Diabetes Mellitus, Type 2NCT07901673
Information-Based Interventions for Influenza Vaccination Among Older Adults With Diabetes in Yangzhou, China
A study testing Standard Information Intervention, Gain-Framed Information Intervention and Loss-Framed Information Intervention in people with Diabetes Mellitus, Type 2 and Influenza, run by Southeast University, China at 4 sites in China.
Trial summary
Influenza can cause serious illness in older adults, particularly those with diabetes. Although influenza vaccination is an important preventive measure, vaccination uptake among older adults in China remains low. Read more about this study
- Who is it for?
- Ages 60 to 75 years
- Conditions the study is for
- Diabetes Mellitus, Type 2, Influenza
- What is being tested?
- Standard Information Intervention, Gain-Framed Information Intervention and Loss-Framed Information Intervention
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 759 participants
- Where
- 4 sitesChina
- Study dates
- 25 Sep 2023to 30 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 60 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 60 to 75 years with physician-diagnosed type 2 diabetes mellitus.
- No influenza vaccination during the 2022-2023 influenza season and no known contraindication to influenza vaccination.
- Residence in the study area for more than 6 months, with no plans to relocate within the following year.
- Voluntary participation and provision of written informed consent.
- Ability to understand the study information and complete the intervention and follow-up assessments.
Who cannot join
- Participation in another clinical trial or similar study.
- Refusal or inability to provide demographic or vaccination-related information.
- Inability to participate in the study because of health status.
- Known contraindication to influenza vaccination.
Trial locations and contacts
4 sites in 1 country.
China4 sites
Changsha Community Health Service Station, Fanshui Town, Yangzhou, Jiangsu
Yangzhou, Jiangsu
Hongqi Community Health Service Station, Fanshui Town
Yangzhou, Jiangsu
Songbu Community Health Service Station, Fanshui Town, Yangzhou, Jiangsu
Yangzhou, Jiangsu
Zhegou Community Health Service Station, Fanshui Town, Yangzhou, Jiangsu
Yangzhou, Jiangsu
About this study
Official title: An Information-Framing-Based Intervention Study on Influenza Vaccination Behavior Among Older Adults With Diabetes
Influenza can cause serious illness in older adults, particularly those with diabetes. Although influenza vaccination is an important preventive measure, vaccination uptake among older adults in China remains low.
This study aimed to evaluate whether different ways of presenting influenza vaccination information could encourage vaccination among older adults with diabetes in Yangzhou, China.
Read more
Adults aged 60 to 75 years with diabetes were assigned to one of four study groups: a control group without intervention text messages, a standard information group, a gain-framed information group emphasizing the benefits of vaccination, and a loss-framed information group emphasizing the potential negative consequences of not being vaccinated.
The primary outcome was influenza vaccination uptake during follow-up. Secondary outcomes included willingness to receive influenza vaccination and vaccine literacy. The study examined whether information-based interventions could improve vaccination-related outcomes compared with the control group.
- Conditions
- Diabetes Mellitus, Type 2, Influenza
- Being tested
- Standard Information Intervention, Gain-Framed Information Intervention, Loss-Framed Information Intervention
- Keywords
- Influenza Vaccination, Message Framing, Vaccination Uptake, Vaccine Literacy
- Medical subject headings
- Diabetes Mellitus, Type 2, Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Information InterventionBehavioural
This intervention provided standard, factual information about influenza and influenza vaccination without emphasizing the benefits of vaccination or the risks of non-vaccination. The intervention consisted of an approximately 10-minute educational video and a subsequent reinforcement reminder card.
Gain-Framed Information InterventionBehavioural
This intervention provided gain-framed information emphasizing the potential benefits of influenza vaccination, including protection against influenza and related complications among older adults with diabetes. The intervention consisted of an approximately 10-minute educational video and a subsequent reinforcement reminder card.
Loss-Framed Information InterventionBehavioural
This intervention provided loss-framed information emphasizing the potential negative consequences of not receiving influenza vaccination, including increased susceptibility to influenza and related health complications among older adults with diabetes. The intervention consisted of an approximately 10-minute educational video and a subsequent reinforcement reminder card.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | Participants in the control group received no study-specific influenza vaccination information intervention. They completed baseline and follow-up assessments. |
| Standard Information Group | Experimental | Participants assigned to this group received standard, factual information about influenza and influenza vaccination, without emphasizing either the benefits of vaccination or the risks of non-vaccination. The intervention consisted of an educational video followed by a reinforcement reminder card. Receives: Behavioral: Standard Information Intervention |
| Gain-Framed Information Group | Experimental | Participants assigned to this group received influenza vaccination information framed to emphasize the potential benefits of vaccination, including protection against influenza and its complications among older adults with diabetes. The intervention consisted of a gain-framed educational video followed by a reinforcement reminder card. Receives: Behavioral: Gain-Framed Information Intervention |
| Loss-Framed Information Group | Experimental | Participants assigned to this group received influenza vaccination information framed to emphasize the potential negative consequences of not being vaccinated, including an increased risk of influenza infection and related complications among older adults with diabetes. The intervention consisted of a loss-framed educational video followed by a reinforcement reminder card. Receives: Behavioral: Loss-Framed Information Intervention |
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 received an influenza vaccine during the follow-up period, as verified through the electronic immunization information system. Vaccination uptake was calculated as the number of vaccinated participants divided by the number of participants with available vaccination outcome data, multiplied by 100%.
Measured: From baseline to approximately 6 months (final follow-up)
Secondary outcomes (2)
Change in Vaccine Literacy Score
Vaccine literacy was assessed using a modified Chinese-adapted version of the Health Literacy about Vaccination of Adults in Italian (HLVa-IT) scale. Items were rated on a five-point Likert scale, and the mean item score was calculated, with higher scores indicating greater vaccine literacy. Change was calculated as the post-intervention mean score minus the baseline mean score.
Measured: Baseline and approximately 6 months (post-intervention)
Change in Influenza Vaccination Intention Score
Influenza vaccination intention was assessed using a single item: 'Will you receive an influenza vaccine in the future?' Responses were rated on a five-point Likert scale from 1 to 5, with higher scores indicating stronger vaccination intention. Change was calculated as the post-intervention score minus the baseline score.
Measured: Baseline and approximately 6 months (post-intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2026
- Study start25 Sep 2023
- Primary completion30 Apr 2024
- Study completion30 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies 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
- Parallel groups
- Model description
- A four-arm, parallel-group, cluster-randomized controlled trial was conducted among older adults with diabetes in Yangzhou, China. Clusters were randomly assigned to one of four groups: a control group, a standard information group, a gain-framed information group, or a loss-framed information group. Participants remained in their assigned groups throughout the intervention and follow-up periods.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 759 participants (actual)
Sponsor and investigators
- Lead sponsor
- Southeast University, China
- Sponsor type
- University, hospital or other
- Collaborators
- Yangzhou Center for Disease Control and Prevention
- Responsible party
- Principal investigator, Hui Jin, Southeast University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07901673
- Sponsor's protocol ID
- KY2023010-PRS
- Status last verified
- Oct 2026
- First submitted
- 22 Oct 2026
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data are not planned to be shared at this time. Any future data sharing would require appropriate ethical approval and safeguards to protect participant privacy and confidentiality.
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Information-Framing-Based Intervention Study on Influenza Vaccination Behavior Among Older Adults With Diabetes
- ClinicalTrials.gov ID
- NCT07901673
- Acronym / sponsor ID
- KY2023010-PRS
- Conditions
- Diabetes Mellitus, Type 2, Influenza
- Keywords
- Influenza Vaccination, Message Framing, Vaccination Uptake, Vaccine Literacy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 759 participants (actual)
- Lead sponsor
- Southeast University, ChinaUniversity, hospital or other
- Collaborators
- Yangzhou Center for Disease Control and Prevention
- Study start
- 25 Sep 2023 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 28 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 can cause serious illness in older adults, particularly those with diabetes. Although influenza vaccination is an important preventive measure, vaccination uptake among older adults in China remains low.
This study aimed to evaluate whether different ways of presenting influenza vaccination information could encourage vaccination among older adults with diabetes in Yangzhou, China.
Adults aged 60 to 75 years with diabetes were assigned to one of four study groups: a control group without intervention text messages, a standard information group, a gain-framed information group emphasizing the benefits of vaccination, and a loss-framed information group emphasizing the potential negative consequences of not being vaccinated.
The primary outcome was influenza vaccination uptake during follow-up. Secondary outcomes included willingness to receive influenza vaccination and vaccine literacy. The study examined whether information-based interventions could improve vaccination-related outcomes compared with the control group.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
- Model description
- A four-arm, parallel-group, cluster-randomized controlled trial was conducted among older adults with diabetes in Yangzhou, China. Clusters were randomly assigned to one of four groups: a control group, a standard information group, a gain-framed information group, or a loss-framed information group. Participants remained in their assigned groups throughout the intervention and follow-up periods.
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –Participants in the control group received no study-specific influenza vaccination information intervention. They completed baseline and follow-up assessments. |
| Standard Information Group | Experimental | Behavioral: Standard Information InterventionParticipants assigned to this group received standard, factual information about influenza and influenza vaccination, without emphasizing either the benefits of vaccination or the risks of non-vaccination. The intervention consisted of an educational video followed by a reinforcement reminder card. |
| Gain-Framed Information Group | Experimental | Behavioral: Gain-Framed Information InterventionParticipants assigned to this group received influenza vaccination information framed to emphasize the potential benefits of vaccination, including protection against influenza and its complications among older adults with diabetes. The intervention consisted of a gain-framed educational video followed by a reinforcement reminder card. |
| Loss-Framed Information Group | Experimental | Behavioral: Loss-Framed Information InterventionParticipants assigned to this group received influenza vaccination information framed to emphasize the potential negative consequences of not being vaccinated, including an increased risk of influenza infection and related complications among older adults with diabetes. The intervention consisted of a loss-framed educational video followed by a reinforcement reminder card. |
Who may qualify
- Ages
- 60 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults aged 60 to 75 years with physician-diagnosed type 2 diabetes mellitus.
- No influenza vaccination during the 2022-2023 influenza season and no known contraindication to influenza vaccination.
- Residence in the study area for more than 6 months, with no plans to relocate within the following year.
- Voluntary participation and provision of written informed consent.
- Ability to understand the study information and complete the intervention and follow-up assessments.
Key exclusion criteria (4 listed)
- Participation in another clinical trial or similar study.
- Refusal or inability to provide demographic or vaccination-related information.
- Inability to participate in the study because of health status.
- Known contraindication to influenza vaccination.
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 |
|---|---|---|
| Standard Information InterventionThis intervention provided standard, factual information about influenza and influenza vaccination without emphasizing the benefits of vaccination or the risks of non-vaccination. The intervention consisted of an approximately 10-minute educational video and a subsequent reinforcement reminder card. | Behavioural | Standard Information Group |
| Gain-Framed Information InterventionThis intervention provided gain-framed information emphasizing the potential benefits of influenza vaccination, including protection against influenza and related complications among older adults with diabetes. The intervention consisted of an approximately 10-minute educational video and a subsequent reinforcement reminder card. | Behavioural | Gain-Framed Information Group |
| Loss-Framed Information InterventionThis intervention provided loss-framed information emphasizing the potential negative consequences of not receiving influenza vaccination, including increased susceptibility to influenza and related health complications among older adults with diabetes. The intervention consisted of an approximately 10-minute educational video and a subsequent reinforcement reminder card. | Behavioural | Loss-Framed Information Group |
Primary outcome
Influenza Vaccination Uptake
Time frame: From baseline to approximately 6 months (final follow-up)
The proportion of participants who received an influenza vaccine during the follow-up period, as verified through the electronic immunization information system. Vaccination uptake was calculated as the number of vaccinated participants divided by the number of participants with available vaccination outcome data, multiplied by 100%.
2 secondary outcomes
Change in Vaccine Literacy Score
Time frame: Baseline and approximately 6 months (post-intervention)
Change in Influenza Vaccination Intention Score
Time frame: Baseline and approximately 6 months (post-intervention)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
- Individual participant dataSharing planned: No. Individual participant data are not planned to be shared at this time. Any future data sharing would require appropriate ethical approval and safeguards to protect participant privacy and confidentiality.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard Information Intervention, Gain-Framed Information Intervention and Loss-Framed Information Intervention in people with Diabetes Mellitus, Type 2 and Influenza, run by Southeast University, China at 4 sites 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 5 inclusion and 4 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: finished, as of the sponsor's last update on 28 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 4 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Influenza Vaccination Uptake (time frame: From baseline to approximately 6 months (final follow-up)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Oct 2026.