- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01931267
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
Unknown
Conditions
Intervention / Treatment
Detailed Description
- To establish the protocol of resiratory teaching mode.
- To evaluate the related factors and the effect of learning on patients with COPD.
- A modified discharge plan with respiratory teaching will implement to COPD patients.
Study Type
Interventional
Enrollment (Anticipated)
154
Phase
- 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 Locations
-
-
-
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
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 |
Intervention / Treatment |
---|---|
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.
|
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.
|
Research nurse give 3 times systematic instruction during hospitalization This arm estimated including 77 subjects.
|
What is the study measuring?
Primary Outcome Measures
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
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.
Investigators
- 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
September 1, 2012
Primary Completion (ANTICIPATED)
December 1, 2015
Study Completion (ANTICIPATED)
December 1, 2015
Study Registration Dates
First Submitted
June 10, 2013
First Submitted That Met QC Criteria
August 28, 2013
First Posted (ESTIMATE)
August 29, 2013
Study Record Updates
Last Update Posted (ESTIMATE)
April 14, 2014
Last Update Submitted That Met QC Criteria
April 11, 2014
Last Verified
April 1, 2014
More Information
Terms related to this study
Other Study ID 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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