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Trial registered on ANZCTR


Registration number
ACTRN12621000473864
Ethics application status
Approved
Date submitted
10/02/2021
Date registered
21/04/2021
Date last updated
2/12/2022
Date data sharing statement initially provided
21/04/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
The influence of stress and lifestyle in hereditary angioedema
Scientific title
The influence of stress and lifestyle in hereditary angioedema; a single case experimental design lifestyle change intervention pilot
Secondary ID [1] 303413 0
None
Universal Trial Number (UTN)
U1111-1259-3312
Trial acronym
HAE Lifestyle (pilot)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hereditary angioedema 320702 0
Condition category
Condition code
Human Genetics and Inherited Disorders 318547 318547 0 0
Other human genetics and inherited disorders
Skin 318970 318970 0 0
Other skin conditions
Inflammatory and Immune System 318971 318971 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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
Intervention code [1] 319716 0
Lifestyle
Intervention code [2] 319717 0
Behaviour
Intervention code [3] 319718 0
Treatment: Other
Comparator / control treatment
N/A
Control group
Uncontrolled

Outcomes
Primary outcome [1] 326507 0
Lifestyle quality score (comprising Firstbeat Lifestyle Assessment overall lifestyle assessment score, stress and recovery balance score, restorative effect of sleep score and health effects of physical activity score)
Timepoint [1] 326507 0
Week 1, Week 13 and follow-up at week 25
Primary outcome [2] 326508 0
Quality of life measured by the HAE Quality of Life Questionnaire (AE-QoL)
Timepoint [2] 326508 0
Week 1, Week 13 and follow-up at week 25
Primary outcome [3] 326509 0
Swelling attack activity measured by the Angioedema Activity Score Questionnaire (AAS)
Timepoint [3] 326509 0
Week 1, Week 13 and follow-up at week 25
Secondary outcome [1] 391726 0
Heart rate variability from the Firstbeat Lifestyle Assessment measurement (using the Firstbeat Bodyguard 2 ECG device)
Timepoint [1] 391726 0
Week 1, Week 13 and follow-up at week 25
Secondary outcome [2] 392986 0
Feasibility of the Firstbeat Lifestyle Assessment tool will be measured by:
• Failed or incomplete measurements as determined by accessing data from the Firstbeat Bodyguard 2 ECG devices on the Firstbeat research portal
• Measurement support required as determined by an audit of the participant engagement log
• Repeat and follow up participation rate, calculated as the percentage of participants who completed both a repeat and baseline measurement, and follow-up measurement and baseline measurement (respectively) as determined by accessing the measurement metrics on the Firstbeat research portal
• Firstbeat related questions from experience survey, determined by an audit of these specific question on the experience survey. The experience survey is designed specifically for this study to solicit feedback from the participants about their experiences.

This feasibility component is considered a primary outcome measure
Timepoint [2] 392986 0
Following completion of the follow-up measurements and experience survey (at the end of the study).
Secondary outcome [3] 394097 0
Acceptability of the intervention programme, will be accessed by determining the retention rate, calculated as the number of participants who completed all phases of the study divided by the number of participants enrolled in the study. This will be determined by an audit of the enrolment / participant database.

This acceptability component is considered a primary outcome measure
Timepoint [3] 394097 0
Following completion of the follow-up measurements (at the end of the study)
Secondary outcome [4] 394098 0
Acceptability of the intervention programme, will be accessed by determining the intervention adherence and completion:
• Individual virtual session uptake / participation level as determined by an audit of the participant engagement log
• Participation in group seminars as determined by an audit of the participant engagement log

This acceptability component is considered a primary outcome measure
Timepoint [4] 394098 0
This acceptability component is assessed for each group after the completion of their respective intervention period.
Secondary outcome [5] 394099 0
Only the net promotor score question will be used to measure satisifcation (as a measure of acceptability). The NPS question adopted was: “On a scale of 0 to 10, with 0 being not at all likely and 10 being extremely likely, how likely is it you would recommend the ‘healthy living’ programme to other people with HAE?”. The NPS question was adminstered via an online survey at the conclusion of the intervention programme, The qualititative component involved a semi-structured, one-on-one interview with the researcher.
Timepoint [5] 394099 0
The experience survey is administered for each group after the completion of their respective intervention period.

Eligibility
Key inclusion criteria
Inclusion criteria – people who:
1. Have been diagnosed by a Clinical Immunologist, to be suffering from hereditary angioedema which does not respond to antihistamine or corticosteroid treatment (determined by family history, presence of symptoms of angioedema, low C1 inhibitor level or function or genetic studies)
2. Have access to on-demand medication
3. Are aged 18 and above
4. Are currently and for the duration of the study, residing in New Zealand
5. Have access to a computer and internet connection to access the online intervention
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria – people who:
1. Are unable to comprehend the information sheet and the consent form or unable to give consent.
2. Are participating in another clinical trial
3. Are engaged in another lifestyle intervention, such as working with a health professional on making lifestyle changes
4. Have acquired angioedema
5. Do not have access to on-demand medication
6. Are aged 17 or less
7. Reside outside of New Zealand or planning to during the study
8. Do not have access to a computer and / or do not have access to an internet connection

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Single group
Other design features
A multiple baseline feature is adopted as part of the SCED to strenghten experimental control and study validity
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
This is a pilot study with a key focus on evaluating the feasibility and acceptability of an intervention programme and a secondary interest in potential efficacy.

Visual analysis with descriptive statistics is adopted as the primary method for assessing the multiple baseline outcomes. To complement the visual analysis, two nonoverlapping statistical calculations are used: The percentage of data exceeding the median (PEM) to measure overlap as an indicator of effect sizeand the Tau-U method to detect and control for baseline trends.

The minimal clinically important difference (MCID) is used in the evaluation of potential efficacy for the non-multiple baseline measures for which the PEM and Tau-U methods cannot be applied

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/07/2021
Date of last participant enrolment
Anticipated
30/04/2021
Actual
11/08/2021
Date of last data collection
Anticipated
30/11/2021
Actual
8/03/2022
Sample size
Target
32
Accrual to date
Final
3
Recruitment outside Australia
Country [1] 23455 0
New Zealand
State/province [1] 23455 0

Funding & Sponsors
Funding source category [1] 307829 0
Hospital
Name [1] 307829 0
Auckland City Hospital
Country [1] 307829 0
New Zealand
Primary sponsor type
University
Name
University of Auckland
Address
University of Auckland
Private Bag 92109
Auckland 1142
Country
New Zealand
Secondary sponsor category [1] 308537 0
Hospital
Name [1] 308537 0
Auckland City Hospital
Address [1] 308537 0
Auckland City Hospital
Dr Karen Lindsay
Immunology Department
2 Park Road,
Grafton,
Auckland 1023
Country [1] 308537 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307833 0
Southern Health and disability Ethics Committee
Ethics committee address [1] 307833 0
Ethics committee country [1] 307833 0
New Zealand
Date submitted for ethics approval [1] 307833 0
27/11/2020
Approval date [1] 307833 0
15/02/2021
Ethics approval number [1] 307833 0
20/STH/242

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 108666 0
Dr Karen Lindsay
Address 108666 0
Auckland City Hospital
Immunology Department
2 Park Road,
Grafton,
Auckland 1023
Country 108666 0
New Zealand
Phone 108666 0
+6421 938 251
Fax 108666 0
Email 108666 0
klindsay@adhb.govt.nz
Contact person for public queries
Name 108667 0
Erik van den Top
Address 108667 0
Auckland City Hospital
Immunology Department
2 Park Road,
Grafton,
Auckland 1023
Country 108667 0
New Zealand
Phone 108667 0
+6421329460
Fax 108667 0
Email 108667 0
e.vandentop@auckland.ac.nz
Contact person for scientific queries
Name 108668 0
Erik van den Top
Address 108668 0
Auckland City Hospital
Immunology Department
2 Park Road,
Grafton,
Auckland 1023
Country 108668 0
New Zealand
Phone 108668 0
+6421329460
Fax 108668 0
Email 108668 0
e.vandentop@auckland.ac.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Protection of privacy


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.