard 2), for 24-hours a day over 5 consecutive days. The device is attached to the body with gel electrodes (one just below the collar bone and one on the lower part of the ribcage). The device captures heart rate, heart rate variability and movement data from which lifestyle quality, stress load and autonomic functioning is derived. Participants record their activities, sleep duration, medication use, alcohol consumption and perceived sleep quality in the (freeform) online Firstbeat journal. The activities are then superimposed on the physiological data, culminating in a lifestyle assessment report that objectifies and contextualises the participants stress and lifestyle. At the start of the measurement, participants provide basic demographic data and complete a lifestyle habits and health questionnaire that includes answering 10 questions on a 5-point Likert scale. The Bodyguard 2 devices is a validated ECG recording device (Parak & Korhonen, n.d.) reliable for longer term heart rate variability (HRV) measurements and is a Class I medical device as per the Australian Therapeutic Goods Administration Australian Regulatory Guidelines for Medical Devices. The programme, being the totality of the intervention, will be delivered once and comprises an online learning platform with access to information, resources and activities, a baseline and repeat Firstbeat Lifestyle Assessment (which is both a key part of the intervention itself as well as a provider of outcome measure data), 5 group sessions (60 to 90 minutes), an individual Firstbeat Lifestyle Assessment debrief session (45 minutes) and 3 individual sessions (30 to 45 minutes). The group sessions commence the week following the individual Firstbeat Lifestyle Assessment debrief sessions and every fortnight thereafter. The individual sessions commence the week after the first group session and every fortnight thereafter, resulting in four individual session periods with an expectation participants attend three of the four session provided for. The intervention is universal for all participants with specific lifestyle advice and changes being personalised on the basis of participant's Firstbeat Lifestyle Assessment report, current lifestyle context and capacity for taking on an assimilating change. The programme will be delivered 100% virtually / online. The programme timeline: • Firstbeat Lifestyle Assessment (baseline) • Week 1 – Individual Firstbeat Lifestyle Assessment Debriefs • Week 2 – Group session 1 • Week 3 – Individual sessions • Week 4 – Group session 2 • Week 5 – Individual sessions • Week 6 – Group session 3 • Week 7 – Individual sessions • Week 8 – Group session 4 • Week 9 – Individual sessions • Week 10 + 11 – Firstbeat Lifestyle Assessment (repeat) • Week 12 – Group session 5 (programme conclusion) The intervention will be delivered by a credentialled Wellness Coach with 10 years of experience in helping people leverage lifestyle for optimal health, wellbeing and functioning. The specific procedures, activities, processes and materials for each of the programme's components are outlined below. 1) Firstbeat Lifestyle Assessment and debrief a. A measurement with an ECG device for 24-hours a day over 5 consecutive days b. Data analysis and report production through Firstbeat’s research portal c. A individual debrief on the report with each participant, to support their report interpretation, personalised advice and selection of targeted lifestyle adjustments Physical / informational materials: • Firstbeat Lifestyle Assessment instructions (online learning platform) • Firstbeat Lifestyle Assessment report (PDF format) • Report interpretation guide (online learning platform) These materials are designed and produced by Firstbeat. 2) Healthy lifestyle learning (the “what”). The provision of learning content and resources on stress, recovery, sleep, nutrition and physical activity. Delivered through: a. Group sessions b. Self-directed access to online materials c. Personalised advice by a Wellness Coach during individual sessions Physical / informational materials: • Group session PowerPoint slides (used in the session and made available in the online learning platform) • Reading resources and videos (online learning platform) 3) Adopting and sustaining lifestyle changes (the “how”). Provision of information on the challenges associated with making lifestyle changes and strategies / techniques to overcome those challenges. Delivered through: a. One of the group sessions b. Providing time in each group session for the sharing of commitments, challenges and wins including time for supporting each other c. Provision of a range of evidence-based strategies / activities / tools with participants adopting a selection – those that are likely to be most effective for the individual participants: i. Change readiness ruler – an exercise involving participants rating the importance of making the changes, their confidence that they can make and sustain the changes and their level of readiness to start making the changes ii. Accountability partnerships – participants teaming up with another participant, family member or friend in an accountability partnership (with guidelines for effective accountability partnerships being provided) iii. Making it public – a technique that involves making lifestyle change commitments public iv. Higher why – an activity involving participants identifying their higher why (ultimate benefit) of making lifestyle changes v. Habit tracking apps – a selection of smart phone apps that enable goal setting and habit tracking vi. Nudge strategy – a strategy from the “choice architecture” literature that involves participants utilising their environment to create habit nudges d. Individual sessions to help participants overcome barriers to change, adopt specific strategies or complete specific activities and stay on track Physical / informational materials: • Group session PowerPoint slides (used in the session and made available in the online learning platform) • Reading resources and videos (online learning platform) • Downloadable activity worksheets and guidelines (online learning platform) Programme retention and adherence will be tracked by the Wellness Coach delivering the intervention and is measured as follows: Retention • Programme retention rate (dropouts) Intervention adherence and completion • Individual virtual session uptake / participation level • Participation in group seminars