The goal of the TACTICAS study is to evaluate if acoustic speech characteristics in patients with asthma or COPD correlate with daily dyspnoea symptoms.
ID
Source
Brief title
Condition
- Bronchial disorders (excl neoplasms)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary objective
To derive a digital fingerprint of dyspnoea in asthma and COPD by combining
speech analysis as well as features extracted from spoken dialogue with daily
dyspnoea measurement as gold standard.
Endpoints for primary objective:
Voice analysis: syllables per breath group during standardized free language
self-report
Daily Dyspnoea burden: E-RS score
Secondary outcome
1. To investigate if the digital dyspnoea fingerprint correlates with asthma
and COPD severity
Voice analysis: syllables per breath group and other acoustic speech
measurements
Disease severity: FEV1 (COPD and asthma), exacerbation burden in the previous
year
2. To investigate if the digital dyspnoea fingerprint in asthma and COPD
correlates with quality of life.
Voice analysis: syllables per breath group and others acoustic speech
measurements
QoL: CAT (COPD), ACT (asthma)
3. To investigate if the digital dyspnoea fingerprint in asthma and COPD
correlates with physical activity.
Voice analysis: syllables per breath group and other acoustic speech
measurements
Physical activity: daily step count, 24-h heart rate, VAS score during physical
activity
4. To investigate if the digital dyspnoea fingerprint in asthma and COPD
correlates with exacerbation occurrence.
Voice analysis: syllables per breath group and other acoustic speech
measurements
Exacerbations: EXACT Score
5. To develop a patient interface consisting of a chatbot smartphone
application plus wearable to objectively measure symptoms in an ecological
momentary assessment. N/A
6. To develop a clinician dashboard that provides meaningful insight into the
generated longitudinal patient data.
7. To test feasibility and evaluate the system in a real-world outpatient care
scenario with COPD and Asthma patients.
Background summary
Telemonitoring (TM) and Mobile health technologies (mHealth) are modernizing
medicine.(1) They have the potential to deliver personalized care at home by
empowering patients to make healthy decisions.(1) Moreover, they can be used to
refine diagnostic processes, tailor treatment choices, improve condition
monitoring for actionable outcomes, such as early signs of relapse, and develop
new intervention models. TM and mHealth is increasingly deployed in many health
care sectors. (2)
Digital phenotyping is the moment-by-moment, in situ quantification of the
individual-level phenotype using data from personal digital devices. Through
artificial intelligence model-based learning it is possible to derive a digital
phenotype or fingerprint from a subject by exploiting the potential of data
that are automatically generated and aggregated by smartphones, wearables and
other connected devices to measure (or offer robust proxies for) human behavior
and function in both health and disease. Today, these data streams include
sensor measurements, activity logs and user-generated content.
Despite the potential of TM and mHealth for improving health care services,
evidence is contradictory in patients with respiratory diseases, mainly asthma
and COPD.(3) There is some evidence that TM might reduce hospitalisation rates
in COPD.(4) On the other hand, a recent meta-analysis showed no effect of TM in
supporting self-management in patients with asthma or COPD.(2 ) Moreover, TM
was not able to reduce the exacerbation rate in COPD patients, which is an
important treatment goal in this population.(5,6)
Symptom relief is another important treatment goal in patients with asthma and
COPD. Dyspnoea is the hallmark symptom in both diseases. Dyspnoea as a symptom
is traditionally monitored and evaluated via questionnaires, such as the visual
analogue score (VAS) or the mMRC scores.(7) Recently, the E-RS score has been
advocated by an American Thoracic Society (ATS) taskforce to monitor daily
dyspnoea symptoms.(8) For remote monitoring and assessment, the effort or
discomfort of breathing should ideally be captured via automatically generated
data that are derived from personal devices, rather than questionnaires which
take patients* time and effort. Mobile health technologies now offer the
possibility to analyse voice. In a pilot study in patients with COPD, it was
shown that several acoustic speech characteristics, such as number of
inhalations per syllable, differed in patients with COPD compared to healthy
controls.(9) Moreover, during an exacerbation this was even more pronounced.(9)
We hypothesize that the quantification of the individual voice of patients with
asthma and COPD is a way to capture and digitalise the respiratory discomfort
experienced by these patients on a daily basis. Therefore, the main goal of the
present pilot study is to investigate correlates in voice analysis that
associate with symptoms in patients with asthma and COPD. This will be done by
using a commercially available mHealth application platform (Zana Technologies
GmbH). Moreover, we will relate these acoustic speech characteristics in voice
to disease severity, quality of life, physical activity and exacerbation rate.
Study objective
The goal of the TACTICAS study is to evaluate if acoustic speech
characteristics in patients with asthma or COPD correlate with daily dyspnoea
symptoms.
Study design
The TACTICAS study will be a prospective, single-center observational cohort
study in adult patients with asthma or COPD attending the university hospital
outpatient clinic of the MUMC+ in the Netherlands. The total duration of the
study will be 74 weeks. All patients will have an evaluation of the asthma or
COPD as part of their routine care at the start and at the end of the study.
After informed consent, patients will receive support and instructions how to
use the Health watch and the mobile app. During the study, patients will be
prompted through a voice dialogue interface on the smartphone three times a day
(once at rest in the morning, once during exercise e.g. while taking a break
and once at the end of the day) to perform the follow speech tasks: (1) Maximum
phonation time (vowel ah) and (2) Free language self-report (e.g. *how are you
feeling today*). Moreover, patients will fill in their daily dyspnoea symptoms
at the end of the day (E-RS). Quality of life questionnaire will be
administered monthly (either CAT or ACT). Passive markers will be collected
throughout the day whilst wearing the Healthwatch: Activity patterns, Heart
rate, SpO2, exercise walking distance and walking time.
Study burden and risks
Because of the observational nature of the study, the present study poses no
risk to patients and burden is only limited to time investment to perform the
measurements. Burden consists of: (1) daily interaction via mobile telephone to
perform a two-minute speech task (three times a day) and to fil in one
questionnaire (at the end of the day), (2) monthly interaction via mobile
telephone to fill in one questionnaire about quality of life, (3) continuous
recording of vital signs while wearing a smartwatch
Minderbroedersberg 4-6
Maastricht 6211 LK
NL
Minderbroedersberg 4-6
Maastricht 6211 LK
NL
Listed location countries
Age
Inclusion criteria
- 18 years or older
- Physician diagnosed asthma or COPD:
- Willingness and demonstration of ability to use a smartphone and fitness
watch and to allow remote monitoring of vital signs.
- Able to understand, read and write Dutch language
Exclusion criteria
- Exacerbation of asthma or COPD within 8 weeks of inclusion into the study
- Chronic respiratory insufficiency, defined as a resting pO2 < 8.0 kPa or pCO2
> 6.5 kPa, measured at sea level
- Co-morbidities that interfere with the registration or interpretation of
symptoms, physical activity or quality of life, such as severe heart failure,
interstitial lung diseases, or neuromuscular disorders.
- Persons who are dependent on others for activities of daily living.
- Persons who use a wheelchair or walker.
- Active malignancy.
- Expected life-expectancy less than 1 year.
- Investigator*s uncertainty about the willingness or ability of the patient to
comply with the protocol requirements.
- Participation in another study involving (non)-investigational products.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL76219.068.20 |
| Other | NL9360 |