Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06090240
Other study ID # IRB-2023-150, HKWC-2023-342
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 20, 2023
Est. completion date January 31, 2025

Study information

Verified date October 2023
Source The University of Hong Kong
Contact Chia-Chin LIN, PhD,FAAN,RN
Phone 852-3917-6600
Email cclin@hku.hk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study aims to evaluate the effectiveness of a motivational interviewing (MI) intervention in enhancing advance care planning (ACP) among older adults who have visited the Emergency Room (ER) in the past six months and their family caregivers. The main question it aims to answer is: The effectiveness of the MI-based ACP intervention implemented within six months of an ER visit on improving older adults' advance directives (AD) completion rate. Compared to participants in the control group who will only receive a self-education booklet, participants in the intervention group will receive a motivational interview educational intervention to see the effectiveness of an MI-based ACP intervention implemented within six months following an emergency room visit regarding the completion of AD for older adults.


Description:

Targeted issue: At present no feasible method exists to empower older adults following ER visits to engage in ACP in Hong Kong. Population: The target group will be dyads comprising older adults who have had ER visits within the previous six months and their family caregivers. Intervention: An MI-based ACP intervention our team developed. Main study aim: To investigate the effectiveness of an MI-based ACP intervention implemented within six months following an emergency room visit on completion of AD for older adults compared to a self-education group. Study method: Investigators will recruit eligible participants from two largest public hospitals, including the geriatric outpatient clinic of Queen Mary Hospital (IRB Ref: UW23-402) and the accident & emergency department of Queen Elizabeth Hospital (IRB Ref: KC/KE-23-0058/ER-1). A parallel RCT (allocation ratio= 1:1) with a post-trial qualitative study will be adopted and three follow-up time points at 3-, 6- and 12-month post-intervention. Participants in the intervention group will receive a motivational interview educational intervention, while participants in the comparison group will receive the pictorial ACP educational booklet for self-learning only. Completion of AD and health service utilization will be assessed at three follow-up time points. In addition, a post-intervention interview, regarding stakeholders' views on the relevance, effectiveness, and experience of the intervention., will be conducted.


Recruitment information / eligibility

Status Recruiting
Enrollment 376
Est. completion date January 31, 2025
Est. primary completion date October 19, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility The target group will be dyads comprising older adults who have had ER visits within the previous six months and their family caregivers. A dyad is defined as one older adult and one primary family caregiver of the older adult. For older adults: Inclusion Criteria: - Aged 65 or older - At least one episode of ER visit in the last six months - Has a family caregiver to be present during the intervention - Able to communicate in Chinese Exclusion Criteria: - Has completion of an AD - Moderate to severe cognitive impairment or diagnosis of dementia, as identified in health records - Communication problems (e.g., deafness or aphasia) For family caregivers: Inclusion Criteria: - Aged 18 or above - Immediate or extended family member or friend nominated by an eligible older adult participant as primary caregiver - Able to communicate in Chinese Exclusion Criteria: - Moderate to severe cognitive impairment - Communication problems (e.g., deafness or aphasia)

Study Design


Intervention

Other:
MI-based ACP intervention
Motivational Interviewing on Advance Care Planning Intervention: Dyads of older adults and family caregivers will receive three MI-based ACP counselling sessions: (1) a preparatory session, (2) motivation session, and (3) planning session. The preparatory session will take 10-15 minutes, and the following two sessions in weeks 2 and 3 will last 30-45 minutes each. Before each session, the nurse interventionist will first assess the dyad's readiness to engage in ACP based on the state of change algorithm. Participants who have never thought about ACP will be in the pre-contemplation state, those who are willing to discuss EOL care and preferences to be in the contemplation state, those ready to talk about EOL planning to be in the preparation state, and those in the action state have a confirmed action plan on signing up their ADs. Readiness-based ACP goals will be established, and state-matched MI counseling will be customized for each participant.

Locations

Country Name City State
Hong Kong University of Hong Kong, School of Nursing Hong Kong

Sponsors (1)

Lead Sponsor Collaborator
The University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change from Baseline in Completion of AD documentation at 3 Months Completion of AD documentation will be measured by reviewing participants' medical records for a new AD document or self-reported AD completion at the 3-month follow-up time point. 3 months
Primary Change from Baseline in Completion of AD documentation at 6 Months Completion of AD documentation will be measured by reviewing participants' medical records for a new AD document or self-reported AD completion at the 6-month follow-up time point. 6 months
Primary Change from Baseline in Completion of AD documentation at 12 Months Completion of AD documentation will be measured by reviewing participants' medical records for a new AD document or self-reported AD completion at the 12-month follow-up time point. 12 months
See also
  Status Clinical Trial Phase
Completed NCT04521374 - The Effects of Texture Modified Diets on Dietary Intake and Appetite Responses in Older Adults N/A
Completed NCT05039879 - Life Improving Factors After a Hip Fracture
Recruiting NCT05978336 - SuPA Mobility: Supporting Physical Activity for Mobility in Mobility-Limited Older Adults N/A
Completed NCT02905370 - Progressing Home Health Rehabilitation for Older Adults N/A
Not yet recruiting NCT06453473 - Transfer Effects of Stationary Bicycle Perturbation Training on Older Adults' Cycling Skills N/A
Completed NCT03039556 - Step-reduction in Older Men and Women N/A
Completed NCT05901506 - Strengthen Family Members' Understanding of Advance Care Planning With a Nurse-led, Motivational Interview N/A
Recruiting NCT06030128 - Core Stabilization Exercise Therapy in Chronic Lower Back Back Management in Community Dwelling Older Adults N/A
Completed NCT04044183 - Managing Pain and Cognitions in Older Adults With Mild Cognitive Impairment or Memory Related Problems and Chronic Pain N/A
Not yet recruiting NCT06323954 - tVNS During Motor Training in Older Adults N/A
Recruiting NCT05366075 - The Preventing Functional Decline in Acutely Hospitalized Older Patients (PREV_FUNC) Study Phase 3
Completed NCT05497960 - Vivo Prediabetes Study: Online, Live, and Interactive Strength Training for Older Adults With Prediabetes N/A
Recruiting NCT05083221 - Effect of an Aural Rehabilitation Program in Hearing-impaired Older Adults N/A
Completed NCT05397158 - Optimization of Intestinal Preparation in Older Patients N/A
Completed NCT05459103 - Remote Interactive Intervention for Loneliness N/A
Completed NCT05025137 - Flexi-Bar and Multi-Component Exercises N/A
Completed NCT04927026 - "Where-there-is-no-psychiatrist Integrated Personal Therapy" Among Community-Dwelling Older Adults N/A
Completed NCT03197038 - Exercise Training and Cognitive Function in Kidney Disease N/A
Recruiting NCT06302686 - engAGE: Managing cognitivE decliNe throuGh Theatre Therapy, Artificial Intelligence and Social Robots drivEn Interventions N/A
Not yet recruiting NCT05078008 - The Role of Balneotherapy in Older Adults With Chronic Low Back Pain N/A