Health Communication Clinical Trial
Official title:
Empowering Older People's Preventive Care Utilization Through Mental Model Approach and Patient Activation Approach: a Randomized Control Trial for Promoting Vaccination Uptake
Objectives: To empower older people's decision making for taking the recommended vaccines including seasonal influenza vaccines, pneumococcal vaccines, and COVID-19 vaccine (if it is recommended annually). Hypotheses to be tested: The interventions designed using Mental Models Approach and Patient Activation Approach will promote older people's confidence in knowledge and skills regarding vaccination decisions, perceived self-efficacy in self-management of health, positive emotional engagement with vaccination decisions and a positive future time perspective which will subsequently promote their uptake of the recommended vaccines. Design and subjects: This will be a two-arm randomized control trial. Subjects will be community-dwelling older people aged 70 years or above. Instruments: A questionnaire will be used to collect baseline data before the interventions and follow-up data 1 months and 4 months, respectively, after the end of interventions. Interventions: Interventions included one booklet to communicate information about preventive care by bridging expert knowledge and older people's existing mental models, and six patient activation sections conducted over telephone. One patient activation section will be delivered per week by trained medical students. Main outcome measures: Main outcomes will be participants' uptake of the three recommended vaccines assessed at 1 month and 4 months after the end of interventions. Data analysis and expected results: Generalized estimating equation logistic regression will be used to assess the intervention effects. The investigators expect that the interventions can promote at least 20% increase in uptake of any one of the three recommended vaccines in the intervention group compared with the control group.
Status | Not yet recruiting |
Enrollment | 270 |
Est. completion date | May 31, 2025 |
Est. primary completion date | May 31, 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 70 Years and older |
Eligibility | Inclusion Criteria: - Community-dwelling older persons aged 70 years who did not persistently receive seasonal influenza vaccine over the past three years (2020-2022) and/or have never received the pneumococcal vaccine (one dose of the 23-valent pneumococcal polysaccharide vaccine (23vPPV) or the 13-valent pneumococcal conjugate vaccine (PCV13)). - Being able to communicate with Cantonese, or Mandarin (the two main spoken language in Hong Kong) and being able to read Chinese. - Inclusion criteria for the informant include age above 18 and can understand Cantonese or Mandarin Exclusion Criteria: - having psychiatric disorders, dementia, or other cognitive difficulties which impede communication or understanding of the intervention and having functional disabilities which impede access to health care services. - subjects who had medical contraindications for immunization. |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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The University of Hong Kong |
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* Note: There are 25 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change of Uptake Rate of the Three Recommended Vaccines from Baseline to within 1 Month and 4 Months after Interventions | Participants' uptake rate of the three recommended vaccines (influenza vaccines, pneumococcal vaccines, and COVID-19 vaccines). | Assessed at baseline, within 1 month and 4 months after the end of interventions. | |
Secondary | Changes in Patient Activation Measure from baseline to within 1 month after intervention ends | Patient Activation Measure is a 4-point Likert scale measuring participants' confidence level and views on self-health management. | At baseline and within one month after the end of the intervention (in the 1st follow-up assessment) | |
Secondary | Changes in Emotional engagement with vaccination decisions measurement from baseline to within 1 month after intervention ends | Emotional engagement with vaccination decisions will be measured by a 5-point Likert scale on the levels and types of emotions involved with vaccination decisions. | At baseline and within one month after the end of the intervention (in the 1st follow-up assessment) | |
Secondary | Changes in Future time perspective measurement from baseline to within 1 month after intervention ends | A 5-point Likert scale measuring participants' future time perspecitve (i.e. participants' views on their future). | At baseline and within one month after the end of the intervention (in the 1st follow-up assessment) | |
Secondary | Changes in lifestyle behaviours from baseline to within 1 month and 4 months after intervention ends | A set of questions will be used to measure particiants' lifestyle behaviours in terms of their frequency of smoking, drinking, physical activities, vegetable intake and fruit intake. | At baseline and within one month (in the 1st follow-up assessment) and four months (2nd outcome assessment)after the end of the intervention | |
Secondary | Changes in other preventive care utilization from baseline to within 1 month and 4 months after intervention ends | A set of questions will be used to measure the frequency of participants' other preventive care utilization | At baseline and within one month (in the 1st follow-up assessment) four months (2nd outcome assessment) after the end of the intervention |
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