Ignite Creation Date:
2024-05-06 @ 11:16 AM
Last Modification Date:
2024-10-26 @ 12:42 PM
Study NCT ID:
NCT03470025
Status:
COMPLETED
Last Update Posted:
2023-06-26
First Post:
2018-03-06
Brief Title:
Improving Psychosocial Well-being in COPD Patients in Rehabilitation
Sponsor:
IRCCS San Raffaele Roma
Organization:
IRCCS San Raffaele Roma
Study Overview
Official Title:
Psychological Intervention to Improve the COPD Patients Psychosocial Well-being
Status:
COMPLETED
Status Verified Date:
2023-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IMPROVE
Brief Summary:
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 patients 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
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
Detailed Description:
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None