Improving Psychosocial Well-being in COPD Patients in Rehabilitation

COPD Clinical Trial

— IMPROVE  

Official title:

Psychological Intervention to Improve the COPD Patients' Psychosocial Well-being

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03470025
• Other study ID #: RP 22/17
• Status: Completed
• Phase: N/A
• Start date: January 10, 2018
• Est. completion date: December 31, 2019

Study information

• Verified date: June 2023
• Source: IRCCS San Raffaele Roma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: December 31, 2019
• Est. primary completion date: May 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Diagnosis of COPD

• Mini-Mental State Examination (MMSE) = 26

• 6 Minute Walking Test = 90 meters , at admission

• Obtaining Written Informed Consent

Exclusion Criteria:

• Comorbidity influencing respiratory ability and functionality

• Delta 6 Minute Walking Distance < 60 meters, at time of admission

Related Conditions & MeSH terms

• COPD

Intervention

Other:
• Psychological Intervention
F-TPI group will be followed for a period of six months with a telephone-based and a face to face psychological intervention, performed by a clinical psychotherapist . TPI group will be followed for a period of six months with a TPI characterized by 10 telephone clinical interviews, performed by a clinical psychotherapist. CTRL group with COPD SoC without PI will follow the standard follow-up program for COPD patients after PR.

Locations

Country	Name	City	State
Italy	IRCCS San Raffaele Pisana	Roma

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS San Raffaele Roma

Country where clinical trial is conducted

Italy, 

References & Publications (22)

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* Note: There are 22 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Health related Quality of Life evaluated by the St. George's Respiratory Questionnaire	the St. George's Respiratory Questionnaire score	day 0 to day 182
Primary	Change in Quality of Life evaluated by the Short Form Health Survey General and Mental Health	the Short Form Health Survey General and Mental Health score	day 0 to day 182
Primary	Change in the degree of enjoyment and satisfaction in areas of daily functioning, evaluated by the Quality Of Life Enjoyment And Satisfaction Questionnaire	the Quality Of Life Enjoyment And Satisfaction Questionnaire score	day 0 to day 182
Primary	Maintenance of Functional Exercise evaluated by the Six Minute Walking Test	the Six Minute Walking Test score	day 0 to day 182
Primary	Maintenance of Respiratory Capacity evaluated by the Borg scale	the Borg scale score	day 0 to day 182
Primary	Assessment of dyspnea in activities of daily living by the Medical Research Council scale	the Medical Research Council score	day 0 to day 21 (period of the Pulmonary Rehabilitation )
Primary	Assessment of Respiratory Capacity by the Maugeri Foundation Respiratory Failure Questionnaire	the Maugeri Foundation Respiratory Failure score	day 0 to day 21 (period of the Pulmonary Rehabilitation)
Primary	Assessment of disability by the Barthel Index	Barthel Index score	day 0 to day 21 (period of the Pulmonary Rehabilitation )
Secondary	Change in psychological status evaluated by the Symptom Check List (SCL-90)	the SCL-90 scores	day 0 to day 182
Secondary	Assessment of the severity of depression by the Beck Depression Inventory II	the Beck Depression Inventory score	day 0 to day 182
Secondary	Assessment of different types of anxiety, state anxiety and trait anxiety, by State-Trait Anxiety Inventory Form Y.	the State-Trait Anxiety Inventory scores	day 0 to day 182
Secondary	Change in the use of the Coping Strategies evaluated by Brief-COPE	Brief-COPE	day 0 to day 182