Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06575114
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-08-26
Brief Title:
COVID-19 Vaccination Willingness in Older Adults Based on Self-determination Theory
Sponsor:
None
Organization:
None
Study Overview
Official Title:
COVID-19 Vaccination Willingness in Older Adults Based on Self-determination Theory
Status:
COMPLETED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CVWIOABOSDT
Brief Summary:
Introduction The COVID-19 vaccine is an effective measure for preventing and controlling COVID-19 epidemics and the World Health Organization lists older adults as a high-priority group for COVID-19 vaccination However the willingness of older people to be vaccinated against COVID-19 remains an important issue in achieving herd immunity We investigated the effectiveness of a COVID-19 vaccine intervention for older adults based on self-determination theory
Methods and analysis Questionnaires were administered to assess vaccine willingness at baseline and at 6 weeks following educational intervention programs concerning vaccination against COVID-19 Four nursing homes with a population size of over 100 will be selected and randomized into intervention and control groups The control group will undergo conventional intervention methods and the intervention group will undergo a comprehensive intervention program based on self-determination theory
Ethics and dissemination The study has been approved by the Ethics Committee of Taizhou Hospital Zhejiang Province China approval number K20230832
Methods and analysis Questionnaires were administered to assess vaccine willingness at baseline and at 6 weeks following educational intervention programs concerning vaccination against COVID-19 Four nursing homes with a population size of over 100 will be selected and randomized into intervention and control groups The control group will undergo conventional intervention methods and the intervention group will undergo a comprehensive intervention program based on self-determination theory
Ethics and dissemination The study has been approved by the Ethics Committee of Taizhou Hospital Zhejiang Province China approval number K20230832
Detailed Description:
1 Study design and data collection This class pilot study will be conducted in September 2023 at a nursing home in Taizhou China This study has been approved by the Ethics Committee of Taizhou Hospital Zhejiang Province China approval number K20230832 All procedures will be performed in accordance with the guidelines of our institutional ethics committee and in compliance with the Declaration of Helsinki The respondents information will remain anonymous
2 Patients and public involvement The study participants will be not involved in the design implementation or reporting of the study
21 Recruitment 221 Inclusion criteria
1 60 years old or above
2 Have not been vaccinated for COVID-19 or have not completed the fourth booster shot of the COVID-19 vaccine
3 Able to communication and willing to participate in the survey voluntarily 222 Exclusion criteria
1 People with contraindications to vaccination 2 People with communication disorders 3 Those who do not want to participate in the survey 233 Grouping of study participants We will select four senior care institutions in Taizhou City with a population of 100 or more residents We will divide them into intervention and control groups
24 Sample size The sample size was determined using GPower software v3192 Heinrich-Heine-Universität Düsseldorf Düsseldorf Germany It will be estimated for repeated measures between the two groups at a significance level of 005 effect size of 019 and power of 95 The final calculated sample size is 182 participants Assuming a 10 attrition rate over the course of the intervention we set a target of recruiting 200 participants Based on the number of repeated measurements this represented 100 participants in each group
25 Composition of investigators
1 One masters degree in public health
2 Four masters degrees in infection
3 Two physicians in infectious diseases
4 Two trained locals 26 Intervention 261 Control group traditional health education In the control group a conventional intervention will be used and health education brochures on the COVID-19 vaccine will be distributed for the study participants to read on their own time The contents of the brochure included basic knowledge concerning the SARS-CoV-2 coronavirus COVID-19 vaccine herd immunity and precautions for vaccination
262 Self-determination theory-based health education measures The intervention group received self-determination theory-based interventions with targeted interventions proposed based on the self-determination theory-including health-related talks and sharing sessions To ensure that older individuals with varying levels of literacy understood the intervention the process was conducted in the local native dialect Health lectures will be conducted to elicit and acknowledge the perspectives and emotions of our cohort of older adults toward vaccination support their choices and initiatives and provide a rationale for vaccination-related recommendations while communicating with them to better understand their major barriers toward vaccination This will be done with the idea of meeting the autonomy and competence needs of our cohort based on one of the basic premises of self-determination theory Health-related lectures empower older adults to make autonomous decisions through cognitive reframing It has been found that successful vaccination planning relies on people acquiring appropriate and adequate health-related knowledge The three basic psychological needs of older adults will be met through communication and interaction both with them and with significant members of their lives eg caregivers family members doctors and nurses during sharing communication sessions We also will seek to motivate the participants by asking them questions and awarding them gifts during each health lecture and sharing session Competence needs will be met by developing challenges for our participant cohort The entire intervention will last 6 weeks and will be followed by a face-to-face questionnaire
2 Patients and public involvement The study participants will be not involved in the design implementation or reporting of the study
21 Recruitment 221 Inclusion criteria
1 60 years old or above
2 Have not been vaccinated for COVID-19 or have not completed the fourth booster shot of the COVID-19 vaccine
3 Able to communication and willing to participate in the survey voluntarily 222 Exclusion criteria
1 People with contraindications to vaccination 2 People with communication disorders 3 Those who do not want to participate in the survey 233 Grouping of study participants We will select four senior care institutions in Taizhou City with a population of 100 or more residents We will divide them into intervention and control groups
24 Sample size The sample size was determined using GPower software v3192 Heinrich-Heine-Universität Düsseldorf Düsseldorf Germany It will be estimated for repeated measures between the two groups at a significance level of 005 effect size of 019 and power of 95 The final calculated sample size is 182 participants Assuming a 10 attrition rate over the course of the intervention we set a target of recruiting 200 participants Based on the number of repeated measurements this represented 100 participants in each group
25 Composition of investigators
1 One masters degree in public health
2 Four masters degrees in infection
3 Two physicians in infectious diseases
4 Two trained locals 26 Intervention 261 Control group traditional health education In the control group a conventional intervention will be used and health education brochures on the COVID-19 vaccine will be distributed for the study participants to read on their own time The contents of the brochure included basic knowledge concerning the SARS-CoV-2 coronavirus COVID-19 vaccine herd immunity and precautions for vaccination
262 Self-determination theory-based health education measures The intervention group received self-determination theory-based interventions with targeted interventions proposed based on the self-determination theory-including health-related talks and sharing sessions To ensure that older individuals with varying levels of literacy understood the intervention the process was conducted in the local native dialect Health lectures will be conducted to elicit and acknowledge the perspectives and emotions of our cohort of older adults toward vaccination support their choices and initiatives and provide a rationale for vaccination-related recommendations while communicating with them to better understand their major barriers toward vaccination This will be done with the idea of meeting the autonomy and competence needs of our cohort based on one of the basic premises of self-determination theory Health-related lectures empower older adults to make autonomous decisions through cognitive reframing It has been found that successful vaccination planning relies on people acquiring appropriate and adequate health-related knowledge The three basic psychological needs of older adults will be met through communication and interaction both with them and with significant members of their lives eg caregivers family members doctors and nurses during sharing communication sessions We also will seek to motivate the participants by asking them questions and awarding them gifts during each health lecture and sharing session Competence needs will be met by developing challenges for our participant cohort The entire intervention will last 6 weeks and will be followed by a face-to-face questionnaire
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None