NCT04081961

Feasibility Study to Use Biosensing Devices to Monitor PA and Resp. Function in Smokers w and w/o Resp. Symptoms/COPD

Completed Results posted Last updated 3 March 2020

What this trial tests

trial testing Anamed OEM device; Air Next mobile spirometry device in Signs and Symptoms, Respiratory in 27 participants. Completed in 31 October 2019.

Timeline

7 June 2019

Primary endpoint
10 October 2019

31 October 2019

Quick facts

Lead sponsor	Kazakhstan Academy of Preventive Medicine
Status	Completed
Study type	OBSERVATIONAL
Enrollment	27
Start date	7 June 2019
Primary completion	10 October 2019
Estimated completion	31 October 2019
Sites	1 location across Kazakhstan

Drugs / interventions tested

• Anamed OEM device; Air Next mobile spirometry device

Conditions studied

• Signs and Symptoms, Respiratory — all drugs for Signs and Symptoms, Respiratory →
• Mobile Applications — all drugs for Mobile Applications →
• Activity Trackers — all drugs for Activity Trackers →
• Respiratory Function Tests — all drugs for Respiratory Function Tests →

Sponsor

Kazakhstan Academy of Preventive Medicine

Who can join

Adults 40 to 59, any sex, with Signs and Symptoms, Respiratory or Mobile Applications. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Rate of Recruitment Primary · Baseline

Recruitment is defined as the number of potential participants screened for study eligibility versus the number of persons who enrolled in the study.

Group	Value	95% CI
Asymptomatic Current Smokers	9
"Grey Zone" Current Smokers	9
Current Smokers With COPD	9

Rate of Retention Primary · through study completion, an average of 90 days

Retention is defined as the proportion of participants enrolled who completed the intervention and all study measures.

Group	Value	95% CI
Asymptomatic Current Smokers	9
"Grey Zone" Current Smokers	9
Current Smokers With COPD	9

Protocol Adherence Primary · through study completion, an average of 90 days

Adherence to the study protocol is determined as the proportion of participants enrolled from whom all mHealth parameters registered every day.

Group	Value	95% CI
Asymptomatic Current Smokers	4
"Grey Zone" Current Smokers	5
Current Smokers With COPD	8

Sponsor's own description

This study examines the feasibility and acceptability of using mobile applications and biosensing (mHealth) devices in detecting vitality parameters in current smokers with and without respiratory symptoms/COPD (e.g., heart rate, blood oxygenation, steps/motion) for a future big-scale study.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Evaluating Mobile Apps and Biosensing Devices to Monitor Physical Activity and Respiratory Function in Smokers With and Without Respiratory Symptoms or Chronic Obstructive Pulmonary Disease: Protocol for a Proof-of-Concept, Open-Label, Feasibility Study.
   Sharman A, Zhussupov B, Sharman D, Kim I. · · 2020 · cited 2× · PMID 32213479 · DOI 10.2196/16461