Heart FailurePANDA-BOOSTNCT07880158
Sequential Digital Intervention to Increase Influenza Vaccination in Patients With Heart Failure
A study testing Routine Influenza Vaccination Recommendation, Repeated AI-Assisted Telephone Intervention and Gain-Framed SMS Reminder in people with Heart Failure and Influenza Vaccination, run by Heart Health Research Center at 1 site in China.
Trial summary
Influenza vaccination is an important preventive measure for patients with heart failure (HF), but vaccination uptake remains low in China. Although previous studies have demonstrated the benefits of actively promoting influenza vaccination, scalable strategies to improve vaccination uptake among patients with HF… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Influenza Vaccination
- What is being tested?
- Routine Influenza Vaccination Recommendation, Repeated AI-Assisted Telephone Intervention and Gain-Framed SMS Reminder
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 588 participants
- Where
- 1 siteChina
- Study dates
- 15 Oct 2026to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Previous participation in the PANDA II randomized clinical trial.
- Confirmed to be alive at the initial artificial intelligence (AI)-assisted telephone assessment.
- Successful telephone contact with sufficient information to determine current-season influenza vaccination status.
- Not having received the 2026-2027 seasonal influenza vaccine at the time of the initial telephone assessment.
Who cannot join
- Receipt of the 2026-2027 seasonal influenza vaccine before or at the initial telephone assessment.
- Unable to establish effective telephone contact after prespecified contact attempts.
- Unable to ascertain current-season influenza vaccination status during the initial telephone assessment.
- Eligibility for Second-Stage Randomization:
- Among participants assigned to the sequential digital intervention group, those who complete the third AI-assisted telephone assessment and remain unvaccinated against seasonal influenza will be eligible for second-stage randomization. Participants who have been vaccinated, cannot be successfully contacted, or have an undetermined vaccination status at the third assessment will not undergo second-stage randomization.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Ruyang Rural Health Institute
Ruyang, Henan, 471200
Yanna Song, +86 17839372777, songyanna@RRH.onaliyun.com
About this study
Official title: A Sequential Digital Intervention to Increase Influenza Vaccination Uptake in Patients With Heart Failure: The PANDA-BOOST Randomized Clinical Trial
Influenza vaccination is an important preventive measure for patients with heart failure (HF), but vaccination uptake remains low in China. Although previous studies have demonstrated the benefits of actively promoting influenza vaccination, scalable strategies to improve vaccination uptake among patients with HF after hospital discharge remain insufficiently evaluated.
The PANDA-BOOST trial is a prospective, pragmatic, open-label, two-stage sequential randomized clinical trial involving participants previously enrolled in the PANDA II trial. The study aims to evaluate whether sequential digital interventions using artificial intelligence (AI)-assisted telephone calls and short message service (SMS) reminders improve influenza vaccination uptake compared with a single routine vaccination recommendation.
Read more
After an initial AI-assisted telephone call providing a standardized influenza vaccination recommendation, eligible unvaccinated participants will be randomized in a 1:2 ratio to a routine recommendation group or a sequential digital intervention group. Participants in the sequential intervention group will receive additional AI-assisted telephone calls approximately 14 and 28 days after the initial call. Those who remain unvaccinated and meet eligibility criteria at the third call will undergo a second randomization in a 1:1:1 ratio to no additional SMS, gain-framed SMS, or loss-framed SMS.
The primary outcome is influenza vaccination uptake within two months after the first-stage randomization.
Read the detailed description
The PANDA-BOOST (Behavioral Optimization of Outreach Strategies Through Technology) trial is a prospective, pragmatic, open-label, two-stage sequential randomized clinical trial designed to evaluate the effectiveness of sequential digital interventions in improving seasonal influenza vaccination uptake among patients previously hospitalized for heart failure.
Study Population Participants will be identified from the population previously enrolled in the PANDA II trial, a multicenter cluster-randomized clinical trial conducted in China. Eligibility for PANDA-BOOST will be determined through an initial AI-assisted telephone assessment. Participants who are successfully contacted, confirmed to be alive, and confirmed not to have received the 2026-2027 seasonal influenza vaccine will be eligible for first-stage randomization. Participants who have already been vaccinated, cannot be successfully contacted, or have an undetermined vaccination status will not undergo first-stage randomization.
First-Stage Randomization
All eligible participants will receive a standardized routine influenza vaccination recommendation during the initial AI-assisted telephone call. Following this assessment, participants will be randomized in a 1:2 ratio to either:
- Routine recommendation group: No additional study-specific vaccination promotion interventions will be provided after the initial telephone call.
- Sequential digital intervention group: Participants will receive additional AI-assisted telephone calls approximately 14 and 28 days after the initial telephone call.
First-stage randomization will use stratified permuted blocks, with stratification based on participants' original randomized assignment in the PANDA II trial.
During the second and third AI-assisted telephone calls, vaccination status will be reassessed. Participants who remain unvaccinated will be asked about their reasons for non-vaccination and will receive another standardized influenza vaccination recommendation. Participants who have already received the seasonal influenza vaccine will not receive further vaccination promotion interventions.
Second-Stage Randomization Participants assigned to the sequential digital intervention group who remain unvaccinated and complete the third AI-assisted telephone assessment will be eligible for second-stage randomization.
Eligible participants will be randomized in a 1:1:1 ratio to one of three groups:
- No additional SMS: No study-specific SMS reminder will be sent.
- Gain-framed SMS: One SMS message emphasizing the potential health benefits of influenza vaccination.
- Loss-framed SMS: One SMS message emphasizing the potential loss of protection and continued health risks associated with not receiving influenza vaccination.
Second-stage randomization will use permuted blocks without stratification. SMS messages will be sent approximately 14 days after second-stage randomization. Participants who receive influenza vaccination after second-stage randomization but before the scheduled SMS intervention will remain in their originally assigned groups for intention-to-treat analysis.
Outcomes and Data Collection The primary outcome is the proportion of participants who receive the 2026-2027 seasonal influenza vaccine within two months after first-stage randomization.
The secondary outcome is the time from first-stage randomization to influenza vaccination.
Exploratory analyses will evaluate the comparative effects of the three second-stage SMS strategies, reasons for non-vaccination, implementation indicators of AI-assisted telephone calls and SMS interventions, all-cause mortality, and influenza-related illness events when reliable data are available.
Vaccination status and vaccination dates will be primarily ascertained through vaccination registry data obtained in collaboration with the Beijing Center for Disease Prevention and Control. Baseline clinical characteristics will be obtained from the existing PANDA II database, supplemented by prospectively collected intervention and follow-up data.
The primary analysis will follow the intention-to-treat principle, comparing vaccination uptake between the first-stage randomized groups. Second-stage comparisons will be conducted as exploratory analyses.
- Conditions
- Heart Failure, Influenza Vaccination
- Being tested
- Routine Influenza Vaccination Recommendation, Repeated AI-Assisted Telephone Intervention, Gain-Framed SMS Reminder, Loss-Framed SMS Reminder
- Keywords
- Influenza Vaccination, Heart Failure, Digital Health, Artificial Intelligence, Text Messaging, Behavioral Intervention
- Medical subject headings
- Heart Failure, Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Routine Influenza Vaccination RecommendationBehavioural
A single standardized influenza vaccination recommendation is provided during the initial AI-assisted telephone call before first-stage randomization. The call also assesses contact status, survival status, and current-season vaccination status.
Repeated AI-Assisted Telephone InterventionBehavioural
Participants assigned to the sequential digital intervention strategy receive additional AI-assisted telephone calls approximately 14 and 28 days after the initial call. Vaccination status is reassessed, and unvaccinated participants are asked about reasons for non-vaccination and receive a repeated vaccination recommendation. Further intervention is discontinued for participants confirmed to have been vaccinated.
Gain-Framed SMS ReminderBehavioural
One gain-framed SMS message emphasizing the potential health protection associated with influenza vaccination is sent approximately 14 days after second-stage randomization to participants assigned to this strategy.
Loss-Framed SMS ReminderBehavioural
One loss-framed SMS message emphasizing the potential loss of protection and continued influenza-related health risks associated with non-vaccination is sent approximately 14 days after second-stage randomization to participants assigned to this strategy.
| Study group | Role | What they receive |
|---|---|---|
| Routine Recommendation Only | Active comparator | All participants receive an initial AI-assisted telephone assessment and a standardized influenza vaccination recommendation before first-stage randomization. Participants assigned to the routine recommendation strategy receive no additional study-specific vaccination promotion interventions after randomization. Receives: Behavioral: Routine Influenza Vaccination Recommendation |
| Sequential AI / No Additional SMS | Experimental | Participants assigned to the sequential digital intervention strategy are scheduled to receive additional AI-assisted telephone calls approximately 14 and 28 days after the initial call, subject to protocol-defined stopping rules. Participants confirmed to have been vaccinated discontinue further vaccination promotion. Only participants who complete the third telephone assessment and remain unvaccinated undergo second-stage randomization. Those assigned to the no additional SMS strategy receive no study-specific SMS reminder. Participants who do not undergo second-stage randomization remain in the first-stage intention-to-treat population. Receives: Behavioral: Repeated AI-Assisted Telephone Intervention |
| Sequential AI / Gain-Framed SMS | Experimental | Participants assigned to the sequential digital intervention strategy are scheduled to receive additional AI-assisted telephone calls approximately 14 and 28 days after the initial call, subject to protocol-defined stopping rules. Participants confirmed to have been vaccinated discontinue further vaccination promotion. Only participants who complete the third telephone assessment and remain unvaccinated undergo second-stage randomization. Those assigned to the gain-framed SMS strategy receive one gain-framed vaccination reminder approximately 14 days after second-stage randomization. Participants who do not undergo second-stage randomization remain in the first-stage intention-to-treat population. Receives: Behavioral: Repeated AI-Assisted Telephone Intervention; Behavioral: Gain-Framed SMS Reminder |
| Sequential AI / Loss-Framed SMS | Experimental | Participants assigned to the sequential digital intervention strategy are scheduled to receive additional AI-assisted telephone calls approximately 14 and 28 days after the initial call, subject to protocol-defined stopping rules. Participants confirmed to have been vaccinated discontinue further vaccination promotion. Only participants who complete the third telephone assessment and remain unvaccinated undergo second-stage randomization. Those assigned to the loss-framed SMS strategy receive one loss-framed vaccination reminder approximately 14 days after second-stage randomization. Participants who do not undergo second-stage randomization remain in the first-stage intention-to-treat population. Receives: Behavioral: Repeated AI-Assisted Telephone Intervention; Behavioral: Loss-Framed SMS Reminder |
What is being measured
The primary outcome is the main question the study is designed to answer.
Influenza Vaccination Uptake
The proportion of participants who receive the 2026-2027 seasonal influenza vaccine within two calendar months after first-stage randomization. Vaccination status will be determined primarily using vaccination registry data from the Beijing Center for Disease Prevention and Control. Participants with a qualifying vaccination record within the assessment window will be classified as vaccinated. Participants with adequate registry coverage but no qualifying record will be classified as unvaccinated. Outcomes that cannot be reliably ascertained will be recorded as indeterminate.
Measured: From first-stage randomization to 2 months after randomization
Secondary outcomes (1)
From first-stage randomization to 2 months after randomization
Time in days from first-stage randomization to receipt of the 2026-2027 seasonal influenza vaccine, based on the recorded vaccination date. Participants who do not receive influenza vaccination within the two-month assessment window will be right-censored at the end of their individual assessment window. Time-to-event analyses will be used to compare the first-stage randomized groups.
Measured: From first-stage randomization to 2 months after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2026
- Study start15 Oct 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- This is a two-stage sequential randomized trial. Following an initial AI-assisted telephone assessment and routine influenza vaccination recommendation, eligible unvaccinated participants are randomized 1:2 to a routine recommendation group or a sequential digital intervention group. Participants in the sequential intervention group receive additional AI-assisted telephone calls approximately 14 and 28 days later. Those who remain unvaccinated and complete the third telephone assessment undergo a second randomization (1:1:1) to no additional SMS, gain-framed SMS, or loss-framed SMS. A single SMS is sent approximately 14 days after the second-stage randomization in the two SMS groups. The primary comparison is based on the first-stage randomization; second-stage comparisons are exploratory.
- Masking
- None (open label)
- Enrolment
- 588 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Heart Health Research Center
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Anzhen Hospital, Ruyang Rural Health Institute, Beijing Center for Disease Control and Prevention
- Responsible party
- Sponsor
- Investigators
- Xin Du, Principal investigator, Beijing Anzhen HospitalPeng Yang, Principal investigator, Beijing Center for Disease Prevention and Control
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07880158
- Sponsor's protocol ID
- PANDA-BOOST-2026
- Acronym
- PANDA-BOOST
- Status last verified
- Oct 2026
- First submitted
- 12 Oct 2026
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Johansen ND, Vaduganathan M, Bhatt AS, Modin D, Chatur S, Claggett BL, Janstrup KH, Larsen CS, Larsen L, Wiese L, Dalager-Pedersen M, Kober L, Solomon SD, Sivapalan P, Jensen JUS, Martel CJ, Krause TG, Biering-Sorensen T. Electronic nudges for sustained influenza vaccination uptake in older adults: the nationwide randomized NUDGE-FLU-2 trial. Nat Med. 2024 Nov;30(11):3142-3149. doi: 10.1038/s41591-024-03202-4. Epub 2024 Aug 30.
PubMed 39215149Zhang Y, Liu R, Zhao Y, Wang Z, Wang C, Li Q, Han D, Anderson CS, Du X, Dong J. Influenza vaccination in patients with acute heart failure (PANDA II): study protocol for a hospital-based, parallel-group, cluster randomized controlled trial in China. Trials. 2024 Nov 25;25(1):792. doi: 10.1186/s13063-024-08452-8.
PubMed 39587669Anderson CS, Hua C, Wang Z, Wang C, Jiang C, Liu R, Han R, Li Q, Shan S, Billot L, Macintyre CR, Patel A, Zhang H, Ma C, Dong J, Du X. Influenza vaccination to improve outcomes for patients with acute heart failure (PANDA II): a multiregional, seasonal, hospital-based, cluster-randomised, controlled trial in China. Lancet. 2025 Sep 6;406(10507):1020-1031. doi: 10.1016/S0140-6736(25)01485-0. Epub 2025 Aug 30.
PubMed 40897187
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Sequential Digital Intervention to Increase Influenza Vaccination Uptake in Patients With Heart Failure: The PANDA-BOOST Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07880158
- Acronym / sponsor ID
- PANDA-BOOST / PANDA-BOOST-2026
- Conditions
- Heart Failure, Influenza Vaccination
- Keywords
- Influenza Vaccination, Heart Failure, Digital Health, Artificial Intelligence, Text Messaging, Behavioral Intervention
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 588 participants (estimated)
- Lead sponsor
- Heart Health Research CenterUniversity, hospital or other
- Collaborators
- Beijing Anzhen Hospital, Ruyang Rural Health Institute, Beijing Center for Disease Control and Prevention
- Study start
- 15 Oct 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 19 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Influenza vaccination is an important preventive measure for patients with heart failure (HF), but vaccination uptake remains low in China. Although previous studies have demonstrated the benefits of actively promoting influenza vaccination, scalable strategies to improve vaccination uptake among patients with HF after hospital discharge remain insufficiently evaluated.
The PANDA-BOOST trial is a prospective, pragmatic, open-label, two-stage sequential randomized clinical trial involving participants previously enrolled in the PANDA II trial. The study aims to evaluate whether sequential digital interventions using artificial intelligence (AI)-assisted telephone calls and short message service (SMS) reminders improve influenza vaccination uptake compared with a single routine vaccination recommendation.
After an initial AI-assisted telephone call providing a standardized influenza vaccination recommendation, eligible unvaccinated participants will be randomized in a 1:2 ratio to a routine recommendation group or a sequential digital intervention group. Participants in the sequential intervention group will receive additional AI-assisted telephone calls approximately 14 and 28 days after the initial call. Those who remain unvaccinated and meet eligibility criteria at the third call will undergo a second randomization in a 1:1:1 ratio to no additional SMS, gain-framed SMS, or loss-framed SMS.
The primary outcome is influenza vaccination uptake within two months after the first-stage randomization.
Detailed description
The PANDA-BOOST (Behavioral Optimization of Outreach Strategies Through Technology) trial is a prospective, pragmatic, open-label, two-stage sequential randomized clinical trial designed to evaluate the effectiveness of sequential digital interventions in improving seasonal influenza vaccination uptake among patients previously hospitalized for heart failure.
Study Population Participants will be identified from the population previously enrolled in the PANDA II trial, a multicenter cluster-randomized clinical trial conducted in China. Eligibility for PANDA-BOOST will be determined through an initial AI-assisted telephone assessment. Participants who are successfully contacted, confirmed to be alive, and confirmed not to have received the 2026-2027 seasonal influenza vaccine will be eligible for first-stage randomization. Participants who have already been vaccinated, cannot be successfully contacted, or have an undetermined vaccination status will not undergo first-stage randomization.
First-Stage Randomization
All eligible participants will receive a standardized routine influenza vaccination recommendation during the initial AI-assisted telephone call. Following this assessment, participants will be randomized in a 1:2 ratio to either:
- Routine recommendation group: No additional study-specific vaccination promotion interventions will be provided after the initial telephone call.
- Sequential digital intervention group: Participants will receive additional AI-assisted telephone calls approximately 14 and 28 days after the initial telephone call.
First-stage randomization will use stratified permuted blocks, with stratification based on participants' original randomized assignment in the PANDA II trial.
During the second and third AI-assisted telephone calls, vaccination status will be reassessed. Participants who remain unvaccinated will be asked about their reasons for non-vaccination and will receive another standardized influenza vaccination recommendation. Participants who have already received the seasonal influenza vaccine will not receive further vaccination promotion interventions.
Second-Stage Randomization Participants assigned to the sequential digital intervention group who remain unvaccinated and complete the third AI-assisted telephone assessment will be eligible for second-stage randomization.
Eligible participants will be randomized in a 1:1:1 ratio to one of three groups:
- No additional SMS: No study-specific SMS reminder will be sent.
- Gain-framed SMS: One SMS message emphasizing the potential health benefits of influenza vaccination.
- Loss-framed SMS: One SMS message emphasizing the potential loss of protection and continued health risks associated with not receiving influenza vaccination.
Second-stage randomization will use permuted blocks without stratification. SMS messages will be sent approximately 14 days after second-stage randomization. Participants who receive influenza vaccination after second-stage randomization but before the scheduled SMS intervention will remain in their originally assigned groups for intention-to-treat analysis.
Outcomes and Data Collection The primary outcome is the proportion of participants who receive the 2026-2027 seasonal influenza vaccine within two months after first-stage randomization.
The secondary outcome is the time from first-stage randomization to influenza vaccination.
Exploratory analyses will evaluate the comparative effects of the three second-stage SMS strategies, reasons for non-vaccination, implementation indicators of AI-assisted telephone calls and SMS interventions, all-cause mortality, and influenza-related illness events when reliable data are available.
Vaccination status and vaccination dates will be primarily ascertained through vaccination registry data obtained in collaboration with the Beijing Center for Disease Prevention and Control. Baseline clinical characteristics will be obtained from the existing PANDA II database, supplemented by prospectively collected intervention and follow-up data.
The primary analysis will follow the intention-to-treat principle, comparing vaccination uptake between the first-stage randomized groups. Second-stage comparisons will be conducted as exploratory analyses.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- This is a two-stage sequential randomized trial. Following an initial AI-assisted telephone assessment and routine influenza vaccination recommendation, eligible unvaccinated participants are randomized 1:2 to a routine recommendation group or a sequential digital intervention group. Participants in the sequential intervention group receive additional AI-assisted telephone calls approximately 14 and 28 days later. Those who remain unvaccinated and complete the third telephone assessment undergo a second randomization (1:1:1) to no additional SMS, gain-framed SMS, or loss-framed SMS. A single SMS is sent approximately 14 days after the second-stage randomization in the two SMS groups. The primary comparison is based on the first-stage randomization; second-stage comparisons are exploratory.
| Arm | Type | Receives |
|---|---|---|
| Routine Recommendation Only | Active comparator | Behavioral: Routine Influenza Vaccination RecommendationAll participants receive an initial AI-assisted telephone assessment and a standardized influenza vaccination recommendation before first-stage randomization. Participants assigned to the routine recommendation strategy receive no additional study-specific vaccination promotion interventions after randomization. |
| Sequential AI / No Additional SMS | Experimental | Behavioral: Repeated AI-Assisted Telephone InterventionParticipants assigned to the sequential digital intervention strategy are scheduled to receive additional AI-assisted telephone calls approximately 14 and 28 days after the initial call, subject to protocol-defined stopping rules. Participants confirmed to have been vaccinated discontinue further vaccination promotion. Only participants who complete the third telephone assessment and remain unvaccinated undergo second-stage randomization. Those assigned to the no additional SMS strategy receive no study-specific SMS reminder. Participants who do not undergo second-stage randomization remain in the first-stage intention-to-treat population. |
| Sequential AI / Gain-Framed SMS | Experimental | Behavioral: Repeated AI-Assisted Telephone Intervention, Behavioral: Gain-Framed SMS ReminderParticipants assigned to the sequential digital intervention strategy are scheduled to receive additional AI-assisted telephone calls approximately 14 and 28 days after the initial call, subject to protocol-defined stopping rules. Participants confirmed to have been vaccinated discontinue further vaccination promotion. Only participants who complete the third telephone assessment and remain unvaccinated undergo second-stage randomization. Those assigned to the gain-framed SMS strategy receive one gain-framed vaccination reminder approximately 14 days after second-stage randomization. Participants who do not undergo second-stage randomization remain in the first-stage intention-to-treat population. |
| Sequential AI / Loss-Framed SMS | Experimental | Behavioral: Repeated AI-Assisted Telephone Intervention, Behavioral: Loss-Framed SMS ReminderParticipants assigned to the sequential digital intervention strategy are scheduled to receive additional AI-assisted telephone calls approximately 14 and 28 days after the initial call, subject to protocol-defined stopping rules. Participants confirmed to have been vaccinated discontinue further vaccination promotion. Only participants who complete the third telephone assessment and remain unvaccinated undergo second-stage randomization. Those assigned to the loss-framed SMS strategy receive one loss-framed vaccination reminder approximately 14 days after second-stage randomization. Participants who do not undergo second-stage randomization remain in the first-stage intention-to-treat population. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Previous participation in the PANDA II randomized clinical trial.
- Confirmed to be alive at the initial artificial intelligence (AI)-assisted telephone assessment.
- Successful telephone contact with sufficient information to determine current-season influenza vaccination status.
- Not having received the 2026-2027 seasonal influenza vaccine at the time of the initial telephone assessment.
Key exclusion criteria (5 listed)
- Receipt of the 2026-2027 seasonal influenza vaccine before or at the initial telephone assessment.
- Unable to establish effective telephone contact after prespecified contact attempts.
- Unable to ascertain current-season influenza vaccination status during the initial telephone assessment.
- Among participants assigned to the sequential digital intervention group, those who complete the third AI-assisted telephone assessment and remain unvaccinated against seasonal influenza will be eligible for second-stage randomization. Participants who have been vaccinated, cannot be successfully contacted, or have an undetermined vaccination status at the third assessment will not undergo second-stage randomization.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Routine Influenza Vaccination RecommendationA single standardized influenza vaccination recommendation is provided during the initial AI-assisted telephone call before first-stage randomization. The call also assesses contact status, survival status, and current-season vaccination status. | Behavioural | Routine Recommendation Only |
| Repeated AI-Assisted Telephone InterventionParticipants assigned to the sequential digital intervention strategy receive additional AI-assisted telephone calls approximately 14 and 28 days after the initial call. Vaccination status is reassessed, and unvaccinated participants are asked about reasons for non-vaccination and receive a repeated vaccination recommendation. Further intervention is discontinued for participants confirmed to have been vaccinated. | Behavioural | Sequential AI / Gain-Framed SMS, Sequential AI / Loss-Framed SMS, Sequential AI / No Additional SMS |
| Gain-Framed SMS ReminderOne gain-framed SMS message emphasizing the potential health protection associated with influenza vaccination is sent approximately 14 days after second-stage randomization to participants assigned to this strategy. | Behavioural | Sequential AI / Gain-Framed SMS |
| Loss-Framed SMS ReminderOne loss-framed SMS message emphasizing the potential loss of protection and continued influenza-related health risks associated with non-vaccination is sent approximately 14 days after second-stage randomization to participants assigned to this strategy. | Behavioural | Sequential AI / Loss-Framed SMS |
Primary outcome
Influenza Vaccination Uptake
Time frame: From first-stage randomization to 2 months after randomization
The proportion of participants who receive the 2026-2027 seasonal influenza vaccine within two calendar months after first-stage randomization. Vaccination status will be determined primarily using vaccination registry data from the Beijing Center for Disease Prevention and Control. Participants with a qualifying vaccination record within the assessment window will be classified as vaccinated. Participants with adequate registry coverage but no qualifying record will be classified as unvaccinated. Outcomes that cannot be reliably ascertained will be recorded as indeterminate.
1 secondary outcome
From first-stage randomization to 2 months after randomization
Time frame: From first-stage randomization to 2 months after randomization
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2026.
- Background: PubMed 39215149Johansen ND, Vaduganathan M, Bhatt AS, Modin D, Chatur S, Claggett BL, Janstrup KH, Larsen CS, Larsen L, Wiese L, Dalager-Pedersen M, Kober L, Solomon SD, Sivapalan P, Jensen JUS, Martel CJ, Krause TG, Biering-Sorensen T. Electronic nudges for sustained influenza vaccination uptake in older adults: the nationwide randomized NUDGE-FLU-2 trial. Nat Med. 2024 Nov;30(11):3142-3149. doi: 10.1038/s41591-024-03202-4. Epub 2024 Aug 30.
- Background: PubMed 39587669Zhang Y, Liu R, Zhao Y, Wang Z, Wang C, Li Q, Han D, Anderson CS, Du X, Dong J. Influenza vaccination in patients with acute heart failure (PANDA II): study protocol for a hospital-based, parallel-group, cluster randomized controlled trial in China. Trials. 2024 Nov 25;25(1):792. doi: 10.1186/s13063-024-08452-8.
- Background: PubMed 40897187Anderson CS, Hua C, Wang Z, Wang C, Jiang C, Liu R, Han R, Li Q, Shan S, Billot L, Macintyre CR, Patel A, Zhang H, Ma C, Dong J, Du X. Influenza vaccination to improve outcomes for patients with acute heart failure (PANDA II): a multiregional, seasonal, hospital-based, cluster-randomised, controlled trial in China. Lancet. 2025 Sep 6;406(10507):1020-1031. doi: 10.1016/S0140-6736(25)01485-0. Epub 2025 Aug 30.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Xin Du principal investigator
Beijing Anzhen Hospital
Peng Yang principal investigator
Beijing Center for Disease Prevention and Control
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Routine Influenza Vaccination Recommendation, Repeated AI-Assisted Telephone Intervention and Gain-Framed SMS Reminder in people with Heart Failure and Influenza Vaccination, run by Heart Health Research Center at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yanna Song (+86 17839372777, songyanna@RRH.onaliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Influenza Vaccination Uptake (time frame: From first-stage randomization to 2 months after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07880158, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2026.