An interventional study of Robot-Assisted Ecological Momentary Intervention (RESPIRE) in Recurrent Respiratory Tract Infections, sponsored by Xi'an Jiaotong University. Completed at 1 site in China. Open to participants aged 2 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-12.
Sponsored by Xi'an Jiaotong University · Not applicable, Interventional, and Prevention
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Among 40 studies in Respiratory Tract Infections with a site in China — 13 open to participants now, 15 under way, 3 of them phase 3. Respiratory Tract Infections · China.
Among the 40 studies in Respiratory Tract Infections with a site in China, this one is the 16th largest by enrollment of the 30 interventional ones that give a count, is one of 8 that started in 2022, is one of 9 with no phase, and was the 40th registered.
753 studies on the registry are indexed under Respiratory Tract Infections; 114 are open to participants now.
Browse Respiratory Tract Infections studies →13 of the 40 studies in Respiratory Tract Infections with a site in China are open now. Recruiting first, the newest first:
Hoffmann-La Roche · Sites in China
Ages 5+ · Healthy volunteers
Fudan University · Sites in China
Ages 18+
Huashan Hospital · Sites in China
Joincare Pharmaceutical Group Industry Co., Ltd · Sites in China
Ages 18–45 · Healthy volunteers
Min-Tze LIONG · Sites in China, Malaysia
Ages 1 days–6 yrs
A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →
Of the 74 Respiratory Tract Infections studies recruiting now, 35 (47%) set no upper age limit and 31 (42%) stop at 75 or younger; 34 take children under 18; 25 take healthy volunteers.
This study: 2 Years and older · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
40 studies; the count open now beside each. This study's row is marked.
First in 2006; this study’s year is marked. 8 started in 2022.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 164 is below the median of 200 across 542 interventional studies indexed under Respiratory Tract Infections.
Median enrollment 202 across the 30 interventional studies, 1,000 across the 10 observational. Of the 19 that completed or were terminated, 1 (5%) have results posted.
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17 of 40 have an industry lead sponsor. The 10 most frequent:
Xi'an Jiaotong University is the lead sponsor of 33 studies on the registry; 8 are open to participants now.
Xi'an Jiaotong University has 2 studies filed under Respiratory Tract Infections — fewer than ten, so there is no comparison to draw.
5 of the studies in Respiratory Tract Infections with a site in China that are under way reach primary completion within a year, 3 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07827599Phase 3Hoffmann-La RocheA Study to Confirm Efficacy of a Single Dose of Baloxavir Marboxil in the Post-exposure Prophylaxis (PEP) of Influenza Virus Infection in Chinese Participants | 2027-04-30 |
| NCT06679140Phase 3PfizerA Study to Learn About a Study Medicine Called Ibuzatrelvir in Adult and Adolescent Patients With COVID-19 Who Are Not Hospitalized But Are at Risk For Severe Disease | 2027-10-01 |
| NCT05624450Phase 3AstraZenecaEfficacy and Safety of Tozorakimab in Patients Hospitalised for Viral Lung Infection Requiring Supplemental Oxygen | 2027-11-04 |
| NCT07085858LanZhou UniversityStudy of the Preventive Effects and Mechanisms of Yeast β-Glucan on Upper Respiratory Tract Infections | 2026-12-31 |
| NCT06645665Shenzhen Shenxin Biotechnology Co., LtdA Study to Describe the Safety and Immunogenicity of a Respiratory Syncytial Virus Vaccine IN006 in Healthy Adult Aged 18 Years and Above | 2027-04 |
Add all 5 to your calendar (.ics) → With an account.
Among the 40 studies in Respiratory Tract Infections with a site in China, from their registry updates:
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Recurrent respiratory tract infections (RRTIs) are common among preschool children and can affect children's health and place considerable caregiving demands on their families. Parents play an important role in recognizing respiratory symptoms, providing appropriate home care, and seeking timely medical attention. Improving parental health literacy and providing accessible health management support may help families manage recurrent respiratory infections.
This study evaluated RESPIRE, a robot-assisted ecological momentary intervention designed to support respiratory symptom monitoring and parental management of RRTIs in preschool children.
The study used a two-arm, parallel-group, cluster-randomized controlled trial design involving two public kindergartens in Dingxi, Gansu Province, China. Eligible preschool children with RRTIs and one primary caregiver for each child were included. The two kindergartens were randomly assigned to either the intervention group or the control group.
The intervention group received an eight-week RESPIRE program combining kindergarten-based robot-assisted health screening with a mobile application for parents. The program included daily respiratory health monitoring, personalized health guidance, interactive health education, and online peer support. The control group received routine kindergarten health care and reported children's respiratory symptoms daily.
The primary outcome was parental health literacy, assessed at baseline, week 4, and week 8. Secondary outcomes included the frequency of respiratory tract infections, the proportion of days with respiratory symptoms, parenting sense of competence, parenting stress, intervention adherence, system usability, and participant satisfaction.
The study aimed to evaluate whether the RESPIRE program could improve parental health literacy and support the management of recurrent respiratory tract infections among preschool children.
The RESPIRE intervention was developed using a patient and public involvement (PPI) approach informed by Nutbeam's health literacy model and the ecological momentary intervention (EMI) framework. The development process included a literature review, two rounds of Delphi consultation with 10 multidisciplinary experts, iterative intervention design involving five caregivers over eight weeks, and an eight-day single-group pilot involving 15 preschool children with recurrent respiratory tract infections (RRTIs) and their caregivers.
The formal evaluation employed a two-arm, parallel-group, cluster-randomized controlled trial. Two public kindergartens were selected from a sampling frame of six kindergartens based on similarities in institutional characteristics, size, and student populations. The kindergartens were randomly allocated using computer-generated random numbers, with one kindergarten assigned to the intervention group and the other to the control group. Eligible children with RRTIs and their primary caregivers were recruited following cluster allocation. The study protocol specified that outcome assessors would remain blinded to group allocation.
The RESPIRE program integrated a kindergarten-based health screening robot with a mobile application designed for parents. The intervention consisted of three major components: (1) Interactive Health Education: Parents accessed educational materials about RRTIs, symptom recognition, home management, and preventive measures through interactive quizzes and personalized feedback. (2) Online Peer Support: A mobile discussion platform enabled parents to exchange experiences, discuss child health concerns, and communicate with health professionals. (3) Intelligent Health Monitoring and Management: A kindergarten-based robot conducted daily non-contact health screening, including preliminary assessments of body temperature, the oropharyngeal region, and the eyes. Suspected abnormalities were reviewed by kindergarten health professionals. Parents received health notifications and individualized guidance through the mobile application. The platform also delivered daily environmental health recommendations and supported symptom tracking through electronic health diaries.
The control group continued to receive routine kindergarten health care, including conventional morning health checks and standard communication with parents when respiratory symptoms were identified. Parents in the control group reported their children's respiratory symptoms daily through a designated WeChat group.
The intervention lasted eight weeks. Parental health literacy, parenting sense of competence, and parenting stress were assessed at baseline, week 4, and week 8. Children's respiratory symptoms were monitored daily, with infection frequency and the proportion of symptomatic days summarized over consecutive two-week periods. Intervention adherence and platform engagement were evaluated using system-generated activity records. System usability and participant satisfaction were assessed at the end of the intervention.
The statistical analysis plan specified generalized estimating equation models to evaluate intervention effects across repeated measurements. Multiple imputation was planned for missing questionnaire data, with analyses of the non-imputed dataset conducted as sensitivity analyses.
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Children:
Parents or Primary Caregivers:
Exclusion Criteria:
Children:
Parents or Primary Caregivers:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants in the intervention group received the eight-week RESPIRE program, a robot-assisted ecological momentary intervention combining kindergarten-based health screening with a parent-oriented mobile application. The program included daily non-contact health screening using a robot, respiratory symptom monitoring, personalized health guidance, interactive education about recurrent respiratory tract infections, online peer support, and daily electronic health diaries. Parents received real-time feedback and individualized recommendations based on their children's respiratory health status and environmental conditions.
Behavioral: Robot-Assisted Ecological Momentary Intervention (RESPIRE)
Participants in the control group received routine kindergarten health care without access to the RESPIRE robot-assisted intervention or mobile application. Children underwent conventional daily morning health checks performed by kindergarten health personnel or teachers, including visual assessment of general health status and body temperature measurement. Parents were informed when respiratory symptoms were suspected and were advised to seek medical care or provide home observation according to routine practices. For study outcome assessment, parents reported their children's respiratory symptoms and severity daily through a designated WeChat group during the eight-week study period.
The RESPIRE program was delivered over eight weeks and combined kindergarten-based robot-assisted health screening with a parent-oriented mobile application. Children underwent daily non-contact health screening using a robot, including preliminary assessments of body temperature, oropharyngeal findings, and eye conditions. Suspected abnormalities were reviewed by kindergarten health personnel. Parents received an integrated ecological momentary intervention consisting of interactive health education and quizzes about recurrent respiratory tract infections, an online peer-support forum, daily environmental health recommendations, real-time screening notifications, personalized symptom management guidance, and electronic health diaries. Parents recorded their children's respiratory symptoms and health behaviors daily. The mobile application provided automated reminders and individualized feedback based on reported symptoms, screening results, and environmental conditions.
Parental Health Literacy Score
Parental health literacy was assessed using a 33-item health literacy scale for parents of preschool children. The scale covers three dimensions: functional health literacy, interactive health literacy, and critical health literacy. The total health literacy score was assessed at three time points to evaluate changes throughout the eight-week intervention period.
Time frame: Baseline (Week 0), Week 4, and Week 8
Number of Respiratory Tract Infection Episodes
The number of newly occurring respiratory tract infection episodes in each consecutive two-week observation period was determined using daily caregiver reports of children's respiratory symptoms. Respiratory infection episodes separated by seven days or fewer were counted as a single episode. Higher counts indicate more frequent respiratory tract infections.
Time frame: Weeks 1-2, 3-4, 5-6, and 7-8
Proportion of Days With Respiratory Tract Infection Symptoms
The proportion of days with respiratory tract infection symptoms was calculated for each consecutive two-week observation period. The numerator was the number of days on which the child experienced respiratory tract infection symptoms, and the denominator was the total number of days with submitted health reports during the same period. The result was expressed as a percentage, with higher values indicating a greater burden of respiratory symptoms.
Time frame: Weeks 1-2, 3-4, 5-6, and 7-8
Parenting Sense of Competence Scale Score
Parenting sense of competence was assessed using the 17-item Parenting Sense of Competence Scale (PSOC), which includes parenting efficacy and parenting satisfaction dimensions. Each item is rated on a six-point Likert scale, with reverse scoring applied to the parenting satisfaction items as specified in the study protocol. The possible total score ranges from 17 to 102, with higher scores indicating greater parenting sense of competence.
Time frame: Baseline (Week 0), Week 4, and Week 8
Parenting Stress Index Short Form Score
Parenting stress was measured using the 15-item Parenting Stress Index Short Form (PSI-SF-15). The instrument includes three dimensions: parental distress, parent-child dysfunctional interaction, and difficult child. Each item is rated on a five-point Likert scale. The total score ranges from 15 to 75, with higher scores indicating greater parenting stress.
Time frame: Baseline (Week 0), Week 4, and Week 8
Daily Electronic Health Diary Completion Rate
The completion rate of daily electronic health diaries was calculated as the number of diary entries completed by caregivers divided by the number of scheduled diary entries during the eight-week intervention, multiplied by 100. Completion data were obtained from RESPIRE application logs. Higher percentages indicate better adherence to daily symptom reporting.
Time frame: Daily throughout the 8-week intervention
System Usability Scale Score
System usability was assessed among intervention-group caregivers using the 10-item System Usability Scale (SUS). Each item was rated on a five-point scale. Item scores were adjusted for positive and negative wording, summed, and multiplied by 2.5 to obtain a total score ranging from 0 to 100. Higher scores indicate better perceived system usability.
Time frame: Week 8
Percentage of Caregivers Satisfied With the RESPIRE Program
Intervention satisfaction was evaluated among caregivers in the RESPIRE group using a five-point Customer Satisfaction Score (CSAT). Ratings of 4 or 5 were classified as satisfied. The overall satisfaction rate was calculated as the number of caregivers reporting satisfaction divided by the total number of intervention participants, multiplied by 100. Higher percentages indicate greater satisfaction.
Time frame: Week 8
Plan to share: No — There is no current plan to share de-identified individual participant data with external researchers. The study involves preschool children and their primary caregivers. Any future data-sharing arrangements would require consideration of informed consent, ethical approval, and applicable data privacy requirements.
No publications or documents are linked to this record.
Ran from May 2022 to primary completion in Aug 2022, 3 months.
Of 119 non-industry interventional studies with no phase under Respiratory Tract Infections, half reached primary completion within 14 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 30. This study's 3 months is below that.
Counting every sponsor, half of 146 studies reached it within 12 months; a quarter within 6 and three quarters within 29.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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Respiratory Tract Infections →
Xi'an Jiaotong University