Older People's Preventive Care Utilization

NCT05691790 | Recruiting

• 1 other identifier: epc20220526
• Study Type: interventional
• Target: 270
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Health Communication

Keywords

Older people; Preventive care; Vaccine decision-making

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Changes in Patient Activation Measure from baseline to within 1 month after intervention ends

  At baseline and within one month after the end of the intervention (in the 1st follow-up assessment)

• Changes in Emotional engagement with vaccination decisions measurement from baseline to within 1 month after intervention ends

  At baseline and within one month after the end of the intervention (in the 1st follow-up assessment)

• Changes in Future time perspective measurement from baseline to within 1 month after intervention ends

  At baseline and within one month after the end of the intervention (in the 1st follow-up assessment)

• Changes in lifestyle behaviours from baseline to within 1 month and 4 months after intervention ends

  At baseline and within one month (in the 1st follow-up assessment) and four months (2nd outcome assessment)after the end of the intervention

• Changes in other preventive care utilization from baseline to within 1 month and 4 months after intervention ends

  At baseline and within one month (in the 1st follow-up assessment) four months (2nd outcome assessment) after the end of the intervention

Study Arms (2)

Control Group

ACTIVE COMPARATOR

Participants who are allocated to the control group will receive a pamphlet about recommendation for influenza vaccines, pneumococcal vaccines, and COVID-19 vaccines (if appropriate) for older people using information from Hong Kong Department of Health. This group will receive six control telephone care visits over six weeks. We will purposively balance the characteristics of the student helpers who do the control telephone visits and the patient activation interviews. Each control telephone care visit will be around 5-10 min during which the student helper will give general guidelines about dietary health and exercise for older people. The control messages are mainly educational and designed using information derived from the websites of Hong Kong Department of Health. In the last telephone care visit, the interviewer will give a summary for how to live a healthy lifestyle and a reminder of taking the recommended vaccinations for older people shown in the pamphlet.

Behavioral: Control Group

Intervention Group

EXPERIMENTAL

Intervention development and delivery The interventions will involve deliver a booklet designed based on MMA and six telephone interviews for patient activation. Design of booklet for older people's preventive care: The booklet will be framed as one series of "Positive aging via preventive care"-vaccination. According to MMA, the booklet will be aimed to translate expert knowledge into information that can fit to older people's mental models (e.g., misperceptions and knowledge deficits revealed in our previous qualitative studies) regarding vaccinations to facilitate cognitive process of the information. Patient activation sections: We will design six telephone-based patient activation sections with accommodation for older people's mental models and decision-making preference. The motivation interviewing (MI) techniques will be incorporated into the design of patient activation sections.

Behavioral: MMA and patient activation intervention scheme

Interventions

MMA and patient activation intervention scheme BEHAVIORAL

Design of booklet for older people's preventive care: We propose that the booklet will include 8 main topics based on what experts and current academic literature believe are important for encouraging older people's preventive care utilization. To add the social norms-related cues for the later three topics of the booklet, one qualitative study on older adults who are active in preventive care is needed. Therefore, we will interview \~20 older adults aged 70 years or above who are active in taking preventive care. We will conduct one-to-one in-depth interview to explore how participants overcome difficulties during decision making for vaccination and their positive feelings after making achievements. We will also explore and identify older adults who have a positive future perspective. Patient activation sections: . Four undergraduate medical students will be trained as the coaches to deliver the patient activation sections over six weeks. Each section will be around 20 min.

Intervention Group

Control Group BEHAVIORAL

Participants in the control group will receive a pamphlet about recommendation for influenza, pneumococcal, and COVID-19 vaccines (if appropriate) for older people using information from Hong Kong Department of Health. As a control for the patient activation interviews, the control group will also be informed that they will join our "telephone-based elderly care project" by the end of the baseline assessment but instead of receiving the patient activation interviews, this group will receive six control telephone care visits over six weeks. Each control telephone care visit will be around 5-10 min during which the student helper will give general guidelines about dietary health and exercise for older people. The control messages are mainly educational and designed using information derived from the websites of Hong Kong Department of Health.

Control Group

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

School of Public Health, The University of Hong Kong

Hong Kong, China, HKG, Hong Kong

RECRUITING

Related Publications (25)

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MeSH Terms

Interventions

Methylmalonic Acid; Control Groups

Intervention Hierarchy (Ancestors)

Malonates; Dicarboxylic Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Central Study Contacts

Qiuyan Liao

CONTACT

39179289; qyliao11@hku.hk

Yuyi Chen

CONTACT

39179056; yuyiccc@hku.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 28, 2022
• First Posted: January 20, 2023
• Study Start: October 1, 2024
• Primary Completion: May 31, 2025
• Study Completion: May 31, 2025
• Last Updated: March 30, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP
• Time Frame: After the study findings are published, an anonymous dataset will be created and managed by the PI from this project and made publicly accessible upon reasonable request by other research PIs for the purpose of research use only. The data will be available for 10 years after publishing.
• Access Criteria: For research use only.

Locations

HK (1)