Interprofessional Education and Collaborative Practice Model for Dementia in Acute Care

February 6, 2020 updated by: Kaohsiung Medical University Chung-Ho Memorial Hospital

Interprofessional Education and Collaborative Practice Model for Dementia in Acute Care: Development, Implementation and Evaluation

The purpose of this study is to develop an interprofessional education and practice model for acute care related to dementia and evaluate its effectiveness of implementation.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The researchers will recruit participants from a medical center (experimental group) and two regional hospitals (control group) in southern Taiwan. Both the experimental group and the control group will contain 150 healthcare professionals and 64 patients with dementia. Both of the groups will receive a six-hour dementia care course. Then, only the experimental group will receive a half-day interprofessional education workshop, maintain a six-month interprofessional practice model, and join interprofessional practice experience-sharing conferences. The evaluation of outcomes will include the analyses of healthcare professionals' knowledge, attitudes, and self-efficacy of dementia care. The evaluation times are to be before and after the dementia care course and after the six months of interprofessional practice. The other evaluation of outcome is comparison of the outcomes of hospitalized patients with dementia between the two groups before the interprofessional education workshop and after the interprofessional practice.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
428

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: PEI-CHAO LIN, doctoarte
  • Phone Number: 2609 886-7-3121101
  • Email: pclin@kmu.edu.tw

Study Locations

  • Taiwan
      • Kaohsiung city, Taiwan, 807
        • Kaohsiung Medical University Chung-Ho Memorial Hospital
        • Contact:
          • Pei-Chao Lin, doctorate
          • Phone Number: 2609 886-7-3121101
          • Email: pclin@kmu.edu.tw

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • healthcare professionals having worked for 3 months or more
  • emergency/hospitalized patients with dementia
  • patients diagnosed dementia
  • scoring 1 or more in Clinical Dementia Rating (CDR).

Exclusion Criteria:

  • healthcare professionals working in obstetrics, pediatrics, outpatient, or hemodialysis.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: experimental group
The experimental group will not only receive six-hour dementia care course, but also a half-day interprofessional education workshop, maintain a six-month interprofessional practice model, and join interprofessional practice experience-sharing conferences.
Other: education and workshop
six-hour dementia care course, half-day interprofessional education workshop, and interprofessional practice
Active Comparator: control group
The control group will only receive six-hour dementia care course.
Other: education
six-hour dementia care course

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change of Dementia Care Knowledge
Time Frame: Before education program(pre-intervention), after education program(10 months), after the workshop(10 months), after the six months interprofessional practice(post intervention)[about 8 months]

testing the change of professionals' Dementia Care Knowledge. The minimum value of this scale is 0, and the maximum value is 16.

Higher scores mean having better Dementia Care Knowledge.
Before education program(pre-intervention), after education program(10 months), after the workshop(10 months), after the six months interprofessional practice(post intervention)[about 8 months]

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change of dementia self-efficacy scale
Time Frame: Before education program(pre-intervention), after education program(10 months), after the workshop(10 months), after the six months interprofessional practice(post intervention)[about 8 months]
testing professionals' dementia self-efficacy. The scale has not developed yet. It will be developed and test the reliability and validity in this study.
Before education program(pre-intervention), after education program(10 months), after the workshop(10 months), after the six months interprofessional practice(post intervention)[about 8 months]
mortality rate of hospitalized patients with dementia
Time Frame: about 2 years
understand the treatment outcomes of hospitalized patients with dementia before the interventions six months and after interventions six months.
about 2 years
length of stays of hospitalized patients with dementia
Time Frame: about 2 years
understand the treatment outcomes of hospitalized patients with dementia before the interventions six months and after interventions six months.
about 2 years
the incidence of fall hospitalized patients with dementia
Time Frame: about 2 years
understand the treatment outcomes of hospitalized patients with dementia before the interventions six months and after interventions six months.
about 2 years
the incidence of pain hospitalized patients with dementia
Time Frame: about 2 years
understand the treatment outcomes of hospitalized patients with dementia before the interventions six months and after interventions six months.
about 2 years
score of Beck depression inventory
Time Frame: about 2 years
testing psychological symptoms of hospitalized patients with dementia
about 2 years
score of Cohen-Mansfield Agitation Inventory (CMAI)
Time Frame: about 2 years
testing behavioral symptoms of hospitalized patients with dementia
about 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Kaohsiung Medical University Chung-Ho Memorial Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2020

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 31, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 31, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 4, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 6, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 10, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 10, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 6, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • KMUHIRB-SV(1)-20170070

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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