Dementia and Disability Simulation for College Nursing Students' Senior Activity Facilitation Skills

• ClinicalTrials.gov Identifier: NCT06040294
• Recruitment Status: Enrolling by invitation
• First Posted: September 15, 2023
• Last Update Posted: September 18, 2023
• Sponsor: Tzu Chi University of Science and Technology
• Information provided by (Responsible Party): Huei-Chuan Sung, Tzu Chi University of Science and Technology

Tracking Information

• First Submitted Date: September 9, 2023
• First Posted Date: September 15, 2023
• Last Update Posted Date: September 18, 2023
• Actual Study Start Date: September 7, 2023
• Estimated Primary Completion Date: August 31, 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: September 9, 2023)

• Dementia Knowledge Assessment Scale (DKAS) [ Time Frame: Baseline, week 12, week 18 ]
  score of knowledge about dementia (0~50) higher scores indicate more knowledge about dementia
• Approaches to Dementia Questionnaire (ADQ) [ Time Frame: Baseline, week 12, week 18 ]
  score of attitude toward people with dementia (19~95) higher scores indicate more positive attitude towards dementia
• Jefferson Scale of Empathy (JSE) [ Time Frame: Baseline, week 12, week 18 ]
  score of empathy (20~140) higher scores indicate more empathy for people with dementia
• Rubrics of activity design skills for seniors [ Time Frame: Baseline, week 12, week 18 ]
  score of activity design skills for seniors (0~45) higher scores indicate better skills of designing activities for seniors

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Dementia and Disability Simulation for College Nursing Students' Senior Activity Facilitation Skills
• Official Title: Evaluation of a Dementia and Disability Simulation Program for Senior Activity Facilitation Skills Among College Nursing Students
• Brief Summary: This study aims to evaluate the effectiveness of a dementia and disability simulation (DDS) program on dementia knowledge, attitude, empathy, and activity design skills for seniors among college nursing students.

Detailed Description

This two-group randomised controlled trial aims to evaluate the effectiveness of a dementia and disability simulation program on dementia knowledge, attitude, empathy, and activity design skills for seniors among college nursing students.

The interventional group will receive a 6-week dementia and disability simulation program of activity design for seniors.

The control group will receive 6 weeks of regular dementia course and group discussion of activity design for seniors with no dementia and disability simulation.

Both groups will be assessed for their dementia knowledge, attitude, empathy and activity design skills for seniors at baseline, week 12, and week 18.

• Study Type: Interventional
• Study Phase: Not Applicable

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

two-group randomised controlled trial

Masking: Single (Outcomes Assessor)
Primary Purpose: Other

• Condition: Dementia

Intervention

• Other: DDS program
  dementia virtual reality and disability simulation of activity design for seniors
• Other: dementia course with no DDS
  Regular dementia course and group discussions of activity design for seniors with no DDS

Study Arms

• Experimental: dementia and disability simulation program (DDS)
  DDS program consists of dementia virtual reality and disability simulation of activity design for seniors
  Intervention: Other: DDS program
• Active Comparator: dementia course with no DDS
  Regular dementia course and group discussions of activity design for seniors with no DDS
  Intervention: Other: dementia course with no DDS

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Enrolling by invitation
• Estimated Enrollment (submitted: September 9, 2023): 52
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: August 31, 2024
• Estimated Primary Completion Date: August 31, 2024 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• college nursing students with age ranged from 19 to 40 years,
• Taiwanese nationality,
• Sophomore and above
• provide informed consent to participate in the study.

Exclusion Criteria:

-college nursing students who do not meet the inclusion criteria

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 19 Years to 40 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Taiwan

Administrative Information

• NCT Number: NCT06040294
• Other Study ID Numbers: YLH-IRB-11210
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

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

• IPD Sharing Statement: Not Provided
• Current Responsible Party: Huei-Chuan Sung, Tzu Chi University of Science and Technology
• Original Responsible Party: Same as current
• Current Study Sponsor: Tzu Chi University of Science and Technology
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Huei-Chuan Sung, PhD; Tzu Chi University of Science and Technology

• PRS Account: Tzu Chi University of Science and Technology
• Verification Date: September 2023