REal-time data monitoring for Shared Adaptive, Multi-domain and Personalised prediction and decision making for Long-term pulmonary care Ecosystems (RE-SAMPLE) Prospective Study Virtual Companionship Programme

Chronic Obstructive Pulmonary Disease (COPD) is a common progressive lung
condition with distressing exacerbations. Many patients with COPD have multiple
complex chronic conditions (CCCs) such as cardiovascular diseases, that
increase the patient burden, mortality, healthcare consumption and costs. These
multi-morbidities in COPD can trigger exacerbations, increase common risk
factors, and have overlapping symptoms and pathophysiology. The complexity of
CCCs requires in-depth understanding of the interplay of not only individual
clinical CCC characteristics, but also the patient*s capabilities, functional
limitations, preferences, and behaviour. Additional critical factors typical of
chronic diseases, such as fragmentation of visits, complexity of care patterns,
and impact of lifestyle call for more personalised treatments. Digital
technologies can support such patient-specific approaches by introducing tools
that enable self-management and more continuous patient-healthcare provider
interactions, leading to so-called virtual companionship programs, where indeed
disease-centred digital solutions could materially improve overall care
efficacy and clinical outcomes. In addition, the integration of Real World Data
(RWD) gathered through such solutions with clinical data will boost the output
on predictions and patterns of exacerbations and impact disease management by
generalising results from clinical research to routine clinical practice. In
order to support patients with COPD and CCCs, the RE-SAMPLE consortium has
developed a Virtual Companionship Programme (VCP) which will support both
healthcare professionals (HCPs) and patients in managing their multimorbid
disease using a tailored approach.

The main objective of the RE-SAMPLE VCP is to facilitate proactive disease
management of COPD and CCCs. The study goal is to evaluate the feasibility of
the VCP by assessing improvements in clinical outcomes, user acceptance,
usability, and engagement in the care pathway of patients with COPD. The
virtual companion will, in fact, support patients with COPD and CCCs in their
self-management behaviour and enable an effective communication approach, where
HCPs and patients can leverage technologies to have timely, tailored, and
targeted treatments.

This is a pragmatic descriptive study to evaluate the feasibility and user
acceptance of a VCP adopted in daily life with a 9-month follow-up. The
adaptive and personalised VCP consists of three parts: i) Virtual companion for
the patient, ii) active support programme for the healthcare professional, and
iii) monitoring and communication console in a non-hospital setting.
Measurements on clinical outcomes and user adherence are collected through the
Healthentia mobile phone application at baseline, daily, at exacerbations or
flare-ups, during follow-up visits and from hospital data. Additionally,
individual semi-structured interviews are conducted with patients and involved
HCPs to obtain in-depth information regarding their perceived effectiveness of
the VCP, preferences, and additional needs (including facilitators and
engagement motivators) to improve its potential uptake and adherence.

The adaptive and personalised VCP consists of three parts: i) Virtual companion
for the patient (mobile application) including a self-management intervention
for COPD and CCCs, ii) active support programme for the HCP (clinical
dashboard), and iii) monitoring and communication console in a non-hospital
setting (mobile application).

Patients will be stimulated in self-managing their COPD and CCC's. At baseline
all patients will attend a 2-hour group session where they receive information
regarding their COPD and CCC'S, such as; Diabetes, Chronic heart failure,
Ischemic heart disease, Paroxysmal atrial fibrillation, and anxiety and/ or
depression. They will be informed about the disease, management of the disease,
recognition of symptoms, common medication for the disease and how the disease
can impact one*s life. Patients can also ask questions and share experiences
regarding the COPD and or CCC's in the group session.

Following the group session all participants will attend a one-hour individual
meeting with a casemanager (pulmonary nurse) where their individual action plan
will be set-up based on their preferences and needs in personal goals (e.g.
physical activity). They will also be taught what actions to take when the
symptoms of their COPD and/ or CCC's increase compared to their usual symptoms
(e.g., when to start self-treatment of an exacerbation or when to call a HCP
for support).

Every three months the action plan will be reviewed by the HCP and patients.
Goals will be adjusted where needed by a phone call-meeting. If needed the
3-month review meetings by phone can be adjusted to physical appointment if
either the patient of HCP sees fit.

In addition to the group session, individual meeting and review meetings,
patients will be asked to visit the hospital three more times for a spirometry,
6-minute walking test and blood test, these will be performed at baseline,
month 6 and at the end of the study (month 9). If a patient already performed -
one of - these tests 3 months prior to baseline and is stable, thus did not
have any flare-ups or exacerbation of their COPD and CCC's, this measurement
can be used for the base-line measurement and there will be one less hospital
visit for the patient.

Within the VCP study some patients will use a smart-inhaler, similar to their
current inhaler, that collects data on inspiratory flow, inhaled volume and
inhalation duration. This data will enable the researchers retrospectively to
assess whether smart-inhalers have a predictive value in the development of
AECOPD.

The risk for adverse events due to participation in this study is negligible as
medical treatment of the patients will be continued and they will receive
regular usual care during the study.