Alzheimer Disease, Late OnsetNCT05407272
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
A study testing Health Education Manual and manual in people with Alzheimer Disease, Late Onset and Stroke, run by Wen-Shiou Pan at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease, Late Onset, Stroke, Heart Failure
- What is being tested?
- Health Education Manual and manual
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- 14 Sep 2021to 30 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: National Taipei University of Nursing and Health Sciences
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.
Read the 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.
- Conditions
- Alzheimer Disease, Late Onset, Stroke, Heart Failure, Pulmonary Disease, Chronic Obstructive, Cystic Fibrosis Pulmonary Exacerbation, Chronic Liver Disease and Cirrhosis
- Being tested
- Health Education Manual, manual
- Keywords
- knowledge of palliative care service, attitude of palliative care service, intention of palliative care service, initiation of palliative care service, home care
- Medical subject headings
- Alzheimer Disease, Stroke, Heart Failure, Pulmonary Disease, Chronic Obstructive, Fibrosis, Acute Kidney Injury, Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health Education ManualOther
A health education manual based on a shared model
manualOther
routine care
| Study group | Role | What they receive |
|---|---|---|
| Shared mode intervention group (experimental group) | Experimental | 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. Receives: Other: Health Education Manual |
| home care routine care group (control group) | Active comparator | 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. Receives: Other: manual |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: six weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2022
- Study start14 Sep 2021
- Primary completion14 Feb 2022
- Study completion30 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer Disease, Late OnsetStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wen-Shiou Pan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Wen-Shiou Pan, National Taipei University of Nursing and Health Sciences
- Investigators
- WEN-SHIOU PAN, Principal investigator, National Taipei University of Nursing and Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05407272
- Sponsor's protocol ID
- WSPan
- Status last verified
- Jun 2022
- First submitted
- 30 May 2022
- Last updated
- 8 Jun 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- National Taipei University of Nursing and Health Sciences
- ClinicalTrials.gov ID
- NCT05407272
- Acronym / sponsor ID
- WSPan
- Conditions
- Alzheimer Disease, Late Onset, Stroke, Heart Failure, Pulmonary Disease, Chronic Obstructive, Cystic Fibrosis Pulmonary Exacerbation, Chronic Liver Disease and Cirrhosis
- Keywords
- knowledge of palliative care service, attitude of palliative care service, intention of palliative care service, initiation of palliative care service, home care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Wen-Shiou PanUniversity, hospital or other
- Study start
- 14 Sep 2021 (actual)
- Primary completion
- 14 Feb 2022 (actual)
- Study completion
- 30 May 2022 (actual)
- First posted
- 7 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Shared mode intervention group (experimental group) | Experimental | Other: Health Education ManualMethods 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. |
| home care routine care group (control group) | Active comparator | Other: manualMethods 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Health Education ManualA health education manual based on a shared model | Other | Shared mode intervention group (experimental group) |
| manualroutine care | Other | home care routine care group (control group) |
Primary outcome
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
Time frame: six weeks
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
WEN-SHIOU PAN principal investigator
National Taipei University of Nursing and Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Health Education Manual and manual in people with Alzheimer Disease, Late Onset and Stroke, run by Wen-Shiou Pan at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: six weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2022.