Trial Outcomes & Findings for Adherence to Guidelines VAccination in Type 1 DIabetes Mellitus Patients (AVADI-1). (NCT NCT03478254)
NCT ID: NCT03478254
Last Updated: 2021-01-11
Results Overview
Adherence to Influenza, Pneumococcal and Hepatitis B Vaccination in adult patients with type 1 Diabetes mellitus.
Recruitment status
COMPLETED
Target enrollment
300 participants
Primary outcome timeframe
1 year
Results posted on
2021-01-11
Participant Flow
Participant milestones
| Measure |
Influenza Vaccination
All type 1 diabetes adults patients attended in Ciudad Real General University Hospital willl be checked for Influenza, Pneumococcal and HBV Vaccination status.
Influenza vaccination: Correct influenza vaccination status was considered in the following situation:
\- Received at least one Influenza vaccine dose in the last year.
Pneumococcal vaccination: Correct pneumococal vaccination status was considered if a subject received at least one of the following options:
* One pneumococcal conjugate vaccine (PCV) 13 dose in the last year.
* One PCV13 dose following a pneumococcal polysaccharide vaccine (PPSV) 23 dose between the following 8 weeks and 12 months.
* One PPSV 23 dose in the last 5 years.
* One PPSV23 dose in the last 5 years and a second PPSV23 dose at 5 years or PCV13 at 1 year.
HBV vaccination: Correct HBV vaccination status was considered in the following situation:
.- Received at least three consecutive doses of HBV vaccine during six consecutive months.
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|---|---|
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Overall Study
STARTED
|
300
|
|
Overall Study
COMPLETED
|
300
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Adherence to Guidelines VAccination in Type 1 DIabetes Mellitus Patients (AVADI-1).
Baseline characteristics by cohort
| Measure |
Adherence Vaccination
n=300 Participants
All type 1 diabetes adults patients attended in Ciudad Real General University Hospital willl be checked for Influenza, pneumococcal and HBV vaccination status.
Influenza vaccination: Correct influenza vaccination status was considered in the following situation:
\- Received at least one Influenza vaccine dose in the last year.
Pneumococcal vaccination: Correct pneumococal vaccination status was considered if a subject received at least one of the following options:
* One pneumococcal conjugate vaccine (PCV) 13 dose in the last year.
* One PCV13 dose following a pneumococcal polysaccharide vaccine (PPSV) 23 dose between the following 8 weeks and 12 months.
* One PPSV 23 dose in the last 5 years.
* One PPSV23 dose in the last 5 years and a second PPSV23 dose at 5 years or PCV13 at 1 year.
HBV vaccination: Correct HBV vaccination status was considered in the following situation:
.- Received at least three consecutive doses of HBV vaccine during six consecutive months.
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|---|---|
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Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
280 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
20 Participants
n=5 Participants
|
|
Age, Continuous
|
40 Years
STANDARD_DEVIATION 14 • n=5 Participants
|
|
Sex: Female, Male
Female
|
160 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
140 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
300 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
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Region of Enrollment
Spain
|
300 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 yearAdherence to Influenza, Pneumococcal and Hepatitis B Vaccination in adult patients with type 1 Diabetes mellitus.
Outcome measures
| Measure |
Adherece Vaccination
n=300 Participants
All type 1 diabetes adults patients attended in Ciudad Real General University Hospital willl be checked for Influenza, Pneumococcal and HBV Vaccination status.
Influenza vaccination: Correct influenza vaccination status was considered in the following situation:
\- Received at least one Influenza vaccine dose in the last year.
Pneumococcal vaccination: Correct pneumococal vaccination status was considered if a subject received at least one of the following options:
* One pneumococcal conjugate vaccine (PCV) 13 dose in the last year.
* One PCV13 dose following a pneumococcal polysaccharide vaccine (PPSV) 23 dose between the following 8 weeks and 12 months.
* One PPSV 23 dose in the last 5 years.
* One PPSV23 dose in the last 5 years and a second PPSV23 dose at 5 years or PCV13 at 1 year.
HBV vaccination: Correct HBV vaccination status was considered in the following situation:
.- Received at least three consecutive doses of HBV vaccine during six consecutive months.
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|---|---|
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Adherence to Regional Guidelines for the Immunization of Adults With Type 1 Diabetes Mellitus (T1DM
influenza vaccination
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165 Participants
|
|
Adherence to Regional Guidelines for the Immunization of Adults With Type 1 Diabetes Mellitus (T1DM
Pneumoccocal vaccination
|
54 Participants
|
|
Adherence to Regional Guidelines for the Immunization of Adults With Type 1 Diabetes Mellitus (T1DM
HBV vaccination
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51 Participants
|
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Adherence to Regional Guidelines for the Immunization of Adults With Type 1 Diabetes Mellitus (T1DM
No vaccination
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30 Participants
|
SECONDARY outcome
Timeframe: 1 yearAge (years)
Outcome measures
| Measure |
Adherece Vaccination
n=300 Participants
All type 1 diabetes adults patients attended in Ciudad Real General University Hospital willl be checked for Influenza, Pneumococcal and HBV Vaccination status.
Influenza vaccination: Correct influenza vaccination status was considered in the following situation:
\- Received at least one Influenza vaccine dose in the last year.
Pneumococcal vaccination: Correct pneumococal vaccination status was considered if a subject received at least one of the following options:
* One pneumococcal conjugate vaccine (PCV) 13 dose in the last year.
* One PCV13 dose following a pneumococcal polysaccharide vaccine (PPSV) 23 dose between the following 8 weeks and 12 months.
* One PPSV 23 dose in the last 5 years.
* One PPSV23 dose in the last 5 years and a second PPSV23 dose at 5 years or PCV13 at 1 year.
HBV vaccination: Correct HBV vaccination status was considered in the following situation:
.- Received at least three consecutive doses of HBV vaccine during six consecutive months.
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|---|---|
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Patient Age According to Vaccination Status
Age : Influenzae vaccination:
|
43.5 years
Standard Deviation 15.2
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Patient Age According to Vaccination Status
Age : No influcenzae vaccination
|
39.7 years
Standard Deviation 13.0
|
|
Patient Age According to Vaccination Status
Age : HBV vaccination
|
28.3 years
Standard Deviation 10.8
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Patient Age According to Vaccination Status
Age : HBV pneumoccocal vaccination
|
44.5 years
Standard Deviation 13.5
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SECONDARY outcome
Timeframe: 1 yearNumber of patients who have taken related sick leaves.
Outcome measures
| Measure |
Adherece Vaccination
n=300 Participants
All type 1 diabetes adults patients attended in Ciudad Real General University Hospital willl be checked for Influenza, Pneumococcal and HBV Vaccination status.
Influenza vaccination: Correct influenza vaccination status was considered in the following situation:
\- Received at least one Influenza vaccine dose in the last year.
Pneumococcal vaccination: Correct pneumococal vaccination status was considered if a subject received at least one of the following options:
* One pneumococcal conjugate vaccine (PCV) 13 dose in the last year.
* One PCV13 dose following a pneumococcal polysaccharide vaccine (PPSV) 23 dose between the following 8 weeks and 12 months.
* One PPSV 23 dose in the last 5 years.
* One PPSV23 dose in the last 5 years and a second PPSV23 dose at 5 years or PCV13 at 1 year.
HBV vaccination: Correct HBV vaccination status was considered in the following situation:
.- Received at least three consecutive doses of HBV vaccine during six consecutive months.
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|---|---|
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Number of Participants Who Have Taken Related Sick Leaves
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17 participants
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Adverse Events
Adherence Vaccination
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Angela M. Seco Segura RN, Endocrinology and Nutrition Department.
Ciudad Real University Hospital. Castilla La Mancha Health Service.
Phone: 926278000
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place