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

NCT03398772 | Unknown

• 1 other identifier: N201704032
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Change from Baseline Lung function at 3 months, 6months

  Spirometry (FEVl % predicted )

  3 months, 6months

• Change from Baseline Exercise Tolerance at 3 months, 6months

  6 Minute walking test

  3 months, 6months

Secondary Outcomes (6)

• 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

Study Arms (2)

Experiment

EXPERIMENTAL

Comprehensive Health Coaching Program

Behavioral: Comprehensive Health Coaching Program

Control

NO INTERVENTION

Guideline-based usual care

Interventions

Comprehensive Health Coaching Program 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.

Experiment

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Taipei Medical University: lead

Study Sites (1)

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

Taipei, Taiwan

RECRUITING

Central Study Contacts

Huang Ya-Hsuan, PhD

CONTACT

0979306004; d432104001@tmu.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 2, 2018
• First Posted: January 12, 2018
• Study Start: March 1, 2018
• Primary Completion: July 31, 2020
• Study Completion: July 31, 2020
• Last Updated: April 26, 2018

Record last verified: 2017-11

Locations

TW (1)