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

NCT ID: NCT03398772

Last Updated: 2018-04-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-01
• Study Completion Date: 2020-07-31

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.

Conditions

Chronic Obstructive Pulmonary Disease Severe; Chronic Obstructive Pulmonary Disease End Stage

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Experiment

Comprehensive Health Coaching Program

Group Type: EXPERIMENTAL

Comprehensive Health Coaching Program

Intervention Type: BEHAVIORAL

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.

Control

Guideline-based usual care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Taipei Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Taipei Medical Hospital-Shuang Ho Hospital,Ministry of Health and Welfare

Taipei, , Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Huang Ya-Hsuan, PhD

Role: CONTACT

d432104001@tmu.edu.tw

0979306004

Other Identifiers

N201704032

Identifier Type: -

Identifier Source: org_study_id