Chronic Kidney DiseasesNCT04312295
ACP Simulation-based Communication Training Program for Nurses Discussing ACP With Chronic Kidney Disease Patients
A study testing ACP-SCT program in people with Chronic Kidney Diseases, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.
Trial summary
This study was to evaluate the effects of ACP simulation-based communication training program (ACP-SCT program) for nurses to discuss ACP with chronic kidney disease patients Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Kidney Diseases
- What is being tested?
- ACP-SCT program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteTaiwan
- Study dates
- 19 Sep 2019to 26 Mar 2020
- 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 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants were nephrology nurses and worked at least one year
Who cannot join
- Non-nephrology nurses
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of an ACP Simulation-based Communication Training Program for Nurses Discussing ACP With Chronic Kidney Disease Patients: A Longitudinal Study
This study was to evaluate the effects of ACP simulation-based communication training program (ACP-SCT program) for nurses to discuss ACP with chronic kidney disease patients
Read the detailed description
The ACP-SCT program was including three stages, as follows Stage I: To discuss ACP knowledge and law Objective: Opportunity to share experiences, and develop a mutual understanding of the the challenge of ACPdiscussing with CKD patients.
Stage II: communication skills section and Feedback section Objective: 1. To provide a structured approach to managing ACP discussions. 2. Opportunity to practice communication skills in a safe environment 3. Opportunity to discuss their experiences of the training program, and reflect future on their own practice and experience.
- Conditions
- Chronic Kidney Diseases
- Being tested
- ACP-SCT program
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACP-SCT programBehavioural
The ACP-SCT program was designed to improve nurses' knowledge and competence in discussing ACP with Chronic Kidney Disease patients.
| Study group | Role | What they receive |
|---|---|---|
| ACP-SCT program | Experimental | The ACP simulation-based communication training (ACP-SCT)program was designed 12 hours (4hours/week) workshop for nephrology nurses. Receives: Behavioral: ACP-SCT program |
| Without ACP-SCT program | No intervention | The control group only gives the ACP simulation-based communication training program handbook. |
What is being measured
The primary outcome is the main question the study is designed to answer.
ACP Knowledge Scale
To evaluate the change of knowledge score for nurses from start of training program to end of training program 3 month later. Nurses' knowledge of discussing ACP will measure using the ACP knowledge Scale developed for this study. This Scale consisting of 20 items; each item consisted of a statement for which a participant could answer ''Yes'' to give 1 point, ''No'' or ''don't know'' to get 0 point. A higher scores indicates more knowledge. Data will analysis using SPSS 22.0 statistical software. Descriptive statistics are calculating as frequencies with percentages and means with standard deviation. Generalized estimating equation (GEE) methods with exchangeable working covariance structure will use to examine group differences in ACP knowledge outcomes, adjusting for changes over time. The GEE provides unbiased estimates of intervention effects.
Measured: pretest (before training program), Immediate test (after training program), post-test (3 month after training program)
ACP Confidence Scale
To evaluate the change of confidence score for nurses from start of training program to end of training program 3 month later. Nurses' self-confidence of communication skills in discussing ACP will measure using the ACP Confidence Scale developed for this study. The instrument consists of 12 items with response options from 0 (not confident at all) to 10(very confident), reflecting an individual's level of confident; higher scores indicates greater confidence. Data will analysis using SPSS 22.0 statistical software. Descriptive statistics are calculating as frequencies with percentages and means with standard deviation. Generalized estimating equation (GEE) methods with exchangeable working covariance structure will use to examine group differences in ACP confidence outcomes, adjusting for changes over time. The GEE provides unbiased estimates of intervention effects.
Measured: pretest (before training program), Immediate test (after training program), post-test (3 month after training program)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2020
- Study start19 Sep 2019
- Primary completion26 Dec 2019
- Study completion26 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney DiseasesStudies 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaohsiung Medical University Chung-Ho Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jui-O Chen, Mater, Principal investigator, Tajen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04312295
- Sponsor's protocol ID
- KMUHIRB-E(I)-20150279
- Status last verified
- Mar 2020
- First submitted
- 9 Mar 2020
- Last updated
- 2 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Chen JO, Chang SC, Lin CC. The development and pilot testing of an ACP simulation-based communication-training program: Feasibility and acceptability. PLoS One. 2021 Aug 24;16(8):e0254982. doi: 10.1371/journal.pone.0254982. eCollection 2021.
PubMed 34428209
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of an ACP Simulation-based Communication Training Program for Nurses Discussing ACP With Chronic Kidney Disease Patients: A Longitudinal Study
- ClinicalTrials.gov ID
- NCT04312295
- Acronym / sponsor ID
- KMUHIRB-E(I)-20150279
- Conditions
- Chronic Kidney Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Kaohsiung Medical University Chung-Ho Memorial HospitalUniversity, hospital or other
- Study start
- 19 Sep 2019 (actual)
- Primary completion
- 26 Dec 2019 (actual)
- Study completion
- 26 Mar 2020 (actual)
- First posted
- 18 Mar 2020 (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.
This study was to evaluate the effects of ACP simulation-based communication training program (ACP-SCT program) for nurses to discuss ACP with chronic kidney disease patients
Detailed description
The ACP-SCT program was including three stages, as follows Stage I: To discuss ACP knowledge and law Objective: Opportunity to share experiences, and develop a mutual understanding of the the challenge of ACPdiscussing with CKD patients.
Stage II: communication skills section and Feedback section Objective: 1. To provide a structured approach to managing ACP discussions. 2. Opportunity to practice communication skills in a safe environment 3. Opportunity to discuss their experiences of the training program, and reflect future on their own practice and experience.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ACP-SCT program | Experimental | Behavioral: ACP-SCT programThe ACP simulation-based communication training (ACP-SCT)program was designed 12 hours (4hours/week) workshop for nephrology nurses. |
| Without ACP-SCT program | No intervention | –The control group only gives the ACP simulation-based communication training program handbook. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Participants were nephrology nurses and worked at least one year
Key exclusion criteria (1 listed)
- Non-nephrology nurses
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 |
|---|---|---|
| ACP-SCT programThe ACP-SCT program was designed to improve nurses' knowledge and competence in discussing ACP with Chronic Kidney Disease patients. | Behavioural | ACP-SCT program |
Primary outcome
ACP Knowledge Scale
Time frame: pretest (before training program), Immediate test (after training program), post-test (3 month after training program)
To evaluate the change of knowledge score for nurses from start of training program to end of training program 3 month later. Nurses' knowledge of discussing ACP will measure using the ACP knowledge Scale developed for this study. This Scale consisting of 20 items; each item consisted of a statement for which a participant could answer ''Yes'' to give 1 point, ''No'' or ''don't know'' to get 0 point. A higher scores indicates more knowledge. Data will analysis using SPSS 22.0 statistical software. Descriptive statistics are calculating as frequencies with percentages and means with standard deviation. Generalized estimating equation (GEE) methods with exchangeable working covariance structure will use to examine group differences in ACP knowledge outcomes, adjusting for changes over time. The GEE provides unbiased estimates of intervention effects.
ACP Confidence Scale
Time frame: pretest (before training program), Immediate test (after training program), post-test (3 month after training program)
To evaluate the change of confidence score for nurses from start of training program to end of training program 3 month later. Nurses' self-confidence of communication skills in discussing ACP will measure using the ACP Confidence Scale developed for this study. The instrument consists of 12 items with response options from 0 (not confident at all) to 10(very confident), reflecting an individual's level of confident; higher scores indicates greater confidence. Data will analysis using SPSS 22.0 statistical software. Descriptive statistics are calculating as frequencies with percentages and means with standard deviation. Generalized estimating equation (GEE) methods with exchangeable working covariance structure will use to examine group differences in ACP confidence outcomes, adjusting for changes over time. The GEE provides unbiased estimates of intervention effects.
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 2 Sep 2021.
- Derived from this study: PubMed 34428209Chen JO, Chang SC, Lin CC. The development and pilot testing of an ACP simulation-based communication-training program: Feasibility and acceptability. PLoS One. 2021 Aug 24;16(8):e0254982. doi: 10.1371/journal.pone.0254982. eCollection 2021.
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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.
Jui-O Chen, Mater principal investigator
Tajen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ACP-SCT program in people with Chronic Kidney Diseases, run by Kaohsiung Medical University Chung-Ho Memorial Hospital 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 1 inclusion and 1 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 2 Sep 2021. 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?
ACP Knowledge Scale (time frame: pretest (before training program), Immediate test (after training program), post-test (3 month after training program)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04312295, which also lists 1 linked publication.
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 2 Sep 2021.