Effects of a Comprehensive Health Coaching Program in Advanced Chronic Obstructive Pulmonary Disease.
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.
調査の概要
状態
研究の種類
入学 (予想される)
段階
- 適用できない
連絡先と場所
研究場所
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-
-
Taipei、台湾
- 募集
- Taipei Medical Hospital-Shuang Ho Hospital,Ministry of Health and Welfare
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：支持療法
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：Experiment
Comprehensive Health Coaching Program
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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.
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介入なし：Control
Guideline-based usual care
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change from Baseline Lung function at 3 months, 6months
時間枠：3 months, 6months
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Spirometry (FEVl % predicted )
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3 months, 6months
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Change from Baseline Exercise Tolerance at 3 months, 6months
時間枠：3 months, 6months
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6 Minute walking test
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3 months, 6months
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change from Baseline Health-related quality of life at 3 months, 6months
時間枠：3 months, 6months
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St. George's Respiratory Questionnaire
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3 months, 6months
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Change from Baseline Fatigue at 3 months, 6months
時間枠：3 months, 6months
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Brief Fatigue Inventory Short Form BFI-Taiwan Form
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3 months, 6months
|
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Change from Baseline Psychological distress at 3 months, 6months
時間枠：3 months, 6months
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Hospital Anxiety and Depression Scale
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3 months, 6months
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Change from Baseline Symptom Distress at 3 months, 6months
時間枠：3 months, 6months
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Taiwanese version of the M. D. Anderson Symptom Inventory
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3 months, 6months
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Change from Baseline Quality of Sleep at 3 months, 6months
時間枠：3 months, 6months
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Taiwanese version of the Pittsburgh Sleep Quality Index
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3 months, 6months
|
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Readmission rate Survival
時間枠：1 year
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pulmonologists blinded to allocation reviewed admission summaries and information to determine as COPD related readmission or mortality
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1 year
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- N201704032
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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