Improving Psychosocial Well-being in COPD Patients in Rehabilitation

NCT03470025 | Completed

• 1 other identifier: RP 22/17
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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 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.

Conditions

COPD

Keywords

Rehabilitation; Psychological Intervention; Quality of life

Outcome Measures

Primary Outcomes (8)

• 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

• 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

• 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

• Maintenance of Functional Exercise evaluated by the Six Minute Walking Test

  the Six Minute Walking Test score

  day 0 to day 182

• Maintenance of Respiratory Capacity evaluated by the Borg scale

  the Borg scale score

  day 0 to day 182

• 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 )

• 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)

• Assessment of disability by the Barthel Index

  Barthel Index score

  day 0 to day 21 (period of the Pulmonary Rehabilitation )

Secondary Outcomes (4)

• Change in psychological status evaluated by the Symptom Check List (SCL-90)

  day 0 to day 182

• 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 the use of the Coping Strategies evaluated by Brief-COPE

  day 0 to day 182

Study Arms (3)

Psychological Intervention

EXPERIMENTAL

A weekly combined face to face \& telephone-based PI (F-TPI); Psychological Intervention and medical therapy

Other: Psychological Intervention

A telephone-based PI (TPI)

EXPERIMENTAL

Psychological Intervention - A telephone-based PI (TPI); Psychological Intervention and medical therapy

Other: Psychological Intervention

Optimal medical therapy

NO INTERVENTION

Patients will receive optimal medical therapy

Interventions

Psychological Intervention OTHER

1. 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 . 2. 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. 3. CTRL group with COPD SoC without PI will follow the standard follow-up program for COPD patients after PR.

Also known as: Medical therapy

A telephone-based PI (TPI); Psychological Intervention

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of COPD
• Mini-Mental State Examination (MMSE) ≥ 26
• Minute Walking Test ≥ 90 meters , at admission
• Obtaining Written Informed Consent

You may not qualify if:

• Comorbidity influencing respiratory ability and functionality
• Delta 6 Minute Walking Distance \< 60 meters, at time of admission

Sponsors & Collaborators

• IRCCS San Raffaele Roma: lead

Study Sites (1)

IRCCS San Raffaele Pisana

Roma, I-00163, Italy

Location

Related Publications (22)

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MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Psychosocial Intervention; Nutrition Therapy

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities; Therapeutics

Study Officials

• Giulia Prinzi, MA

  IRCCS San Raffaele Pisana

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2018
• First Posted: March 19, 2018
• Study Start: January 10, 2018
• Primary Completion: May 30, 2019
• Study Completion: December 31, 2019
• Last Updated: June 26, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)