Psychological Intervention to Improve the COPD Patients' Psychosocial Well-being
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Assessment of Respiratory Capacity by the Maugeri Foundation Respiratory Failure Questionnaire
研究概览
简要总结
Because of a lack of clinical trials, there is currently a paucity of evidence on the most effective strategies to identify and address psychological co-morbidity in COPD, or on targeting these interventions to specific patient groups. The relationship between physiological disease impairment and patient's disease experience is weak. Some patients have highly impaired Quality of life (QoL) despite relatively minor lung function impairment, and others have good QoL despite severe lung function impairment. It is likely that psychological and behavioral factors may be relevant; moreover the coping strategies used by patients and their relationship to individual psychological factors have been incompletely explored. Pulmonary Rehabilitation (PR) is part of integrated COPD patient management and its potential impact on QoL should be underlined: several studies have found that physical exercise has a beneficial effect on depression symptoms [GOLD, 2017].
Before initiating PR a comprehensive and careful assessment should be performed: treatment goals, specific healthcare needs, smoking status, nutritional health, self-management capacity, health educational, psychological health status and social circumstances, medical history and comorbidities, and exercise capabilities and limitations. Moreover, PR has beneficial effects on mood status and daily activities.
Sustaining Pulmonary Rehabilitation benefits and regular exercise over the long term is difficult without any maintenance strategy. The main aim of this study is to assess the Effect of the Psychological Intervention (PI) on Quality of life, psychological status and well-being, and the maintenance of Pulmonary Rehabilitation benefits, in COPD patients.
A PI based on psychoeducation and psychological and emotional support may be a key to improve Quality of life and to bring COPD patients to show a greater awareness of their health status.
详细描述
In this pilot study we will perform two different methodologies of the Psychological Intervention: a telephone-based Psychological Intervention and combined face to face & telephone-based Psychological Intervention, integrating the COPD rehabilitation.
The study will be carried out in a real life setting. An initial sample of 36 COPD patients satisfying the inclusion criteria and accepting the participation of the study will be enrolled at the PR Unit of the IRCCS "San Raffaele Pisana" Roma-Italy. The study enrollment period will be of maximum six months, the treatment period is of six months, and the interim treatment evaluation is of three months will be performed. Max study duration will be of 12 months.
The participants will be recruited prospectively from consecutively admitted patients to the inpatient PR Unit. Participants will be required to have the diagnosis of COPD according to the ATS' Guideline [Qaseem et al., 2011]. All participants will sign informed consent approved by the Institutional Ethic Committee.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of COPD
- •Mini-Mental State Examination (MMSE) ≥ 26
- •6 Minute Walking Test ≥ 90 meters , at admission
- •Obtaining Written Informed Consent
排除标准
- •Comorbidity influencing respiratory ability and functionality
- •Delta 6 Minute Walking Distance < 60 meters, at time of admission
研究组 & 干预措施
Psychological Intervention
A weekly combined face to face & telephone-based PI (F-TPI); Psychological Intervention and medical therapy
干预措施: Psychological Intervention (Other)
A telephone-based PI (TPI)
Psychological Intervention - A telephone-based PI (TPI); Psychological Intervention and medical therapy
干预措施: Psychological Intervention (Other)
Optimal medical therapy
Patients will receive optimal medical therapy
结局指标
主要结局
Assessment of Respiratory Capacity by the Maugeri Foundation Respiratory Failure Questionnaire
时间窗: day 0 to day 21 (period of the Pulmonary Rehabilitation)
the Maugeri Foundation Respiratory Failure score
Change in the degree of enjoyment and satisfaction in areas of daily functioning, evaluated by the Quality Of Life Enjoyment And Satisfaction Questionnaire
时间窗: day 0 to day 182
the Quality Of Life Enjoyment And Satisfaction Questionnaire score
Maintenance of Functional Exercise evaluated by the Six Minute Walking Test
时间窗: day 0 to day 182
the Six Minute Walking Test score
Maintenance of Respiratory Capacity evaluated by the Borg scale
时间窗: day 0 to day 182
the Borg scale score
Assessment of disability by the Barthel Index
时间窗: day 0 to day 21 (period of the Pulmonary Rehabilitation )
Barthel Index score
Change in Quality of Life evaluated by the Short Form Health Survey General and Mental Health
时间窗: day 0 to day 182
the Short Form Health Survey General and Mental Health score
Change in Health related Quality of Life evaluated by the St. George's Respiratory Questionnaire
时间窗: day 0 to day 182
the St. George's Respiratory Questionnaire score
Assessment of dyspnea in activities of daily living by the Medical Research Council scale
时间窗: day 0 to day 21 (period of the Pulmonary Rehabilitation )
the Medical Research Council score
次要结局
- Assessment of the severity of depression by the Beck Depression Inventory II(day 0 to day 182)
- Assessment of different types of anxiety, state anxiety and trait anxiety, by State-Trait Anxiety Inventory Form Y.(day 0 to day 182)
- Change in psychological status evaluated by the Symptom Check List (SCL-90)(day 0 to day 182)
- Change in the use of the Coping Strategies evaluated by Brief-COPE(day 0 to day 182)