NCT06847828

Brief Summary

Foreign studies on caregivers' use of QPL in end-of-life care, decision-making, and satisfaction are mostly conducted with family members who share the same language. Foreign family caregivers are a local cultural feature of Taiwan. This study explores the role of foreign family caregivers in end-of-life care in Taiwan. Cultural issues and differences, whether the number of questions asked, care readiness and self-efficacy can be increased after the intervention of the end-of-life care QPL, and the use of QPL that is appropriate for Indonesian culture to communicate and prepare for end-of-life care in hospice home care, is expected to provide A reference for communication between medical teams and foreign home caregivers and improvement of care quality.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 31, 2023

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

January 23, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 26, 2025

Completed
Last Updated

February 26, 2025

Status Verified

February 1, 2025

Enrollment Period

1.3 years

First QC Date

January 23, 2025

Last Update Submit

February 21, 2025

Conditions

Outcome Measures

Primary Outcomes (4)

  • caregiving preparedness

    The scale assesses two aspects: "Preparedness for Patient Care" and "Preparedness for Caregiving Situations." A score of 1 indicates no preparedness, while 10 indicates full preparedness. Higher scores reflect greater perceived readiness.

    3 days

  • communication self-efficacy

    The communication self-efficacy measure was designed to measure the Indonesian home caregivers' ability and confidence in the communication process, with a total of 7 questions. Respondents responded on a scale of 1-10, with 1 being "very unconfident", 5 being "average", and 10 being "very confident".Higher scores reflect greater self-efficacy.

    3days

  • satisfaction levels

    Communication satisfaction questionnaire. The control group had 9 questions and the intervention group had 15 questions (including the experience of using the end-of-life care questionnaire). 1 is "not prepared at all", 2 is "somewhat prepared", 3 is "average", 4 is "mostly prepared", and 5 is "very prepared". The higher the score, the higher the satisfaction.

    3days

  • number of questions asked education communication

    Within 3 days after the pretest, the researcher and the nurse visited the case together. During the visit, the researcher was a bystander and did not intervene in the communication and interaction between the nurse and the case. He only recorded the case's questions during the interaction process and asked for consent during the interaction process. The results were recorded in the form of audio recordings. The experimental group asked an Indonesian home care worker to review the content, circle or ask questions they wanted to know. The results of the audio recordings of the research process were translated into text and analyzed by two senior nurses with a master's degree or above. After the analysis was completed, the researcher and the two analysts held a consensus meeting to communicate on the inconsistent parts. The completed result is to calculate the number of questions asked in the communication interaction process.

    3days

Study Arms (2)

Experimental Group

EXPERIMENTAL

During recruitment, the researcher contacts participants 1-3 days before the nurse's visit to explain the study and obtain consent. After signing, participants complete a pretest questionnaire and are randomly assigned to the experimental or control group. To assess baseline question-asking ability, the researcher first asks if participants have any caregiving-related questions. The intervention group receives the Indonesian QPL, consent form, and questionnaire, with instructions on QPL use. Within three days post-pretest, the researcher observes a nurse's visit without interfering, recording participant questions with consent. After the health education session, posttest data on end-of-life care preparedness, communication self-efficacy, and satisfaction are collected.

Other: QPL

control group.

NO INTERVENTION

During recruitment, the researcher contacts participants 1-3 days before the nurse's visit to explain the study and obtain consent. After signing, participants complete a pretest questionnaire and are randomly assigned to the experimental or control group. To assess baseline question-asking ability, the researcher first asks if participants have any caregiving-related questions. The control group receives an Indonesian consent form and questionnaire, with usual health education provided by nurses. Translation support is available if needed. Within three days post-pretest, the researcher observes a nurse's visit without interfering, recording participant questions with consent. Afterward, posttest data on end-of-life care preparedness, communication self-efficacy, and satisfaction are collected.

Interventions

QPLOTHER

The QPL is in the form of a structured list of questions that caregivers would like to ask. It includes 17 questions on concept communication and 20 questions on end-of-life care. You can check the questions you want to ask and then discuss them with the medical team.

Experimental Group

Eligibility Criteria

Age20 Years - 65 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Those who are fluent in Mandarin or Indonesian and have no reading or hearing impairment;
  • Agree to accept the commission and the Taxation Committee issues a letter of approval for the legal Indonesian guardian

You may not qualify if:

  • Those who are unable to communicate in Mandarin or Indonesian;
  • The employer of the patient has changed jobs and the patient cannot be contacted after the patient passes away;
  • Those who are under great pressure of end-of-life care or are physically unfit to take the questionnaire

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tzu Chi University

Hualien City, 970, Taiwan

Location

Study Officials

  • Chuan Mei Chang

    Ph.D

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
single-blind study
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: randomized control-group pretest-posttest design
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
student

Study Record Dates

First Submitted

January 23, 2025

First Posted

February 26, 2025

Study Start

August 31, 2023

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

February 26, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations