Pneumococcal VaccineNCT05721092
Assessment of Knowledge on Pneumococcal Vaccination Among Diabetologists in India
An observational study of Pneumococcal Vaccine, run by M.V. Hospital for Diabetes at 1 site in India.
Trial summary
Asia has the highest burden with the largest contribution of pneumonia burden from India. Pneumonia is also observed as 5th leading cause of deaths in India. People with diabetes with uncontrolled glucose are significantly at higher risk of development of pneumonia. Read more about this study
- Who is it for?
- Ages 25 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Pneumococcal Vaccine
- What is being tested?
- Pre and Post Education on practice of pneumococcal vaccination
- Type of treatment
- Vaccines
- How many people
- 100 participants
- Where
- 1 siteIndia
- Study dates
- 20 Feb 2023to 22 Mar 2024
- Phase
- Observational
- 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 25 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Diabetologists aged 25 to 65, practicing in India
Who may be able to join
- Diabetologists willing to participate in the study
Who cannot join
- Unwillingness to give consent for participation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Knowledge, Facilitators and Barriers of Pneumococcal Vaccination: A Cross-sectional Study Among Diabetologists in India
Asia has the highest burden with the largest contribution of pneumonia burden from India. Pneumonia is also observed as 5th leading cause of deaths in India. People with diabetes with uncontrolled glucose are significantly at higher risk of development of pneumonia. Even though, pneumonia is a vaccine-preventable disease, hospitalization for pneumonia of patients with diabetes are rising. Very limited literature is available on the knowledge and practice of pneumonia vaccination among diabetologists and the rate of pneumonia vaccination received by the patients with diabetes. Hence this study aims to assess their knowledge on the same. In addition, this study also aims to identify the real barriers and facilitators of pneumococcal vaccination among diabetologists in India. A cross-sectional study will be conducted among 25diabetologists in each of the four zones in India representing all directions - North, East, West and South. Diabetologists will be selected through purposive sampling. A semi-structured questionnaire (study tool) is designed based on the existing literature that addresses our objectives. An education session on Pneumococcal vaccination will be conducted for the diabetologists through webinar after completing the survey. A post assessment will be done using the same questionnaire among the study participants after the education session in order to see an increase in the knowledge of pneumococcal vaccination.
- Conditions
- Pneumococcal Vaccine
- Being tested
- Pre and Post Education on practice of pneumococcal vaccination
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pre and Post Education on practice of pneumococcal vaccinationOther
A cross-sectional study will be conducted among 25 diabetologists in each of the four zones in India representing all directions - North, East, West and South. Diabetologists will be selected through purposive sampling. A semi-structured questionnaire (study tool) is designed based on the existing literature that addresses our objectives. An education session on Pneumococcal vaccination will be conducted for the diabetologists through webinar after completing the survey. A post assessment will be done using the same questionnaire among the study participants after the education session in order to see an increase in the knowledge of pneumococcal vaccination.
What is being measured
The primary outcome is the main question the study is designed to answer.
To identify the facilitators and barriers of pneumococcal vaccination among diabetologists in India.
Measured: 6 months
Secondary outcomes (3)
To assess the knowledge, attitude and practices of pneumococcal vaccination among select diabetologists across India.
Measured: 6 months
To examine the association of knowledge and practice of vaccination among diabetologists
Measured: 6 months
To assess the change in the knowledge of pneumococcal vaccination post educational intervention
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2023
- Study start20 Feb 2023
- Primary completion22 Mar 2024
- Study completion22 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pneumococcal VaccineStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.V. Hospital for Diabetes
- Sponsor type
- University, hospital or other
- Collaborators
- MSD Pharmaceuticals LLC
- Responsible party
- Principal investigator, Vijay Viswanathan, M.V. Hospital for Diabetes
- Investigators
- Vijay Viswanathan, Principal investigator, M V Hospital for Diabetes [P] Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05721092
- Sponsor's protocol ID
- 2023_01_MSDMVH
- Status last verified
- Mar 2024
- First submitted
- 31 Jan 2023
- Last updated
- 25 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Knowledge, Facilitators and Barriers of Pneumococcal Vaccination: A Cross-sectional Study Among Diabetologists in India
- ClinicalTrials.gov ID
- NCT05721092
- Acronym / sponsor ID
- 2023_01_MSDMVH
- Conditions
- Pneumococcal Vaccine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- M.V. Hospital for DiabetesUniversity, hospital or other
- Collaborators
- MSD Pharmaceuticals LLC
- Study start
- 20 Feb 2023 (actual)
- Primary completion
- 22 Mar 2024 (actual)
- Study completion
- 22 Mar 2024 (actual)
- First posted
- 9 Feb 2023 (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.
Asia has the highest burden with the largest contribution of pneumonia burden from India. Pneumonia is also observed as 5th leading cause of deaths in India. People with diabetes with uncontrolled glucose are significantly at higher risk of development of pneumonia. Even though, pneumonia is a vaccine-preventable disease, hospitalization for pneumonia of patients with diabetes are rising. Very limited literature is available on the knowledge and practice of pneumonia vaccination among diabetologists and the rate of pneumonia vaccination received by the patients with diabetes. Hence this study aims to assess their knowledge on the same. In addition, this study also aims to identify the real barriers and facilitators of pneumococcal vaccination among diabetologists in India. A cross-sectional study will be conducted among 25diabetologists in each of the four zones in India representing all directions - North, East, West and South. Diabetologists will be selected through purposive sampling. A semi-structured questionnaire (study tool) is designed based on the existing literature that addresses our objectives. An education session on Pneumococcal vaccination will be conducted for the diabetologists through webinar after completing the survey. A post assessment will be done using the same questionnaire among the study participants after the education session in order to see an increase in the knowledge of pneumococcal vaccination.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Diabetologists aged 25 to 65, practicing in India
Key inclusion criteria (1 listed)
- Diabetologists willing to participate in the study
Key exclusion criteria (1 listed)
- Unwillingness to give consent for participation
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 |
|---|---|---|
| Pre and Post Education on practice of pneumococcal vaccinationA cross-sectional study will be conducted among 25 diabetologists in each of the four zones in India representing all directions - North, East, West and South. Diabetologists will be selected through purposive sampling. A semi-structured questionnaire (study tool) is designed based on the existing literature that addresses our objectives. An education session on Pneumococcal vaccination will be conducted for the diabetologists through webinar after completing the survey. A post assessment will be done using the same questionnaire among the study participants after the education session in order to see an increase in the knowledge of pneumococcal vaccination. | Other | – |
Primary outcome
To identify the facilitators and barriers of pneumococcal vaccination among diabetologists in India.
Time frame: 6 months
3 secondary outcomes
To assess the knowledge, attitude and practices of pneumococcal vaccination among select diabetologists across India.
Time frame: 6 months
To examine the association of knowledge and practice of vaccination among diabetologists
Time frame: 6 months
To assess the change in the knowledge of pneumococcal vaccination post educational intervention
Time frame: 6 months
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 25 Mar 2024.
- Individual participant dataSharing planned: No
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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.
Vijay Viswanathan principal investigator
M V Hospital for Diabetes [P] Limited
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pneumococcal Vaccine, run by M.V. Hospital for Diabetes at 1 site in India.
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 1 inclusion and 1 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 25 Mar 2024. 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 India. 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?
To identify the facilitators and barriers of pneumococcal vaccination among diabetologists in India. (time frame: 6 months). 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 25 Mar 2024.