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

NCT06575114 | Completed DMC

• 1 other identifier: K20230832
• Study Type: interventional
• Target: 264
• Locations: 1 country
• Sites: 1

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).

Conditions

Old Age; Debility; Vaccine Hesitancy; Vaccine Refusal

Keywords

Basic psychological needs; booster dose; COVID-19 vaccine; older adults; SARS-CoV-2; self-determination theory; willingness

Outcome Measures

Primary Outcomes (1)

• Willingness to vaccinate

  Changes in Vaccination Wiilingness Scores for the Elderly

  6 weeks

Secondary Outcomes (2)

• Basic psychological needs

  6 weeks

• Vaccine literacy

  6 weeks

Study Arms (2)

Control group: traditional health education

OTHER

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

Intervention group: Self-determination theory-based health education measures

OTHER

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

Interventions

Self-determination theory-based health education measures OTHER

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.

Also known as: traditional health education

Control group: traditional health education; Intervention group: Self-determination theory-based health education measures

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (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.

You may not qualify if:

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

Sponsors & Collaborators

• Jing-Shan Deng: lead

Study Sites (1)

Taizhou Hospital

Taizhou, Linhai, 317000, China

Location

Related Publications (5)

• Patrick H, Williams GC. Self-determination theory: its application to health behavior and complementarity with motivational interviewing. Int J Behav Nutr Phys Act. 2012 Mar 2;9:18. doi: 10.1186/1479-5868-9-18.

  PMID: 22385676 RESULT

• Silva MN, Markland D, Minderico CS, Vieira PN, Castro MM, Coutinho SR, Santos TC, Matos MG, Sardinha LB, Teixeira PJ. A randomized controlled trial to evaluate self-determination theory for exercise adherence and weight control: rationale and intervention description. BMC Public Health. 2008 Jul 9;8:234. doi: 10.1186/1471-2458-8-234.

  PMID: 18613959 RESULT

• Dube E, Gagnon D, Ouakki M, Bettinger JA, Guay M, Halperin S, Wilson K, Graham J, Witteman HO, MacDonald S, Fisher W, Monnais L, Tran D, Gagneur A, Guichon J, Saini V, Heffernan JM, Meyer S, Driedger SM, Greenberg J, MacDougall H; Canadian Immunization Research Network. Understanding Vaccine Hesitancy in Canada: Results of a Consultation Study by the Canadian Immunization Research Network. PLoS One. 2016 Jun 3;11(6):e0156118. doi: 10.1371/journal.pone.0156118. eCollection 2016.

  PMID: 27257809 RESULT

• Ntoumanis N, Ng JYY, Prestwich A, Quested E, Hancox JE, Thogersen-Ntoumani C, Deci EL, Ryan RM, Lonsdale C, Williams GC. A meta-analysis of self-determination theory-informed intervention studies in the health domain: effects on motivation, health behavior, physical, and psychological health. Health Psychol Rev. 2021 Jun;15(2):214-244. doi: 10.1080/17437199.2020.1718529. Epub 2020 Feb 3.

  PMID: 31983293 RESULT

• Gillison FB, Rouse P, Standage M, Sebire SJ, Ryan RM. A meta-analysis of techniques to promote motivation for health behaviour change from a self-determination theory perspective. Health Psychol Rev. 2019 Mar;13(1):110-130. doi: 10.1080/17437199.2018.1534071. Epub 2018 Oct 16.

  PMID: 30295176 RESULT

MeSH Terms

Conditions

Frailty; Vaccination Hesitancy; Vaccination Refusal

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Treatment Refusal; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Jing-Shan Deng, postgraduate

  Jing-Shan Deng WenZhou Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Main responsibility and supervision

Study Record Dates

• First Submitted: August 26, 2024
• First Posted: August 28, 2024
• Study Start: September 1, 2023
• Primary Completion: November 17, 2023
• Study Completion: November 17, 2023
• Last Updated: August 28, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)