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Explore the Sharing Model Intervene to Improve the Knowledge, Attitudes, Service Intentions and Service Start-up Effects of the Eight Major Non-cancer Disease End-stage Caregivers on Well-being and Palliative Care

Primary Purpose

Alzheimer Disease, Late Onset, Stroke, Heart Failure

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Health Education Manual
manual
Sponsored by
Wen-Shiou Pan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Alzheimer Disease, Late Onset focused on measuring knowledge of palliative care service, attitude of palliative care service, intention of palliative care service, initiation of palliative care service, home care

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Caregivers of terminally ill patients with eight major non-cancer diseases diagnosed by a physician.
  2. The caregiver must be at least 18 years old and literate.
  3. The caregiver has a clear awareness and can communicate in Mandarin or Taiwanese

Exclusion Criteria:

  1. Diagnosed by a physician as a terminally ill patient with eight major non-cancer diseases.
  2. Clear awareness and able to communicate in Mandarin or Taiwanese.

Sites / Locations

  • Wen-Shiou Pan

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Shared mode intervention group (experimental group)

home care routine care group (control group)

Arm Description

Methods of collecting cases The subjects whose identity card numbers last in odd numbers are in the experimental group and even numbers are in the control group. They are randomly divided into two groups - the shared mode intervention group (experimental group) and the home care routine care group (control group). The experimental group was given a weekly sharing mode intervention for six weeks, 20-60 minutes per week; the control group was given the home health education manual in the third week.

Methods of collecting cases The subjects whose identity card numbers last in odd numbers are in the experimental group and even numbers are in the control group. They are randomly divided into two groups - the shared mode intervention group (experimental group) and the home care routine care group (control group). The experimental group was given a weekly sharing mode intervention for six weeks, 20-60 minutes per week; the control group was given the home health education manual in the third week.

Outcomes

Primary Outcome Measures

the knowledge, attitudes, service intentions and service start-up effects of the eight major non-cancer disease end-stage caregivers on well-being and palliative care
The content of the outcome measurement questionnaire includes: basic information of the eight non-cancer terminal caregivers, the palliative care knowledge scale, the palliative care attitude scale, and palliative care service initiation intention scale. Data were analyzed by statistical methods such as descriptive analysis, independent sample t-test, paired-samples t-test, Pearson correlation analysis and one-way ANOVA.

Secondary Outcome Measures

Full Information

First Posted
May 30, 2022
Last Updated
June 6, 2022
Sponsor
Wen-Shiou Pan
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1. Study Identification

Unique Protocol Identification Number
NCT05407272
Brief Title
Explore the Sharing Model Intervene to Improve the Knowledge, Attitudes, Service Intentions and Service Start-up Effects of the Eight Major Non-cancer Disease End-stage Caregivers on Well-being and Palliative Care
Official Title
National Taipei University of Nursing and Health Sciences
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
September 14, 2021 (Actual)
Primary Completion Date
February 14, 2022 (Actual)
Study Completion Date
May 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Wen-Shiou Pan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Since September 1st, 2009, Taiwan has begun to pay attention to the care of patients with organ failure, dementia and the elderly, and brought eight of non-cancer terminal patients into health insurance subsidies to implement the goal of universal palliative care and local aging. Taiwan has entered the aged society since March 2018, become the heavy burden of expenditure in Taiwan because of the health care needs and costs associated with the rapid aging of the population. With advanced medical technology, when facing inevitable death situation, should not use too much medical treatment on terminally ill patients. The waste of medical resources and bring both patients and family members so much pain. In Taiwan, people have misconception about tranquil palliative care. The low rate of home palliative care for non-terminal cancer patients. The purpose of this study is investigating the eight non-cancer terminal caregivers' knowledge, attitudes and service intentions of palliative care, and getting the result by research intervention. In this study, a randomized experimental research design was applied by two-group pre-and post-test. The targets are the eight non-cancer terminal caregivers in a home care institution of a regional teaching hospital located in Yilan. Targets' ID end with odd numbers are in experimental group received shared mode intervention, and even numbers are in control group received home routine care. The experimental group was implementing measures of weekly shared mode intervention in 20 to 60 minutes for six weeks; the control group started to implement measures of home care medical instructions booklet in the third week. The content of the outcome measurement questionnaire includes: basic information of the eight non-cancer terminal caregivers, the palliative care knowledge scale, the palliative care attitude scale, and palliative care service initiation intention scale. Data were analyzed by statistical methods such as descriptive analysis, independent sample t-test, paired-samples t-test, Pearson correlation analysis and one-way ANOVA.
Detailed Description
The valid sample of this study consisted of 60 individuals, 31 females and 29 males, with a mean age of 56.3 years, and one attrition (death), with an attrition rate of 1.67%. The results showed that (1) there was a significant difference between the experimental group and the control group in the mean pre-test and post-test of hospice and palliative care knowledge (t=-4.973, p=0.00) and palliative attitude (t=-2.424, p=0.02). (2) There were significant differences in the pre-test and post-tests of hospice and palliative care knowledge (p=0.000), hospice and palliative care attitude (p=0.008), and hospice and palliative care intention (p=0.009) in the experimental group; there were significant differences in the pre-test and post-tests of hospice and palliative care knowledge in the control group (p=0.002). (3) There were significant differences in hospice knowledge, attitude, intention and hospice initiation between subjects in the experimental group with and without a signed DNR or ACP, indicating that those with a signed DNR or ACP had higher scores in hospice knowledge, attitude, intention and hospice initiation, which was a significant factor in the results of this study; there were significant differences in hospice knowledge and intention between the control group in terms of education level. This means that higher education level, higher score of hospice knowledge and intention. (4) After the shared model study intervention, 24 (72.7%) signed the DNR or ACP consent form and 16 (48.5%) initiated hospice services; after the home care routine care, 3 (11.1%) signed the DNR or ACP consent form and 0 (0%) initiated hospice services.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease, Late Onset, Stroke, Heart Failure, Pulmonary Disease, Chronic Obstructive, Cystic Fibrosis Pulmonary Exacerbation, Chronic Liver Disease and Cirrhosis, Kidney Failure, Acute, Kidney Failure, Chronic
Keywords
knowledge of palliative care service, attitude of palliative care service, intention of palliative care service, initiation of palliative care service, home care

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Shared mode intervention group (experimental group)
Arm Type
Experimental
Arm Description
Methods of collecting cases The subjects whose identity card numbers last in odd numbers are in the experimental group and even numbers are in the control group. They are randomly divided into two groups - the shared mode intervention group (experimental group) and the home care routine care group (control group). The experimental group was given a weekly sharing mode intervention for six weeks, 20-60 minutes per week; the control group was given the home health education manual in the third week.
Arm Title
home care routine care group (control group)
Arm Type
Active Comparator
Arm Description
Methods of collecting cases The subjects whose identity card numbers last in odd numbers are in the experimental group and even numbers are in the control group. They are randomly divided into two groups - the shared mode intervention group (experimental group) and the home care routine care group (control group). The experimental group was given a weekly sharing mode intervention for six weeks, 20-60 minutes per week; the control group was given the home health education manual in the third week.
Intervention Type
Other
Intervention Name(s)
Health Education Manual
Intervention Description
A health education manual based on a shared model
Intervention Type
Other
Intervention Name(s)
manual
Intervention Description
routine care
Primary Outcome Measure Information:
Title
the knowledge, attitudes, service intentions and service start-up effects of the eight major non-cancer disease end-stage caregivers on well-being and palliative care
Description
The content of the outcome measurement questionnaire includes: basic information of the eight non-cancer terminal caregivers, the palliative care knowledge scale, the palliative care attitude scale, and palliative care service initiation intention scale. Data were analyzed by statistical methods such as descriptive analysis, independent sample t-test, paired-samples t-test, Pearson correlation analysis and one-way ANOVA.
Time Frame
six weeks

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Caregivers of terminally ill patients with eight major non-cancer diseases diagnosed by a physician. The caregiver must be at least 18 years old and literate. The caregiver has a clear awareness and can communicate in Mandarin or Taiwanese Exclusion Criteria: Diagnosed by a physician as a terminally ill patient with eight major non-cancer diseases. Clear awareness and able to communicate in Mandarin or Taiwanese.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
WEN-SHIOU PAN
Organizational Affiliation
National Taipei University of Nursing and Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wen-Shiou Pan
City
Yilan
ZIP/Postal Code
260
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Explore the Sharing Model Intervene to Improve the Knowledge, Attitudes, Service Intentions and Service Start-up Effects of the Eight Major Non-cancer Disease End-stage Caregivers on Well-being and Palliative Care

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