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.

Effects of a Comprehensive Health Coaching Program in Advanced Chronic Obstructive Pulmonary Disease.



Sponsors


Source

Taipei Medical University

Oversight Info

Is Fda Regulated Drug

No

Is Fda Regulated Device

No


Brief 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. 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.

Overall Status

Not yet recruiting

Start Date

2018-03-01

Completion Date

2020-07-31

Primary Completion Date

2020-07-31

Phase

N/A

Study Type

Interventional

Primary Outcome

Measure

Time Frame

Change from Baseline Lung function at 3 months, 6months
3 months, 6months
Change from Baseline Exercise Tolerance at 3 months, 6months
3 months, 6months

Secondary Outcome

Measure

Time Frame

Change from Baseline Health-related quality of life at 3 months, 6months
3 months, 6months
Change from Baseline Fatigue at 3 months, 6months
3 months, 6months
Change from Baseline Psychological distress at 3 months, 6months
3 months, 6months
Change from Baseline Symptom Distress at 3 months, 6months
3 months, 6months
Change from Baseline Quality of Sleep at 3 months, 6months
3 months, 6months
Readmission rate Survival
1 year

Enrollment

50

Conditions


Intervention

Intervention Type

Behavioral

Intervention Name


Description

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.

Arm Group Label

Experiment


Eligibility

Criteria

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

Gender

All

Minimum Age

40 Years

Maximum Age

80 Years

Healthy Volunteers

No


Overall Contact

Last Name

Huang Ya-Hsuan, PhD

Phone

0979306004

Email



Verification Date

2017-11-01

Lastchanged Date

2018-01-06

Firstreceived Date

2018-01-02

Responsible Party

Responsible Party Type

Sponsor


Has Expanded Access

No

Condition Browse


Number Of Arms

2

Arm Group

Arm Group Label

Experiment

Arm Group Type

Experimental

Description

Comprehensive Health Coaching Program


Arm Group Label

Control

Arm Group Type

No Intervention

Description

Guideline-based usual care



Firstreceived Results Date

N/A

Firstreceived Results Disposition Date

N/A

Study Design Info

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary Purpose

Supportive Care

Masking

Single (Participant)


Study First Submitted

January 2, 2018

Study First Submitted Qc

January 6, 2018

Study First Posted

January 12, 2018

Last Update Submitted

January 6, 2018

Last Update Submitted Qc

January 6, 2018

Last Update Posted

January 12, 2018


ClinicalTrials.gov processed this data on January 12, 2018

Conditions

Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov, conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions

Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied. Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase

Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions that study is seeking to answer:

In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.

In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.

In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.

In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.

These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.



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