NCT04312295

Brief 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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
96

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2019

Shorter than P25 for not_applicable

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

September 19, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 26, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 9, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 18, 2020

Completed
8 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 26, 2020

Completed
Last Updated

September 2, 2021

Status Verified

March 1, 2020

Enrollment Period

3 months

First QC Date

March 9, 2020

Last Update Submit

August 31, 2021

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    pretest (before training program), Immediate test (after training program), post-test (3 month after training program)

Study Arms (2)

ACP-SCT program

EXPERIMENTAL

The ACP simulation-based communication training (ACP-SCT)program was designed 12 hours (4hours/week) workshop for nephrology nurses.

Behavioral: ACP-SCT program

Without ACP-SCT program

NO INTERVENTION

The control group only gives the ACP simulation-based communication training program handbook.

Interventions

ACP-SCT programBEHAVIORAL

The ACP-SCT program was designed to improve nurses' knowledge and competence in discussing ACP with Chronic Kidney Disease patients.

ACP-SCT program

Eligibility Criteria

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

You may qualify if:

  • Participants were nephrology nurses and worked at least one year

You may not qualify if:

  • Non-nephrology nurses

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tajen University

Pingtung City, Yanpu Township, 90741, Taiwan

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Jui-O Chen, Mater

    Tajen University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 9, 2020

First Posted

March 18, 2020

Study Start

September 19, 2019

Primary Completion

December 26, 2019

Study Completion

March 26, 2020

Last Updated

September 2, 2021

Record last verified: 2020-03

Locations