- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03398772
Effects of a Comprehensive Health Coaching Program in Advanced Chronic Obstructive Pulmonary Disease.
Effects of a Comprehensive Health Coaching Program on Lung Function, Exercise Tolerance, Symptom Distress, Quality of Life, Readmission, and Survival in Advanced Chronic Obstructive Pulmonary Disease Patients: A Randomized Controlled Trial.
Chronic obstructive pulmonary disease due to incurable and prevalence has increased steadily, chronic respiratory disease is considered hazardous to health and quality of life of the disease. GOLD treatment guidelines (global initiative for chronic obstructive lung disease guideline) pointed out the pulmonary rehabilitation is one of the non-drug treatment in patients with severe COPD, shown to improve exercise capacity and reduce the short of breathing, improve the quality of life and reduce the anxiety associated and depression and improved survival advantages. Meanwhile, a few studies have examined effect the exercise training in severe COPD patients' symptom distress and quality of life, so as to make severe COPD patients to improve the effectiveness of the campaign to ongoing regular pulmonary rehabilitation movement, is considered an important issue.
It has been proposed that physical activity enhancement or exercise training can be effective in improving symptoms and quality of life in these patients. However, it has not been examined systematically. Therefore, the main purposes of this study are: 1.Prevalence of symptom distress; 2.The physical preferences; 3.The relationship between quality of life and physical activity; 4.Effects of Comprehensive Health coaching exercise training on improving fatigue, sleep disturbances, quality of life, readmission, and survival. In the first year of this study, a descriptive-correlational design will be used and in the second and third years of study, the experimental design and prospective longitudinal study will be undertaken. Instruments include motion sensors, physical activity scale, Physical Activity Preferences, Pittsburgh Sleep Quality of Life Index. Statistical analyses include descriptive statistics, t-test, one-way ANOVA, latent growth modeling, Logistic models, GEE, and survival analysis. Results from this study will provide important implications for improving symptom management and quality of life for sever chronic obstructive pulmonary disease patients.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Taipei, Taiwan
- Recruiting
- Taipei Medical Hospital-Shuang Ho Hospital,Ministry of Health and Welfare
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- age ≥40 years and ≦80 years
- patients with advanced COPD are defined according to the diagnostic criteria for severe (GOLD 3) and very severe (GOLD 4)
- pulmonologist assess need pulmonary rehabilitation, but not accept any rehabilitation exercise program.
- pulmonologist assessment the patients with a stable state.
- awareness, has the ability to read, write, and communication.
- willing to communicate by phone, and can operate smart phones.
Exclusion Criteria:
- COPD AE requiring corticosteroids, antibiotics, emergency room visit or hospitalization within the past 3 month.
- diagnosed mentally or cognitive disorder, such as dementia or unable to cooperate.
- severe hip, knee disease, can not perform exercise, or with neuromuscular dysfunction, such as limb hemiplegia, no independent walking function or other deterioration due to bone and joint disease.
- combined with severe heart disease, such as AMI, severe arrhythmia or heart failure.
- current regular practice of physical activity
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Experiment
Comprehensive Health Coaching Program
|
Comprehensive Health Coaching Program: included physical activity and motivational interviewing techniques, participants were encouraged to set goals with decision-making, self-management and self-monitor their progress, and received support from researcher.
|
No Intervention: Control
Guideline-based usual care
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from Baseline Lung function at 3 months, 6months
Time Frame: 3 months, 6months
|
Spirometry (FEVl % predicted )
|
3 months, 6months
|
Change from Baseline Exercise Tolerance at 3 months, 6months
Time Frame: 3 months, 6months
|
6 Minute walking test
|
3 months, 6months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from Baseline Health-related quality of life at 3 months, 6months
Time Frame: 3 months, 6months
|
St. George's Respiratory Questionnaire
|
3 months, 6months
|
Change from Baseline Fatigue at 3 months, 6months
Time Frame: 3 months, 6months
|
Brief Fatigue Inventory Short Form BFI-Taiwan Form
|
3 months, 6months
|
Change from Baseline Psychological distress at 3 months, 6months
Time Frame: 3 months, 6months
|
Hospital Anxiety and Depression Scale
|
3 months, 6months
|
Change from Baseline Symptom Distress at 3 months, 6months
Time Frame: 3 months, 6months
|
Taiwanese version of the M. D. Anderson Symptom Inventory
|
3 months, 6months
|
Change from Baseline Quality of Sleep at 3 months, 6months
Time Frame: 3 months, 6months
|
Taiwanese version of the Pittsburgh Sleep Quality Index
|
3 months, 6months
|
Readmission rate Survival
Time Frame: 1 year
|
pulmonologists blinded to allocation reviewed admission summaries and information to determine as COPD related readmission or mortality
|
1 year
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- N201704032
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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