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

Primary Purpose

Chronic Obstructive Pulmonary Disease Severe, Chronic Obstructive Pulmonary Disease End Stage

Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Comprehensive Health Coaching Program
Sponsored by
Taipei Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Chronic Obstructive Pulmonary Disease Severe

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Taipei Medical Hospital-Shuang Ho Hospital,Ministry of Health and WelfareRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Experiment

Control

Arm Description

Comprehensive Health Coaching Program

Guideline-based usual care

Outcomes

Primary Outcome Measures

Change from Baseline Lung function at 3 months, 6months
Spirometry (FEVl % predicted )
Change from Baseline Exercise Tolerance at 3 months, 6months
6 Minute walking test

Secondary Outcome Measures

Change from Baseline Health-related quality of life at 3 months, 6months
St. George's Respiratory Questionnaire
Change from Baseline Fatigue at 3 months, 6months
Brief Fatigue Inventory Short Form BFI-Taiwan Form
Change from Baseline Psychological distress at 3 months, 6months
Hospital Anxiety and Depression Scale
Change from Baseline Symptom Distress at 3 months, 6months
Taiwanese version of the M. D. Anderson Symptom Inventory
Change from Baseline Quality of Sleep at 3 months, 6months
Taiwanese version of the Pittsburgh Sleep Quality Index
Readmission rate Survival
pulmonologists blinded to allocation reviewed admission summaries and information to determine as COPD related readmission or mortality

Full Information

First Posted
January 2, 2018
Last Updated
April 24, 2018
Sponsor
Taipei Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT03398772
Brief Title
Effects of a Comprehensive Health Coaching Program in Advanced Chronic Obstructive Pulmonary Disease.
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.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2018 (Actual)
Primary Completion Date
July 31, 2020 (Anticipated)
Study Completion Date
July 31, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Taipei Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease Severe, Chronic Obstructive Pulmonary Disease End Stage

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experiment
Arm Type
Experimental
Arm Description
Comprehensive Health Coaching Program
Arm Title
Control
Arm Type
No Intervention
Arm Description
Guideline-based usual care
Intervention Type
Behavioral
Intervention Name(s)
Comprehensive Health Coaching Program
Intervention 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.
Primary Outcome Measure Information:
Title
Change from Baseline Lung function at 3 months, 6months
Description
Spirometry (FEVl % predicted )
Time Frame
3 months, 6months
Title
Change from Baseline Exercise Tolerance at 3 months, 6months
Description
6 Minute walking test
Time Frame
3 months, 6months
Secondary Outcome Measure Information:
Title
Change from Baseline Health-related quality of life at 3 months, 6months
Description
St. George's Respiratory Questionnaire
Time Frame
3 months, 6months
Title
Change from Baseline Fatigue at 3 months, 6months
Description
Brief Fatigue Inventory Short Form BFI-Taiwan Form
Time Frame
3 months, 6months
Title
Change from Baseline Psychological distress at 3 months, 6months
Description
Hospital Anxiety and Depression Scale
Time Frame
3 months, 6months
Title
Change from Baseline Symptom Distress at 3 months, 6months
Description
Taiwanese version of the M. D. Anderson Symptom Inventory
Time Frame
3 months, 6months
Title
Change from Baseline Quality of Sleep at 3 months, 6months
Description
Taiwanese version of the Pittsburgh Sleep Quality Index
Time Frame
3 months, 6months
Title
Readmission rate Survival
Description
pulmonologists blinded to allocation reviewed admission summaries and information to determine as COPD related readmission or mortality
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Huang Ya-Hsuan, PhD
Phone
0979306004
Email
d432104001@tmu.edu.tw
Facility Information:
Facility Name
Taipei Medical Hospital-Shuang Ho Hospital,Ministry of Health and Welfare
City
Taipei
Country
Taiwan
Individual Site Status
Recruiting

12. IPD Sharing Statement

Learn more about this trial

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

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