Chronic Obstructive Pulmonary Disease
Conditions
Keywords
Augmented Reality, Spirometry, Chronic Obstructive Pulmonary Disease, Primary Health Care, Digital Health, Study Protocol
Brief summary
Spirometry is the gold-standard tool for diagnosing Chronic Obstructive Pulmonary Disease (COPD). However, its implementation in primary care is often limited by a shortage of qualified technicians and inconsistent testing quality. This study will use Augmented Reality (AR) glasses to provide real-time interaction and guidance to participants during spirometry. It will be designed as a two-phase study to evaluate the technical validity and clinical effectiveness of AR-assisted spirometry (AR-SPIRO) system.
Detailed description
The AR-SPIRO system includes a portable spirometer, an iPad for data processing, and AR glasses for visual and voice instructions. In phase 1, 60 participants will undergo spirometry under two guidance modes (AR-assisted guidance and senior technician-led guidance) at the China-Japan Friendship Hospital. Researchers will compare the quality grades from both methods. If the agreement score (Kappa) is 0.7 or higher, the study will move to the phase 2. In phase 2, 650 people will participate at 14 primary care medical institutions. They will be randomly assigned in a 1:1 ratio to either the intervention (AR-assisted guidance) or the control group (routine guidance by primary-care technicians).
Interventions
DEVICEAR-Assisted Spirometry Guidance System
An innovative digital health intervention integrating a portable spirometer (PF910), a mobile terminal (iPad) for real-time flow data processing via Bluetooth, and AR glasses (XREAL One). The system provides synchronized visual-auditory feedback and voice interactive prompts based on real-time expiratory flow data. Participants perform forced maneuvers following AR instructions autonomously while a technician monitors for safety without providing verbal or gestural coaching.
OTHERRoutine Technician-led Spirometry Guidance
Spirometry performed using the same PF910 spirometer model but without AR assistance. Guidance is provided entirely by a technician through standardized verbal and gestures coaching, strictly adhering to routine clinical practice and national spirometry standardization protocols. All technicians at primary care sites receive unified training on COPD guidelines and standardization protocols prior to study initiation.
Sponsors
China-Japan Friendship Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Phase 1 * Age ≥ 18 years. * Able to provide written informed consent. Phase 2 * Age ≥ 40 years. * Cumulative smoking history of ≥10 pack-years or history of biomass fuel exposure for ≥10 years. * Able to provide written informed consent.
Exclusion criteria
(both two phase): * Presence of absolute or relative contraindications to spirometry. * Current pregnancy. * Severe vision or hearing impairments that preclude the effective use of Augmented Reality (AR) glasses.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The consistency of quality grades distribution | At the completion of the spirometry session (Day 1) | The primary outcome in Phase 1 is the consistency of spirometry quality grades distribution (A-F) between AR-assisted and senior technician-led guidance mode. The quality grade serves as the critical metric for determining the clinical reliability of spirometry results. Variables of good quality are those of grades A and B, of sufficient quality are those of grade C, and variables of grades D and lower are not useful for interpretation. |
| Number of attempts for a successful spirometry examination | At the completion of the spirometry session (Day 1) | This study defines a successful examination as achieving a quality grade of B or higher. The primary outcome in Phase 2 is the number of attempts required to complete a successful examination. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Examination time (phase 2) | At the completion of the spirometry session (Day 1) | The total duration from the initial instruction to the conclusion of the final maneuver. |
| Success rate (phase 2) | Through trial completion, an average of 2 months | The proportion of participants achieving a successful examination in the Intention-to-Treat (ITT) population. |
| Participant satisfaction (phase 2) | Immediately post-test | It reflect the comfort and clarity of the instructions provided, assessed via a 5-point Likert scale. The scale ranges from 1 to 5, with higher scores representing better comfort and clearer instructions. |
| Incremental Cost-Effectiveness Ratio (phase 2) | At enrollment | The ratio of the difference in mean total medical costs to the difference in success rates between the intervention and control groups. The medical costs include direct and indirect costs. Data for indirect costs, including transportation expenses and productivity loss estimated based on wages and work time loss, will be collected via an economic questionnaire at enrollment. |
Contacts
CONTACTTianqi Peng
CONTACTHongtao Niu
PRINCIPAL_INVESTIGATORHongtao Niu
China-Japan Friendship Hospital
Outcome results
None listed