An Coach-based Intervention Study of an Extended Discharge Planning Program on Patients With COPD

April 11, 2014 updated by: National Taiwan University Hospital

An Intervention Study of an Extended Discharge Planning and Disease Management Program on Patients With COPD

The purpose of this 4-year study is to investigate the relationship between cognition and learning ability on patients with COPD during hospitalization to establish and evaluate the effects of the community-extended discharge planning program. The transition theory is used as the theoretical base in this study. The patients with diagnosis of COPD in hospital will be invited to participate. The data of demographic variables, the cognitive function¸ the respiratory function, the effect of learning and the usage of medical resources after discharged will be collected. In the first year, we will establish the protocol of respiratory teaching in two modes, and to compare the differences among computer interaction game intervention, face to face teaching and routine nursing intervention, also to evaluate the related factors and the effect of learning on patients with COPD for determining the needs of patients' learning mode and the optimal frequency of nursing teaching mode during hospitalization in the second year. For the second year, build upon the results of the first year, the preliminary draft of the community-extended discharge planning program that base on the experts' meeting and the interview with the patients. Also, a pilot study that revising the content and testing the feasibility of respiratory teaching protocol will be conducted. For the 3rd and 4th year, using case-control RCT design, the community-extended discharge planning program will be tested in patients during their hospital stay and post-discharge period. The effects of this community-extended discharge planning program will be evaluated on outcome variables of patients' cognitive learning function, utilization of health care resources. The results of this study will help to develop a community-extended discharge planning for patients with COPD on cognition level and learning ability. Furthermore, the protocol of the community-extended discharge planning will serve as references to prolong the development of disease deterioration, reduce the probability of readmission and improve the quality of life.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

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

  1. To establish the protocol of resiratory teaching mode.
  2. To evaluate the related factors and the effect of learning on patients with COPD.
  3. A modified discharge plan with respiratory teaching will implement to COPD patients.

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.
154

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: Hui-Ya Chan, Master
  • Phone Number: 63179 886-2-23123456
  • Email: freya@ntuh.gov.tw

Study Contact Backup

  • Name: Yu-Tzu Dai, Doctor
  • Phone Number: 88437 886-2-23123456
  • Email: yutzu@ntu.edu.tw

Study Locations

  • Taiwan
      • Taipai, Taiwan
        • Recruiting
        • National Taiwan University

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

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Being COPD Diagnosed Inpatients

Exclusion Criteria:

  • Cancer with active treatment plan
  • Lost speak ability
  • Psychiatric problem
  • Active TB

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: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

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: Tablet Computer Motivated Instruction
Using Tablet Computer Motivated Instruction to motivate patient learning breath skill and maintain practive. Research nurse will give 3 times instruction to patients during hospitalization. This arm estimated including 77 subjects.
Behavioral: Tablet Computer Motivated Instruction
Using tablet computer to motivate patient learning breath skill and maintain practive. Research nurse will give 3 times instruction to patients during hospitalization. This arm estimated including 77 subjects
ACTIVE_COMPARATOR: systematic instruction
Research nurse give 3 times systematic instruction during hospitalization This arm estimated including 77 subjects.
Behavioral: Systematic Instruction
Research nurse give 3 times systematic instruction during hospitalization This arm estimated including 77 subjects.

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
patient breath retraining skill
Time Frame: up to three months after discharge
We held a professional commettee to draft a checklist(7 items) of breath retraining skill which comment to teach COPD patients. After retest and confirm the detail from pilot, we observated and rated patients breath retraing skill from none(0) to complete done(3). The higher points means the more correct skill that patients learned.
up to three months after discharge

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
self efficacy
Time Frame: baseline, one and three month after discharge
PRAISAL questinnaire will be adopt after we consulted and get the author permission to use. Patients answered questionnaire(15 items) by their intuition. Rate point from 1 to 4 grades. The more confidence patient consider they have will rate more points. We propose patients learning the breath retraining skill well and correct during prepared discharge, they would get more confident.
baseline, one and three month after discharge

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.
National Taiwan University Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Yu-Tzu Dai, PhD, National Taiwan University

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

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.
September 1, 2012

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.
December 1, 2015

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.
December 1, 2015

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).
June 10, 2013

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.
August 28, 2013

First Posted (ESTIMATE)

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.
August 29, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

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.
April 14, 2014

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.
April 11, 2014

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.
April 1, 2014

More Information

Terms related to this study

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.
  • 201112134RIC

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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