COVID-19 Vaccination Willingness in Older Adults Based on Self-determination Theory (CVWIOABOSDT)

August 26, 2024 updated by: Jing-Shan Deng

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

2.1 Recruitment 2.2.1 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 2.2.2 Exclusion criteria

(1) People with contraindications to vaccination (2) People with communication disorders (3) Those who do not want to participate in the survey 2.3.3 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.

2.4 Sample size The sample size was determined using G*Power software v3.1.9.2 (Heinrich-Heine-Universität Düsseldorf, Düsseldorf, Germany). It will be estimated for repeated measures between the two groups at a significance level of 0.05, effect size of 0.19, 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.

2.5 Composition of investigators

  1. One master's degree in public health
  2. Four master's degrees in infection
  3. Two physicians in infectious diseases
  4. Two trained locals 2.6 Intervention 2.6.1 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.

2.6.2 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 (e.g., 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 Type

Interventional

Enrollment (Actual)

264

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Linhai
      • Taizhou, Linhai, China, 317000
        • Taizhou Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

(1) ≥ 60 years of age; (2) had not previously been vaccinated with a COVID-19 vaccine, or had not yet received their fourth booster dose of the vaccine; and (3) had the ability to communicate verbally and volunteered to participate in the survey.

Exclusion Criteria:

(1) contraindications to vaccination; (2) communication disorders; and (3) unwillingness to participate.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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.
Other: Self-determination theory-based health education measures
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 intervention group will receive self-determination theory-based interventions, with targete 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 will be conducted in the local native dialect.
Other Names:
  • traditional health education
Other: Intervention group: Self-determination theory-based health education measures
The intervention group will receive self-determination theory-based interventions, with targete 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 will be conducted in the local native dialect.
Other: Self-determination theory-based health education measures
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 intervention group will receive self-determination theory-based interventions, with targete 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 will be conducted in the local native dialect.
Other Names:
  • traditional health education

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Willingness to vaccinate
Time Frame: 6 weeks
Changes in Vaccination Wiilingness Scores for the Elderly
6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Basic psychological needs
Time Frame: 6 weeks
Changes in Basic psychological needs Scores for the Elderly
6 weeks
Vaccine literacy
Time Frame: 6 weeks
Changes in Vaccine literacy Scores for the Elderly
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jing-Shan Deng

Investigators

  • Principal Investigator: Jing-Shan Deng, postgraduate, Jing-Shan Deng WenZhou Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2023

Primary Completion (Actual)

November 17, 2023

Study Completion (Actual)

November 17, 2023

Study Registration Dates

First Submitted

August 26, 2024

First Submitted That Met QC Criteria

August 26, 2024

First Posted (Actual)

August 28, 2024

Study Record Updates

Last Update Posted (Actual)

August 28, 2024

Last Update Submitted That Met QC Criteria

August 26, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • K20230832

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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