Old Age; DebilityCVWIOABOSDTNCT06575114
COVID-19 Vaccination Willingness in Older Adults Based on Self-determination Theory
A study testing Self-determination theory-based health education measures in people with Old Age; Debility and Vaccine Hesitancy, run by Jing-Shan Deng at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Old Age; Debility, Vaccine Hesitancy, Vaccine Refusal
- What is being tested?
- Self-determination theory-based health education measures
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 264 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2023to 17 Nov 2023
- Phase
- Interventional
- 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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ≥ 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.
Who cannot join
- contraindications to vaccination; (2) communication disorders; and (3) unwillingness to participate.
Trial locations and contacts
1 site in 1 country.
About this study
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).
Read the detailed description
- 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.
- 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
- 60 years old or above
- Have not been vaccinated for COVID-19 or have not completed the fourth booster shot of the COVID-19 vaccine
- 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
- One master's degree in public health
- Four master's degrees in infection
- Two physicians in infectious diseases
- 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.
- Conditions
- Old Age; Debility, Vaccine Hesitancy, Vaccine Refusal
- Being tested
- Self-determination theory-based health education measures
- Keywords
- Basic psychological needs, booster dose, COVID-19 vaccine, older adults, SARS-CoV-2, self-determination theory, willingness
- Medical subject headings
- Frailty, Vaccination Hesitancy, Vaccination Refusal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-determination theory-based health education measuresOther
Also called 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 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Self-determination theory-based health education measures |
What is being measured
The primary outcome is the main question the study is designed to answer.
Willingness to vaccinate
Changes in Vaccination Wiilingness Scores for the Elderly
Measured: 6 weeks
Secondary outcomes (2)
Basic psychological needs
Changes in Basic psychological needs Scores for the Elderly
Measured: 6 weeks
Vaccine literacy
Changes in Vaccine literacy Scores for the Elderly
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2024
- Study start1 Sep 2023
- Primary completion17 Nov 2023
- Study completion17 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Old Age; DebilityStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 264 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jing-Shan Deng
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jing-Shan Deng, Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University
- Investigators
- Jing-Shan Deng, postgraduate, Principal investigator, Jing-Shan Deng WenZhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06575114
- Sponsor's protocol ID
- K20230832
- Acronym
- CVWIOABOSDT
- Status last verified
- Aug 2024
- First submitted
- 26 Aug 2024
- Last updated
- 28 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 22385676Silva 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.
PubMed 18613959Dube 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.
PubMed 27257809Ntoumanis 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.
PubMed 31983293Gillison 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.
PubMed 30295176
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COVID-19 Vaccination Willingness in Older Adults Based on Self-determination Theory
- ClinicalTrials.gov ID
- NCT06575114
- Acronym / sponsor ID
- CVWIOABOSDT / 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 264 participants (actual)
- Lead sponsor
- Jing-Shan DengUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 17 Nov 2023 (actual)
- Study completion
- 17 Nov 2023 (actual)
- First posted
- 28 Aug 2024 (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.
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).
Detailed description
- 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.
- 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
- 60 years old or above
- Have not been vaccinated for COVID-19 or have not completed the fourth booster shot of the COVID-19 vaccine
- 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
- One master's degree in public health
- Four master's degrees in infection
- Two physicians in infectious diseases
- 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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group: traditional health education | Other | Other: Self-determination theory-based health education measuresIn 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. |
| Intervention group: Self-determination theory-based health education measures | Other | Other: Self-determination theory-based health education measuresThe 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. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ≥ 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.
Key exclusion criteria (1 listed)
- contraindications to vaccination; (2) communication disorders; and (3) unwillingness to participate.
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 |
|---|---|---|
| Self-determination theory-based health education measuresAlso: traditional health educationIn 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 | Control group: traditional health education, Intervention group: Self-determination theory-based health education measures |
Primary outcome
Willingness to vaccinate
Time frame: 6 weeks
Changes in Vaccination Wiilingness Scores for the Elderly
2 secondary outcomes
Basic psychological needs
Time frame: 6 weeks
Vaccine literacy
Time frame: 6 weeks
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 28 Aug 2024.
- Results publication: PubMed 22385676Patrick 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.
- Results publication: PubMed 18613959Silva 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.
- Results publication: PubMed 27257809Dube 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.
- Results publication: PubMed 31983293Ntoumanis 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.
- Results publication: PubMed 30295176Gillison 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.
- Individual participant dataSharing planned: No
Related trials for Old Age; Debility
Recruiting
Perioperative Multicomponent Rehabilitation and Outcomes in Elderly Patients With Frailty
Old Age; Debility, Digestive Cancer
Recruiting
Fall Prevention Pathways
Old Age; Debility
Recruiting
Impact of a Physical Exercise Program in a Rural Area
Old Age; Debility
Recruiting
Dual Task Perturbation Training for OAwMCI
Mild Cognitive Impairment, Old Age; Debility
Recruiting
Combined Effects of NMES and LIRT on Muscle Strength, Girth, and Physical Endurance in the Geriatric Population
Old Age; Debility
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.
Jing-Shan Deng, postgraduate principal investigator
Jing-Shan Deng WenZhou Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-determination theory-based health education measures in people with Old Age; Debility and Vaccine Hesitancy, run by Jing-Shan Deng at 1 site in China.
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 28 Aug 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 China. 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?
Willingness to vaccinate (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06575114, which also lists 5 linked publications.
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 28 Aug 2024; AzTrials last refreshed its copy on 7 Nov 2026.