Chronic Obstructive Pulmonary Disease SevereNCT03398772
Effects of a Comprehensive Health Coaching Program in Advanced Chronic Obstructive Pulmonary Disease.
A study testing Comprehensive Health Coaching Program in people with Chronic Obstructive Pulmonary Disease Severe and Chronic Obstructive Pulmonary Disease End Stage, run by Taipei Medical University at 1 site in Taiwan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease Severe, Chronic Obstructive Pulmonary Disease End Stage
- What is being tested?
- Comprehensive Health Coaching Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Mar 2018to 31 Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Taipei Medical Hospital-Shuang Ho Hospital,Ministry of Health and Welfare
Taipei
About this study
Official title: 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.
- Conditions
- Chronic Obstructive Pulmonary Disease Severe, Chronic Obstructive Pulmonary Disease End Stage
- Being tested
- Comprehensive Health Coaching Program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comprehensive Health Coaching ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Experiment | Experimental | Comprehensive Health Coaching Program Receives: Behavioral: Comprehensive Health Coaching Program |
| Control | No intervention | Guideline-based usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline Lung function at 3 months, 6months
Spirometry (FEVl % predicted )
Measured: 3 months, 6months
Change from Baseline Exercise Tolerance at 3 months, 6months
6 Minute walking test
Measured: 3 months, 6months
Secondary outcomes (6)
Change from Baseline Health-related quality of life at 3 months, 6months
St. George's Respiratory Questionnaire
Measured: 3 months, 6months
Change from Baseline Fatigue at 3 months, 6months
Brief Fatigue Inventory Short Form BFI-Taiwan Form
Measured: 3 months, 6months
Change from Baseline Psychological distress at 3 months, 6months
Hospital Anxiety and Depression Scale
Measured: 3 months, 6months
Change from Baseline Symptom Distress at 3 months, 6months
Taiwanese version of the M. D. Anderson Symptom Inventory
Measured: 3 months, 6months
Change from Baseline Quality of Sleep at 3 months, 6months
Taiwanese version of the Pittsburgh Sleep Quality Index
Measured: 3 months, 6months
Readmission rate Survival
pulmonologists blinded to allocation reviewed admission summaries and information to determine as COPD related readmission or mortality
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2018
- Study start1 Mar 2018
- Primary completion31 Jul 2020 (estimated)
- Study completion31 Jul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary Disease SevereStudies of the same condition, open and under way.
- More trials run by Taipei Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03398772
- Sponsor's protocol ID
- N201704032
- Status last verified
- Nov 2017
- First submitted
- 2 Jan 2018
- Last updated
- 26 Apr 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT03398772
- Acronym / sponsor ID
- N201704032
- Conditions
- Chronic Obstructive Pulmonary Disease Severe, Chronic Obstructive Pulmonary Disease End Stage
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Taipei Medical UniversityUniversity, hospital or other
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 31 Jul 2020 (estimated)
- Study completion
- 31 Jul 2020 (estimated)
- First posted
- 12 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experiment | Experimental | Behavioral: Comprehensive Health Coaching ProgramComprehensive Health Coaching Program |
| Control | No intervention | –Guideline-based usual care |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Comprehensive Health Coaching ProgramComprehensive 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. | Behavioural | Experiment |
Primary outcome
Change from Baseline Lung function at 3 months, 6months
Time frame: 3 months, 6months
Spirometry (FEVl % predicted )
Change from Baseline Exercise Tolerance at 3 months, 6months
Time frame: 3 months, 6months
6 Minute walking test
6 secondary outcomes
Change from Baseline Health-related quality of life at 3 months, 6months
Time frame: 3 months, 6months
Change from Baseline Fatigue at 3 months, 6months
Time frame: 3 months, 6months
Change from Baseline Psychological distress at 3 months, 6months
Time frame: 3 months, 6months
Change from Baseline Symptom Distress at 3 months, 6months
Time frame: 3 months, 6months
Change from Baseline Quality of Sleep at 3 months, 6months
Time frame: 3 months, 6months
Readmission rate Survival
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Comprehensive Health Coaching Program in people with Chronic Obstructive Pulmonary Disease Severe and Chronic Obstructive Pulmonary Disease End Stage, run by Taipei Medical University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Huang Ya-Hsuan, PhD (0979306004, d432104001@tmu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline Lung function at 3 months, 6months (time frame: 3 months, 6months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2018.